| AbbVie |
00074357501 |
LUPRON DEPOT PED 6M 45MG |
Brand |
FDA |
2023-04-27 |
23578.5900 |
LUPRON DEPOT-PED is a prescription medicine used to treat pediatric patients with central precocious puberty (CPP). The Wholesale Acquisition Cost (WAC) of LUPRON DEPOT PED is $23,578.59 per kit (6 month supply). |
None |
5802 |
None |
None |
None |
None |
None |
None |
Response on estimated volume of patients who may be prescribed the drug (see Cal. Health & Saf. Code § 96076(b)(2):
The estimated patients per month of 5,802 represents the average number of patients on LUPRON DEPOT-PED 45mg for 6-month administration at any given time during the year. The estimated number of prescriptions filled each month is approximately 967. |
None |
| ACADIA Pharmaceuticals Inc. |
63090066001 |
Daybue Oral Solution 200 MG/ML, 450 ML, Bottle |
Brand |
FDA |
2023-03-21 |
9495.0000 |
None |
1 |
574 |
None |
1 |
None |
None |
None |
None |
None |
None |
| Acer Therapeutics Inc. |
72542020009 |
OLPRUVA™ 2 G Kit (sodium phenylbutyrate) |
Brand |
FDA |
2023-07-13 |
17100.0000 |
None |
1 |
2100 |
None |
None |
None |
None |
None |
None |
None |
None |
| Acer Therapeutics Inc. |
72542030009 |
OLPRUVA™ 3 G Kit (sodium phenylbutyrate) |
Brand |
FDA |
2023-07-13 |
25650.0000 |
None |
1 |
2100 |
None |
None |
None |
None |
None |
None |
None |
None |
| Acer Therapeutics Inc. |
72542060018 |
OLPRUVA™ 6 G Kit (sodium phenylbutyrate) |
Brand |
FDA |
2023-07-13 |
51300.0000 |
None |
1 |
2100 |
None |
None |
None |
None |
None |
None |
None |
None |
| Acer Therapeutics Inc. |
72542066718 |
OLPRUVA™ 6.67 G Kit (sodium phenylbutyrate) |
Brand |
FDA |
2023-07-13 |
57028.5000 |
None |
1 |
2100 |
None |
None |
None |
None |
None |
None |
None |
None |
| Acer Therapeutics Inc. |
72542040018 |
OLPRUVA™ 4 G Kit (sodium phenylbutyrate) |
Brand |
FDA |
2023-07-19 |
34200.0000 |
None |
1 |
2100 |
None |
None |
None |
None |
None |
None |
None |
None |
| Acer Therapeutics Inc. |
72542050018 |
OLPRUVA™ 5 G Kit (sodium phenylbutyrate) |
Brand |
FDA |
2023-07-19 |
42750.0000 |
None |
1 |
2100 |
None |
None |
None |
None |
None |
None |
None |
None |
| Aimmune Therapeutics |
71881040012 |
fecal microbiota spores, live-brpk |
Brand |
FDA |
2023-06-01 |
17500.0000 |
None |
1 |
1295 |
None |
None |
None |
None |
None |
None |
None |
None |
| Almaject, Inc |
72611087410 |
Regadenoson Injection, 0.4mg/5ml (0.08 mg/ml) |
Generic |
FDA |
2023-07-07 |
850.0000 |
Almaject considers various factors in deciding the wholesale acquisition cost (WAC) at which to set its prescription drugs, including Regadenoson. These factors include, but are not limited to: market based factors such as the competitive landscape and pricing environment; manufacturing and supply considerations; profitability; inflation and costs, including cost of administrative and commercial activities; therapeutic class and patient population, as well as patient needs and access; and contracts and relationships with customers. |
None |
1000000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Almatica |
52427085060 |
Gralise Tablets, 750mg |
Brand |
FDA |
2023-04-20 |
957.7200 |
Gralise is promoted by our commercial field team to healthcare professionals to educate them on our product. We use various means of promotion including in-office visits, virtual meetings, and non-personal digital marketing. A website www.gralise.com provides further information about Gralise.
Almatica considers various factors in deciding the wholesale acquisition cost (WAC) at which to set its prescription drugs, including Gralise. These factors include but are not limited to: market-based factors such as the competitive landscape and pricing environment; manufacturing and supply considerations; profitability; inflation and costs, including increased cost of administrative and commercial activities; therapeutic class and patient population, as well as patient needs and access; and contracts and relationships with customers. |
None |
137 |
None |
None |
None |
None |
None |
None |
None |
None |
| Almatica |
52427089060 |
Gralise Tablets, 900mg |
Brand |
FDA |
2023-04-20 |
957.7200 |
Gralise is promoted by our commercial field team to healthcare professionals to educate them on our product. We use various means of promotion including in-office visits, virtual meetings, and non-personal digital marketing. A website www.gralise.com provides further information about Gralise.
Almatica considers various factors in deciding the wholesale acquisition cost (WAC) at which to set its prescription drugs, including Gralise. These factors include but are not limited to: market-based factors such as the competitive landscape and pricing environment; manufacturing and supply considerations; profitability; inflation and costs, including increased cost of administrative and commercial activities; therapeutic class and patient population, as well as patient needs and access; and contracts and relationships with customers. |
None |
273 |
None |
None |
None |
None |
None |
None |
None |
None |
| ALVOGEN |
47781056201 |
Lisdexamfetamine Dimesylate CII Capsule, 10mg |
Generic |
FDA |
2023-08-25 |
932.0000 |
Alvogen considers various factors in deciding the wholesale acquisition cost (WAC) at which to set its prescription drugs, including Lisdexamfextamine. These factors include but are not limited to: market-based factors such as the competitive landscape and pricing environment; manufacturing and supply considerations; profitability; inflation and costs, including cost of administrative and commercial activities; therapeutic class and patient population, as well as patient needs and access; and contracts and relationships with customers. |
None |
1500000 |
None |
None |
None |
None |
None |
None |
None |
None |
| ALVOGEN |
47781056301 |
Lisdexamfetamine Dimesylate CII Capsule, 20mg |
Generic |
FDA |
2023-08-25 |
932.0000 |
Alvogen considers various factors in deciding the wholesale acquisition cost (WAC) at which to set its prescription drugs, including Lisdexamfextamine. These factors include but are not limited to: market-based factors such as the competitive landscape and pricing environment; manufacturing and supply considerations; profitability; inflation and costs, including cost of administrative and commercial activities; therapeutic class and patient population, as well as patient needs and access; and contracts and relationships with customers. |
None |
1500000 |
None |
None |
None |
None |
None |
None |
None |
None |
| ALVOGEN |
47781056401 |
Lisdexamfetamine Dimesylate CII Capsule, 30mg |
Generic |
FDA |
2023-08-25 |
932.0000 |
Alvogen considers various factors in deciding the wholesale acquisition cost (WAC) at which to set its prescription drugs, including Lisdexamfextamine. These factors include but are not limited to: market-based factors such as the competitive landscape and pricing environment; manufacturing and supply considerations; profitability; inflation and costs, including cost of administrative and commercial activities; therapeutic class and patient population, as well as patient needs and access; and contracts and relationships with customers. |
None |
1500000 |
None |
None |
None |
None |
None |
None |
None |
None |
| ALVOGEN |
47781056501 |
Lisdexamfetamine Dimesylate CII Capsule, 40mg |
Generic |
FDA |
2023-08-25 |
932.0000 |
Alvogen considers various factors in deciding the wholesale acquisition cost (WAC) at which to set its prescription drugs, including Lisdexamfextamine. These factors include but are not limited to: market-based factors such as the competitive landscape and pricing environment; manufacturing and supply considerations; profitability; inflation and costs, including cost of administrative and commercial activities; therapeutic class and patient population, as well as patient needs and access; and contracts and relationships with customers. |
None |
1500000 |
None |
None |
None |
None |
None |
None |
None |
None |
| ALVOGEN |
47781056601 |
Lisdexamfetamine Dimesylate CII Capsule, 50mg |
Generic |
FDA |
2023-08-25 |
932.0000 |
Alvogen considers various factors in deciding the wholesale acquisition cost (WAC) at which to set its prescription drugs, including Lisdexamfextamine. These factors include but are not limited to: market-based factors such as the competitive landscape and pricing environment; manufacturing and supply considerations; profitability; inflation and costs, including cost of administrative and commercial activities; therapeutic class and patient population, as well as patient needs and access; and contracts and relationships with customers. |
None |
1500000 |
None |
None |
None |
None |
None |
None |
None |
None |
| ALVOGEN |
47781056701 |
Lisdexamfetamine Dimesylate CII Capsule, 60mg |
Generic |
FDA |
2023-08-25 |
932.0000 |
Alvogen considers various factors in deciding the wholesale acquisition cost (WAC) at which to set its prescription drugs, including Lisdexamfextamine. These factors include but are not limited to: market-based factors such as the competitive landscape and pricing environment; manufacturing and supply considerations; profitability; inflation and costs, including cost of administrative and commercial activities; therapeutic class and patient population, as well as patient needs and access; and contracts and relationships with customers. |
None |
1500000 |
None |
None |
None |
None |
None |
None |
None |
None |
| ALVOGEN |
47781056801 |
Lisdexamfetamine Dimesylate CII Capsule, 70mg |
Generic |
FDA |
2023-08-25 |
932.0000 |
Alvogen considers various factors in deciding the wholesale acquisition cost (WAC) at which to set its prescription drugs, including Lisdexamfextamine. These factors include but are not limited to: market-based factors such as the competitive landscape and pricing environment; manufacturing and supply considerations; profitability; inflation and costs, including cost of administrative and commercial activities; therapeutic class and patient population, as well as patient needs and access; and contracts and relationships with customers. |
None |
1500000 |
None |
None |
None |
None |
None |
None |
None |
None |
| American Regent |
00517430001 |
Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-bound), 100mg per Vial SDV |
Brand |
FDA |
2023-05-02 |
1575.3200 |
We do intend to engage in domestic only marketing activities relating to the Paclitaxel launch to create market awareness of this new vial presentation. Our marketing efforts to promote the new drug are generally through digital media, eblasts and the American Regent website. Printed marketing materials are only for the use of the sales force and are used to facilitate a conversation. Our pricing plans are not in the public domain. |
None |
82584 |
None |
None |
None |
None |
None |
None |
None |
https://reports.siera.hcai.ca.gov/api/report/drug-pricing/attachment?id=681 |
| American Regent |
00517107501 |
Levocarnitine 200mg/mL 20mL Vial |
Generic |
FDA |
2023-06-26 |
142.6800 |
We do intend to engage in domestic only marketing activities relating to the Levocarnitine launch to create market awareness of this new product. Our marketing efforts to promote the new drug are generally through digital media, eblasts and the American Regent website. Printed marketing materials are only for the use of the sales force and are used to facilitate a conversation. Our pricing plans are not in the public domain. |
None |
20000 |
None |
None |
None |
None |
None |
None |
None |
None |
| American Regent |
00517104505 |
Levocarnitine 1g/5mL (200mg/mL) |
Generic |
FDA |
2023-09-11 |
178.3500 |
We do intend to engage in domestic only marketing activities relating to the Levocarnitine launch to create market awareness of this new product. Our marketing efforts to promote the new drug are generally through digital media, eblasts and the American Regent website. Printed marketing materials are only for the use of the sales force and are used to facilitate a conversation. Our pricing plans are not in the public domain. |
None |
850000 |
None |
None |
None |
None |
None |
None |
General Comments
We provide the following comment regarding the acquisition fields: To clarify our response, this product was not acquired from another Manufacturer.
We provide the following comment regarding the patient estimate: It is estimated that 850,000 vials are used annually. If we then assume that an estimated 1 vials per patient then this total is 850,000 unique patients annually or 70,833 per month for the entire market.
We provide the following general comment: We have limited the information included in this submission to that which is otherwise in the public domain or publicly available, as the California requirements permit. |
None |
| American Regent |
00517250525 |
Potassium Phosphates Injection, USP Phosphorus 150 mmol/50mL (3 mmol/mL) Potassium 220 mEq/50mL (4.4 mEq/mL) |
Generic |
FDA |
2023-10-13 |
2967.5000 |
We do intend to engage in domestic only marketing activities relating to the Potassium Phosphate launch to create market awareness of this new product. Our marketing efforts to promote the new drug are generally through digital media, eblasts and the American Regent website. Printed marketing materials are only for the use of the sales force and are used to facilitate a conversation. Our pricing plans are not in the public domain. |
None |
285000 |
None |
None |
None |
None |
None |
None |
We provide the following comment regarding the acquisition fields: To clarify our response, this product was not acquired from another Manufacturer.
We provide the following comment regarding the patient estimate: It is estimated that 285,000 vials are used annually. If we then assume that an estimated 80 vials per patient then this total is 35,625 unique patients annually or 2,969 per month for the entire market.
We provide the following general comment: We have limited the information included in this submission to that which is otherwise in the public domain or publicly available, as the California requirements permit. |
None |
| American Regent |
00517210225 |
Potassium Phosphates Injection, USP Phosphorus 45 mmol/15 mL (3 mmol/mL) Potassium 66 mEq/15 mL (4.4 mEq/mL) |
Generic |
FDA |
2023-10-13 |
1198.7500 |
We do intend to engage in domestic only marketing activities relating to the Potassium Phosphate launch to create market awareness of this new product. Our marketing efforts to promote the new drug are generally through digital media, eblasts and the American Regent website. Printed marketing materials are only for the use of the sales force and are used to facilitate a conversation. Our pricing plans are not in the public domain. |
None |
3000000 |
None |
None |
None |
None |
None |
None |
We provide the following comment regarding the acquisition fields: To clarify our response, this product was not acquired from another Manufacturer.
We provide the following comment regarding the patient estimate: It is estimated that 3,000,000 vials are used annually. If we then assume that an estimated 80 vials per patient then this total is 111,111 unique patients annually or 9,259 per month for the entire market.
We provide the following general comment: We have limited the information included in this submission to that which is otherwise in the public domain or publicly available, as the California requirements permit. |
None |
| American Regent |
00517205125 |
Potassium Phosphates Injection, USP Phosphorus |
Generic |
FDA |
2023-10-16 |
599.2500 |
Marketing Pricing Plan Description We do intend to engage in domestic only marketing activities relating to the Potassium Phosphate launch to create market awareness of this new product. Our marketing efforts to promote the new drug are generally through digital media, eblasts and the American Regent website. Printed marketing materials are only for the use of the sales force and are used to facilitate a conversation. Our pricing plans are not in the public domain. |
None |
360000 |
None |
None |
None |
None |
None |
None |
We provide the following comment regarding the acquisition fields: To clarify our response, this product was not acquired from another Manufacturer.
We provide the following comment regarding the patient estimate: It is estimated that 360,000 vials are used annually. If we then assume that an estimated 80 vials per patient then this total is 4,500 unique patients annually or 375 per month for the entire market.
We provide the following general comment: We have limited the information included in this submission to that which is otherwise in the public domain or publicly available, as the California requirements permit. |
None |
| Amgen |
55513041101 |
AMJEVITA (20 mg/0.4 mL prefilled syringe, 1 pk) |
Generic |
FDA |
2023-01-31 |
3288.2400 |
There is a direct-to-consumer marketing plan for AMJEVITA. Efforts in the public domain consist of: (1) patient website www.AMJEVITA.com, (2) patient education brochures (1 brochure in print & digital form) and (3) emails for those patients that opt into communications & enroll in patient support. The purpose of the website is to educate patients on AMJEVITA (aligned to USPI), biosimilars, and patient support services. Patients can also enroll directly to patient support services via AMJEVITA.com. The purpose of the emails is to provide patients with important reminders following their being prescribed AMJEVITA such as to look out for a call from their specialty pharmacy call, education on how to inject AMJEVITA using the SureClick device or the pre-filled syringe and tips on how to stay on track with AMJEVITA.
Promotional activities to HCPs include the HCP website, www.AMJEVITAPro.com, printed resources, a national webinar program, email blasts and other digital resources in line with the AMJEVITA USPI. The purpose of these tools is to educate HCPs about the availability of the therapy, clinical aspects including efficacy, safety, dosing and administration, along with applicable support services. AMJEVITA offers a sample program as well. |
None |
None |
None |
None |
None |
None |
None |
None |
Per CA Health & Safety Code §127681(c) Amgen respectfully declines to submit the Estimated Number of Patients, as it is not otherwise in the public domain or publicly available. |
None |
| Amgen |
72511040001 |
AMJEVITA (40 mg/0.8 mL Autoinjector, 1 pack) |
Generic |
FDA |
2023-01-31 |
1557.5900 |
There is a direct-to-consumer marketing plan for AMJEVITA. Efforts in the public domain consist of: (1) patient website www.AMJEVITA.com, (2) patient education brochures (1 brochure in print & digital form) and (3) emails for those patients that opt into communications & enroll in patient support. The purpose of the website is to educate patients on AMJEVITA (aligned to USPI), biosimilars, and patient support services. Patients can also enroll directly to patient support services via AMJEVITA.com. The purpose of the emails is to provide patients with important reminders following their being prescribed AMJEVITA such as to look out for a call from their specialty pharmacy call, education on how to inject AMJEVITA using the SureClick device or the pre-filled syringe and tips on how to stay on track with AMJEVITA.
Promotional activities to HCPs include the HCP website, www.AMJEVITAPro.com, printed resources, a national webinar program, email blasts and other digital resources in line with the AMJEVITA USPI. The purpose of these tools is to educate HCPs about the availability of the therapy, clinical aspects including efficacy, safety, dosing and administration, along with applicable support services. AMJEVITA offers a sample program as well. |
None |
None |
None |
None |
None |
None |
None |
None |
Per CA Health & Safety Code §127681(c) Amgen respectfully declines to submit the Estimated Number of Patients, as it is not otherwise in the public domain or publicly available. |
None |
| Amgen |
55513040001 |
AMJEVITA (40 mg/0.8 mL Autoinjector, 1 pk) |
Generic |
FDA |
2023-01-31 |
3288.2400 |
There is a direct-to-consumer marketing plan for AMJEVITA. Efforts in the public domain consist of: (1) patient website www.AMJEVITA.com, (2) patient education brochures (1 brochure in print & digital form) and (3) emails for those patients that opt into communications & enroll in patient support. The purpose of the website is to educate patients on AMJEVITA (aligned to USPI), biosimilars, and patient support services. Patients can also enroll directly to patient support services via AMJEVITA.com. The purpose of the emails is to provide patients with important reminders following their being prescribed AMJEVITA such as to look out for a call from their specialty pharmacy call, education on how to inject AMJEVITA using the SureClick device or the pre-filled syringe and tips on how to stay on track with AMJEVITA.
Promotional activities to HCPs include the HCP website, www.AMJEVITAPro.com, printed resources, a national webinar program, email blasts and other digital resources in line with the AMJEVITA USPI. The purpose of these tools is to educate HCPs about the availability of the therapy, clinical aspects including efficacy, safety, dosing and administration, along with applicable support services. AMJEVITA offers a sample program as well. |
None |
None |
None |
None |
None |
None |
None |
None |
Per CA Health & Safety Code §127681(c) Amgen respectfully declines to submit the Estimated Number of Patients, as it is not otherwise in the public domain or publicly available. |
None |
| Amgen |
72511040002 |
AMJEVITA (40 mg/0.8 mL Autoinjector, 2 pack) |
Generic |
FDA |
2023-01-31 |
3115.1800 |
There is a direct-to-consumer marketing plan for AMJEVITA. Efforts in the public domain consist of: (1) patient website www.AMJEVITA.com, (2) patient education brochures (1 brochure in print & digital form) and (3) emails for those patients that opt into communications & enroll in patient support. The purpose of the website is to educate patients on AMJEVITA (aligned to USPI), biosimilars, and patient support services. Patients can also enroll directly to patient support services via AMJEVITA.com. The purpose of the emails is to provide patients with important reminders following their being prescribed AMJEVITA such as to look out for a call from their specialty pharmacy call, education on how to inject AMJEVITA using the SureClick device or the pre-filled syringe and tips on how to stay on track with AMJEVITA.
Promotional activities to HCPs include the HCP website, www.AMJEVITAPro.com, printed resources, a national webinar program, email blasts and other digital resources in line with the AMJEVITA USPI. The purpose of these tools is to educate HCPs about the availability of the therapy, clinical aspects including efficacy, safety, dosing and administration, along with applicable support services. AMJEVITA offers a sample program as well. |
None |
None |
None |
None |
None |
None |
None |
None |
Per CA Health & Safety Code §127681(c) Amgen respectfully declines to submit the Estimated Number of Patients, as it is not otherwise in the public domain or publicly available. |
None |
| Amgen |
55513040002 |
AMJEVITA (40 mg/0.8 mL Autoinjector, 2 pk) |
Generic |
FDA |
2023-01-31 |
6576.4800 |
There is a direct-to-consumer marketing plan for AMJEVITA. Efforts in the public domain consist of: (1) patient website www.AMJEVITA.com, (2) patient education brochures (1 brochure in print & digital form) and (3) emails for those patients that opt into communications & enroll in patient support. The purpose of the website is to educate patients on AMJEVITA (aligned to USPI), biosimilars, and patient support services. Patients can also enroll directly to patient support services via AMJEVITA.com. The purpose of the emails is to provide patients with important reminders following their being prescribed AMJEVITA such as to look out for a call from their specialty pharmacy call, education on how to inject AMJEVITA using the SureClick device or the pre-filled syringe and tips on how to stay on track with AMJEVITA.
Promotional activities to HCPs include the HCP website, www.AMJEVITAPro.com, printed resources, a national webinar program, email blasts and other digital resources in line with the AMJEVITA USPI. The purpose of these tools is to educate HCPs about the availability of the therapy, clinical aspects including efficacy, safety, dosing and administration, along with applicable support services. AMJEVITA offers a sample program as well. |
None |
None |
None |
None |
None |
None |
None |
None |
Per CA Health & Safety Code §127681(c) Amgen respectfully declines to submit the Estimated Number of Patients, as it is not otherwise in the public domain or publicly available. |
None |
| Amgen |
55513041001 |
AMJEVITA (40 mg/0.8 mL prefilled syringe, 1 pk) |
Generic |
FDA |
2023-01-31 |
3288.2400 |
There is a direct-to-consumer marketing plan for AMJEVITA. Efforts in the public domain consist of: (1) patient website www.AMJEVITA.com, (2) patient education brochures (1 brochure in print & digital form) and (3) emails for those patients that opt into communications & enroll in patient support. The purpose of the website is to educate patients on AMJEVITA (aligned to USPI), biosimilars, and patient support services. Patients can also enroll directly to patient support services via AMJEVITA.com. The purpose of the emails is to provide patients with important reminders following their being prescribed AMJEVITA such as to look out for a call from their specialty pharmacy call, education on how to inject AMJEVITA using the SureClick device or the pre-filled syringe and tips on how to stay on track with AMJEVITA.
Promotional activities to HCPs include the HCP website, www.AMJEVITAPro.com, printed resources, a national webinar program, email blasts and other digital resources in line with the AMJEVITA USPI. The purpose of these tools is to educate HCPs about the availability of the therapy, clinical aspects including efficacy, safety, dosing and administration, along with applicable support services. AMJEVITA offers a sample program as well. |
None |
None |
None |
None |
None |
None |
None |
None |
Per CA Health & Safety Code §127681(c) Amgen respectfully declines to submit the Estimated Number of Patients, as it is not otherwise in the public domain or publicly available. |
None |
| Amicus Therapeutics US, LLC |
71904020001 |
POMBILITI (cipaglucosidase alfa-atga), For injection: one (1) 105 mg single-dose vial of cipaglucosidase alfa-atga as a lyophilized powder for reconstitution, 20 mg/kg (of actual body weight) administered every other week as an intravenous infusion |
Brand |
FDA |
2023-10-16 |
1785.0000 |
None |
1 |
600 |
1 |
None |
None |
None |
None |
None |
None |
None |
| Amneal Pharmaceuticals |
60219164207 |
Pirfenidone 267mg Capsules |
Generic |
FDA |
2023-01-12 |
1000.0000 |
This is a generic product that is not marketed. |
None |
463901 |
None |
None |
None |
None |
None |
None |
This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house. |
None |
| Amneal Pharmaceuticals |
70121250301 |
Lioresal ® Intrathecal 40 mg/20 mL (2000 mcg/mL) 1 |
Brand |
FDA |
2023-03-14 |
945.1400 |
None |
1 |
60168 |
None |
1 |
2022-02-09 |
None |
1 |
None |
Amneal Pharmaceuticals considers the process of assessing and developing a marketing plan to be a trade secret using confidential information and cannot release this data into the public domain. Amneal is launching a drug that was previously launched in the market with new NDC's to align this product to our labeler. |
None |
| Amneal Pharmaceuticals |
70121250502 |
Lioresal ® Intrathecal 40 mg/20 mL (2000 mcg/mL) 2 |
Brand |
FDA |
2023-03-14 |
1890.2800 |
None |
1 |
31080 |
None |
1 |
2022-02-09 |
None |
1 |
None |
Amneal Pharmaceuticals considers the process of assessing and developing a marketing plan to be a trade secret using confidential information and cannot release this data into the public domain. Amneal is launching a drug that was previously launched in the market with new NDC's to align this product to our labeler. |
None |
| Amneal Pharmaceuticals |
69238254803 |
Tasimelteon IR |
Generic |
FDA |
2023-03-27 |
20570.9600 |
None |
1 |
412 |
None |
None |
None |
None |
None |
None |
This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house. |
None |
| Amneal Pharmaceuticals |
70121174304 |
Nelarabine Injection |
Generic |
FDA |
2023-04-26 |
3966.0000 |
None |
1 |
60900 |
None |
None |
None |
None |
None |
None |
This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house. |
None |
| Amneal Pharmaceuticals |
60219175406 |
Abiraterone Acetate 500mg Tablets, 60ct |
Generic |
FDA |
2023-06-19 |
2109.7700 |
Amneal Pharmaceuticals LLC considers the process of assessing and developing a marketing and pricing plan to be a trade secret using confidential information and cannot release this data into the public domain. |
None |
340795 |
None |
None |
None |
None |
None |
None |
This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house. |
None |
| Amneal Pharmaceuticals |
69238239101 |
Sodium Oxybate Oral Solution 0.5 g/mL (180mL) |
Generic |
FDA |
2023-07-03 |
5535.0000 |
None |
1 |
280 |
None |
1 |
None |
None |
None |
None |
This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house. |
None |
| Amneal Pharmaceuticals |
70121169402 |
Plerixafor Injection |
Generic |
FDA |
2023-07-24 |
3987.2300 |
None |
1 |
22000 |
None |
None |
None |
None |
None |
None |
This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house. |
None |
| Amneal Pharmaceuticals |
70121146705 |
Medroxyprogesterone Acetate Inj |
Generic |
FDA |
2023-08-25 |
915.9200 |
None |
1 |
159068 |
None |
None |
None |
None |
None |
None |
This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house. |
None |
| Amneal Pharmaceuticals |
80830236309 |
Calcium Gluconate in Sodium Chloride Injection |
Generic |
FDA |
2023-09-12 |
948.0000 |
None |
1 |
972000 |
None |
None |
None |
None |
None |
None |
This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house. |
None |
| Amneal Pharmaceuticals |
69238202702 |
Spironolactone Oral Suspension 25 MG/5ML |
Generic |
FDA |
2023-10-31 |
1579.2200 |
None |
1 |
2923 |
None |
None |
None |
None |
None |
None |
This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house. |
None |
| Amneal Pharmaceuticals |
80830169202 |
Potassium Phosphates Inj., USP 4.4 mEq/mL, 50 mL |
Generic |
FDA |
2023-11-14 |
1170.0000 |
None |
1 |
1000000 |
None |
None |
None |
None |
None |
None |
This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house. |
None |
| Amneal Pharmaceuticals |
60219142505 |
Vigabatrin 500mg Powder for Oral Solution |
Generic |
FDA |
2023-12-05 |
4839.1200 |
None |
1 |
12088 |
None |
None |
None |
None |
None |
None |
This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house. |
None |
| Analog Pharma |
70505022060 |
NITISINONE capsules, for oral use. 20 mg |
Generic |
FDA |
2023-06-05 |
43594.0000 |
Orphan drug, extremely rare disease with less than 300 patients and 25% less than the brand. |
None |
300 |
None |
None |
None |
None |
None |
None |
None |
None |
| ANIP |
70954049610 |
NITROFURANTOIN 25 mg/5 mL 230mL bottle, SUSPENSION, ORAL (FINAL DOSE FORM) |
Generic |
FDA |
2023-04-18 |
1428.7000 |
ANI does not do any marketing for generic products, marketing is $0. WAC was set in line with our Pricing SOP by reviewing other manufacturer pricing that sell in the same channel as ANI Pharmaceuticals, Inc. compared our WACs to the most recent entrants. |
None |
54400000 |
None |
None |
None |
None |
None |
None |
None |
None |
| ANIP |
62559086011 |
CORTROPHIN 80 [USP'U]/mL; 1 VIAL, MULTI-DOSE in 1 CARTON (62559-860-11) / 1 mL in 1 VIAL, MULTI-DOSE |
Brand |
FDA |
2023-07-06 |
6995.0000 |
The Purified Cortrophin Gel marketing plan includes a small field-based sales force. Their efforts focus on helping clinicians understand how to identify the appropriate chronic autoimmune disorder patients who could potentially benefit from treatment with Cortrophin Gel. |
None |
9200000 |
None |
None |
2016-01-08 |
75000000.0000 |
None |
The Acquisition Price provided reflects the purchase of two NDAs. |
None |
None |
| Apellis Pharmaceuticals |
73606002001 |
Syfovre 15 MG/0.1ML Solution, Intravitreal Injection, 1 vial in carton |
Brand |
FDA |
2023-02-27 |
2190.0000 |
Marketing: SYFOVRE is a FDA approved treatment for Geographic Atophy (GA), secondary to age-related macular degeneration (AMD). SYFOVRE is the first and only FDA-approved therapy indicated for GA. Apellis' Marketing plan consists of items for HCP promotions covering salaries and compensation for promotional field teams calling on HCPs, electronic and print materials for direct promotion to HCPs, HCP focused websites, digital and print HCP media, educational events for HCPs for information about GA and SYFOVRE, and sponsorships and exhibit production costs for HCP congresses. The Marketing plan also includes items to educate consumers on GA and SYFOVRE via TV, magazines, internet and social media advertising, search engine marketing, consumer focused websites, and print materials.
Pricing: SYFOVRE has been developed for the treatment of patients with Geographic Atrophy (GA), secondary to age-related macular degeneration (AMD). SYFOVRE provides an option to deliver a safe, effective treatment that slows lesion progression. SYFOVRE is priced responsibly. Pricing accounts for development costs, complexity of manufacturing, distribution, and storage. Apellis places a priority on patient access and ensuring all eligible patients with the potential to benefit can receive SYFOVRE. Apellis performed a thorough analysis of the clinical value of SYFOVRE in GA, examined relevant benchmarks, and considered patient access to determine the list price. Pricing Methodology for Syfovre was based on the fact that EMPAVELI demonstrated a clinically meaningful effect on lesion size reduction. Based on market research and analog products within the retinal class, a cross functional team evaluated the clinical value of the product, based on the entirety of the data available, to establish the list price. |
None |
1000000 |
None |
1 |
None |
None |
None |
None |
None |
None |
| Apotex Corp |
60505361305 |
Varenicline 0.5mg |
Generic |
FDA |
2023-01-26 |
415.5500 |
None |
1 |
110000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Apotex Corp |
60505361405 |
Varenicline 1mg |
Generic |
FDA |
2023-01-26 |
415.5500 |
None |
1 |
110000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Apotex Corp |
60505447803 |
Teriflunomide Tab 14 mg |
Generic |
FDA |
2023-04-06 |
2058.7800 |
None |
1 |
16000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Apotex Corp |
60505447703 |
Teriflunomide Tab 7 mg |
Generic |
FDA |
2023-04-06 |
2058.7800 |
None |
1 |
1300 |
None |
None |
None |
None |
None |
None |
None |
None |
| Apotex Corp |
60505453202 |
LENALIDOMIDE CAP 2.5MG 28 BTL |
Generic |
FDA |
2023-04-14 |
20157.3600 |
None |
1 |
11065 |
None |
None |
None |
None |
None |
None |
None |
None |
| Apotex Corp |
60505453602 |
LENALIDOMIDE CAP 20MG 21 BTL |
Generic |
FDA |
2023-04-14 |
15118.0400 |
None |
1 |
11065 |
None |
None |
None |
None |
None |
None |
None |
None |
| Apotex Corp |
60505622800 |
BENDAMUSTINE INJ 100MG/4ML VIAL |
Brand |
FDA |
2023-04-26 |
3209.5400 |
None |
1 |
30 |
None |
None |
None |
None |
None |
None |
None |
None |
| Apotex Corp |
60505451203 |
GEFITINIB TAB 250MG 30 BTL |
Generic |
FDA |
2023-05-30 |
7103.4600 |
None |
1 |
54 |
None |
None |
None |
None |
None |
None |
None |
None |
| Apotex Corp |
60505609600 |
BENDAMUSTINE FOR INJ 100 MG 20ML SDV |
Generic |
FDA |
2023-06-19 |
1600.0000 |
None |
1 |
10 |
None |
None |
None |
None |
None |
None |
None |
None |
| Apotex Corp |
60505609500 |
BENDAMUSTINE FOR INJ 25 MG 10ML SDV |
Generic |
FDA |
2023-06-19 |
400.0000 |
None |
1 |
10 |
None |
None |
None |
None |
None |
None |
None |
None |
| Apotex Corp |
60505626200 |
Piperacillin and Tazobactam Injection 40.5G |
Generic |
FDA |
2023-09-12 |
69.0000 |
Product launched at a price that is below Brand. |
None |
192 |
None |
None |
None |
None |
None |
None |
None |
None |
| Apotex Corp |
60505477907 |
PAZOPANIB HCl FCT 200MG 120 BTL USA 200MG |
Generic |
FDA |
2023-10-19 |
15392.4800 |
There was no budgeted or actual spending for direct-to consumer or physician marketing. |
None |
1128 |
None |
None |
None |
None |
None |
None |
None |
None |
| Apotex Corp |
60505473901 |
LISDEXAMFETAMINE CAP 10MG 100 BTL USA |
Generic |
FDA |
2023-10-25 |
1122.7300 |
We are priced below the brand and in line with 2 of our generic competitors, both of which are just below the brand. |
None |
42747 |
None |
None |
None |
None |
None |
None |
None |
None |
| Apotex Corp |
60505474001 |
LISDEXAMFETAMINE CAP 20MG 100 BTL USA |
Generic |
FDA |
2023-10-25 |
1122.7300 |
We are priced below the brand and in line with 2 of our generic competitors, both of which are just below the brand. |
None |
139548 |
None |
None |
None |
None |
None |
None |
None |
None |
| Apotex Corp |
60505474101 |
LISDEXAMFETAMINE CAP 30MG 100 BTL USA |
Generic |
FDA |
2023-10-25 |
1122.7300 |
We are priced below the brand and in line with 2 of our generic competitors, both of which are just below the brand. |
None |
255721 |
None |
None |
None |
None |
None |
None |
None |
None |
| Apotex Corp |
60505474201 |
LISDEXAMFETAMINE CAP 40MG 100 BTL USA |
Generic |
FDA |
2023-10-25 |
1122.7300 |
We are priced below the brand and in line with 2 of our generic competitors, both of which are just below the brand. |
None |
251600 |
None |
None |
None |
None |
None |
None |
None |
None |
| Apotex Corp |
60505474301 |
LISDEXAMFETAMINE CAP 50MG 100 BTL USA |
Generic |
FDA |
2023-10-25 |
1122.7300 |
We are priced below the brand and in line with 2 of our generic competitors, both of which are just below the brand. |
None |
220062 |
None |
None |
None |
None |
None |
None |
None |
None |
| Apotex Corp |
60505474401 |
LISDEXAMFETAMINE CAP 60MG 100 BTL USA |
Generic |
FDA |
2023-10-25 |
1122.7300 |
We are priced below the brand and in line with 2 of our generic competitors, both of which are just below the brand. |
None |
139387 |
None |
None |
None |
None |
None |
None |
None |
None |
| Apotex Corp |
60505474501 |
LISDEXAMFETAMINE CAP 70MG 100 BTL USA |
Generic |
FDA |
2023-10-25 |
1122.7300 |
We are priced below the brand and in line with 2 of our generic competitors, both of which are just below the brand. |
None |
142476 |
None |
None |
None |
None |
None |
None |
None |
None |
| Apotex Corp |
60505466503 |
Tasimelteon Caps |
Generic |
FDA |
2023-11-07 |
20570.9600 |
We are in alignment with our generic competition. |
None |
186 |
None |
None |
None |
None |
None |
None |
None |
None |
| Apotex Corp |
60606618800 |
Teriparatide Injection 250MCG/ML 2.4ML |
Not Available |
Not Available |
2023-11-21 |
3798.4300 |
We are priced below the brand and below our generic competition. |
None |
16728 |
None |
None |
None |
None |
None |
None |
None |
None |
| Apotex Corp |
60505627101 |
AZACITIDINE PINJ 100MG/ML |
Generic |
FDA |
2023-12-12 |
100.0000 |
None |
1 |
32 |
None |
None |
None |
None |
None |
None |
None |
None |
| Archis Pharma LLC |
72819015404 |
Mitomycin for Injection USP, 40mg/Vial Vial |
Generic |
FDA |
2023-06-22 |
1263.9600 |
None |
1 |
100 |
None |
None |
2020-11-01 |
None |
1 |
This ANDA 202670 purchased from Mylan on 11/01/2020. The acquisition price is proprietary information. |
This is a new NDC for Archis Pharma currently in production and will be available in the next few weeks. The presentation consists of one 40mg vial of Mitomycin Intravenous Solution Reconstituted. |
None |
| Archis Pharma LLC |
72819015608 |
Mycophenolate Sodium Oral Tablet Delayed Release 360 MG |
Generic |
FDA |
2023-06-22 |
877.2000 |
None |
1 |
100 |
None |
None |
2020-11-01 |
None |
1 |
The ANDA 091248 was acquired from Mylan on 11/01/2020. The acquisition price is proprietary information. |
This is a new NDC for Archis Pharma currently in production and will be available in the next few weeks. |
None |
| Archis Pharma LLC |
72819016003 |
Paliperidone ER Oral tablet Extended Release 24Hr 9mg 30 Count Bottle |
Generic |
FDA |
2023-06-22 |
1100.2300 |
None |
1 |
100 |
None |
None |
2020-11-01 |
None |
1 |
The ANDA 203802 was acquired from Mylan on 11/01/2020. The acquisition price is proprietary information. |
This is a new NDC for Archis Pharma currently in production and will be available in the next few weeks. |
None |
| Ardelyx, Inc. |
73154012060 |
XPHOZAH 20 mg, Oral Tablets, 60 Each, Unit-of-Use, Bottle |
Brand |
FDA |
2023-11-07 |
2960.0000 |
MARKETING
Key elements of the XPHOZAH marketing strategy include:
• XPHOZAH marketing will leverage the market need for expanded therapeutic options to treat adults with chronic kidney disease (CKD) on dialysis who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy.
• XPHOZAH will be positioned as a first-in-class NHE3 inhibitor. XPHOZAH, with its novel mechanism of action and clinical profile provides an attractive therapeutic option for adults with IBS-C.
• Marketing messaging will emphasize that the XPHOZAH MOA is differentiated from existing therapies, and the clinical data that demonstrates significant improvement in serum phosphorus levels in adults with chronic kidney disease (CKD) on dialysis.
• Sales efforts will be further amplified by omnichannel tactics leveraging the rapidly advancing dynamics in the marketplace on how and where HCPs receive their information.
• XPHOZAH will have a specialty pharmacy distribution model.
• XPHOZAH will have a strong commercial and medical presence at the largest nephrology conferences.
PRICING
An in-depth pricing analysis was conducted to analyze the price range of all prescription therapies utilized in the treatment of serum phosphorus in adults with CKD on dialysis. Additional factors considered for determination of WAC for XPHOZAH included:
• Unmet need in the treatment of serum phosphorus in adults with CKD on dialysis
• Limited number of treatment options for patients in this therapeutic space
• Novel mechanism of tenapanor relative to currently available prescription therapies
• Payor consideration and positioning relative to currently available therapies |
None |
300000 |
None |
None |
None |
None |
None |
None |
"XPHOZAH is indicated to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy. While there are approximately 550,000 patients on dialysis in the United States, not all patients require phosphate-lowering medication. In addition, not all dialysis patients who are on phosphate-lowering medication have serum phosphorus concentrations outside of target levels, and dialysis patients may fluctuate within and outside serum phosphorus target levels from month-to-month. There are no historical, reliable patient data available for this new drug. As an estimate, approximately 200-300,000 dialysis patients in the United States may be on a phosphate-lowering medication with serum phosphorus concentrations outside of target levels." |
None |
| Ardelyx, Inc. |
73154013060 |
XPHOZAH 30 mg, Oral Tablets, 60 Each, Unit-of-Use, Bottle |
Brand |
FDA |
2023-11-07 |
2960.0000 |
MARKETING
Key elements of the XPHOZAH marketing strategy include:
• XPHOZAH marketing will leverage the market need for expanded therapeutic options to treat adults with chronic kidney disease (CKD) on dialysis who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy.
• XPHOZAH will be positioned as a first-in-class NHE3 inhibitor. XPHOZAH, with its novel mechanism of action and clinical profile provides an attractive therapeutic option for adults with IBS-C.
• Marketing messaging will emphasize that the XPHOZAH MOA is differentiated from existing therapies, and the clinical data that demonstrates significant improvement in serum phosphorus levels in adults with chronic kidney disease (CKD) on dialysis.
• Sales efforts will be further amplified by omnichannel tactics leveraging the rapidly advancing dynamics in the marketplace on how and where HCPs receive their information.
• XPHOZAH will have a specialty pharmacy distribution model.
• XPHOZAH will have a strong commercial and medical presence at the largest nephrology conferences.
PRICING
An in-depth pricing analysis was conducted to analyze the price range of all prescription therapies utilized in the treatment of serum phosphorus in adults with CKD on dialysis. Additional factors considered for determination of WAC for XPHOZAH included:
• Unmet need in the treatment of serum phosphorus in adults with CKD on dialysis
• Limited number of treatment options for patients in this therapeutic space
• Novel mechanism of tenapanor relative to currently available prescription therapies
• Payor consideration and positioning relative to currently available therapies |
None |
300000 |
None |
None |
None |
None |
None |
None |
"XPHOZAH is indicated to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy. While there are approximately 550,000 patients on dialysis in the United States, not all patients require phosphate-lowering medication. In addition, not all dialysis patients who are on phosphate-lowering medication have serum phosphorus concentrations outside of target levels, and dialysis patients may fluctuate within and outside serum phosphorus target levels from month-to-month. There are no historical, reliable patient data available for this new drug. As an estimate, approximately 200-300,000 dialysis patients in the United States may be on a phosphate-lowering medication with serum phosphorus concentrations outside of target levels." |
None |
| argenx US Inc. |
73475310203 |
VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) Injection 180 mg/mL & 2000 Units/mL |
Brand |
FDA |
2023-07-10 |
15773.0000 |
None |
1 |
17000 |
None |
1 |
None |
None |
None |
None |
None |
None |
| Astellas Pharma US, Inc. |
00469286035 |
CRESEMBA® (isavuconazonium sulfate) 74.5mg Capsules |
Brand |
FDA |
2023-09-12 |
1501.5000 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
Astellas has not released the information requested in column 7 (estimated volume of patients that may be prescribed the drug) in the public domain. Further, Astellas does not believe this information is in the public domain or publicly available. As a result, Astellas is limiting its response to this reporting requirement pursuant to Cal. Health & Safety Code Section 127681(c). Cresemba Capsules 74.5MG was not acquired; therefore, columns 10 – 13 are intentionally left blank. |
None |
| AstraZeneca |
00310320005 |
ANDEXXA PWD 200MG VI 5X20ML US |
Brand |
FDA |
2023-07-03 |
12500.0000 |
When setting the price of medicines AstraZeneca aims to reflect its value to patients, to payers, and to society in general as well as the cost of research and development (R&D). AstraZeneca’s pricing decisions are based on many factors that reflect our commitment to patients and the US Healthcare System as well as our obligation to shareholders. We are mindful of healthcare costs and are working to explore innovative opportunities and solutions working with others in the US Healthcare system to deliver innovative medicines while considering cost and value. Importantly, the WAC or list price is rarely the price paid by an individual patient as it does not account for a series of factors, including individual insurance plan design, provider access, assistance programs or savings offers. |
None |
6100 |
None |
None |
None |
None |
None |
None |
This launch introduces a new package option of Andexxa with 5 vials per package. The existing 4-vial package option will continue to be available. The price per vial remains the same. |
None |
| AstraZeneca |
00310950001 |
TAB 160MG 64 COUNT BOTTLE |
Brand |
FDA |
2023-11-28 |
22922.0000 |
When setting the price of medicines AstraZeneca aims to reflect its value to patients, to payers, and to society in general as well as the cost of research and development (R&D). AstraZeneca’s pricing decisions are based on many factors that reflect our commitment to patients and the US Healthcare System as well as our obligation to shareholders. We are mindful of healthcare costs and are working to explore innovative opportunities and solutions working with others in the US Healthcare system to deliver innovative medicines while considering cost and value. Importantly, the WAC or list price is rarely the price paid by an individual patient as it does not account for a series of factors, including individual insurance plan design, provider access, assistance programs or savings offers. |
None |
3000 |
None |
1 |
None |
None |
None |
None |
None |
None |
| AstraZeneca |
00310950101 |
TAB 200MG 64 COUNT BOTTLE |
Brand |
FDA |
2023-11-28 |
22922.0000 |
When setting the price of medicines AstraZeneca aims to reflect its value to patients, to payers, and to society in general as well as the cost of research and development (R&D). AstraZeneca’s pricing decisions are based on many factors that reflect our commitment to patients and the US Healthcare System as well as our obligation to shareholders. We are mindful of healthcare costs and are working to explore innovative opportunities and solutions working with others in the US Healthcare system to deliver innovative medicines while considering cost and value. Importantly, the WAC or list price is rarely the price paid by an individual patient as it does not account for a series of factors, including individual insurance plan design, provider access, assistance programs or savings offers. |
None |
3000 |
None |
1 |
None |
None |
None |
None |
None |
None |
| Aucta Pharmacuticals Inc. |
73289006302 |
Motpoly XR™ 100 mg, 60 |
Brand |
FDA |
2023-10-02 |
1250.0000 |
Pricing based on similar marketed brand anti-seizure medications. |
None |
1900000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Aucta Pharmacuticals Inc. |
73289006402 |
Motpoly XR™ 150 mg, 60 |
Brand |
FDA |
2023-10-02 |
1250.0000 |
Pricing based on similar marketed brand anti-seizure medications. |
None |
1900000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Aucta Pharmacuticals Inc. |
73289006502 |
Motpoly XR™ 200 mg, 60 |
Brand |
FDA |
2023-10-02 |
1250.0000 |
Pricing based on similar marketed brand anti-seizure medications. |
None |
1900000 |
None |
None |
None |
None |
None |
None |
None |
None |
| AuroMedics Pharma LLC |
55150045910 |
Carboprost Tromethamine Injection 250mcg/mL - 10s |
Generic |
FDA |
2023-06-09 |
2700.0000 |
None |
1 |
1000 |
None |
None |
None |
None |
None |
None |
None |
None |
| AuroMedics Pharma LLC |
55150037024 |
Vasopressin Injection USP, MDV 20 units/1mL - 25s NOVAPLUS |
Generic |
FDA |
2023-10-12 |
1875.0000 |
We plan to market the drug to clinics and hospitals. |
None |
10000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Avadel CNS Pharmaceuticals |
13551000130 |
sodium oxybate 4.5g powder in pack 30 each |
Brand |
FDA |
2023-05-01 |
8730.0200 |
LUMRYZ will be marketed to Healthcare Professionals, Patients, Payers, and other appropriate audiences. Avadel engaged extensively with health economists, public health experts, and payers about LUMRYZ. We have established a price for LUMRYZ that reflects the overall value this treatment brings to patients, caregivers, and society, and one that will enable continuous innovation and is in line with other products within the therapeutic class. Avadel has determined the launch price of LUMRYZ based on our belief in the impact of treatment as well as the size of the appropriate patient population based on the entry criteria of our clinical trials. |
None |
140000 |
None |
None |
None |
None |
None |
None |
There are approximately 140,000 patients in the United States with conditions treated by this therapeutic class of drugs. However, it is unknown at this time what percentage of them might be prescribed LUMRYZ. |
None |
| Avadel CNS Pharmaceuticals |
13551000107 |
sodium oxybate 4.5g powder in pack 7 each |
Brand |
FDA |
2023-05-01 |
2037.0000 |
LUMRYZ will be marketed to Healthcare Professionals, Patients, Payers, and other appropriate audiences. Avadel engaged extensively with health economists, public health experts, and payers about LUMRYZ. We have established a price for LUMRYZ that reflects the overall value this treatment brings to patients, caregivers, and society, and one that will enable continuous innovation and is in line with other products within the therapeutic class. Avadel has determined the launch price of LUMRYZ based on our belief in the impact of treatment as well as the size of the appropriate patient population based on the entry criteria of our clinical trials. |
None |
140000 |
None |
None |
None |
None |
None |
None |
There are approximately 140,000 patients in the United States with conditions treated by this therapeutic class of drugs. However, it is unknown at this time what percentage of them might be prescribed LUMRYZ. |
None |
| Avadel CNS Pharmaceuticals |
13551000230 |
sodium oxybate 6.0g powder in pack 30 each |
Brand |
FDA |
2023-05-01 |
11640.0200 |
LUMRYZ will be marketed to Healthcare Professionals, Patients, Payers, and other appropriate audiences. Avadel engaged extensively with health economists, public health experts, and payers about LUMRYZ. We have established a price for LUMRYZ that reflects the overall value this treatment brings to patients, caregivers, and society, and one that will enable continuous innovation and is in line with other products within the therapeutic class. Avadel has determined the launch price of LUMRYZ based on our belief in the impact of treatment as well as the size of the appropriate patient population based on the entry criteria of our clinical trials. |
None |
140000 |
None |
None |
None |
None |
None |
None |
There are approximately 140,000 patients in the United States with conditions treated by this therapeutic class of drugs. However, it is unknown at this time what percentage of them might be prescribed LUMRYZ. |
None |
| Avadel CNS Pharmaceuticals |
13551000207 |
sodium oxybate 6.0g powder in pack 7 each |
Brand |
FDA |
2023-05-01 |
2716.0000 |
LUMRYZ will be marketed to Healthcare Professionals, Patients, Payers, and other appropriate audiences. Avadel engaged extensively with health economists, public health experts, and payers about LUMRYZ. We have established a price for LUMRYZ that reflects the overall value this treatment brings to patients, caregivers, and society, and one that will enable continuous innovation and is in line with other products within the therapeutic class. Avadel has determined the launch price of LUMRYZ based on our belief in the impact of treatment as well as the size of the appropriate patient population based on the entry criteria of our clinical trials. |
None |
140000 |
None |
None |
None |
None |
None |
None |
There are approximately 140,000 patients in the United States with conditions treated by this therapeutic class of drugs. However, it is unknown at this time what percentage of them might be prescribed LUMRYZ. |
None |
| Avadel CNS Pharmaceuticals |
13551000330 |
sodium oxybate 7.5g powder in pack 30 each |
Brand |
FDA |
2023-05-01 |
14550.0300 |
LUMRYZ will be marketed to Healthcare Professionals, Patients, Payers, and other appropriate audiences. Avadel engaged extensively with health economists, public health experts, and payers about LUMRYZ. We have established a price for LUMRYZ that reflects the overall value this treatment brings to patients, caregivers, and society, and one that will enable continuous innovation and is in line with other products within the therapeutic class. Avadel has determined the launch price of LUMRYZ based on our belief in the impact of treatment as well as the size of the appropriate patient population based on the entry criteria of our clinical trials. |
None |
140000 |
None |
None |
None |
None |
None |
None |
There are approximately 140,000 patients in the United States with conditions treated by this therapeutic class of drugs. However, it is unknown at this time what percentage of them might be prescribed LUMRYZ. |
None |
| Avadel CNS Pharmaceuticals |
13551000307 |
sodium oxybate 7.5g powder in pack 7 each |
Brand |
FDA |
2023-05-01 |
3395.0100 |
LUMRYZ will be marketed to Healthcare Professionals, Patients, Payers, and other appropriate audiences. Avadel engaged extensively with health economists, public health experts, and payers about LUMRYZ. We have established a price for LUMRYZ that reflects the overall value this treatment brings to patients, caregivers, and society, and one that will enable continuous innovation and is in line with other products within the therapeutic class. Avadel has determined the launch price of LUMRYZ based on our belief in the impact of treatment as well as the size of the appropriate patient population based on the entry criteria of our clinical trials. |
None |
140000 |
None |
None |
None |
None |
None |
None |
There are approximately 140,000 patients in the United States with conditions treated by this therapeutic class of drugs. However, it is unknown at this time what percentage of them might be prescribed LUMRYZ. |
None |
| Avadel CNS Pharmaceuticals |
13551000430 |
sodium oxybate 9.0g powder in pack 30 each |
Brand |
FDA |
2023-05-01 |
17460.0300 |
LUMRYZ will be marketed to Healthcare Professionals, Patients, Payers, and other appropriate audiences. Avadel engaged extensively with health economists, public health experts, and payers about LUMRYZ. We have established a price for LUMRYZ that reflects the overall value this treatment brings to patients, caregivers, and society, and one that will enable continuous innovation and is in line with other products within the therapeutic class. Avadel has determined the launch price of LUMRYZ based on our belief in the impact of treatment as well as the size of the appropriate patient population based on the entry criteria of our clinical trials. |
None |
140000 |
None |
None |
None |
None |
None |
None |
There are approximately 140,000 patients in the United States with conditions treated by this therapeutic class of drugs. However, it is unknown at this time what percentage of them might be prescribed LUMRYZ. |
None |
| Avadel CNS Pharmaceuticals |
13551000407 |
sodium oxybate 9.0g powder in pack 7 each |
Brand |
FDA |
2023-05-01 |
4074.0100 |
LUMRYZ will be marketed to Healthcare Professionals, Patients, Payers, and other appropriate audiences. Avadel engaged extensively with health economists, public health experts, and payers about LUMRYZ. We have established a price for LUMRYZ that reflects the overall value this treatment brings to patients, caregivers, and society, and one that will enable continuous innovation and is in line with other products within the therapeutic class. Avadel has determined the launch price of LUMRYZ based on our belief in the impact of treatment as well as the size of the appropriate patient population based on the entry criteria of our clinical trials. |
None |
140000 |
None |
None |
None |
None |
None |
None |
There are approximately 140,000 patients in the United States with conditions treated by this therapeutic class of drugs. However, it is unknown at this time what percentage of them might be prescribed LUMRYZ. |
None |
| AvKare |
69097060473 |
Lenalidomide Capsules 2.5mg 28ct |
Generic |
FDA |
2023-04-11 |
20157.3600 |
None |
1 |
34000 |
1 |
None |
None |
None |
None |
None |
None |
None |
| AvKare |
69097038481 |
Lenalidomide Capsules 20mg 21ct |
Generic |
FDA |
2023-04-11 |
15118.0400 |
None |
1 |
34000 |
1 |
None |
None |
None |
None |
None |
None |
None |
| AvKare |
72291007201 |
Bexaratone 75mg Capsule 100ct |
Not Available |
Not Available |
2023-05-10 |
1152.0000 |
None |
1 |
18000 |
None |
None |
None |
None |
None |
None |
None |
None |
| AvKare |
42291091960 |
Posaconazole DR Tabs 100mg 60ct |
Generic |
FDA |
2023-06-01 |
852.7400 |
None |
1 |
300000 |
None |
None |
None |
None |
None |
None |
Confirming product was not available on the market prior to 6/1/2023 |
None |
| AvKare |
42291083130 |
Teriflunomide 14mg Tablet 30ct |
Generic |
FDA |
2023-06-13 |
2139.8900 |
None |
1 |
1000000 |
None |
None |
None |
None |
None |
None |
Confirming that this poduct was not available on the market prior to 6/13/2023 |
None |
| AvKare |
42291083030 |
Teriflunomide 7mg Tablet 30ct |
Generic |
FDA |
2023-06-13 |
2139.8900 |
None |
1 |
1000000 |
None |
None |
None |
None |
None |
None |
Confirming that this poduct was not available on the market prior to 6/13/2023 |
None |
| AvKare |
70377001311 |
Everolimus 10mg Tablets 30ct |
Generic |
FDA |
2023-07-11 |
1600.0000 |
Change of packing configuration from 28ct blister to 30ct bottle. Supplied to large wholesalers and specialty pharmacies including AmerisourceBergen, Oncology Supply, Cardinal Health, McKesson, CVS Health Specialty, and Acaria. Biocon offers an eVoucherRx® program to lower patient co-pays at the point of sale. |
None |
11000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Bausch Health US, LLC |
00187000625 |
CABTREO™ (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel, 1.2%/0.15%/3.1%, 50g Pump |
Brand |
FDA |
2023-12-11 |
950.0000 |
None |
1 |
50000000 |
None |
None |
None |
None |
None |
None |
Comment regarding patient estimate: There are an estimated 50 million patients that suffer from acne vulgaris. We do not know how many patients will be prescribed CABTREO™; Comment regarding acquisition: CABTREO™ was developed internally, not acquired. |
None |
| Baxter Healthcare Corporation |
10019007901 |
Bendamustine HCl Injection |
Brand |
FDA |
2023-02-08 |
2340.0000 |
None |
1 |
1000 |
None |
None |
None |
None |
None |
None |
Estimated number of patients is based on per year. |
None |
| Baxter Healthcare Corporation |
43066008910 |
Foscarnet Sodium Injection |
Generic |
FDA |
2023-09-22 |
3600.0000 |
Not required for generic drugs. |
None |
700 |
1 |
None |
None |
None |
None |
None |
None |
None |
| Bayer |
50419039302 |
VITRAKVI 20MG/ML SOLU BT 1X50ML |
Brand |
FDA |
2023-04-19 |
8250.5000 |
Product is not new. Oral Solution has changed from 1x100ml bottle to 2x50ml bottles. Everything remains consistent with previous marketing plan. |
None |
60 |
None |
None |
None |
None |
None |
None |
Price setting is a part of the company?s overall global competitive strategy and is developed by the company?s senior leadership both in the U.S. and Globally. The ultimate factors considered in determining the price increase is on a need-to-know basis and known only to a handful of key global and U.S. executives. The information is not protected under patent or trademark laws and can be protected only by treating it as trade secret. Price setting has actual commercial value to the company and is key to competition in the market place and in obtaining competitive advantage over our competitors. It is not to the best interest of the public to disclose this information because such disclosure will reduce competition in the marketplace |
https://reports.siera.hcai.ca.gov/api/report/drug-pricing/attachment?id=679 |
| Bayer |
50419039303 |
VITRAKVI 20MG/ML SOLU BT 2X50ML US |
Brand |
FDA |
2023-04-19 |
16501.0000 |
Product is not new. Oral Solution has changed from 1x100ml bottle to 2x50ml bottles. Everything remains consistent with previous marketing plan. |
None |
60 |
None |
None |
None |
None |
None |
None |
Price setting is a part of the company?s overall global competitive strategy and is developed by the company?s senior leadership both in the U.S. and Globally. The ultimate factors considered in determining the price increase is on a need-to-know basis and known only to a handful of key global and U.S. executives. The information is not protected under patent or trademark laws and can be protected only by treating it as trade secret. Price setting has actual commercial value to the company and is key to competition in the market place and in obtaining competitive advantage over our competitors. It is not to the best interest of the public to disclose this information because such disclosure will reduce competition in the marketplace |
https://reports.siera.hcai.ca.gov/api/report/drug-pricing/attachment?id=680 |
| BE Pharmaceuticals Inc. |
71839013710 |
Carboprost Tromethamine Intramuscular Solution, 250 MCG/mL, 1mL vials, 10 count in 1 box. |
Generic |
FDA |
2023-06-09 |
1330.0000 |
None |
1 |
14000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Biocon Biologics Inc. |
83257000541 |
FULPHILA® (pegfilgrastim-jmdb) injection 6 mg/0.6 mL -Single-Dose Prefilled Syringe |
Generic |
FDA |
2023-10-03 |
2087.5000 |
This is a new NDC for a product acquired by Biocon in November 2022. There are no additional changes to the marketing approach for this NDC change. Possible marketing activities include general advertisements, direct-to-consumer promotional incentives, and promotion of the drug to physicians or other health professionals based on the approved indication of the product as detailed in the product's FDA approved label. |
None |
22000 |
None |
None |
2022-11-29 |
None |
1 |
Biocon acquired the biosimiliar product portfolio of Viatris in November 2022. Biocon is now launching a new NDC for this particular acquired product. |
None |
None |
| Biocon Biologics Inc. |
83257000412 |
Ogivri (trastuzumab-dkst) for injection 420 mg/Vial, Multi-Dose Vial and Bacteriostatic Water for Injection, USP, Multiple-Dose vial -20 mL |
Brand |
FDA |
2023-10-03 |
2625.0500 |
This is a new NDC for a product acquired by Biocon in November 2022. There are no additional changes to the marketing approach for this NDC change. Possible marketing activities include general advertisements, direct-to-consumer promotional incentives, and promotion of the drug to physicians or other health professionals based on the approved indication of the product as detailed in the product's FDA approved label. |
None |
40151 |
None |
None |
2022-11-29 |
None |
1 |
Biocon acquired the biosimiliar product portfolio of Viatris in November 2022. Biocon is now launching a new NDC for this particular acquired product. |
None |
None |
| Biocon Biologics Inc. |
83257000111 |
Ogivri (trastuzumab-dkst) for injection 150 mg/Vial, Single-Dose Vial |
Brand |
FDA |
2023-10-04 |
940.5100 |
This is a new NDC for a product acquired by Biocon in November 2022. There are no additional changes to the marketing approach for this NDC change. Possible marketing activities include general advertisements, direct-to-consumer promotional incentives, and promotion of the drug to physicians or other health professionals based on the approved indication of the product as detailed in the product's FDA approved label. |
None |
40151 |
None |
None |
2022-11-29 |
None |
1 |
Biocon acquired the biosimiliar product portfolio of Viatris in November 2022. Biocon is now launching a new NDC for this particular acquired product. |
None |
None |
| Biocon Limited |
70377001311 |
Everolimus Tablets 10mg 30ct |
Generic |
FDA |
2023-07-11 |
1600.0000 |
Change of packing configuration from 28ct blister to 30ct bottle. Supplied to large wholesalers and specialty pharmacies including AmerisourceBergen, Oncology Supply, Cardinal Health, McKesson, CVS Health Specialty, and Acaria. Biocon offers an eVoucherRx® program to lower patient co-pays at the point of sale. |
None |
11000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Biocon Limited |
70377001211 |
Everolimus Tablets 7.5mg 30ct |
Generic |
FDA |
2023-09-20 |
1600.0000 |
Change of packing configuration from 28ct blister to 30ct bottle. Supplied to large wholesalers and specialty pharmacies including AmerisourceBergen, Oncology Supply, Cardinal Health, McKesson, CVS Health Specialty, and Acaria. Biocon offers an eVoucherRx® program to lower patient co-pays at the point of sale. |
None |
2300 |
None |
None |
None |
None |
None |
None |
None |
None |
| Biocon Limited |
70377001111 |
Everolimus Tablets 5mg 30ct |
Generic |
FDA |
2023-11-09 |
1600.0000 |
Change of packing configuration from 28ct blister to 30ct bottle. Supplied to large wholesalers and specialty pharmacies including AmerisourceBergen, Oncology Supply, Cardinal Health, McKesson, CVS Health Specialty, and Acaria. Biocon offers an eVoucherRx® program to lower patient co-pays at the point of sale. There were not amounts spent on direct-to-consumer marketing or advertising, as well as not amount spent to promote the drugs to physicians. |
None |
6500 |
None |
None |
None |
None |
None |
None |
None |
None |
| Biogen |
64406010901 |
Qalsody 100 mg/15 mL (6.7 mg/mL) solution in a single-dose vial |
Brand |
FDA |
2023-04-25 |
14230.0000 |
QALSODY will be marketed to Healthcare Professionals, Patients, Payers, and other appropriate audiences.
Biogen has a set of Pricing Principles that inform pricing decisions for its products. Those principles are: 1. Value to Patients, 2. Present and Future Benefit to Society, 3. Fulfilling our commitment to Innovation, 4. Evolution toward Value Based Care, and 5. Affordability & Sustainability.
Further information can be found at:
https://www.biogen.com/content/dam/corporate/en_us/pdfs/BIOGEN_PricingPrinciplesInfographic_4-26-19.pdf |
None |
330 |
None |
1 |
None |
None |
None |
None |
QALSODY ™ (tofersen) is a 100 mg/15 mL injection for the treatment of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene. The estimated number of patients provided in column #7 is the number of people in the U.S. living with the disease. |
None |
| Biogen |
64406002901 |
ZURZUVAE 20mg capsules in a 14-count bottle |
Brand |
FDA |
2023-12-01 |
7950.0000 |
ZURZUVAE will be marketed to Healthcare Professionals, Patients, Payers, and other appropriate audiences.
Biogen has a set of Pricing Principles that inform pricing decisions for its products. Those principles are: 1. Value to Patients, 2. Present and Future Benefit to Society, 3. Fulfilling our commitment to Innovation, 4. Evolution toward Value Based Care, and 5. Affordability & Sustainability.
Further information can be found at:
https://www.biogen.com/content/dam/corporate/en_us/pdfs/BIOGEN_PricingPrinciplesInfographic_4-26-19.pdf |
None |
500000 |
1 |
1 |
None |
None |
None |
None |
The estimated number of patients provided is the number of women in the United States who report experiencing symptoms of postpartum depression each year. |
None |
| Biogen |
64406003002 |
ZURZUVAE 25mg capsules in a 28-count blister pack |
Brand |
FDA |
2023-12-01 |
15900.0000 |
ZURZUVAE will be marketed to Healthcare Professionals, Patients, Payers, and other appropriate audiences.
Biogen has a set of Pricing Principles that inform pricing decisions for its products. Those principles are: 1. Value to Patients, 2. Present and Future Benefit to Society, 3. Fulfilling our commitment to Innovation, 4. Evolution toward Value Based Care, and 5. Affordability & Sustainability.
Further information can be found at:
https://www.biogen.com/content/dam/corporate/en_us/pdfs/BIOGEN_PricingPrinciplesInfographic_4-26-19.pdf |
None |
500000 |
1 |
1 |
None |
None |
None |
None |
The estimated number of patients provided is the number of women in the United States who report experiencing symptoms of postpartum depression each year. |
None |
| Biogen |
64406003101 |
ZURZUVAE 30mg capsules in a 14-count bottle |
Brand |
FDA |
2023-12-01 |
15900.0000 |
ZURZUVAE will be marketed to Healthcare Professionals, Patients, Payers, and other appropriate audiences.
Biogen has a set of Pricing Principles that inform pricing decisions for its products. Those principles are: 1. Value to Patients, 2. Present and Future Benefit to Society, 3. Fulfilling our commitment to Innovation, 4. Evolution toward Value Based Care, and 5. Affordability & Sustainability.
Further information can be found at:
https://www.biogen.com/content/dam/corporate/en_us/pdfs/BIOGEN_PricingPrinciplesInfographic_4-26-19.pdf |
None |
500000 |
1 |
1 |
None |
None |
None |
None |
The estimated number of patients provided is the number of women in the United States who report experiencing symptoms of postpartum depression each year. |
None |
| BiolineRX LTD |
82737007301 |
APHEXDA (motixafortide) For Injection: 62 mg as a lyophilized powder in a single-dose vial for reconstitution.The recommended dosage of APHEXDA is 1.25 mg/kg administered via subcutaneous injection. |
Brand |
FDA |
2023-09-22 |
5900.0000 |
APHEXDA will be promoted by our Transplant Account Managers to healthcare professionals to educate them on our product via in-office and virtual visits. Pricing was established by a comprehensive review of the competitive market and market conditions, years of product development investments, and various operational costs. |
None |
8000 |
None |
None |
None |
None |
None |
None |
None |
None |
| BioMarin Pharmaceutical Inc |
68135092748 |
ROCTAVIAN (valoctocogene roxaparvovec-rvox) suspension for intravenous infusion is supplied in vials designed to deliver 8 mL. Each mL contains 2 × 10^13 vector genomes. The recommended dose of ROCTAVIAN is 16 × 10^13 vector genomes per kg of body weight. |
Brand |
FDA |
2023-08-16 |
90625.0000 |
Consistent with Cal Health & Safety Code 127681(c), BioMarin’s response is limited to information publicly available/in public domain. The marketing and pricing plans are confidential and proprietary and are not in the public domain or publicly available. |
None |
27 |
1 |
None |
None |
None |
None |
None |
None |
None |
| Boehringer Ingelheim |
00597044587 |
PRADAXA® 110mg Oral Pellets |
Brand |
FDA |
2023-02-14 |
4717.4600 |
Specific Marketing and Pricing Plans for Pradaxa Pellets® are not in the public domain or publicly available. Boehringer Ingelheim considered several factors in determining the price. These factors included: the value of innovative medicines; investments made (including in research and development), manufacturing, and other costs and the risks undertaken. Boehringer Ingelheim invests 20% of its net sales into research and development. |
None |
3500 |
None |
1 |
None |
None |
None |
None |
The WAC at Intro to Market is $4717.46 (not $4717.16) and we have been unable to make the correction in Column 4 in the online system for this NDC. Pursuant to SB17, the information reported is limited to that which is otherwise in the public domain or publicly available. |
None |
| Boehringer Ingelheim |
00597045016 |
PRADAXA® 150mg Oral Pellets |
Brand |
FDA |
2023-02-14 |
4717.4600 |
Specific Marketing and Pricing Plans for Pradaxa Pellets® are not in the public domain or publicly available. Boehringer Ingelheim considered several factors in determining the price. These factors included: the value of innovative medicines; investments made (including in research and development), manufacturing, and other costs and the risks undertaken. Boehringer Ingelheim invests 20% of its net sales into research and development. |
None |
3500 |
None |
1 |
None |
None |
None |
None |
The WAC at Intro to Market is $4717.46 (not $4717.16) and we have been unable to make the correction in Column 4 in the online system for this NDC. Pursuant to SB17, the information reported is limited to that which is otherwise in the public domain or publicly available. |
None |
| Boehringer Ingelheim |
00597042578 |
PRADAXA® 20mg Oral Pellets |
Brand |
FDA |
2023-02-14 |
4717.4600 |
Specific Marketing and Pricing Plans for Pradaxa Pellets® are not in the public domain or publicly available. Boehringer Ingelheim considered several factors in determining the price. These factors included: the value of innovative medicines; investments made (including in research and development), manufacturing, and other costs and the risks undertaken. Boehringer Ingelheim invests 20% of its net sales into research and development. |
None |
3500 |
None |
1 |
None |
None |
None |
None |
Pursuant to SB17, the information reported is limited to that which is otherwise in the public domain or publicly available. |
None |
| Boehringer Ingelheim |
00597043018 |
PRADAXA® 30mg Oral Pellets |
Brand |
FDA |
2023-02-14 |
4717.4600 |
Specific Marketing and Pricing Plans for Pradaxa Pellets® are not in the public domain or publicly available. Boehringer Ingelheim considered several factors in determining the price. These factors included: the value of innovative medicines; investments made (including in research and development), manufacturing, and other costs and the risks undertaken. Boehringer Ingelheim invests 20% of its net sales into research and development. |
None |
3500 |
None |
1 |
None |
None |
None |
None |
Pursuant to SB17, the information reported is limited to that which is otherwise in the public domain or publicly available. |
None |
| Boehringer Ingelheim |
00597043596 |
PRADAXA® 40mg Oral Pellets |
Brand |
FDA |
2023-02-14 |
4717.4600 |
Specific Marketing and Pricing Plans for Pradaxa Pellets® are not in the public domain or publicly available. Boehringer Ingelheim considered several factors in determining the price. These factors included: the value of innovative medicines; investments made (including in research and development), manufacturing, and other costs and the risks undertaken. Boehringer Ingelheim invests 20% of its net sales into research and development. |
None |
3500 |
None |
1 |
None |
None |
None |
None |
Pursuant to SB17, the information reported is limited to that which is otherwise in the public domain or publicly available. |
None |
| Boehringer Ingelheim |
00597044053 |
PRADAXA® 50mg Oral Pellets |
Brand |
FDA |
2023-02-14 |
4717.4600 |
Specific Marketing and Pricing Plans for Pradaxa Pellets® are not in the public domain or publicly available. Boehringer Ingelheim considered several factors in determining the price. These factors included: the value of innovative medicines; investments made (including in research and development), manufacturing, and other costs and the risks undertaken. Boehringer Ingelheim invests 20% of its net sales into research and development. |
None |
3500 |
None |
1 |
None |
None |
None |
None |
Pursuant to SB17, the information reported is limited to that which is otherwise in the public domain or publicly available. |
None |
| Boehringer Ingelheim |
00597037597 |
Cyltezo Pen 40mg/0.8mL (50mg/mL) 2ct |
Brand |
FDA |
2023-07-01 |
6576.4900 |
Specific Marketing and Pricing Plans for Cyltezo are not in the public domain or publicly available. Boehringer Ingelheim considered several factors in determining the price of our medicines. These factors include: the life transforming value that is delivered to patients, investments made with research and development and beyond, the patient population size, manufacturing, the risks undertaken, and the continued need for scientific innovation for generations to come. Boehringer Ingelheim invests up to 21% of its net sales into research and development, including clinical trials. |
None |
20000000 |
None |
None |
None |
None |
None |
None |
Pursuant to SB 17 and the implementing regulations, we limit the information included in this submission to that which is otherwise in the public domain or publicly available. |
None |
| Boehringer Ingelheim |
00597037523 |
Cyltezo Pen 40mg/0.8mL (50mg/mL) 4ct |
Brand |
FDA |
2023-07-01 |
13152.9800 |
Specific Marketing and Pricing Plans for Cyltezo are not in the public domain or publicly available. Boehringer Ingelheim considered several factors in determining the price of our medicines. These factors include: the life transforming value that is delivered to patients, investments made with research and development and beyond, the patient population size, manufacturing, the risks undertaken, and the continued need for scientific innovation for generations to come. Boehringer Ingelheim invests up to 21% of its net sales into research and development, including clinical trials. |
None |
20000000 |
None |
None |
None |
None |
None |
None |
Pursuant to SB 17 and the implementing regulations, we limit the information included in this submission to that which is otherwise in the public domain or publicly available. |
None |
| Boehringer Ingelheim |
00597037516 |
Cyltezo Pen 40mg/0.8mL (50mg/mL) 6ct |
Brand |
FDA |
2023-07-01 |
19729.4700 |
Specific Marketing and Pricing Plans for Cyltezo are not in the public domain or publicly available. Boehringer Ingelheim considered several factors in determining the price of our medicines. These factors include: the life transforming value that is delivered to patients, investments made with research and development and beyond, the patient population size, manufacturing, the risks undertaken, and the continued need for scientific innovation for generations to come. Boehringer Ingelheim invests up to 21% of its net sales into research and development, including clinical trials. |
None |
20000000 |
None |
None |
None |
None |
None |
None |
Pursuant to SB 17 and the implementing regulations, we limit the information included in this submission to that which is otherwise in the public domain or publicly available. |
None |
| Boehringer Ingelheim |
00597040089 |
Cyltezo PFS 10mg/0.2mL (50mg/mL) 2ct |
Brand |
FDA |
2023-07-01 |
6576.4900 |
Specific Marketing and Pricing Plans for Cyltezo are not in the public domain or publicly available. Boehringer Ingelheim considered several factors in determining the price of our medicines. These factors include: the life transforming value that is delivered to patients, investments made with research and development and beyond, the patient population size, manufacturing, the risks undertaken, and the continued need for scientific innovation for generations to come. Boehringer Ingelheim invests up to 21% of its net sales into research and development, including clinical trials. |
None |
20000000 |
None |
None |
None |
None |
None |
None |
Pursuant to SB 17 and the implementing regulations, we limit the information included in this submission to that which is otherwise in the public domain or publicly available. |
None |
| Boehringer Ingelheim |
00597040580 |
Cyltezo PFS 20mg/0.4mL (50mg/mL) 2ct |
Brand |
FDA |
2023-07-01 |
6576.4900 |
Specific Marketing and Pricing Plans for Cyltezo are not in the public domain or publicly available. Boehringer Ingelheim considered several factors in determining the price of our medicines. These factors include: the life transforming value that is delivered to patients, investments made with research and development and beyond, the patient population size, manufacturing, the risks undertaken, and the continued need for scientific innovation for generations to come. Boehringer Ingelheim invests up to 21% of its net sales into research and development, including clinical trials. |
None |
20000000 |
None |
None |
None |
None |
None |
None |
Pursuant to SB 17 and the implementing regulations, we limit the information included in this submission to that which is otherwise in the public domain or publicly available. |
None |
| Boehringer Ingelheim |
00597037082 |
Cyltezo PFS 40mg/0.8mL (50mg/mL) 2ct |
Brand |
FDA |
2023-07-01 |
6576.4900 |
Specific Marketing and Pricing Plans for Cyltezo are not in the public domain or publicly available. Boehringer Ingelheim considered several factors in determining the price of our medicines. These factors include: the life transforming value that is delivered to patients, investments made with research and development and beyond, the patient population size, manufacturing, the risks undertaken, and the continued need for scientific innovation for generations to come. Boehringer Ingelheim invests up to 21% of its net sales into research and development, including clinical trials. |
None |
20000000 |
None |
None |
None |
None |
None |
None |
Pursuant to SB 17 and the implementing regulations, we limit the information included in this submission to that which is otherwise in the public domain or publicly available. |
None |
| Boehringer Ingelheim |
00597054522 |
adalimumab-adbm Pen 40mg/0.8mL (50mg/mL) 2ct |
Brand |
FDA |
2023-10-02 |
1315.3000 |
Specific Marketing and Pricing Plans for adalimumab-adbm are not in the public domain or publicly available. Boehringer Ingelheim considered several factors in determining the price of our medicines. These factors include: the life transforming value that is delivered to patients, investments made with research and development and beyond, the patient population size, manufacturing, the risks undertaken, consideration for access to patients and the continued need for scientific innovation for generations to come. Boehringer Ingelheim invests up to 21% of its net sales into research and development, including clinical trials. |
None |
20000000 |
None |
None |
None |
None |
None |
None |
Pursuant to SB 17 and the implementing regulations, we limit the information included in this submission to that which is otherwise in the public domain or publicly available. |
None |
| Boehringer Ingelheim |
00597054544 |
adalimumab-adbm Pen 40mg/0.8mL (50mg/mL) 4ct |
Brand |
FDA |
2023-10-02 |
2630.6000 |
Specific Marketing and Pricing Plans for adalimumab-adbm are not in the public domain or publicly available. Boehringer Ingelheim considered several factors in determining the price of our medicines. These factors include: the life transforming value that is delivered to patients, investments made with research and development and beyond, the patient population size, manufacturing, the risks undertaken, consideration for access to patients and the continued need for scientific innovation for generations to come. Boehringer Ingelheim invests up to 21% of its net sales into research and development, including clinical trials. |
None |
20000000 |
None |
None |
None |
None |
None |
None |
Pursuant to SB 17 and the implementing regulations, we limit the information included in this submission to that which is otherwise in the public domain or publicly available. |
None |
| Boehringer Ingelheim |
00597054566 |
adalimumab-adbm Pen 40mg/0.8mL (50mg/mL) 6ct |
Brand |
FDA |
2023-10-02 |
3945.8900 |
Specific Marketing and Pricing Plans for adalimumab-adbm are not in the public domain or publicly available. Boehringer Ingelheim considered several factors in determining the price of our medicines. These factors include: the life transforming value that is delivered to patients, investments made with research and development and beyond, the patient population size, manufacturing, the risks undertaken, consideration for access to patients and the continued need for scientific innovation for generations to come. Boehringer Ingelheim invests up to 21% of its net sales into research and development, including clinical trials. |
None |
20000000 |
None |
None |
None |
None |
None |
None |
Pursuant to SB 17 and the implementing regulations, we limit the information included in this submission to that which is otherwise in the public domain or publicly available. |
None |
| Boehringer Ingelheim |
00597058589 |
adalimumab-adbm PFS 10mg/0.2mL (50mg/mL) 2ct |
Brand |
FDA |
2023-10-02 |
1315.3000 |
Specific Marketing and Pricing Plans for adalimumab-adbm are not in the public domain or publicly available. Boehringer Ingelheim considered several factors in determining the price of our medicines. These factors include: the life transforming value that is delivered to patients, investments made with research and development and beyond, the patient population size, manufacturing, the risks undertaken, consideration for access to patients and the continued need for scientific innovation for generations to come. Boehringer Ingelheim invests up to 21% of its net sales into research and development, including clinical trials. |
None |
20000000 |
None |
None |
None |
None |
None |
None |
Pursuant to SB 17 and the implementing regulations, we limit the information included in this submission to that which is otherwise in the public domain or publicly available. |
None |
| Boehringer Ingelheim |
00597055580 |
adalimumab-adbm PFS 20mg/0.4mL (50mg/mL) 2ct |
Brand |
FDA |
2023-10-02 |
1315.3000 |
Specific Marketing and Pricing Plans for adalimumab-adbm are not in the public domain or publicly available. Boehringer Ingelheim considered several factors in determining the price of our medicines. These factors include: the life transforming value that is delivered to patients, investments made with research and development and beyond, the patient population size, manufacturing, the risks undertaken, consideration for access to patients and the continued need for scientific innovation for generations to come. Boehringer Ingelheim invests up to 21% of its net sales into research and development, including clinical trials. |
None |
20000000 |
None |
None |
None |
None |
None |
None |
Pursuant to SB 17 and the implementing regulations, we limit the information included in this submission to that which is otherwise in the public domain or publicly available. |
None |
| Boehringer Ingelheim |
00597059520 |
adalimumab-adbm PFS 40mg/0.8mL (50mg/mL) 2ct |
Brand |
FDA |
2023-10-02 |
1315.3000 |
Specific Marketing and Pricing Plans for adalimumab-adbm are not in the public domain or publicly available. Boehringer Ingelheim considered several factors in determining the price of our medicines. These factors include: the life transforming value that is delivered to patients, investments made with research and development and beyond, the patient population size, manufacturing, the risks undertaken, consideration for access to patients and the continued need for scientific innovation for generations to come. Boehringer Ingelheim invests up to 21% of its net sales into research and development, including clinical trials. |
None |
20000000 |
None |
None |
None |
None |
None |
None |
Pursuant to SB 17 and the implementing regulations, we limit the information included in this submission to that which is otherwise in the public domain or publicly available. |
None |
| Braeburn Rx |
58284022801 |
BRIXADI 128 mg/0.36 mL; injection, solution |
Brand |
FDA |
2023-08-15 |
1595.0000 |
None |
1 |
3000000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Braeburn Rx |
58284021601 |
BRIXADI 16 mg/0.32 mL; injection, solution |
Brand |
FDA |
2023-08-15 |
415.0000 |
None |
1 |
3000000 |
None |
None |
None |
None |
None |
None |
This is a weekly product. The total cost for a four week supply is $1,660.00. |
None |
| Braeburn Rx |
58284022401 |
BRIXADI 24 mg/0.48 mL; injection, solution |
Brand |
FDA |
2023-08-15 |
415.0000 |
None |
1 |
3000000 |
None |
None |
None |
None |
None |
None |
This is a weekly product. The total cost for a four week supply is $1,660.00. |
None |
| Braeburn Rx |
58284023201 |
BRIXADI 32 mg/0.64 mL; injection, solution |
Brand |
FDA |
2023-08-15 |
415.0000 |
None |
1 |
3000000 |
None |
None |
None |
None |
None |
None |
This is a weekly product. The total cost for a four week supply is $1,660.00. |
None |
| Braeburn Rx |
58284026401 |
BRIXADI 64 mg/0.18 mL; injection, solution |
Brand |
FDA |
2023-08-15 |
1595.0000 |
None |
1 |
3000000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Braeburn Rx |
58284020801 |
BRIXADI 8 mg/0.16 mL; injection, solution |
Brand |
FDA |
2023-08-15 |
415.0000 |
None |
1 |
3000000 |
None |
None |
None |
None |
None |
None |
This is a weekly product. The total cost for a four week supply is $1,660.00. |
None |
| Braeburn Rx |
58284029601 |
BRIXADI 96 mg/0.27 mL; injection, solution |
Brand |
FDA |
2023-08-15 |
1595.0000 |
None |
1 |
3000000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Bristol Myers Squibb |
00003404012 |
AUGTYRO™ (repotrectinib) 40mg capsules are available in bottles of 120 count for oral use. AUGTYRO™ hard shell capsules are white, opaque, immediate release, Size 0, filled with white to off-white powder which may appear as a plug, imprinted with “REP 40” |
Brand |
FDA |
2023-11-16 |
14500.0000 |
We consider multiple factors when setting a list price for a medicine, including: (i) The benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. (ii) Market and business considerations, including: Ongoing research-investment costs; BMS invests more than 21% of its annual revenues in R&D, among the highest of any large company in any industry in the world; and Medical- and patient-service costs; this includes funding growing patient assistance programs; Inflationary and capital-investment costs associated with manufacturing, storage and supply. |
None |
35 |
1 |
1 |
2022-08-17 |
4100000000.0000 |
None |
Bristol Myers Squibb acquired Turning Point Therapeutics for $76.00 per share. The transaction was unanimously approved by both the Bristol Myers Squibb and Turning Point Therapeutics Boards of Directors and closed during the third quarter of 2022. Turning Point Therapeutics is a clinical-stage precision oncology company with a pipeline of investigational medicines designed to target the most common mutations associated with oncogenesis. |
Comment regarding "Estimated Number of Patients": 30-35 patients per month (forecast). This number reflects estimate for average new patients starts only and does not include continuing patients from previous months. Estimate reflects new patients across all channels (commercial and access programs for 2024). However, BMS is unable to provide an exact number of patients who will be prescribed AUGTYRO each month. |
None |
| Bristol Myers Squibb |
00003404060 |
AUGTYRO™ (repotrectinib) 40mg capsules are available in bottles of 60 count for oral use. AUGTYRO™ hard shell capsules are white, opaque, immediate release, Size 0, filled with white to off-white powder which may appear as a plug, imprinted with “REP 40” |
Brand |
FDA |
2023-11-16 |
7250.0000 |
We consider multiple factors when setting a list price for a medicine, including: (i) The benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. (ii) Market and business considerations, including; Ongoing research-investment costs; BMS invests more than 21% of its annual revenues in R&D, among the highest of any large company in any industry in the world; and Medical- and patient-service costs; this includes funding growing patient assistance programs; Inflationary and capital-investment costs associated with manufacturing, storage and supply. |
None |
35 |
1 |
1 |
2022-08-17 |
4100000000.0000 |
None |
Bristol Myers Squibb acquired Turning Point Therapeutics for $76.00 per share. The transaction was unanimously approved by both the Bristol Myers Squibb and Turning Point Therapeutics Boards of Directors and closed during the third quarter of 2022. Turning Point Therapeutics is a clinical-stage precision oncology company with a pipeline of investigational medicines designed to target the most common mutations associated with oncogenesis. |
Comment regarding "Estimated Number of Patients": 30-35 patients per month (forecast). This number reflects estimate for average new patients starts only and does not include continuing patients from previous months. Estimate reflects new patients across all channels (commercial and access programs for 2024). However, BMS is unable to provide an exact number of patients who will be prescribed AUGTYRO each month. |
None |
| Camber Pharmaceuticals, Inc. |
31722025928 |
Lenalidomide Capsules 10mg, 28ct |
Generic |
FDA |
2023-05-30 |
20157.3600 |
None |
1 |
32000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Camber Pharmaceuticals, Inc. |
31722026021 |
Lenalidomide Capsules 15mg, 21ct |
Generic |
FDA |
2023-05-30 |
15118.0400 |
None |
1 |
32000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Camber Pharmaceuticals, Inc. |
31722025728 |
Lenalidomide Capsules 2.5mg, 28ct |
Generic |
FDA |
2023-05-30 |
20157.3600 |
None |
1 |
32000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Camber Pharmaceuticals, Inc. |
31722026121 |
Lenalidomide Capsules 20mg, 21ct |
Generic |
FDA |
2023-05-30 |
15118.0400 |
None |
1 |
32000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Camber Pharmaceuticals, Inc. |
31722026221 |
Lenalidomide Capsules 25mg, 21ct |
Generic |
FDA |
2023-05-30 |
15118.0400 |
None |
1 |
32000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Camber Pharmaceuticals, Inc. |
31722025828 |
Lenalidomide Capsules 5mg, 28ct |
Generic |
FDA |
2023-05-30 |
20157.3600 |
None |
1 |
32000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Camber Pharmaceuticals, Inc. |
31722003032 |
Deferasirox Oral Granules 180mg 30ct |
Generic |
FDA |
2023-06-12 |
2000.0000 |
None |
1 |
16000000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Camber Pharmaceuticals, Inc. |
31722003132 |
Deferasirox Oral Granules 360mg 30ct |
Generic |
FDA |
2023-06-12 |
4000.0000 |
None |
1 |
16000000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Camber Pharmaceuticals, Inc. |
31722002932 |
Deferasirox Oral Granules 90mg 30ct |
Generic |
FDA |
2023-06-12 |
1000.0000 |
None |
1 |
16000000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Celgene |
59572089028 |
ZEPOSIA® (ozanimod) Capsules, 0.23,0.46,0.92MG, bottle of 28 count |
Brand |
FDA |
2023-06-07 |
7636.6400 |
We consider multiple factors when setting a list price for a medicine, including: (i) The benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. (ii) Market and business considerations, including: Ongoing research-investment costs; BMS invests more than 25% of its annual revenues in R&D, among the highest of any large company in any industry in the world; and Medical- and patient-service costs; this includes funding growing patient assistance programs; Inflationary and capital-investment costs associated with manufacturing, storage and supply. |
None |
280000 |
None |
None |
None |
None |
None |
None |
Comment regarding "Estimated Number of Patients": Total class of RRMS (Relapsing-remitting multiple sclerosis) and SPMS (Secondary-progressive multiple sclerosis) is estimated at 280,000 patients. BMS is unable to provide an estimate of the number of patients who will be prescribed ZEPOSIA®
Bristol-Myers Squibb obtained rights to ZEPOSIA® as part of the Celgene acquisition, which completed on November 20, 2019. This acquisition did not consist of costs for individual assets. |
None |
| Celltrion USA, Inc. |
72606001101 |
Vegzelma bevacizumab-adcd INTRAVENOUS 4 ml |
Brand |
FDA |
2023-04-04 |
677.4000 |
Vegzelma will be launched in the U.S. for appropriate and eligible patients treated at oncology clinics and hospitals. All marketing, sales, and promotional activities messages will be limited to the approved product label data and information.
A Wholesale Acquisition Cost has been set and published. Celltrion USA will offer discounts and rebates to hospitals and clinics off the Wholesale Acquisition Cost. |
None |
2235 |
None |
None |
None |
None |
None |
None |
None |
None |
| Celltrion USA, Inc. |
72606001201 |
Vegzelma bevacizumab-adcd INTRAVENOUS
16ml |
Brand |
FDA |
2023-04-04 |
2709.6000 |
Vegzelma will be launched in the U.S. for appropriate and eligible patients treated at oncology clinics and hospitals. All marketing, sales, and promotional activities messages will be limited to the approved product label data and information.
A Wholesale Acquisition Cost has been set and published. Celltrion USA will offer discounts and rebates to hospitals and clinics off the Wholesale Acquisition Cost. |
None |
2235 |
None |
None |
None |
None |
None |
None |
None |
None |
| Celltrion USA, Inc. |
72606003009 |
Yuflyma Subcutaneous Auto-injector Kit 40 MG/0.4ML, 1 Each, Unit-Dose, Box |
Brand |
FDA |
2023-07-05 |
3288.2500 |
Marketing plans: In support of the launch of Yuflyma, Celltion has employed highly trained Immunology Sales Specialists that will make on-site visits to healthcare providers. During these visits, the sales specialists will provide an educational brochure to showcase the patient financial assistance options and how to enroll in the program. This patient assistance program will include an application that is downloadable and can be printed and provided to the health care provider at the time of a visit. An additional feature of the program is a video that is embedded on the website to assist the patient with self-inject guidance. Instructional video’s will be available via a YouTube platform and will also be embedded in the CelltrionConnect website. The sales team will attend industry appropriate conferences such as American College of Rheumatology conference and support the launch process of Yuflyma with focused efforts on patient education and support through website presentations and on-site efforts. Pricing methodology: Celltrion’s product is priced 5% below the referenced product and is priced the same as the other competitors within the class that has launched a biosimilar with this packaging configuration containing the same delivery system. Additional packaging configurations of Yuflyma will be launched as they become available thereby providing further options for eligible patients, leading to increased patient choice and access. |
None |
398619 |
None |
None |
None |
None |
None |
None |
None |
None |
| Celltrion USA, Inc. |
72606003010 |
Yuflyma Subcutaneous Auto-injector Kit 40 MG/0.4ML, 1 Each, Unit-Dose, Box Qty 2 |
Brand |
FDA |
2023-07-05 |
6576.5000 |
Marketing plans: In support of the launch of Yuflyma, Celltion has employed highly trained Immunology Sales Specialists that will make on-site visits to healthcare providers. During these visits, the sales specialists will provide an educational brochure to showcase the patient financial assistance options and how to enroll in the program. This patient assistance program will include an application that is downloadable and can be printed and provided to the health care provider at the time of a visit. An additional feature of the program is a video that is embedded on the website to assist the patient with self-inject guidance. Instructional video’s will be available via a YouTube platform and will also be embedded in the CelltrionConnect website. The sales team will attend industry appropriate conferences such as American College of Rheumatology conference and support the launch process of Yuflyma with focused efforts on patient education and support through website presentations and on-site efforts. Pricing methodology: Celltrion’s product is priced 5% below the referenced product and is priced the same as the other competitors within the class that has launched a biosimilar with this packaging configuration containing the same delivery system. Additional packaging configurations of Yuflyma will be launched as they become available thereby providing further options for eligible patients, leading to increased patient choice and access. |
None |
398619 |
None |
None |
None |
None |
None |
None |
None |
None |
| Celltrion USA, Inc. |
72606002304 |
Yuflyma Subcutaneous Auto-injector Kit 80 MG/0.8ML |
Brand |
FDA |
2023-12-13 |
3288.2500 |
Yuflyma is a biosimilar in the adalimumab class in this package configuration (auto-injector) and has been granted approval for eight indications: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn's Disease, Ulcerative Colitis, Plaque Psoriasis and Hidradenitis Suppurativa. As part of the determination to launch Yuflyma, Celltrion conducted extensive market research utilizing data established in the US and abroad. Based on this information along with the market competitiveness as well as establishing a convenient delivery system which provides patients with one of only a few FDA-approved adalimumab biosimilars that has a high-concentration, citrate-free formulation. This formulation can reduce injection discomfort for patients with chronic conditions like rheumatoid arthritis, thereby improving adherence to treatment. Celltrion’s product is priced 5% below the referenced product and is priced the same as the other competitors within the class that has launched a biosimilar with this packaging configuration containing the same delivery system. |
None |
398619 |
None |
None |
None |
None |
None |
None |
None |
None |
| Celltrion USA, Inc. |
72606002307 |
Yuflyma-CD/UC/HS Starter Subcutaneous Auto-injector Kit 80 MG/0.8ML |
Brand |
FDA |
2023-12-13 |
9864.7500 |
Yuflyma is a biosimilar in the adalimumab class in this package configuration (auto-injector) and has been granted approval for eight indications: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn's Disease, Ulcerative Colitis, Plaque Psoriasis and Hidradenitis Suppurativa. As part of the determination to launch Yuflyma, Celltrion conducted extensive market research utilizing data established in the US and abroad. Based on this information along with the market competitiveness as well as establishing a convenient delivery system which provides patients with one of only a few FDA-approved adalimumab biosimilars that has a high-concentration, citrate-free formulation. This formulation can reduce injection discomfort for patients with chronic conditions like rheumatoid arthritis, thereby improving adherence to treatment. Celltrion’s product is priced 5% below the referenced product and is priced the same as the other competitors within the class that has launched a biosimilar with this packaging configuration containing the same delivery system. |
None |
398619 |
None |
None |
None |
None |
None |
None |
None |
None |
| Chartwell Rx LLC |
62135070290 |
Amoxapine Oral Tablet 100 MG 90CT |
Generic |
FDA |
2023-09-15 |
1350.0000 |
None |
1 |
10500000 |
None |
None |
2021-09-02 |
None |
1 |
Chartwell acquired this ANDA file from the prior owner on the Acquisition Date stated in Section 10. ANDA was acquired as part of a bulk transaction for multiple ANDAs and no specific cost or value can be assigned to this particular ANDA.
Chartwell does not have a press release to provide proof of the acquisition. We have, however, attached copies of the FDA letters that transferred the ANDA from the prior holder to Chartwell. Please let us know if you would accept this as proof of the acquisition. |
The information contained in this report is subject to the following limitations and assumptions: Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Chartwell believes is otherwise in the public domain or publicly available. Chartwell did not assume marketing functions from prior owner, and did not receive any historical data from the sellers of the ANDAs. Chartwell also does not have information regarding the estimated amount of patients prescribed this product. These data elements are therefore not publicly available and are left blank as a result.
Chartwell does not have an estimated number of patients for its amoxapine products or access to any data regarding the number of patients who might be prescribed the products. However, we appreciate the opportunity to revise the reports to include a figure that represents an estimated number of U.S. patients who are prescribed tricyclic medication for depression, the condition for which the amoxapine products are indicated. A recent article on the national prescription patterns of antidepressants found that approximately 3.2 percent of the U.S. adult population are prescribed tricyclic antidepressants (including but not limited to amoxapine). Yan Luo et al., National Prescription Patterns of Antidepressants in the Treatment of Adults with Major Depression in the US Between 1996 and 2015: A Population Representative Survey Based Analysis, FRONTIERS IN PSYCHIATRY 11, 35 (2020). Assuming a U.S. population of approximately 330 million people, the estimated number of patients in the U.S. that could in theory be prescribed amoxapine is around 10.5 million. |
None |
| Chartwell Rx LLC |
62135070090 |
Amoxapine Oral Tablet 25 MG 90CT |
Generic |
FDA |
2023-09-15 |
1170.0000 |
None |
1 |
10500000 |
None |
None |
2021-09-02 |
None |
1 |
Chartwell acquired this ANDA file from the prior owner on the Acquisition Date stated in Section 10. ANDA was acquired as part of a bulk transaction for multiple ANDAs and no specific cost or value can be assigned to this particular ANDA.
Chartwell does not have a press release to provide proof of the acquisition. We have, however, attached copies of the FDA letters that transferred the ANDA from the prior holder to Chartwell. Please let us know if you would accept this as proof of the acquisition. |
The information contained in this report is subject to the following limitations and assumptions: Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Chartwell believes is otherwise in the public domain or publicly available. Chartwell did not assume marketing functions from prior owner, and did not receive any historical data from the sellers of the ANDAs. Chartwell also does not have information regarding the estimated amount of patients prescribed this product. These data elements are therefore not publicly available and are left blank as a result.
Chartwell does not have an estimated number of patients for its amoxapine products or access to any data regarding the number of patients who might be prescribed the products. However, we appreciate the opportunity to revise the reports to include a figure that represents an estimated number of U.S. patients who are prescribed tricyclic medication for depression, the condition for which the amoxapine products are indicated. A recent article on the national prescription patterns of antidepressants found that approximately 3.2 percent of the U.S. adult population are prescribed tricyclic antidepressants (including but not limited to amoxapine). Yan Luo et al., National Prescription Patterns of Antidepressants in the Treatment of Adults with Major Depression in the US Between 1996 and 2015: A Population Representative Survey Based Analysis, FRONTIERS IN PSYCHIATRY 11, 35 (2020). Assuming a U.S. population of approximately 330 million people, the estimated number of patients in the U.S. that could in theory be prescribed amoxapine is around 10.5 million. |
None |
| Chartwell Rx LLC |
62135070190 |
Amoxapine Oral Tablet 50 MG 90CT |
Generic |
FDA |
2023-09-15 |
1260.0000 |
None |
1 |
10500000 |
None |
None |
2021-09-02 |
None |
1 |
Chartwell acquired this ANDA file from the prior owner on the Acquisition Date stated in Section 10. ANDA was acquired as part of a bulk transaction for multiple ANDAs and no specific cost or value can be assigned to this particular ANDA.
Chartwell does not have a press release to provide proof of the acquisition. We have, however, attached copies of the FDA letters that transferred the ANDA from the prior holder to Chartwell. Please let us know if you would accept this as proof of the acquisition. |
The information contained in this report is subject to the following limitations and assumptions: Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Chartwell believes is otherwise in the public domain or publicly available. Chartwell did not assume marketing functions from prior owner, and did not receive any historical data from the sellers of the ANDAs. Chartwell also does not have information regarding the estimated amount of patients prescribed this product. These data elements are therefore not publicly available and are left blank as a result.
Chartwell does not have an estimated number of patients for its amoxapine products or access to any data regarding the number of patients who might be prescribed the products. However, we appreciate the opportunity to revise the reports to include a figure that represents an estimated number of U.S. patients who are prescribed tricyclic medication for depression, the condition for which the amoxapine products are indicated. A recent article on the national prescription patterns of antidepressants found that approximately 3.2 percent of the U.S. adult population are prescribed tricyclic antidepressants (including but not limited to amoxapine). Yan Luo et al., National Prescription Patterns of Antidepressants in the Treatment of Adults with Major Depression in the US Between 1996 and 2015: A Population Representative Survey Based Analysis, FRONTIERS IN PSYCHIATRY 11, 35 (2020). Assuming a U.S. population of approximately 330 million people, the estimated number of patients in the U.S. that could in theory be prescribed amoxapine is around 10.5 million. |
None |
| Chartwell Rx LLC |
62135073690 |
Flurazepam HCl Oral Capsule 15 MG |
Generic |
FDA |
2023-09-19 |
1365.3000 |
None |
1 |
8000000 |
None |
None |
2023-03-07 |
None |
1 |
Chartwell acquired this ANDA file from the prior owner on the Acquisition Date stated in Column 10. ANDA was acquired as part of a bulk transaction for multiple ANDAs and no specific cost or value can be assigned to this particular ANDA.
Chartwell does not have a press release to provide proof of the acquisition. We have, however, attached a copy of the FDA letter that transferred the ANDA from the prior holder to Chartwell. Please let us know if you would accept this as proof of the acquisition. |
The information contained in this report is subject to the following limitations and assumptions: Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Chartwell believes is otherwise in the public domain or publicly available. Chartwell did not assume marketing functions from prior owner, and did not receive any historical data from the sellers of the ANDAs. Chartwell also does not have information regarding the estimated amount of patients prescribed this product. These data elements are therefore not publicly available and are left blank as a result.
Chartwell does not have an estimated number of patients for its flurazepam products or access to any data regarding the number of patients who might be prescribed the products. However, we appreciate the opportunity to revise the reports to include a figure that represents an estimated number of U.S. patients who are prescribed medication for insomnia, the condition for which the flurazepam products are indicated. A recent article on the pharmacological management of insomnia found that approximately 2.5 percent of the U.S. population takes hypnotics (including but not limited to flurazepam) for insomnia. Sarika Maradi et al., Pharmacological Management of Insomnia, Neurotherapeutics 18, 44-52 (2021). Assuming a U.S. population of approximately 330 million people, the estimated number of patients in the U.S. with insomnia is around 8 million. |
None |
| Chartwell Rx LLC |
62135073790 |
Flurazepam HCl Oral Capsule 30 MG |
Generic |
FDA |
2023-09-19 |
1446.3000 |
None |
1 |
8000000 |
None |
None |
2023-03-07 |
None |
1 |
Chartwell acquired this ANDA file from the prior owner on the Acquisition Date stated in Column 10. ANDA was acquired as part of a bulk transaction for multiple ANDAs and no specific cost or value can be assigned to this particular ANDA.
Chartwell does not have a press release to provide proof of the acquisition. We have, however, attached a copy of the FDA letter that transferred the ANDA from the prior holder to Chartwell. Please let us know if you would accept this as proof of the acquisition. |
The information contained in this report is subject to the following limitations and assumptions: Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Chartwell believes is otherwise in the public domain or publicly available. Chartwell did not assume marketing functions from prior owner, and did not receive any historical data from the sellers of the ANDAs. Chartwell also does not have information regarding the estimated amount of patients prescribed this product. These data elements are therefore not publicly available and are left blank as a result.
Chartwell does not have an estimated number of patients for its flurazepam products or access to any data regarding the number of patients who might be prescribed the products. However, we appreciate the opportunity to revise the reports to include a figure that represents an estimated number of U.S. patients who are prescribed medication for insomnia, the condition for which the flurazepam products are indicated. A recent article on the pharmacological management of insomnia found that approximately 2.5 percent of the U.S. population takes hypnotics (including but not limited to flurazepam) for insomnia. Sarika Maradi et al., Pharmacological Management of Insomnia, Neurotherapeutics 18, 44-52 (2021). Assuming a U.S. population of approximately 330 million people, the estimated number of patients in the U.S. with insomnia is around 8 million. |
None |
| Chartwell Rx LLC |
62135071618 |
Meloxicam Oral Tablet 15 MG 180CT |
Generic |
FDA |
2023-10-17 |
900.0000 |
None |
1 |
333333 |
None |
None |
2023-03-07 |
None |
1 |
Chartwell acquired this ANDA file from the prior owner on the Acquisition Date listed. ANDA was acquired as part of a bulk transaction for multiple ANDAs and no specific cost or value can be assigned to this particular ANDA. |
The information contained in this report is subject to the following limitations and assumptions: Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Chartwell believes is otherwise in the public domain or publicly available. Chartwell does not have an estimated number of patients who are prescribed this product or access to any data regarding the number of patients who might be prescribed this product. However, we have included a figure that represents Chartwell's best estimate based on publicly available data. This figure is based on an estimated number of U.S. patients who are prescribed meloxicam, divided by the number of available meloxicam drugs listed on FDA's drug database. Approximately 6 million patients in the U.S. are prescribed meloxicam. There are 18 available meloxicam drugs. Chartwell therefore estimates that approximately 333,333 patients may be prescribed this drug product. |
https://reports.siera.hcai.ca.gov/api/report/drug-pricing/attachment?id=711 |
| Chartwell Rx LLC |
62135078412 |
Capecitabine Oral Tablet 500MG 120CT |
Generic |
FDA |
2023-11-03 |
1200.0000 |
None |
1 |
12500 |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions: Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Chartwell believes is otherwise in the public domain or publicly available. Chartwell does not have an estimated number of patients who are prescribed this product or access to any data regarding the number of patients who might be prescribed this product. However, we have included a figure that represents Chartwell's best estimate based on publicly available data. FDA/CDER's Office of Surveillance and Epidemiology found that approximately 100,000 U.S. patients were prescribed the brand drug product (XELODA) over a four year period. Since that time period, FDA's drug database shows that eight generics have been approved. Chartwell therefore estimates that approximately 12,500 patients may be prescribed this drug product. In addition, although Chartwell did not develop this drug product, it also did not acquire it from another manufacturer. There is no publicly available date or price of acquisition because no acquisition took place. Per Cal. Health & Safety Code § 96076(c), these fields are therefore left blank. |
None |
| Chartwell Rx LLC |
62135014157 |
Benztropine Mesylate Oral Tablet 0.5MG 540CT |
Generic |
FDA |
2023-11-29 |
1215.0000 |
None |
1 |
315849 |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions: Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Chartwell believes is otherwise in the public domain or publicly available. Chartwell does not have an internal estimate of patients who may be prescribed this drug product. However, Chartwell has provided an estimate based on publicly available drug usage statistics from the third-party website, ClinCalc.com. We note that this figure estimates all patients who are prescribed any form of this drug, and therefore most likely overstates the estimated patient population. Chartwell has not independently reviewed this estimate and does not have access to any data with which to do so. However, this figure represents the best estimate available to Chartwell. |
https://reports.siera.hcai.ca.gov/api/report/drug-pricing/attachment?id=712 |
| Chiesi USA |
10122010405 |
Ferrirprox 1000mg 50 ct bottle |
Brand |
FDA |
2023-03-06 |
10423.1200 |
None |
1 |
150 |
None |
None |
None |
None |
None |
None |
Acquired while in development. Approved while owned by Chiesi USA. |
None |
| Chiesi USA |
10122018002 |
Lamzede® (velmanase alfa-tycv). |
Brand |
FDA |
2023-04-13 |
4000.0000 |
None |
1 |
22 |
None |
1 |
None |
None |
None |
None |
Lamzede has been approved but will not be commercially available until Q2 2023. |
None |
| Chiesi USA |
10122016005 |
Elfabrio Five Single 20?mg/10?mL (2?mg/mL) dose vials in a carton |
Brand |
FDA |
2023-05-23 |
20675.5500 |
None |
1 |
120 |
None |
None |
None |
None |
None |
None |
Product was developed by Chiesi |
None |
| Chiesi USA |
10122016002 |
Elfabrio One single 20?mg/10?mL (2?mg/mL) dose vial in a carton |
Brand |
FDA |
2023-05-23 |
4135.1100 |
None |
1 |
120 |
None |
None |
None |
None |
None |
None |
Product was developed by Chiesi |
None |
| Chiesi USA |
10122016010 |
Elfabrio Ten single 20?mg/10?mL (2?mg/mL) dose vials in a carton |
Brand |
FDA |
2023-05-23 |
41351.1000 |
None |
1 |
120 |
None |
None |
None |
None |
None |
None |
Product was developed by Chiesi |
None |
| Cintex Services LLC |
24470092460 |
Diclofenac Potassium Tablets, USP 25 mg, 60ct |
Generic |
FDA |
2023-12-13 |
1950.0000 |
None |
1 |
2000 |
None |
None |
None |
None |
None |
None |
Manufacturer changed the first date of commercial availability from 12/29/23 to 12/13/23. Please reflect the new date in this filing. |
None |
| Cipla USA, Inc. |
69097094093 |
Pirfenidone Caps 267 mg 270 Ct |
Generic |
FDA |
2023-01-17 |
1800.0000 |
None |
1 |
100000 |
None |
1 |
None |
None |
None |
None |
None |
None |
| Cipla USA, Inc. |
69097056053 |
Deferasirox Oral Granues 180mg 30ct Sachets |
Generic |
FDA |
2023-06-01 |
2000.0000 |
None |
1 |
19500 |
None |
None |
None |
None |
None |
None |
None |
None |
| Cipla USA, Inc. |
69097057053 |
Deferasirox Oral Granues 360mg 30ct Sachets |
Generic |
FDA |
2023-06-01 |
4000.0000 |
None |
1 |
19500 |
None |
None |
None |
None |
None |
None |
None |
None |
| Cipla USA, Inc. |
69097055053 |
Deferasirox Oral Granues 90mg 30ct Sachets |
Generic |
FDA |
2023-06-01 |
1025.0100 |
None |
1 |
19500 |
None |
None |
None |
None |
None |
None |
None |
None |
| Civica, Inc |
72572006710 |
Cisatracurium Besylate Intravenous Solution 200 MG/20ML 10 Vials |
Generic |
FDA |
2023-02-27 |
940.0000 |
Civica selects products (including Cisatracurium Besylate) that are identified and prioritized by Civica's member health systems - by doctors and pharmacists on the front lines - as the medications most important for quality patient care. Each Civica member health system has the option to make a long-term commitment to purchase Cisatracurium from Civica by executing a Purchase Commitment Form. The Purchase Commitment Form contains the required duration of the purchase commitment and the expected annual minimum volume purchase commitment for each participating member (based on the member's historical pro rata usage volume relative to the other members).
Civica sets a single, transparent price per Cisatracurium Besylate product for each of its members, regardless of the volume purchased. Civica sets its Cisatracurium Besylate prices at approximately cost plus a margin to cover Civica's overhead and research and development expenses. |
None |
1 |
None |
None |
None |
None |
None |
None |
Civica is selling under a product supply agreement under the manufacturer. There was no licensing fee, or acquisition price, only a fee per unit purchased from the manufacturer.
Civica does not have access to a reliable estimate of “the number of patients in the United States with a condition for which the new prescription drug may be prescribed.” Cisatracurium Besylate Injection has three indications listed in the drug label information (available at: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c93166b5-43fe-4ba1-9222-14eb71a24dd5): (1) as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age, (2) to provide skeletal muscle relaxation during surgical procedures or during mechanical ventilation in the ICU, and (3) to provide skeletal muscle relaxation during surgical procedures via infusion in pediatric patients 2 years and older. According to the NIH, between 13 and 20 million intubations are performed annually in the United States (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7517927/#:~:text=Between%2013%20and%2020%20million,emergency%20to%20secure%20the%20airway.), but Civica is not in a position to estimate the proportion of those intubations for which Cisatracurium would be indicated. Likewise, Civica is unable to estimate the proportion of the estimated 40 to 50 million major surgeries performed in the United States annually (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7388795/#:~:text=Globally%2C%20a%20staggering%20310%20million,be%20readmitted%20within%2030%20days.) for which Cisatracurium would be indicated. Civica does not believe there is any publicly available data that accurately represents the estimated number of patients for these indications and we are not comfortable speculating about such information. |
None |
| CMP Pharma |
46287005501 |
Sildenafil oral suspension 122 mL |
Brand |
FDA |
2023-06-12 |
1895.0000 |
LIQREV will be promoted by our sales force to healthcare professionals to educate them on our product. We will use various means of promotion including in-office visits, ad campaigns, and multimedia marketing. Pricing was established by a comprehensive review to reflect the competitive market, years of product development investments, and various operational costs. |
None |
130 |
None |
None |
None |
None |
None |
None |
None |
None |
| Cordavis Limited |
83457010001 |
Hyrimoz Subcutaneous Solution Auto-injector 40 MG/0.4ML, 0.4ml per pen, 2 pens per package |
Generic |
FDA |
2023-12-01 |
1300.0000 |
Cordavis Hyrimoz was developed as a co-manufacturing biosimilar initiative. Hyrimoz exists on the market today under another manufacturer's NDCs. There is currently no specific marketing and/or advertising budget or plan associated with this NDC. Cordavis is introducing the Hyrimoz NDC to create competition in the Biosimilar market and help drive down the overall cost of drugs. The Cordavis Hyrimoz pricing strategy is to bring a biosimilar to market at a price point that is at least 80% below the list price of the brand equivalent. |
None |
57831 |
None |
None |
None |
None |
None |
None |
None |
None |
| Cordavis Limited |
83457010201 |
Hyrimoz Subcutaneous Solution Auto-injector 40 MG/0.8ML, 0.8ml per pen, 2 pens per package |
Generic |
FDA |
2023-12-01 |
1300.0000 |
Cordavis Hyrimoz was developed as a co-manufacturing biosimilar initiative. Hyrimoz exists on the market today under another manufacturer's NDCs. There is currently no specific marketing and/or advertising budget or plan associated with this NDC. Cordavis is introducing the Hyrimoz NDC to create competition in the Biosimilar market and help drive down the overall cost of drugs. The Cordavis Hyrimoz pricing strategy is to bring a biosimilar to market at a price point that is at least 80% below the list price of the brand equivalent. |
None |
7022 |
None |
None |
None |
None |
None |
None |
None |
None |
| Cordavis Limited |
83457010101 |
Hyrimoz Subcutaneous Solution Prefilled Syringe 40 MG/0.4ML. 0.4ml per pen, 2 pens per package |
Generic |
FDA |
2023-12-01 |
1300.0000 |
Cordavis Hyrimoz was developed as a co-manufacturing biosimilar initiative. Hyrimoz exists on the market today under another manufacturer's NDCs. There is currently no specific marketing and/or advertising budget or plan associated with this NDC. Cordavis is introducing the Hyrimoz NDC to create competition in the Biosimilar market and help drive down the overall cost of drugs. The Cordavis Hyrimoz pricing strategy is to bring a biosimilar to market at a price point that is at least 80% below the list price of the brand equivalent. |
None |
4961 |
None |
None |
None |
None |
None |
None |
None |
None |
| Cordavis Limited |
83457010301 |
Hyrimoz Subcutaneous Solution Prefilled Syringe 40 MG/0.8ML, 0.8ml per pen, 2 pens per package |
Generic |
FDA |
2023-12-01 |
1300.0000 |
Cordavis Hyrimoz was developed as a co-manufacturing biosimilar initiative. Hyrimoz exists on the market today under another manufacturer's NDCs. There is currently no specific marketing and/or advertising budget or plan associated with this NDC. Cordavis is introducing the Hyrimoz NDC to create competition in the Biosimilar market and help drive down the overall cost of drugs. The Cordavis Hyrimoz pricing strategy is to bring a biosimilar to market at a price point that is at least 80% below the list price of the brand equivalent. |
None |
1534 |
None |
None |
None |
None |
None |
None |
None |
None |
| CSL Behring LLC |
00053021021 |
HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 101-105kg |
Brand |
FDA |
2023-06-14 |
3500000.0000 |
HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system. |
None |
800 |
1 |
1 |
2021-05-06 |
450000000.0000 |
None |
CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.? |
None |
None |
| CSL Behring LLC |
00053022022 |
HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 106-110kg |
Brand |
FDA |
2023-06-14 |
3500000.0000 |
HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system. |
None |
800 |
1 |
1 |
2021-05-06 |
450000000.0000 |
None |
CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.? |
None |
None |
| CSL Behring LLC |
00053023023 |
HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 111-115kg |
Brand |
FDA |
2023-06-14 |
3500000.0000 |
HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system. |
None |
800 |
1 |
1 |
2021-05-06 |
450000000.0000 |
None |
CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.? |
None |
None |
| CSL Behring LLC |
00053024024 |
HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 116-120kg |
Brand |
FDA |
2023-06-14 |
3500000.0000 |
HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system. |
None |
800 |
1 |
1 |
2021-05-06 |
450000000.0000 |
None |
CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.? |
None |
None |
| CSL Behring LLC |
00053025025 |
HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 121-125kg |
Brand |
FDA |
2023-06-14 |
3500000.0000 |
HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system. |
None |
800 |
1 |
1 |
2021-05-06 |
450000000.0000 |
None |
CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.? |
None |
None |
| CSL Behring LLC |
00053026026 |
HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 126-130kg |
Brand |
FDA |
2023-06-14 |
3500000.0000 |
HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system. |
None |
800 |
1 |
1 |
2021-05-06 |
450000000.0000 |
None |
CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.? |
None |
None |
| CSL Behring LLC |
00053027027 |
HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 131-135kg |
Brand |
FDA |
2023-06-14 |
3500000.0000 |
HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system. |
None |
800 |
1 |
1 |
2021-05-06 |
450000000.0000 |
None |
CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.? |
None |
None |
| CSL Behring LLC |
00053028028 |
HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 136-140kg |
Brand |
FDA |
2023-06-14 |
3500000.0000 |
HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system. |
None |
800 |
1 |
1 |
2021-05-06 |
450000000.0000 |
None |
CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.? |
None |
None |
| CSL Behring LLC |
00053029029 |
HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 141-145kg |
Brand |
FDA |
2023-06-14 |
3500000.0000 |
HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system. |
None |
800 |
1 |
1 |
2021-05-06 |
450000000.0000 |
None |
CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.? |
None |
None |
| CSL Behring LLC |
00053030030 |
HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 146-150kg |
Brand |
FDA |
2023-06-14 |
3500000.0000 |
HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system. |
None |
800 |
1 |
1 |
2021-05-06 |
450000000.0000 |
None |
CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.? |
None |
None |
| CSL Behring LLC |
00053031031 |
HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 151-155kg |
Brand |
FDA |
2023-06-14 |
3500000.0000 |
HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system. |
None |
800 |
1 |
1 |
2021-05-06 |
450000000.0000 |
None |
CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.? |
None |
None |
| CSL Behring LLC |
00053032032 |
HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 156-160kg |
Brand |
FDA |
2023-06-14 |
3500000.0000 |
HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system. |
None |
800 |
1 |
1 |
2021-05-06 |
450000000.0000 |
None |
CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.? |
None |
None |
| CSL Behring LLC |
00053033033 |
HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 161-165kg |
Brand |
FDA |
2023-06-14 |
3500000.0000 |
HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system. |
None |
800 |
1 |
1 |
2021-05-06 |
450000000.0000 |
None |
CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.? |
None |
None |
| CSL Behring LLC |
00053034034 |
HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 166-170kg |
Brand |
FDA |
2023-06-14 |
3500000.0000 |
HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system. |
None |
800 |
1 |
1 |
2021-05-06 |
450000000.0000 |
None |
CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.? |
None |
None |
| CSL Behring LLC |
00053035035 |
HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 171-175kg |
Brand |
FDA |
2023-06-14 |
3500000.0000 |
HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system. |
None |
800 |
1 |
1 |
2021-05-06 |
450000000.0000 |
None |
CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.? |
None |
None |
| CSL Behring LLC |
00053036036 |
HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 176-180kg |
Brand |
FDA |
2023-06-14 |
3500000.0000 |
HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system. |
None |
800 |
1 |
1 |
2021-05-06 |
450000000.0000 |
None |
CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.? |
None |
None |
| CSL Behring LLC |
00053037037 |
HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 181-185kg |
Brand |
FDA |
2023-06-14 |
3500000.0000 |
HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system. |
None |
800 |
1 |
1 |
2021-05-06 |
450000000.0000 |
None |
CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.? |
None |
None |
| CSL Behring LLC |
00053038038 |
HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 186-190kg |
Brand |
FDA |
2023-06-14 |
3500000.0000 |
HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system. |
None |
800 |
1 |
1 |
2021-05-06 |
450000000.0000 |
None |
CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.? |
None |
None |
| CSL Behring LLC |
00053039039 |
HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 191-195kg |
Brand |
FDA |
2023-06-14 |
3500000.0000 |
HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system. |
None |
800 |
1 |
1 |
2021-05-06 |
450000000.0000 |
None |
CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.? |
None |
None |
| CSL Behring LLC |
00053040040 |
HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 196-200kg |
Brand |
FDA |
2023-06-14 |
3500000.0000 |
HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system. |
None |
800 |
1 |
1 |
2021-05-06 |
450000000.0000 |
None |
CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.? |
None |
None |
| CSL Behring LLC |
00053041041 |
HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 201-205kg |
Brand |
FDA |
2023-06-14 |
3500000.0000 |
HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system. |
None |
800 |
1 |
1 |
2021-05-06 |
450000000.0000 |
None |
CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.? |
None |
None |
| CSL Behring LLC |
00053042042 |
HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 206-210kg |
Brand |
FDA |
2023-06-14 |
3500000.0000 |
HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system. |
None |
800 |
1 |
1 |
2021-05-06 |
450000000.0000 |
None |
CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.? |
None |
None |
| CSL Behring LLC |
00053043043 |
HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 211-215kg |
Brand |
FDA |
2023-06-14 |
3500000.0000 |
HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system. |
None |
800 |
1 |
1 |
2021-05-06 |
450000000.0000 |
None |
CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.? |
None |
None |
| CSL Behring LLC |
00053044044 |
HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 216-220kg |
Brand |
FDA |
2023-06-14 |
3500000.0000 |
HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system. |
None |
800 |
1 |
1 |
2021-05-06 |
450000000.0000 |
None |
CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.? |
None |
None |
| CSL Behring LLC |
00053045045 |
HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 221-225kg |
Brand |
FDA |
2023-06-14 |
3500000.0000 |
HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system. |
None |
800 |
1 |
1 |
2021-05-06 |
450000000.0000 |
None |
CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.? |
None |
None |
| CSL Behring LLC |
00053046046 |
HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 226-230kg |
Brand |
FDA |
2023-06-14 |
3500000.0000 |
HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system. |
None |
800 |
1 |
1 |
2021-05-06 |
450000000.0000 |
None |
CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.? |
None |
None |
| CSL Behring LLC |
00053047047 |
HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 231-235kg |
Brand |
FDA |
2023-06-14 |
3500000.0000 |
HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system. |
None |
800 |
1 |
1 |
2021-05-06 |
450000000.0000 |
None |
CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.? |
None |
None |
| CSL Behring LLC |
00053048048 |
HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 236-240kg |
Brand |
FDA |
2023-06-14 |
3500000.0000 |
HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system. |
None |
800 |
1 |
1 |
2021-05-06 |
450000000.0000 |
None |
CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.? |
None |
None |
| CSL Behring LLC |
00053011011 |
HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 51-55kg |
Brand |
FDA |
2023-06-14 |
3500000.0000 |
HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system. |
None |
800 |
1 |
1 |
2021-05-06 |
450000000.0000 |
None |
CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.? |
None |
None |
| CSL Behring LLC |
00053012012 |
HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 56-60kg |
Brand |
FDA |
2023-06-14 |
3500000.0000 |
HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system. |
None |
800 |
1 |
1 |
2021-05-06 |
450000000.0000 |
None |
CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.? |
None |
None |
| CSL Behring LLC |
00053013013 |
HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 61-65kg |
Brand |
FDA |
2023-06-14 |
3500000.0000 |
HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system. |
None |
800 |
1 |
1 |
2021-05-06 |
450000000.0000 |
None |
CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.? |
None |
None |
| CSL Behring LLC |
00053014014 |
HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 66-70kg |
Brand |
FDA |
2023-06-14 |
3500000.0000 |
HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system. |
None |
800 |
1 |
1 |
2021-05-06 |
450000000.0000 |
None |
CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.? |
None |
None |
| CSL Behring LLC |
00053015015 |
HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 71-75kg |
Brand |
FDA |
2023-06-14 |
3500000.0000 |
HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system. |
None |
800 |
1 |
1 |
2021-05-06 |
450000000.0000 |
None |
CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.? |
None |
None |
| CSL Behring LLC |
00053016016 |
HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 76-80kg |
Brand |
FDA |
2023-06-14 |
3500000.0000 |
HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system. |
None |
800 |
1 |
1 |
2021-05-06 |
450000000.0000 |
None |
CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.? |
None |
None |
| CSL Behring LLC |
00053017017 |
HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 81-85kg |
Brand |
FDA |
2023-06-14 |
3500000.0000 |
HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system. |
None |
800 |
1 |
1 |
2021-05-06 |
450000000.0000 |
None |
CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.? |
None |
None |
| CSL Behring LLC |
00053018018 |
HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 86-90kg |
Brand |
FDA |
2023-06-14 |
3500000.0000 |
HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system. |
None |
800 |
1 |
1 |
2021-05-06 |
450000000.0000 |
None |
CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.? |
None |
None |
| CSL Behring LLC |
00053019019 |
HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 91-95kg |
Brand |
FDA |
2023-06-14 |
3500000.0000 |
HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system. |
None |
800 |
1 |
1 |
2021-05-06 |
450000000.0000 |
None |
CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.? |
None |
None |
| CSL Behring LLC |
00053020020 |
HEMGENIX (etranacogene dezaparovovec-drlb) Injection, for IV Infusion, 96-100kg |
Brand |
FDA |
2023-06-14 |
3500000.0000 |
HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system. |
None |
800 |
1 |
1 |
2021-05-06 |
450000000.0000 |
None |
CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.? |
None |
None |
| CSL Behring LLC |
00053010010 |
HEMGENIX (etranacogene dezaparovovec-drlb?) Injection, for IV Infusion, 46-50kg |
Brand |
FDA |
2023-06-14 |
3500000.0000 |
HEMGENIX is a one-time gene therapy for the treatment of adults with hemophilia B who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Marketing activities that support the promotion of HEMGENIX are designed to increase awareness and understanding with healthcare providers and patients regarding the approved indication, efficacy / safety information, and practical considerations for education, eligibility screening, administration, and long-term follow-up. Our goal at CSL Behring is to develop medicines that will significantly improve patient care and provide meaningful value to healthcare systems, payers, and healthcare providers. When evaluating how we price medicines, we look at the value to patient care and take into consideration the costs of manufacturing, research and development and the ability for patients to access our medicines. The price for HEMGENIX reflects the significant clinical, societal, economic, and innovative value represented by this novel gene therapy, while also taking into consideration patient access to treatment and benefit to the overall healthcare system. |
None |
800 |
1 |
1 |
2021-05-06 |
450000000.0000 |
None |
CSL did not develop or acquire HEMGENIX. CSL entered into a Commercialization and Licensing agreement with uniQure. uniQure received an upfront cash payment of US$450 million, with the potential for regulatory and commercial sales milestone payments and royalties as the therapy is developed and commercialized.? |
None |
None |
| Daiichi Sankyo, Inc. |
65597050404 |
Vanflyta 17.7mg capsule 14 count |
Brand |
FDA |
2023-08-09 |
7644.0000 |
See attached |
None |
6033 |
1 |
1 |
None |
None |
None |
None |
In the U.S., an estimated 20,380 new cases of AML will be diagnosed in 2023. Up to 37% of newly diagnosed cases of AML have a FLT3 gene mutation and approximately 80% of these have FLT3-ITD mutations. The total estimated patient population is derived from these estimates provided by the American Cancer Society (https://www.cancer.org/cancer/types/acute-myeloid-leukemia/about/key-statistics.html) |
https://reports.siera.hcai.ca.gov/api/report/drug-pricing/attachment?id=707 |
| Daiichi Sankyo, Inc. |
65597050428 |
Vanflyta 17.7mg capsule 28 count |
Brand |
FDA |
2023-08-09 |
15288.0000 |
See attached |
None |
6033 |
1 |
1 |
None |
None |
None |
None |
In the U.S., an estimated 20,380 new cases of AML will be diagnosed in 2023. Up to 37% of newly diagnosed cases of AML have a FLT3 gene mutation and approximately 80% of these have FLT3-ITD mutations. The total estimated patient population is derived from these estimates provided by the American Cancer Society (https://www.cancer.org/cancer/types/acute-myeloid-leukemia/about/key-statistics.html) |
https://reports.siera.hcai.ca.gov/api/report/drug-pricing/attachment?id=706 |
| Daiichi Sankyo, Inc. |
65597051104 |
Vanflyta 26.5mg capsule 14 count |
Brand |
FDA |
2023-08-09 |
7644.0000 |
See attached |
None |
6033 |
1 |
1 |
None |
None |
None |
None |
In the U.S., an estimated 20,380 new cases of AML will be diagnosed in 2023. Up to 37% of newly diagnosed cases of AML have a FLT3 gene mutation and approximately 80% of these have FLT3-ITD mutations. The total estimated patient population is derived from these estimates provided by the American Cancer Society (https://www.cancer.org/cancer/types/acute-myeloid-leukemia/about/key-statistics.html) |
https://reports.siera.hcai.ca.gov/api/report/drug-pricing/attachment?id=709 |
| Daiichi Sankyo, Inc. |
65597051128 |
Vanflyta 26.5mg capsule 28 count |
Brand |
FDA |
2023-08-09 |
15288.0000 |
See attached |
None |
6033 |
1 |
1 |
None |
None |
None |
None |
In the U.S., an estimated 20,380 new cases of AML will be diagnosed in 2023. Up to 37% of newly diagnosed cases of AML have a FLT3 gene mutation and approximately 80% of these have FLT3-ITD mutations. The total estimated patient population is derived from these estimates provided by the American Cancer Society (https://www.cancer.org/cancer/types/acute-myeloid-leukemia/about/key-statistics.html) |
https://reports.siera.hcai.ca.gov/api/report/drug-pricing/attachment?id=708 |
| Dash Pharmaceuticals, LLC |
69339016803 |
Gefitinib 250mg |
Generic |
FDA |
2023-06-05 |
3995.0000 |
Marketed as a typical generic to wholesalers and distributors |
None |
12 |
None |
None |
None |
None |
None |
None |
Not Acquired, priced in line with other generic competitors in this low volume product |
None |
| Dr. Reddy's Laboratories, Inc. |
43598014206 |
Nelarabine Inj. 250mg/50mL 6's USA |
Generic |
FDA |
2023-01-12 |
3966.0000 |
None |
1 |
6000 |
None |
None |
None |
None |
None |
None |
1) Dr. Reddy’s did not acquire the product. 2) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. Estimate provided is the number of patients diagnosed with T-cell acute lymphoblastic leukemia. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598004563 |
Sunitinib Malate Caps 12.5mg 28s |
Generic |
FDA |
2023-01-16 |
4151.0900 |
None |
1 |
6000 |
None |
None |
None |
None |
None |
None |
1) Dr. Reddy’s did not acquire the product. 2) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. Estimate provided is the number of patients diagnosed with gastrointestinal stromal tumors (GIST) per year. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598004863 |
Sunitinib Malate Caps 50mg 28s |
Generic |
FDA |
2023-01-20 |
14452.9600 |
None |
1 |
6000 |
None |
None |
None |
None |
None |
None |
1) Dr. Reddy’s did not acquire the product. 2) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. Estimate provided is the number of patients diagnosed with gastrointestinal stromal tumors (GIST) per year. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598004663 |
Sunitinib Malate Caps 25mg 28s |
Generic |
FDA |
2023-02-16 |
8302.2100 |
None |
1 |
6000 |
None |
None |
None |
None |
None |
None |
1) Dr. Reddy’s did not acquire the product. 2) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. Estimate provided is the number of patients diagnosed with gastrointestinal stromal tumors (GIST) per year. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598023531 |
Cycloserine Capsules 250mg, 30s |
Generic |
FDA |
2023-03-30 |
2297.0000 |
None |
1 |
8300 |
None |
None |
None |
None |
None |
None |
Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. The estimate provided is the number of pulmonary tuberculosis patients in the US. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598064711 |
Treprostinil Injection 100 mg/20 mL (5 mg/mL), 20ml |
Generic |
FDA |
2023-04-20 |
5729.9400 |
None |
1 |
1000 |
None |
None |
None |
None |
None |
None |
1) This product was not acquired; 2) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. The estimate provided is based on the number of cases of pulmonary arterial hypertension in the US per year. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598064911 |
Treprostinil Injection 20 mg/20 mL (1 mg/mL), 20ml |
Generic |
FDA |
2023-04-20 |
1145.9900 |
None |
1 |
1000 |
None |
None |
None |
None |
None |
None |
1) This product was not acquired; 2) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Dr. Reddy’s lacks sufficient information to determine the
total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. The estimate provided is based on the number of cases of pulmonary arterial hypertension in the US per year. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598064811 |
Treprostinil Injection 200 mg/20 mL (10 mg/mL), 20ml |
Generic |
FDA |
2023-04-20 |
11459.8800 |
None |
1 |
1000 |
None |
None |
None |
None |
None |
None |
1) This product was not acquired; 2) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. The estimate provided is based on the number of cases of pulmonary arterial hypertension in the US per year. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598064611 |
Treprostinil Injection 50 mg/20 mL (2.5 mg/mL), 20ml |
Generic |
FDA |
2023-04-20 |
2864.9700 |
None |
1 |
1000 |
None |
None |
None |
None |
None |
None |
1) This product was not acquired; 2) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. The estimate provided is based on the number of cases of pulmonary arterial hypertension in the US per year. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598030823 |
Plerixafor Injection 24 mg/1.2mL 1s USA |
Generic |
FDA |
2023-11-28 |
1200.0000 |
None |
1 |
80550 |
None |
None |
None |
None |
None |
None |
1) Product was not acquired; 2) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Dr. Reddy’s lacks sufficient information to determine the
total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. The number provided is the estimate of people diagnosed with non-Hodgkin lymphoma in the US; and 3) Dr. Reddy’s Plerixafor was introduced to market on 11/28/2023. That is the date when the product was available for sale. The publicly available published date of 11/06/2023 is simply the date that the WAC pricing was listed with the pricing compendia. However, for generic products, listing of the WAC does not trigger the statute as that date is not the date that the product is available for sale. For purchases of this product, the drug was not available for sale in California until 11/28/2023. This was the same date that was filed in our 3-day reports, and the reports submitted to other states under their drug price transparency statutes, as well as the date for purposes of computing government price reporting. |
None |
| Edenbridge Pharmaceuticals, LLC |
42799070915 |
100mg Capsule, 15ct in 1 box |
Generic |
FDA |
2023-11-01 |
4018.5300 |
None |
1 |
12 |
None |
None |
None |
None |
None |
None |
None |
None |
| Edenbridge Pharmaceuticals, LLC |
82111095502 |
Hemady - 20mg Tablet, 100ct bottle |
Brand |
FDA |
2023-12-01 |
2739.7100 |
None |
1 |
10000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Edenbridge Pharmaceuticals, LLC |
42799095402 |
Donepezil HCl Oral Tablet 23 MG, 90ct 1 bottle |
Generic |
FDA |
2023-12-05 |
851.7700 |
None |
1 |
2000 |
None |
None |
None |
None |
None |
None |
This product has been listed in the compendium with an effective start date of 10/24/2023. The first lot of product is still in production, and the actual date of physical availability on the market is estimated to be in early December. |
None |
| Eisai Inc. |
62856021201 |
Leqembi 200mg/2ml |
Brand |
FDA |
2023-01-18 |
254.8100 |
Marketing Plan - During accelerated approval, Eisai's marketing engagements with healthcare professionals generally will be limited to and focused on understanding how an AD therapy will be integrated into practice.
Pricing Plan - Eisai considered a holistic approach in assessing value and making decisions that may affect patient access, so that our LEQEMBI pricing approach can maximize value for all stakeholders (patients, families, caregivers, healthcare providers, payers, employees and shareholders). This approach includes clinical outcome assessments of our medicines and the benefits we deliver to patients, their families and caregivers as the "clinical value," as well as the projected "social value" that help improve patients' and caregivers' quality of life and productivity. Moreover, we assess the simulated impact of our medicines on reducing demand for health services and global burden of disease as potential "economic value" while enhancing further innovations in AD.?
?Eisai decided to price LEQEMBI below the quantified societal value. For further details, including Eisai’s calculation of the societal value, please see Eisai’s press release dated January 6, 2023 titled EISAI'S APPROACH TO U.S. PRICING FOR LEQEMBI™ (LECANEMAB), A TREATMENT FOR EARLY ALZHEIMER'S DISEASE, SETS FORTH OUR CONCEPT OF "SOCIETAL VALUE OF MEDICINE" IN RELATION TO "PRICE OF MEDICINE" |
None |
100000 |
1 |
1 |
None |
None |
None |
None |
Estimated Volume of Patients - "In the U.S., we estimate that the diagnosed eligible Early AD population will reach approximately 100,000 individuals by year 3 representing a measured initial attainment in the real world and will increase gradually over the mid-to-long term given the time required to advance new screening and diagnostic technologies such as blood-based biomarkers to confirm amyloid beta pathology." |
None |
| Eisai Inc. |
62856021501 |
Leqembi 500mg/5ml |
Brand |
FDA |
2023-01-18 |
637.0200 |
Marketing Plan - During accelerated approval, Eisai's marketing engagements with healthcare professionals generally will be limited to and focused on understanding how an AD therapy will be integrated into practice.
Pricing Plan - Eisai considered a holistic approach in assessing value and making decisions that may affect patient access, so that our LEQEMBI pricing approach can maximize value for all stakeholders (patients, families, caregivers, healthcare providers, payers, employees and shareholders). This approach includes clinical outcome assessments of our medicines and the benefits we deliver to patients, their families and caregivers as the "clinical value," as well as the projected "social value" that help improve patients' and caregivers' quality of life and productivity. Moreover, we assess the simulated impact of our medicines on reducing demand for health services and global burden of disease as potential "economic value" while enhancing further innovations in AD.?
?Eisai decided to price LEQEMBI below the quantified societal value. For further details, including Eisai’s calculation of the societal value, please see Eisai’s press release dated January 6, 2023 titled EISAI'S APPROACH TO U.S. PRICING FOR LEQEMBI™ (LECANEMAB), A TREATMENT FOR EARLY ALZHEIMER'S DISEASE, SETS FORTH OUR CONCEPT OF "SOCIETAL VALUE OF MEDICINE" IN RELATION TO "PRICE OF MEDICINE" |
None |
100000 |
1 |
1 |
None |
None |
None |
None |
Estimated Volume of Patients - "In the U.S., we estimate that the diagnosed eligible Early AD population will reach approximately 100,000 individuals by year 3 representing a measured initial attainment in the real world and will increase gradually over the mid-to-long term given the time required to advance new screening and diagnostic technologies such as blood-based biomarkers to confirm amyloid beta pathology." |
None |
| Eli Lilly and Company |
00002702660 |
Jaypirca 100mg 60 tablets |
Brand |
FDA |
2023-01-27 |
21000.0000 |
None |
1 |
3500 |
None |
None |
2019-02-15 |
6920000000.0000 |
None |
Lilly acquired Loxo Oncology, Inc, on February 15, 2019 for a purchase price of approximately $6.92 billion, net of cash acquired. Under the terms of the agreement, Lilly acquired a pipeline of investigational medicines, including pirtobrutinib (Loxo-305). [https://investor.lilly.com/static-files/cd4a37af-ec28-449c-9bfb-ae380700209a] |
Pirtobrutinib is a highly selective, non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor. BTK plays a key role in the B-cell antigen receptor signaling pathway, which is required for the development, activation and survival of normal white blood cells, known as B-cells, and malignant B-cells.
Based on data from the National Cancer Institutes’ SEER Cancer Statistics Review, approximately 3500 patients in the US are diagnosed with Mantle-cell lymphoma (MCL) per year. MCL incidence is 0.8 per 100,000 people. (SEER, 2017. Trends in SEER Incidence and US Mortality; 1975-2017. Table 19.26 All Lymphoid Neoplasms with Detailed Non-Hodgkin Lymphoma Subtypes 2008-2017. Available at: Non-Hodgkin Lymphoma, CSR 1975-2017 (cancer.gov)). People with MCL may or may not use Jaypirca.
All information is provided by Eli Lilly and Company ("Lilly") to the best of our knowledge at the time of submission. Lilly provides this report consistent with its understanding and interpretation of California Health and Safety Code Chapter 9 §127675-127686 and its related provisions. In providing this report, Lilly does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California Health and Safety Code Chapter 9 §127675-127686 as it may relate to Lilly or any of its affiliates now or in the future. Lilly, on behalf of itself and affiliates, expressly reserves all such rights. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Lilly believes is otherwise in the public domain or publicly available. For more information, see https://investor.lilly.com/news-releases/news-release-details/us-fda-approves-jaypircatm-pirtobrutinib-first-and-only-non. |
None |
| Eli Lilly and Company |
00002690230 |
Jaypirca 50mg 30 tablets |
Brand |
FDA |
2023-01-27 |
7000.0000 |
None |
1 |
3500 |
None |
None |
2019-02-15 |
6920000000.0000 |
None |
Lilly acquired Loxo Oncology, Inc, on February 15, 2019 for a purchase price of approximately $6.92 billion, net of cash acquired. Under the terms of the agreement, Lilly acquired a pipeline of investigational medicines, including pirtobrutinib (Loxo-305). [https://investor.lilly.com/static-files/cd4a37af-ec28-449c-9bfb-ae380700209a] |
Pirtobrutinib is a highly selective, non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor. BTK plays a key role in the B-cell antigen receptor signaling pathway, which is required for the development, activation and survival of normal white blood cells, known as B-cells, and malignant B-cells.
Based on data from the National Cancer Institutes’ SEER Cancer Statistics Review, approximately 3500 patients in the US are diagnosed with Mantle-cell lymphoma (MCL) per year. MCL incidence is 0.8 per 100,000 people. (SEER, 2017. Trends in SEER Incidence and US Mortality; 1975-2017. Table 19.26 All Lymphoid Neoplasms with Detailed Non-Hodgkin Lymphoma Subtypes 2008-2017. Available at: Non-Hodgkin Lymphoma, CSR 1975-2017 (cancer.gov)). People with MCL may or may not use Jaypirca.
All information is provided by Eli Lilly and Company ("Lilly") to the best of our knowledge at the time of submission. Lilly provides this report consistent with its understanding and interpretation of California Health and Safety Code Chapter 9 §127675-127686 and its related provisions. In providing this report, Lilly does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California Health and Safety Code Chapter 9 §127675-127686 as it may relate to Lilly or any of its affiliates now or in the future. Lilly, on behalf of itself and affiliates, expressly reserves all such rights. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Lilly believes is otherwise in the public domain or publicly available. For more information, see https://investor.lilly.com/news-releases/news-release-details/us-fda-approves-jaypircatm-pirtobrutinib-first-and-only-non. |
None |
| Eli Lilly and Company |
00002801127 |
OMVOH 100 mg/mL 2 single patient-use prefilled pens |
Brand |
FDA |
2023-10-27 |
10360.6700 |
None |
1 |
730000 |
None |
None |
None |
None |
None |
None |
Omvoh™ (mirikizumab-mrkz) infusion (300 mg/15 mL)/injection (100 mg/mL) is the first and only FDA approved interleukin-23p19 (IL-23p19) antagonist for the treatment of moderately to severely active ulcerative colitis (UC) in adults. Marking a significant milestone, Omvoh is the only UC treatment that selectively targets the p19 subunit of IL-23, which plays a role in inflammation related to UC.
Approximately 730,000 adults in the United States have ulcerative colitis (see, for example Prevalence of Inflammatory Bowel Disease Among Medicare Fee-For-Service Beneficiaries — United States, 2001-2018 | MMWR at https://www.cdc.gov/mmwr/volumes/70/wr/mm7019a2.htm# (estimating prevalence in adults 65 and older) and Prevalence of Inflammatory Bowel Disease in Pediatric and Adult Populations: Recent Estimates From Large National Databases in the United States, 2007–2016 | Inflammatory Bowel Diseases | Oxford Academic at https://academic.oup.com/ibdjournal/article/26/4/619/5554163 (estimating prevalence in adults 18-65); see also Definition & Facts of Ulcerative Colitis - NIDDK at https://www.niddk.nih.gov/health-information/digestive-diseases/ulcerative-colitis/definition-facts). People with ulcerative colitis may or may not use Omvoh.
All information is provided by Eli Lilly and Company ("Lilly") to the best of our knowledge at the time of submission. Lilly provides this report consistent with its understanding and interpretation of California Health and Safety Code Chapter 9 §127675-127686 and its related provisions. In providing this report, Lilly does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California Health and Safety Code Chapter 9 §127675-127686 as it may relate to Lilly or any of its affiliates now or in the future. Lilly, on behalf of itself and affiliates, expressly reserves all such rights. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Lilly believes is otherwise in the public domain or publicly available. For more information, see https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-omvohtm-mirikizumab-mrkz-first-class. |
None |
| Eli Lilly and Company |
00002757501 |
OMVOH 20 mg/mL (300 mg/15 mL) 1 300 mg vial |
Brand |
FDA |
2023-10-27 |
9593.2200 |
None |
1 |
730000 |
None |
None |
None |
None |
None |
None |
Omvoh™ (mirikizumab-mrkz) infusion (300 mg/15 mL)/injection (100 mg/mL) is the first and only FDA approved interleukin-23p19 (IL-23p19) antagonist for the treatment of moderately to severely active ulcerative colitis (UC) in adults. Marking a significant milestone, Omvoh is the only UC treatment that selectively targets the p19 subunit of IL-23, which plays a role in inflammation related to UC.
Approximately 730,000 adults in the United States have ulcerative colitis (see, for example Prevalence of Inflammatory Bowel Disease Among Medicare Fee-For-Service Beneficiaries — United States, 2001-2018 | MMWR at https://www.cdc.gov/mmwr/volumes/70/wr/mm7019a2.htm# (estimating prevalence in adults 65 and older) and Prevalence of Inflammatory Bowel Disease in Pediatric and Adult Populations: Recent Estimates From Large National Databases in the United States, 2007–2016 | Inflammatory Bowel Diseases | Oxford Academic at https://academic.oup.com/ibdjournal/article/26/4/619/5554163 (estimating prevalence in adults 18-65); see also Definition & Facts of Ulcerative Colitis - NIDDK at https://www.niddk.nih.gov/health-information/digestive-diseases/ulcerative-colitis/definition-facts). People with ulcerative colitis may or may not use Omvoh.
All information is provided by Eli Lilly and Company ("Lilly") to the best of our knowledge at the time of submission. Lilly provides this report consistent with its understanding and interpretation of California Health and Safety Code Chapter 9 §127675-127686 and its related provisions. In providing this report, Lilly does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California Health and Safety Code Chapter 9 §127675-127686 as it may relate to Lilly or any of its affiliates now or in the future. Lilly, on behalf of itself and affiliates, expressly reserves all such rights. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Lilly believes is otherwise in the public domain or publicly available. For more information, see https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-omvohtm-mirikizumab-mrkz-first-class. |
None |
| Eli Lilly and Company |
00002247180 |
ZepboundTM 10mg/ 0.5 mL 4 single-dose pens |
Brand |
FDA |
2023-11-09 |
1059.8700 |
None |
1 |
124000000 |
None |
1 |
None |
None |
None |
None |
Zepbound™ (tirzepatide) injection is the first and only obesity treatment that works by activating both GIP and GLP-1 hormone receptors. Zepbound is indicated for use in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese); or a BMI of 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition. Zepbound was approved by the FDA in November 2023.
Zepbound™ (tirzepatide) is indicated for use in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese); or a BMI of 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition. Based on an abstract submitted to the Journal of the American College of Cardiology, data from the National Health and Nutrition Examination Survey (NHANES) from 2015-2018 showed 51% (124 million) of US adults were eligible for anti-obesity medications. (Journal of American College of Cardiology, Volume 79, Issue 9, Supplement, 2022, page 1444. Available at: https://doi.org/10.1016/S0735-1097(22)02435-4). Eligible patients may or may not use Zepbound.
All information is provided by Eli Lilly and Company ("Lilly") to the best of our knowledge at the time of submission. Lilly provides this report consistent with its understanding and interpretation of California Health and Safety Code Chapter 9 §127675-127686 and its related provisions. In providing this report, Lilly does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California Health and Safety Code Chapter 9 §127675-127686 as it may relate to Lilly or any of its affiliates now or in the future. Lilly, on behalf of itself and affiliates, expressly reserves all such rights. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Lilly believes is otherwise in the public domain or publicly available. For more information, see https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-zepboundtm-tirzepatide-chronic-weight. |
None |
| Eli Lilly and Company |
00002246080 |
ZepboundTM 12.5mg/ 0.5 mL 4 single-dose pens |
Brand |
FDA |
2023-11-09 |
1059.8700 |
None |
1 |
124000000 |
None |
1 |
None |
None |
None |
None |
Zepbound™ (tirzepatide) injection is the first and only obesity treatment that works by activating both GIP and GLP-1 hormone receptors. Zepbound is indicated for use in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese); or a BMI of 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition. Zepbound was approved by the FDA in November 2023.
Zepbound™ (tirzepatide) is indicated for use in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese); or a BMI of 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition. Based on an abstract submitted to the Journal of the American College of Cardiology, data from the National Health and Nutrition Examination Survey (NHANES) from 2015-2018 showed 51% (124 million) of US adults were eligible for anti-obesity medications. (Journal of American College of Cardiology, Volume 79, Issue 9, Supplement, 2022, page 1444. Available at: https://doi.org/10.1016/S0735-1097(22)02435-4). Eligible patients may or may not use Zepbound.
All information is provided by Eli Lilly and Company ("Lilly") to the best of our knowledge at the time of submission. Lilly provides this report consistent with its understanding and interpretation of California Health and Safety Code Chapter 9 §127675-127686 and its related provisions. In providing this report, Lilly does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California Health and Safety Code Chapter 9 §127675-127686 as it may relate to Lilly or any of its affiliates now or in the future. Lilly, on behalf of itself and affiliates, expressly reserves all such rights. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Lilly believes is otherwise in the public domain or publicly available. For more information, see https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-zepboundtm-tirzepatide-chronic-weight. |
None |
| Eli Lilly and Company |
00002245780 |
ZepboundTM 15mg/ 0.5 mL 4 single-dose pens |
Brand |
FDA |
2023-11-09 |
1059.8700 |
None |
1 |
124000000 |
None |
1 |
None |
None |
None |
None |
Zepbound™ (tirzepatide) injection is the first and only obesity treatment that works by activating both GIP and GLP-1 hormone receptors. Zepbound is indicated for use in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese); or a BMI of 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition. Zepbound was approved by the FDA in November 2023.
Zepbound™ (tirzepatide) is indicated for use in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese); or a BMI of 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition. Based on an abstract submitted to the Journal of the American College of Cardiology, data from the National Health and Nutrition Examination Survey (NHANES) from 2015-2018 showed 51% (124 million) of US adults were eligible for anti-obesity medications. (Journal of American College of Cardiology, Volume 79, Issue 9, Supplement, 2022, page 1444. Available at: https://doi.org/10.1016/S0735-1097(22)02435-4). Eligible patients may or may not use Zepbound.
All information is provided by Eli Lilly and Company ("Lilly") to the best of our knowledge at the time of submission. Lilly provides this report consistent with its understanding and interpretation of California Health and Safety Code Chapter 9 §127675-127686 and its related provisions. In providing this report, Lilly does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California Health and Safety Code Chapter 9 §127675-127686 as it may relate to Lilly or any of its affiliates now or in the future. Lilly, on behalf of itself and affiliates, expressly reserves all such rights. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Lilly believes is otherwise in the public domain or publicly available. For more information, see https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-zepboundtm-tirzepatide-chronic-weight. |
None |
| Eli Lilly and Company |
00002250680 |
ZepboundTM 2.5mg/ 0.5 mL 4 single-dose pens |
Brand |
FDA |
2023-11-09 |
1059.8700 |
None |
1 |
124000000 |
None |
1 |
None |
None |
None |
None |
Zepbound™ (tirzepatide) injection is the first and only obesity treatment that works by activating both GIP and GLP-1 hormone receptors. Zepbound is indicated for use in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese); or a BMI of 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition. Zepbound was approved by the FDA in November 2023.
Zepbound™ (tirzepatide) is indicated for use in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese); or a BMI of 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition. Based on an abstract submitted to the Journal of the American College of Cardiology, data from the National Health and Nutrition Examination Survey (NHANES) from 2015-2018 showed 51% (124 million) of US adults were eligible for anti-obesity medications. (Journal of American College of Cardiology, Volume 79, Issue 9, Supplement, 2022, page 1444. Available at: https://doi.org/10.1016/S0735-1097(22)02435-4). Eligible patients may or may not use Zepbound.
All information is provided by Eli Lilly and Company ("Lilly") to the best of our knowledge at the time of submission. Lilly provides this report consistent with its understanding and interpretation of California Health and Safety Code Chapter 9 §127675-127686 and its related provisions. In providing this report, Lilly does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California Health and Safety Code Chapter 9 §127675-127686 as it may relate to Lilly or any of its affiliates now or in the future. Lilly, on behalf of itself and affiliates, expressly reserves all such rights. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Lilly believes is otherwise in the public domain or publicly available. For more information, see https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-zepboundtm-tirzepatide-chronic-weight. |
None |
| Eli Lilly and Company |
00002249580 |
ZepboundTM 5mg/ 0.5 mL 4 single-dose pens |
Brand |
FDA |
2023-11-09 |
1059.8700 |
None |
1 |
124000000 |
None |
1 |
None |
None |
None |
None |
Zepbound™ (tirzepatide) injection is the first and only obesity treatment that works by activating both GIP and GLP-1 hormone receptors. Zepbound is indicated for use in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese); or a BMI of 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition. Zepbound was approved by the FDA in November 2023.
Zepbound™ (tirzepatide) is indicated for use in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese); or a BMI of 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition. Based on an abstract submitted to the Journal of the American College of Cardiology, data from the National Health and Nutrition Examination Survey (NHANES) from 2015-2018 showed 51% (124 million) of US adults were eligible for anti-obesity medications. (Journal of American College of Cardiology, Volume 79, Issue 9, Supplement, 2022, page 1444. Available at: https://doi.org/10.1016/S0735-1097(22)02435-4). Eligible patients may or may not use Zepbound.
All information is provided by Eli Lilly and Company ("Lilly") to the best of our knowledge at the time of submission. Lilly provides this report consistent with its understanding and interpretation of California Health and Safety Code Chapter 9 §127675-127686 and its related provisions. In providing this report, Lilly does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California Health and Safety Code Chapter 9 §127675-127686 as it may relate to Lilly or any of its affiliates now or in the future. Lilly, on behalf of itself and affiliates, expressly reserves all such rights. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Lilly believes is otherwise in the public domain or publicly available. For more information, see https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-zepboundtm-tirzepatide-chronic-weight. |
None |
| Eli Lilly and Company |
00002248480 |
ZepboundTM 7.5mg/ 0.5 mL 4 single-dose pens |
Brand |
FDA |
2023-11-09 |
1059.8700 |
None |
1 |
124000000 |
None |
1 |
None |
None |
None |
None |
Zepbound™ (tirzepatide) injection is the first and only obesity treatment that works by activating both GIP and GLP-1 hormone receptors. Zepbound is indicated for use in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese); or a BMI of 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition. Zepbound was approved by the FDA in November 2023.
Zepbound™ (tirzepatide) is indicated for use in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese); or a BMI of 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition. Based on an abstract submitted to the Journal of the American College of Cardiology, data from the National Health and Nutrition Examination Survey (NHANES) from 2015-2018 showed 51% (124 million) of US adults were eligible for anti-obesity medications. (Journal of American College of Cardiology, Volume 79, Issue 9, Supplement, 2022, page 1444. Available at: https://doi.org/10.1016/S0735-1097(22)02435-4). Eligible patients may or may not use Zepbound.
All information is provided by Eli Lilly and Company ("Lilly") to the best of our knowledge at the time of submission. Lilly provides this report consistent with its understanding and interpretation of California Health and Safety Code Chapter 9 §127675-127686 and its related provisions. In providing this report, Lilly does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California Health and Safety Code Chapter 9 §127675-127686 as it may relate to Lilly or any of its affiliates now or in the future. Lilly, on behalf of itself and affiliates, expressly reserves all such rights. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Lilly believes is otherwise in the public domain or publicly available. For more information, see https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-zepboundtm-tirzepatide-chronic-weight. |
None |
| Epic Pharma |
42806037230 |
Deferasirox 180mg Oral Granules 30 sachets |
Generic |
FDA |
2023-04-12 |
2049.9800 |
None |
1 |
1000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Epic Pharma |
42806037330 |
Deferasirox 360mg Oral Granules 30 sachets |
Generic |
FDA |
2023-04-12 |
4099.8700 |
None |
1 |
1000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Epic Pharma |
42806037130 |
Deferasirox 90mg Oral Granules 30 sachets |
Generic |
FDA |
2023-04-12 |
1025.0100 |
None |
1 |
1000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Exelan Pharmaceuticals, Inc. |
76282071527 |
Pirfenidone Capsules 267mg 270ct |
Generic |
FDA |
2023-01-23 |
5194.5600 |
None |
1 |
100000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Exelan Pharmaceuticals, Inc. |
76282052530 |
Lurasidone HCL 120mg Tab 30ct |
Generic |
FDA |
2023-09-29 |
1221.4600 |
None |
1 |
2400000 |
None |
None |
None |
None |
None |
None |
Product was not acquired |
None |
| Ferring Pharmaceuticals |
55566980010 |
REBYOTA (Fecal microbiota, live -jslm) |
Brand |
FDA |
2023-01-23 |
9000.0000 |
None |
1 |
4500 |
1 |
1 |
None |
None |
None |
None |
REBYOTA was not acquired. Comment regarding estimated patients: Ferring estimates the annual patient estimate to be in the range of 4,000-5,000. This patient estimate is based on a national annual projection for the product based on disease state and indication. We do not have estimates for individual states at this time. |
None |
| Ferring Pharmaceuticals |
55566105001 |
ADSTILADRIN® (nadofaragene firadenovec-vncg), 4 x 80 mL Intravesical Suspension, Vial |
Brand |
FDA |
2023-09-05 |
60000.0000 |
None |
1 |
8500 |
1 |
1 |
None |
None |
None |
None |
Adstiladrin was not acquired. Comment regarding estimated patients: Based on current supply constraints, Ferring is capable of supplying Adstiladrin to approximately 400 patients in 2023 and 900 patients in 2024. Overall market when supply constraint is lifted in 2025 will be 8-9k patients per year. This patient estimate is based on a national annual projection for the product based on disease state and indication. We do not have estimates for individual states at this time. |
https://reports.siera.hcai.ca.gov/api/report/drug-pricing/attachment?id=710 |
| Florida Pharmaceutical Products, LLC |
71921017706 |
Purple oval shaped, biconvex bevel edged film-coated tablets, debossed with "A" on one side and "500" on the other side |
Generic |
FDA |
2023-05-08 |
1800.0000 |
Since this ANDA is already generic in the US market and there are other generics available to pharmacies, there is no additional marketing plan required. Our general marketing plan for generic pharmaceuticals is to speak to buyers at wholesale distributors and retail pharmacy chains. Our pricing per bottle will be in alignment with average net pricing currently available. There is no intention to speak to prescribers. |
None |
24000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Fresenius Kabi USA LLC |
65219037110 |
Stimufend Subcutaneous Solution Prefilled Syringe 6 MG/0.6ML Package Size 0.6 Package Quantity 1 |
Brand |
FDA |
2023-02-08 |
4175.0000 |
None |
1 |
1500 |
None |
None |
None |
None |
None |
None |
None |
None |
| Fresenius Kabi USA LLC |
65219040303 |
Zinc Sulfate Intravenous Solution 3 MG/ML Package Size 10 Package Quantity 25 |
Generic |
FDA |
2023-02-15 |
1050.0000 |
None |
None |
83 |
None |
None |
None |
None |
None |
None |
None |
None |
| Fresenius Kabi USA LLC |
65219040505 |
Zinc Sulfate Intravenous Solution 5 MG/ML Package Size 5 Package Quantity 25 |
Generic |
FDA |
2023-02-15 |
875.0000 |
None |
None |
3900 |
None |
None |
None |
None |
None |
None |
None |
None |
| Fresenius Kabi USA LLC |
65219056420 |
Mitomycin intravenous solution reconstituted 5 MG 1 Vial |
Generic |
FDA |
2023-03-01 |
243.2700 |
None- generic product. |
None |
100 |
None |
None |
None |
None |
None |
None |
None |
None |
| Fresenius Kabi USA LLC |
65219056620 |
mitoMYcin Intravenous Solution Reconstituted 20 MG Package Size 1 Package Quantity 1 |
Generic |
FDA |
2023-03-07 |
631.9800 |
None- generic product. $0 – There was no budgeted or actual spending for direct-to-consumer or physician marketing. |
None |
100 |
None |
None |
None |
None |
None |
None |
None |
None |
| Fresenius Kabi USA LLC |
65219056800 |
mitoMYcin Intravenous Solution Reconstituted 40 MG Package Size 1 Package Quantity 1 |
Generic |
FDA |
2023-03-28 |
1263.9600 |
None- generic product. $0 – There was no budgeted or actual spending for direct-to-consumer or physician marketing. |
None |
100 |
None |
None |
None |
None |
None |
None |
None |
None |
| Fresenius Kabi USA LLC |
63323057905 |
Sincalide Injection Solution Reconstituted 5 MCG Package Size 1 Package Quantity 10 |
Brand |
FDA |
2023-06-20 |
1241.3000 |
None |
1 |
800000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Fresenius Kabi USA LLC |
65219055438 |
Idacio for Crohns Disease/UC Subcutaneous Auto-injector Kit 40 MG/0.8ML Package Size 1 Package Quantity 3 |
Brand |
FDA |
2023-07-01 |
19729.4700 |
None |
1 |
600000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Fresenius Kabi USA LLC |
65219055428 |
Idacio for Plaque Psoriasis Subcutaneous Auto-injector Kit 40 MG/0.8ML Package Size 1 Package Quantity 2 |
Brand |
FDA |
2023-07-01 |
13152.9800 |
None |
1 |
600000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Fresenius Kabi USA LLC |
65219055408 |
Idacio Subcutaneous Auto-injector Kit 40 MG/0.8ML Package Size 1 Package Quantity 1 |
Brand |
FDA |
2023-07-01 |
6576.4900 |
None |
1 |
600000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Fresenius Kabi USA LLC |
65219055618 |
Idacio Subcutaneous Prefilled Syringe Kit 40 MG/0.8ML Package Size 1 Package Quantity 1 |
Brand |
FDA |
2023-07-01 |
6576.4900 |
None |
1 |
600000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Fresenius Kabi USA LLC |
65219002805 |
Ganirelix Acetate Subcutaneous Solution Prefilled Syringe 250 MCG/0.5ML |
Generic |
FDA |
2023-07-07 |
216.4500 |
None |
1 |
230000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Fresenius Kabi USA LLC |
65219025810 |
Cardioplegic Perfusion Solution Package Size 1000 ML Package Quantity 10 |
Generic |
FDA |
2023-07-18 |
495.1000 |
None |
None |
21600 |
None |
None |
None |
None |
None |
None |
WAC is 495.10 with a package quantity of 10 bags however a 30 day course of therapy can range from 2-20 bags. Therefore if 20 bags are needed in a 30 day course of therapy the WAC would be $990.20 |
None |
| Fresenius Kabi USA LLC |
65219028412 |
Plerixafor Subcutaneous Solution 24 MG/1.2ML Package Size 1.2 ML Package Quantity 1 |
Generic |
FDA |
2023-07-24 |
2990.0000 |
None |
1 |
12000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Fresenius Kabi USA LLC |
65219057901 |
Carboprost Tromethamine Intramuscular Solution 250 MCG/ML 10 Vials |
Generic |
FDA |
2023-07-25 |
1320.0000 |
None |
1 |
20000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Fresenius Kabi USA LLC |
65219028110 |
Gadobutrol Intravenous Solution Package Size 10 ML Package Quantity 20 |
Generic |
FDA |
2023-07-31 |
1162.0000 |
None |
1 |
13200000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Fresenius Kabi USA LLC |
65219028107 |
Gadobutrol Intravenous Solution Package Size 7.5 ML Package Quantity 20 |
Generic |
FDA |
2023-07-31 |
871.6000 |
None |
1 |
13200000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Fresenius Kabi USA LLC |
65219028115 |
Gadobutrol Intravenous Solution Package Size 15 ML Package Quantity 20 |
Generic |
FDA |
2023-07-31 |
1743.0000 |
None |
1 |
13200000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Gamida Cell Inc. |
73441080004 |
Omisirge Cultured Fraction =8.0x10^8 TVNC and Non-Cultured Fraction =4.0x10^8 TVNC Intravenous, 1 each |
Brand |
FDA |
2023-04-18 |
338000.0000 |
OMISIRGE® will be promoted by our account management team to healthcare professionals to educate them on our product. We will use various means of promotion including in-office visits and through online channels such as websites. Pricing was established by performing extensive market research and analysis on our clinical and healthcare resource utilization data. Additionally, it involved years of product development investments and various operational costs.
Gamida Cell’s detailed marketing or pricing plans for OMISIRGE® are not publicly available. |
None |
2200 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Genentech USA |
50242015901 |
1 mg/1 mL vial |
Brand |
FDA |
2023-01-09 |
594.0600 |
Marketing activities that support the launch of a new medicine are designed to raise awareness and understanding with healthcare providers and - in some cases - patients about the approved indication(s), efficacy and safety data contained within the medicine's FDA approved label.
We take decisions related to the prices of our medicines very seriously. When determining pricing, we consider a number of factors including: how well the medicine works and how it compares to other available treatments; the financial resources required to continue discovering new medicines for people with serious diseases; and how to ensure that the price doesn’t prevent our medicines getting to people who need them. |
None |
589 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Genentech USA |
50242014201 |
30 mg/30 mL vial |
Brand |
FDA |
2023-01-09 |
17821.7800 |
Marketing activities that support the launch of a new medicine are designed to raise awareness and understanding with healthcare providers and - in some cases - patients about the approved indication(s), efficacy and safety data contained within the medicine's FDA approved label.
We take decisions related to the prices of our medicines very seriously. When determining pricing, we consider a number of factors including: how well the medicine works and how it compares to other available treatments; the financial resources required to continue discovering new medicines for people with serious diseases; and how to ensure that the price doesn’t prevent our medicines getting to people who need them. |
None |
589 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Genentech USA |
50242012701 |
Columvi 10mg/10mL Vial |
Brand |
FDA |
2023-06-27 |
10218.9800 |
Marketing activities that support the launch of a new medicine are designed to raise awareness and understanding with healthcare providers and - in some cases - patients about the approved indication(s), efficacy and safety data contained within the medicine's FDA approved label.
We take decisions related to the prices of our medicines very seriously. When determining pricing, we consider a number of factors including: how well the medicine works and how it compares to other available treatments; the financial resources required to continue discovering new medicines for people with serious diseases; and how to ensure that the price doesn’t prevent our medicines getting to people who need them. |
None |
216 |
None |
1 |
None |
None |
None |
None |
None |
None |
| Genentech USA |
50242012501 |
Columvi 2.5mg/2.5mL Vial |
Brand |
FDA |
2023-06-27 |
2554.7400 |
Marketing activities that support the launch of a new medicine are designed to raise awareness and understanding with healthcare providers and - in some cases - patients about the approved indication(s), efficacy and safety data contained within the medicine's FDA approved label.
We take decisions related to the prices of our medicines very seriously. When determining pricing, we consider a number of factors including: how well the medicine works and how it compares to other available treatments; the financial resources required to continue discovering new medicines for people with serious diseases; and how to ensure that the price doesn’t prevent our medicines getting to people who need them. |
None |
216 |
None |
1 |
None |
None |
None |
None |
None |
None |
| GENMAB US, INC. |
82705001001 |
EPKINLY 48mg/0.8mL Injection |
Brand |
FDA |
2023-05-31 |
15225.5600 |
Marketing Plan
Activities that support the launch of EPKINLY™ (epcoritamab-bysp) include interactions with healthcare professionals, patients, and payers. These activities are designed to raise awareness and understanding of the approved indication, efficacy and safety data contained in the medicine's FDA approved label. Awareness of EPKINLY™ will be raised through educational websites, print and digital media, and the use of sales representatives to educate about the FDA-approved indication.
Pricing Plan
At Genmab, we are driven by patient impact. We positively impact the lives of people with cancer when our transformational science becomes medicine, and our medicines reach the people who need them and help them live better.
The price of our medicines reflects the novelty of our science, its impact on patients, and our commitment to bringing that science to patients.
The price of EPKINLY™ (epcoritamab-bysp) takes into consideration its transformational potential as the first and only T-cell engaging bispecific antibody treatment administered subcutaneously for patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL), which is an aggressive disease with limited treatment options. |
None |
30400 |
None |
1 |
None |
None |
None |
None |
EPKINLY™ (epcoritamab-bysp) is the first-and-only bispecific antibody given by subcutaneous injection and approved to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma that has come back or that didn't respond after 2 or more prior treatments. DLBCL is the most common type of Non-Hodgkin’s lymphoma (NHL) worldwide, accounting for approximately 30 percent of all NHL cases and comprising an estimated 30,400 U.S. cases in 2022. Exact information for the EPKINLY™ indicated patient population is not available in the public domain. |
None |
| GENMAB US, INC. |
82705000201 |
EPKINLY 4mg/0.8mL Injection |
Brand |
FDA |
2023-05-31 |
1268.8000 |
Marketing Plan
Activities that support the launch of EPKINLY™ (epcoritamab-bysp) include interactions with healthcare professionals, patients, and payers. These activities are designed to raise awareness and understanding of the approved indication, efficacy and safety data contained in the medicine's FDA approved label. Awareness of EPKINLY™ will be raised through educational websites, print and digital media, and the use of sales representatives to educate about the FDA-approved indication.
Pricing Plan
At Genmab, we are driven by patient impact. We positively impact the lives of people with cancer when our transformational science becomes medicine, and our medicines reach the people who need them and help them live better.
The price of our medicines reflects the novelty of our science, its impact on patients, and our commitment to bringing that science to patients.
The price of EPKINLY™ (epcoritamab-bysp) takes into consideration its transformational potential as the first and only T-cell engaging bispecific antibody treatment administered subcutaneously for patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL), which is an aggressive disease with limited treatment options. |
None |
30400 |
None |
1 |
None |
None |
None |
None |
EPKINLY™ (epcoritamab-bysp) is the first-and-only bispecific antibody given by subcutaneous injection and approved to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma that has come back or that didn't respond after 2 or more prior treatments. DLBCL is the most common type of Non-Hodgkin’s lymphoma (NHL) worldwide, accounting for approximately 30 percent of all NHL cases and comprising an estimated 30,400 U.S. cases in 2022. Exact information for the EPKINLY™ indicated patient population is not available in the public domain. |
None |
| Gilead Sciences, Inc. |
61958300201 |
SUNLENCA® (lenacapavir), sterile solution for injection, 309 mg/mL, 1.5 mL/vial, 2 vial kit |
Brand |
FDA |
2023-01-09 |
19500.0000 |
None |
1 |
5000 |
1 |
1 |
None |
None |
None |
None |
Gilead has not provided a response to the drug acquisition related data fields for this drug product because Gilead developed this drug product.
The information provided in this report is subject to general limitations and assumptions Gilead has shared with OSHPD. The limitations and assumptions address gaps in guidance related to the definition and interpretation of various data elements within New Drug Reports. Additionally, consistent with the relevant statutes and regulations, the information provided in this report is limited to that which Kite believes is in the public domain or otherwise publicly available.
Consistent with Section 127681(c) of the California Health and Safety Code, Gilead is providing the best publicly available estimated number of patients in the United States with a condition for which SUNLENCA may be prescribed. |
None |
| Gilead Sciences, Inc. |
61958300101 |
SUNLENCA® (lenacapavir), tablet, 300 mg, 4 count, blister pack |
Brand |
FDA |
2023-01-09 |
3250.0000 |
None |
1 |
5000 |
1 |
1 |
None |
None |
None |
None |
Gilead has not provided a response to the drug acquisition related data fields for this drug product because Gilead developed this drug product.
The information provided in this report is subject to general limitations and assumptions Gilead has shared with OSHPD. The limitations and assumptions address gaps in guidance related to the definition and interpretation of various data elements within New Drug Reports. Additionally, consistent with the relevant statutes and regulations, the information provided in this report is limited to that which Kite believes is in the public domain or otherwise publicly available.
Consistent with Section 127681(c) of the California Health and Safety Code, Gilead is providing the best publicly available estimated number of patients in the United States with a condition for which SUNLENCA may be prescribed. |
None |
| Gilead Sciences, Inc. |
61958300102 |
SUNLENCA® (lenacapavir), tablet, 300 mg, 5 count, blister pack |
Brand |
FDA |
2023-01-09 |
4062.5000 |
None |
1 |
5000 |
1 |
1 |
None |
None |
None |
None |
Gilead has not provided a response to the drug acquisition related data fields for this drug product because Gilead developed this drug product.
The information provided in this report is subject to general limitations and assumptions Gilead has shared with OSHPD. The limitations and assumptions address gaps in guidance related to the definition and interpretation of various data elements within New Drug Reports. Additionally, consistent with the relevant statutes and regulations, the information provided in this report is limited to that which Kite believes is in the public domain or otherwise publicly available.
Consistent with Section 127681(c) of the California Health and Safety Code, Gilead is providing the best publicly available estimated number of patients in the United States with a condition for which SUNLENCA may be prescribed. |
None |
| GlaxoSmithKline |
00173090913 |
ZEJULA TABLET, 100 mg, 30 EA |
Brand |
FDA |
2023-07-17 |
17289.3000 |
None |
1 |
10348 |
None |
None |
None |
None |
None |
None |
GSK has not released ZEJULA's (NDC: 00173090913) marketing or pricing plan information in the public domain and is limiting its response to that which is publicly available pursuant to California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c).
ZEJULA (NDC: 00173090913, 00173091213, and 00173091513) is indicated for first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who have a complete or partial response to platinum-based chemotherapy and for second-line maintenance of patients with deleterious or suspected deleterious germline BRCA mutations (gBRCAmut). There are an estimated 19,710 new cases of ovarian cancer in the US in 2023.1 Of those, around 70% are diagnosed at an advanced stage.2 The standard of care therapy for advanced ovarian cancer is surgery along with platinum-based chemotherapy. Approximately 75% of these patients will achieve a complete or partial response to the chemotherapy and would be eligible for maintenance treatment with a PARP inhibitor.3 Given that, there is an estimated 10,348 new patients that would be eligible for maintenance PARP inhibitor therapy each year. Eligible patients may or may not be prescribed ZEJULA (NDC: 00173090913, 00173091213, and 00173091513) depending on their known resistance to the medicines and other patient specific factors such as allergic reactions or other medical conditions that may preclude a patient's ability to be effectively treated with ZEJULA (NDC: 00173090913, 00173091213, and 00173091513).
Sources
1. https://seer.cancer.gov/statfacts/html/ovary.html
2. Cortez, Alexander J., et al. "Advances in ovarian cancer therapy." Cancer chemotherapy and pharmacology 81 (2018): 17-38.
3. Kemp, Z., and J. A. Ledermann. "Update on first-line treatment of advanced ovarian carcinoma." International journal of women's health (2013): 45-51. |
None |
| GlaxoSmithKline |
00173091213 |
ZEJULA TABLET, 200 mg, 30 EA |
Brand |
FDA |
2023-07-17 |
17289.3000 |
None |
1 |
10348 |
None |
None |
None |
None |
None |
None |
GSK has not released ZEJULA's (NDC: 00173090913) marketing or pricing plan information in the public domain and is limiting its response to that which is publicly available pursuant to California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c).
ZEJULA (NDC: 00173090913, 00173091213, and 00173091513) is indicated for first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who have a complete or partial response to platinum-based chemotherapy and for second-line maintenance of patients with deleterious or suspected deleterious germline BRCA mutations (gBRCAmut). There are an estimated 19,710 new cases of ovarian cancer in the US in 2023.1 Of those, around 70% are diagnosed at an advanced stage.2 The standard of care therapy for advanced ovarian cancer is surgery along with platinum-based chemotherapy. Approximately 75% of these patients will achieve a complete or partial response to the chemotherapy and would be eligible for maintenance treatment with a PARP inhibitor.3 Given that, there is an estimated 10,348 new patients that would be eligible for maintenance PARP inhibitor therapy each year. Eligible patients may or may not be prescribed ZEJULA (NDC: 00173090913, 00173091213, and 00173091513) depending on their known resistance to the medicines and other patient specific factors such as allergic reactions or other medical conditions that may preclude a patient's ability to be effectively treated with ZEJULA (NDC: 00173090913, 00173091213, and 00173091513).
Sources
1. https://seer.cancer.gov/statfacts/html/ovary.html
2. Cortez, Alexander J., et al. "Advances in ovarian cancer therapy." Cancer chemotherapy and pharmacology 81 (2018): 17-38.
3. Kemp, Z., and J. A. Ledermann. "Update on first-line treatment of advanced ovarian carcinoma." International journal of women's health (2013): 45-51. |
None |
| GlaxoSmithKline |
00173091513 |
ZEJULA TABLET, 300 mg, 30 EA |
Brand |
FDA |
2023-07-17 |
17289.3000 |
None |
1 |
10348 |
None |
None |
None |
None |
None |
None |
GSK has not released ZEJULA's (NDC: 00173090913) marketing or pricing plan information in the public domain and is limiting its response to that which is publicly available pursuant to California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c).
ZEJULA (NDC: 00173090913, 00173091213, and 00173091513) is indicated for first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who have a complete or partial response to platinum-based chemotherapy and for second-line maintenance of patients with deleterious or suspected deleterious germline BRCA mutations (gBRCAmut). There are an estimated 19,710 new cases of ovarian cancer in the US in 2023.1 Of those, around 70% are diagnosed at an advanced stage.2 The standard of care therapy for advanced ovarian cancer is surgery along with platinum-based chemotherapy. Approximately 75% of these patients will achieve a complete or partial response to the chemotherapy and would be eligible for maintenance treatment with a PARP inhibitor.3 Given that, there is an estimated 10,348 new patients that would be eligible for maintenance PARP inhibitor therapy each year. Eligible patients may or may not be prescribed ZEJULA (NDC: 00173090913, 00173091213, and 00173091513) depending on their known resistance to the medicines and other patient specific factors such as allergic reactions or other medical conditions that may preclude a patient's ability to be effectively treated with ZEJULA (NDC: 00173090913, 00173091213, and 00173091513).
Sources
1. https://seer.cancer.gov/statfacts/html/ovary.html
2. Cortez, Alexander J., et al. "Advances in ovarian cancer therapy." Cancer chemotherapy and pharmacology 81 (2018): 17-38.
3. Kemp, Z., and J. A. Ledermann. "Update on first-line treatment of advanced ovarian carcinoma." International journal of women's health (2013): 45-51. |
None |
| GlaxoSmithKline |
58160084811 |
AREXVY (Respiratory Syncytial Virus Vaccine Recombinant, Adjuvanted Vaccine) INJECTION; 120mcg; Package of 10 Doses |
Brand |
FDA |
2023-07-26 |
2800.0000 |
None |
1 |
None |
None |
1 |
None |
None |
None |
None |
GSK has not released AREXVY's (NDC: 58160084811) marketing or pricing plan information in the public domain and is limiting its response to that which is publicly available pursuant to California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c).
GSK is limiting its response to information that which is otherwise in the public domain or publicly available per California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c). We are unable to identify specific and accurate information in the public domain regarding the estimated volume of patients who may be prescribed AREXVY (NDC: 58160084811) for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus in individuals 60 years of age and older. The US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted in favor of recommending the use of Arexvy (respiratory syncytial virus vaccine, adjuvanted) in adults aged 60 and older using shared clinical decision making. Shared clinical decision making empowers patients in consultation with their healthcare providers to determine whether RSV vaccination is appropriate for them.
There are an estimated 55.8 million people aged 65 and older in the US1 who are at increased risk of RSV, a common, contagious virus that can lead to serious respiratory illness.2 RSV causes approximately 177,000 hospitalizations and an estimated 14,000 deaths in this age group in the US each year.2,3,4 For adults 60 and older, data suggest an increased risk for severe RSV infection that can lead to hospitalisation.5,6 Older adults, including those with underlying medical conditions*, such as chronic heart disease, chronic lung disease or diabetes, are at high risk of severe RSV illness and account for the majority of RSV hospitalisations.5
* According to the CDC, adults aged 60 and older at even greater risk of severe respiratory illness include those with chronic lung diseases, chronic cardiovascular diseases, immune-compromise, hematologic disorders, neurologic disorders, endocrine disorders, kidney and liver disorders and other factors 7
References
1. United States Census Bureau. The older population: 2020. Accessed May 2023. Available at: https://www2.census.gov/library/publications/decennial/2020/census-briefs/c2020br-07.pdf
2. Centers for Disease Control and Prevention. RSV in Older Adults and Adults with Chronic Medical Conditions. Accessed May 2023. Available at: www.cdc.gov/rsv/high-risk/older-adults.html
3. National Foundation for Infectious Diseases. Respiratory Syncytial Virus. Accessed May 2023. Available at: www.nfid.org/infectious-disease/rsv/
4. Falsey AR, et al. Respiratory syncytial virus infection in elderly and high-risk adults. N Engl J Med 2005; 352:1749-1759.
5. Tseng HF, et al. Severe morbidity and short- and mid- to long-term mortality in older adults hospitalized with respiratory syncytial virus infection. J Infect Dis. 2020;222(8):1298-1310. doi:10.1093/infdis/jiaa361. ?
6. Belongia EA, et al. Clinical features, severity, and incidence of RSV illness during 12 consecutive seasons in a community cohort of adults =60 years old. Open Forum Infect Dis. 2018;5(12):ofy316. doi:10.1093/ofid/ofy316.
7. CDC presentation. 21 June 2023. Available at: www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-06-21-23/07-RSV-Adults-Britton-508.pdf" |
None |
| GlaxoSmithKline |
81864010330 |
OJJAARA TABLET, 100 mg, 30 EA |
Brand |
FDA |
2023-09-25 |
26900.0000 |
None |
1 |
8958 |
None |
None |
2022-07-01 |
1900000000.0000 |
None |
The stated acquisition price is representative of the acquisition of Sierra Oncology, including lat- stage asset momelotinib |
GSK has not released OJJAARA's (NDC: 81864010330) marketing or pricing plan information in the public domain and is limiting its response to that which is publicly available pursuant to California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c).
OJJAARA (NDC: 81864010330, 81864010230, and 81864010130) is a kinase inhibitor indicated for the treatment of intermediate or high-risk myelofibrosis (MF), including primary MF or secondary MF [post-polycythemia vera (PV) and post-essential thrombocythemia (ET)], in adults with anemia. There are an estimated 20,845 cases of MF per year1 in US adults based on 2020 census data2. 87.7% are intermediate/high risk3, and 49% have anemia3,4. Given that, there are an estimated 8,958 new patients eligible for OJJAARA each year. Eligible patients may or may not be prescribed OJJAARA (NDC: 81864010330, 81864010230, and 81864010130) depending on their known resistance to the medicines and other patient specific factors such as allergic reactions or other medical conditions that may preclude a patient's ability to be effectively treated with OJJAARA (NDC: 81864010330, 81864010230, and 81864010130).
Sources
1. Verstovsek S, Yu J, Scherber RM, et al. Changes in the incidence and overall survival of patients with myeloproliferative neoplasms between 2002 and 2016 in the United States. Leuk Lymphoma. 2022;63(3):694-702. doi:http://dx.doi.org/10.1080/10428194.2021.1992756
2. https://www.census.gov/library/stories/2021/08/united-states-adult-population-grew-faster-than-nations-total-population-from-2010-to-2020.html
3.Tefferi A, Lasho TL, Jimma T, et al. One thousand patients with primary myelofibrosis: the Mayo Clinic experience. Mayo Clin Proc. 2012;87(1):25-33.
4. Nicolosi M, Mudireddy M, Lasho TL, et al. Sex and degree of severity influence the prognostic impact of anemia in primary myelofibrosis: analysis based on 1109 consecutive patients. Leukemia. 2018;32(5):1254-1258. |
None |
| GlaxoSmithKline |
81864010230 |
OJJAARA TABLET, 150 mg, 30 EA |
Brand |
FDA |
2023-09-25 |
26900.0000 |
None |
1 |
8958 |
None |
None |
2022-07-01 |
1900000000.0000 |
None |
The stated acquisition price is representative of the acquisition of Sierra Oncology, including lat- stage asset momelotinib |
GSK has not released OJJAARA's (NDC: 81864010330) marketing or pricing plan information in the public domain and is limiting its response to that which is publicly available pursuant to California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c).
OJJAARA (NDC: 81864010330, 81864010230, and 81864010130) is a kinase inhibitor indicated for the treatment of intermediate or high-risk myelofibrosis (MF), including primary MF or secondary MF [post-polycythemia vera (PV) and post-essential thrombocythemia (ET)], in adults with anemia. There are an estimated 20,845 cases of MF per year1 in US adults based on 2020 census data2. 87.7% are intermediate/high risk3, and 49% have anemia3,4. Given that, there are an estimated 8,958 new patients eligible for OJJAARA each year. Eligible patients may or may not be prescribed OJJAARA (NDC: 81864010330, 81864010230, and 81864010130) depending on their known resistance to the medicines and other patient specific factors such as allergic reactions or other medical conditions that may preclude a patient's ability to be effectively treated with OJJAARA (NDC: 81864010330, 81864010230, and 81864010130).
Sources
1. Verstovsek S, Yu J, Scherber RM, et al. Changes in the incidence and overall survival of patients with myeloproliferative neoplasms between 2002 and 2016 in the United States. Leuk Lymphoma. 2022;63(3):694-702. doi:http://dx.doi.org/10.1080/10428194.2021.1992756
2. https://www.census.gov/library/stories/2021/08/united-states-adult-population-grew-faster-than-nations-total-population-from-2010-to-2020.html
3.Tefferi A, Lasho TL, Jimma T, et al. One thousand patients with primary myelofibrosis: the Mayo Clinic experience. Mayo Clin Proc. 2012;87(1):25-33.
4. Nicolosi M, Mudireddy M, Lasho TL, et al. Sex and degree of severity influence the prognostic impact of anemia in primary myelofibrosis: analysis based on 1109 consecutive patients. Leukemia. 2018;32(5):1254-1258. |
None |
| GlaxoSmithKline |
81864010130 |
OJJAARA TABLET, 200 mg, 30 EA |
Brand |
FDA |
2023-09-25 |
26900.0000 |
None |
1 |
8958 |
None |
None |
2022-07-01 |
1900000000.0000 |
None |
The stated acquisition price is representative of the acquisition of Sierra Oncology, including lat- stage asset momelotinib |
GSK has not released OJJAARA's (NDC: 81864010330) marketing or pricing plan information in the public domain and is limiting its response to that which is publicly available pursuant to California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c).
OJJAARA (NDC: 81864010330, 81864010230, and 81864010130) is a kinase inhibitor indicated for the treatment of intermediate or high-risk myelofibrosis (MF), including primary MF or secondary MF [post-polycythemia vera (PV) and post-essential thrombocythemia (ET)], in adults with anemia. There are an estimated 20,845 cases of MF per year1 in US adults based on 2020 census data2. 87.7% are intermediate/high risk3, and 49% have anemia3,4. Given that, there are an estimated 8,958 new patients eligible for OJJAARA each year. Eligible patients may or may not be prescribed OJJAARA (NDC: 81864010330, 81864010230, and 81864010130) depending on their known resistance to the medicines and other patient specific factors such as allergic reactions or other medical conditions that may preclude a patient's ability to be effectively treated with OJJAARA (NDC: 81864010330, 81864010230, and 81864010130).
Sources
1. Verstovsek S, Yu J, Scherber RM, et al. Changes in the incidence and overall survival of patients with myeloproliferative neoplasms between 2002 and 2016 in the United States. Leuk Lymphoma. 2022;63(3):694-702. doi:http://dx.doi.org/10.1080/10428194.2021.1992756
2. https://www.census.gov/library/stories/2021/08/united-states-adult-population-grew-faster-than-nations-total-population-from-2010-to-2020.html
3.Tefferi A, Lasho TL, Jimma T, et al. One thousand patients with primary myelofibrosis: the Mayo Clinic experience. Mayo Clin Proc. 2012;87(1):25-33.
4. Nicolosi M, Mudireddy M, Lasho TL, et al. Sex and degree of severity influence the prognostic impact of anemia in primary myelofibrosis: analysis based on 1109 consecutive patients. Leukemia. 2018;32(5):1254-1258. |
None |
| GlaxoSmithKline |
00173091413 |
JESDUVROQ Tablet, 8 mg, 30EA |
Brand |
FDA |
2023-10-04 |
938.4000 |
None |
1 |
512000 |
None |
None |
None |
None |
None |
None |
GSK has not released JESDUVROQ's (NDC: 00173091413) marketing or pricing plan information in the public domain and is limiting its response to that which is publicly available pursuant to California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c).
JESDUVROQ (NDC: 00173091413 and other strengths not required for reporting) is a hypoxia-inducible factor prolyl hydroxylase (HIF PH) inhibitor indicated for the treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least four months. There are an estimated 938,000 cases of end-stage renal disease in the US in based on the US population in 2020.1,2 Of those, around 72.9% are patients receiving dialysis.1 Approximately 75% of these patients are treated with ESAs for anemia.3 Given that, there are an estimated 512,000 patients that would be eligible for JESDUVROQ. Eligible patients may or may not be prescribed JESDUVROQ (NDC: 00173091413 and other strengths not required for reporting) depending on their known resistance to the medicines and other patient specific factors such as allergic reactions or other medical conditions that may preclude a patient's ability to be effectively treated with JESDUVROQ (NDC: 00173091413 and other strengths not required for reporting).
Sources
1. 2022 USRDS Annual Data Report: Epidemiology of kidney disease in the United States. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2022. https://usrds-adr.niddk.nih.gov/2022/end-stage-renal-disease/1-incidence-prevalence-patient-characteristics-and-treatment-modalities
2. https://www.census.gov/quickfacts/fact/table/US/POP010220
3. 2021 USRDS Annual Data Report: Epidemiology of kidney disease in the United States. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2021. https://usrds-adr.niddk.nih.gov/2022/end-stage-renal-disease/3-clinical-indicators-and-preventive-care |
None |
| Glenmark Pharmaceuticals Inc., USA |
68462012190 |
NICARDIPINE HCL CAP 30MG 90 |
Generic |
FDA |
2023-01-09 |
1046.1400 |
None |
1 |
3352 |
None |
None |
None |
None |
None |
None |
Marketing/Pricing Plan not in the public domain or publically available. Estimated patients not known. However, IQVIA MAT data for the 12 months ending November 22 is 3,352 prescriptions for 30 mg. Acquisition fields left blank as drug was developed by Glenmark. |
None |
| Glenmark Pharmaceuticals Inc., USA |
68462072790 |
Saxagliptin, 5 MG, 90 |
Generic |
FDA |
2023-08-14 |
1257.2900 |
None |
1 |
149261 |
None |
None |
None |
None |
None |
None |
Marketing/Pricing Plan not in the public domain or publically available. Estimated patients not known. However, IQVIA MAT data for the 12 months ending June 2023 is 149,261 prescriptions. Acquisition fields left blank as drug was developed by Glenmark. |
None |
| Glenmark Pharmaceuticals Inc., USA |
68462072690 |
Saxagliptin, 2.5 MG, 90 |
Generic |
FDA |
2023-08-16 |
1257.2900 |
None |
1 |
149261 |
None |
None |
None |
None |
None |
None |
Marketing/Pricing Plan not in the public domain or publically available. Estimated patients not known. However, IQVIA MAT data for the 12 months ending June 2023 is 149,261 prescriptions. Acquisition fields left blank as drug was developed by Glenmark. |
None |
| Hikma Pharmaceuticals USA Inc |
00054962857 |
Sodium Oxybate Oral Solution 500 MG/ML, 180 ML Bottle |
Generic |
FDA |
2023-01-01 |
5535.0000 |
This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only. |
None |
200000 |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product.
Hikma has not evaluated the volume of patients in the USA. Sodium Oxybate oral solution is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age an older with narcolepsy. According to the National Institute of Neurological Disorders and Stroke, approximately 135,000 to 200,000 people in the U.S. have narcolepsy. |
None |
| Hikma Pharmaceuticals USA Inc |
00054043825 |
Levorphanol Tartrate Tablets, 2mg USP, CII, 1 bottle of 100 |
Generic |
FDA |
2023-02-02 |
3337.5000 |
This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only. |
None |
110000000 |
None |
None |
2022-11-30 |
None |
1 |
Hikma manufactured this product for Sentynl pursuant to a CMO relationship. Hikma, who acquired Roxane, now has re-acquired the ANDA and has transitioned this product back to Hikma owned and Hikma labeling. |
Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available.
Hikma has not evaluated the volume of patients in the USA. Levorphanol Tartrate is indicated for the management of pain severe enough to require an opioid analgesic. According to the CDC, 1/3 of the US population have received an opioid prescription, therefore approximately 110,000,000. |
None |
| Hikma Pharmaceuticals USA Inc |
00054044949 |
Posaconazole Oral Suspension, 200mg/5mL, 105mL bottle |
Generic |
FDA |
2023-03-29 |
1312.8700 |
This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only. |
None |
25000 |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product.
Hikma has not evaluated the volume of patients in the USA. Posaconazole is indicated for the treatment of oropharyngeal candidiasis. According to the CDC, approximately 25,000 cases of candidemia occur nationwide each year. |
None |
| Hikma Pharmaceuticals USA Inc |
00054037025 |
Lisdexamfetamine Dimesylate Capsules, CII, 20mg, 1 bottle of 100 |
Generic |
FDA |
2023-08-25 |
1052.5500 |
This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only. |
None |
8700000 |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product.
Hikma has not evaluated the volume of patients in the USA. Lisdexamfetamine dimesylate is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older and moderate to severe binge eating disorder in adults. According to the Journal of Managed Care and Specialty Pharmacy, an estimated 8.7 million adults live with ADHD in the United States. |
None |
| Hikma Pharmaceuticals USA Inc |
00054037125 |
Lisdexamfetamine Dimesylate Capsules, CII, 30mg, 1 bottle of 100 |
Generic |
FDA |
2023-08-25 |
1052.5500 |
This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only. |
None |
8700000 |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product.
Hikma has not evaluated the volume of patients in the USA. Lisdexamfetamine dimesylate is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older and moderate to severe binge eating disorder in adults. According to the Journal of Managed Care and Specialty Pharmacy, an estimated 8.7 million adults live with ADHD in the United States. |
None |
| Hikma Pharmaceuticals USA Inc |
00054037225 |
Lisdexamfetamine Dimesylate Capsules, CII, 40mg, 1 bottle of 100 |
Generic |
FDA |
2023-08-25 |
1052.5500 |
This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only. |
None |
8700000 |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product.
Hikma has not evaluated the volume of patients in the USA. Lisdexamfetamine dimesylate is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older and moderate to severe binge eating disorder in adults. According to the Journal of Managed Care and Specialty Pharmacy, an estimated 8.7 million adults live with ADHD in the United States. |
None |
| Hikma Pharmaceuticals USA Inc |
00054037325 |
Lisdexamfetamine Dimesylate Capsules, CII, 50mg, 1 bottle of 100 |
Generic |
FDA |
2023-08-25 |
1052.5500 |
This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only. |
None |
8700000 |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product.
Hikma has not evaluated the volume of patients in the USA. Lisdexamfetamine dimesylate is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older and moderate to severe binge eating disorder in adults. According to the Journal of Managed Care and Specialty Pharmacy, an estimated 8.7 million adults live with ADHD in the United States. |
None |
| Hikma Pharmaceuticals USA Inc |
00054037425 |
Lisdexamfetamine Dimesylate Capsules, CII, 60mg, 1 bottle of 100 |
Generic |
FDA |
2023-08-25 |
1052.5500 |
This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only. |
None |
8700000 |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product.
Hikma has not evaluated the volume of patients in the USA. Lisdexamfetamine dimesylate is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older and moderate to severe binge eating disorder in adults. According to the Journal of Managed Care and Specialty Pharmacy, an estimated 8.7 million adults live with ADHD in the United States. |
None |
| Hikma Pharmaceuticals USA Inc |
00054037525 |
Lisdexamfetamine Dimesylate Capsules, CII, 70mg, 1 bottle of 100 |
Generic |
FDA |
2023-08-25 |
1052.5500 |
This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only. |
None |
8700000 |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product.
Hikma has not evaluated the volume of patients in the USA. Lisdexamfetamine dimesylate is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older and moderate to severe binge eating disorder in adults. According to the Journal of Managed Care and Specialty Pharmacy, an estimated 8.7 million adults live with ADHD in the United States. |
None |
| i3 Pharmaceuticals, LLC |
72319002502 |
Maraviroc Tablets 300mg 60CT |
Generic |
FDA |
2023-11-22 |
1410.8200 |
None |
1 |
1200000 |
None |
None |
None |
None |
None |
None |
None |
None |
| i3 Pharmaceuticals, LLC |
72319002402 |
Maraviroc Tablets 150mg 60CT |
Generic |
FDA |
2023-12-04 |
1410.8200 |
None |
1 |
1200000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Incyte Corporation |
50881000603 |
Zynyz Intravenous Solution 500mg/ 20ml 1 Vial per Carton |
Brand |
FDA |
2023-04-06 |
14240.0000 |
To market Zynyz, Incyte designed activities to increase awareness and understanding with healthcare providers about the product. Marketing activities will include education and training provided by our sales force. Consumer-directed communications to educate patients on the disease state and Zynyz are planned. At Incyte, we are driven by rigorous science and committed to ensuring patients have access to our innovative medicines.
We responsibly price our drugs by balancing the value of the outcomes and innovation they bring to patients and the health care system within market and societal expectations. Zynyz is indicated for the treatment of metastatic or recurrent locally advanced merkel cell carcinoma (MCC). |
None |
1000 |
None |
1 |
None |
None |
None |
None |
Comment regarding Field 7: Literature was used to derive an estimate of the MCC patient population because MCC is a niche tumor and is not included in recent SEER, American Cancer Facts or Globocan Cancer Fact Sheets. Literature included 1) D. Jacobs Assessment of Age, Period, and Birth Control Effects and Trends in Merkel Cell Carcinoma Incidence in the United States; JAMA Dermatology Jan. 2021 Volume 157 Number 1 2) Becker J. Merkel cell carcinoma. Ann Oncol 2010;21(suppl 7):81–85 and 3) Information from 21,445 cases of MCC in the USA. Data for 2001–2014 from National Program of Cancer Registries and SEER*Stat Database.
Comment regarding Fields 8 and 9: Acquisition fields left blank as drug was developed by Incyte.
Comment regarding Field 7: MCC is a rare and aggressive type of skin cancer and impacts less than 1 per 100,000 people in the U.S., but incidence rates are rapidly rising, especially in adults over the age of 65. There are ~1,000 estimated patients per year with locally advanced or metastatic MCC disease.
General Comment: In the event 2017 California Senate Bill 17 (“SB-17”) and the laws it implements, including Cal. Health & Safety Code § 127677, are found unconstitutional or otherwise unlawful, Incyte reserves all of its legal rights. In issuing this report in an attempt to comply with Cal. Health & Safety Code § 127677, Incyte does not waive any legal claims or legal rights related to SB-17. Please note that portions of this report and its contents may be exempted from disclosure under the California Public Records Act, Cal. Gov. Code § 6250 et seq. (“PRA”) as the material contains and constitutes Incyte’s proprietary commercial information and otherwise would not be in the public interest to disclose. We ask that you please contact the Incyte legal department at 1801 Augustine Cut-Off, Wilmington, DE 19803 if you receive any PRA requests so that we may take appropriate steps to work with you to protect such information. |
None |
| Ingenus Pharmaceuticals, LLC |
50742036630 |
Gefitinib Tablets 250mg |
Generic |
FDA |
2023-05-02 |
3995.0000 |
Gefitinib 250 mg, 30 count tablets (ANDA 211591) have been priced in accordance with Ingenus Pharmaceuticals Contracts and Management Team policies and procedures. Establishing the WAC price at $3,995.00 constitutes a substantial reduction in the WAC pricing of the referenced listed drug, Iressa, listed at $7,788.88. At the time our pricing analysis was completed, our price represented a 49% reduction in price. Several factors were taken into consideration while determining Ingenus’ WAC pricing including but limited to API, production, packaging, and shipping costs. Ingenus’ WAC pricing will enable it to: i) recoup the costs it incurred in evaluating the economic landscape surrounding prospective products; ii) cover distribution costs; iii) provide rebates and discounts as required by partners in the supply chain; and iv) earn a reasonable return on investment. |
None |
15000 |
None |
None |
None |
None |
None |
None |
As a generic pharmaceutical manufacturer, Ingenus does not estimate the number of patients. The number entered in that field is based on a simple google search. |
None |
| Ipsen Biopharmaceuticals, Inc. |
15054001501 |
SOHONOS 1.5mg Capsules (14 count) |
Brand |
FDA |
2023-10-05 |
7182.0000 |
SOHONOS is a product indicated to treat patients with fibrodysplasia ossificans progressiva (FOP), a rare disease. It will be promoted by our commercial field team to healthcare professionals to educate them on the product and the disease state.
Ipsen carefully considers many factors when determining a new prescription medication's Wholesaler Acquisition Cost, including the following: achieving accessibility and affordability of its products for patients and payors, financing important research and development that enables us to bring new and improved products to market for patients, and at the same time meeting our obligations to shareholders. |
None |
289 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Ipsen Biopharmaceuticals, Inc. |
15054010001 |
SOHONOS 10mg Capsules (14 count) |
Brand |
FDA |
2023-10-05 |
47880.0000 |
SOHONOS is a product indicated to treat patients with fibrodysplasia ossificans progressiva (FOP), a rare disease. It will be promoted by our commercial field team to healthcare professionals to educate them on the product and the disease state.
Ipsen carefully considers many factors when determining a new prescription medication's Wholesaler Acquisition Cost, including the following: achieving accessibility and affordability of its products for patients and payors, financing important research and development that enables us to bring new and improved products to market for patients, and at the same time meeting our obligations to shareholders. |
None |
289 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Ipsen Biopharmaceuticals, Inc. |
15054001001 |
SOHONOS 1mg Capsules (14 count) |
Brand |
FDA |
2023-10-05 |
4788.0000 |
SOHONOS is a product indicated to treat patients with fibrodysplasia ossificans progressiva (FOP), a rare disease. It will be promoted by our commercial field team to healthcare professionals to educate them on the product and the disease state.
Ipsen carefully considers many factors when determining a new prescription medication's Wholesaler Acquisition Cost, including the following: achieving accessibility and affordability of its products for patients and payors, financing important research and development that enables us to bring new and improved products to market for patients, and at the same time meeting our obligations to shareholders. |
None |
289 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Ipsen Biopharmaceuticals, Inc. |
15054002501 |
SOHONOS 2.5mg Capsules (14 count) |
Brand |
FDA |
2023-10-05 |
11970.0000 |
SOHONOS is a product indicated to treat patients with fibrodysplasia ossificans progressiva (FOP), a rare disease. It will be promoted by our commercial field team to healthcare professionals to educate them on the product and the disease state.
Ipsen carefully considers many factors when determining a new prescription medication's Wholesaler Acquisition Cost, including the following: achieving accessibility and affordability of its products for patients and payors, financing important research and development that enables us to bring new and improved products to market for patients, and at the same time meeting our obligations to shareholders. |
None |
289 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Ipsen Biopharmaceuticals, Inc. |
15054005001 |
SOHONOS 5mg Capsules (14 count) |
Brand |
FDA |
2023-10-05 |
23940.0000 |
SOHONOS is a product indicated to treat patients with fibrodysplasia ossificans progressiva (FOP), a rare disease. It will be promoted by our commercial field team to healthcare professionals to educate them on the product and the disease state.
Ipsen carefully considers many factors when determining a new prescription medication's Wholesaler Acquisition Cost, including the following: achieving accessibility and affordability of its products for patients and payors, financing important research and development that enables us to bring new and improved products to market for patients, and at the same time meeting our obligations to shareholders. |
None |
289 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Iveric Bio |
82829000201 |
IZERVAY, glass vial; intravitreal injection; 2 mg (0.1 mL of 20 mg/mL solution); single-dose vial. |
Brand |
FDA |
2023-08-29 |
2100.0000 |
None |
1 |
1000000 |
1 |
1 |
2023-07-11 |
590000000.0000 |
None |
Because the purchase of IZERVAY™ was part of the purchase of a company, Iveric Bio, an Astellas Company submits the following explanation as to what else was included in the acquisition:
On July 11, 2023, Berry Merger Sub, Inc. (a wholly owned subsidiary of Astellas US Holding, Inc. (“Astellas”)) was merged with and into IVERIC bio, Inc. (“IVERIC bio”) with IVERIC bio surviving the merger and becoming a wholly owned subsidiary of Astellas (“Iveric Bio, An Astellas Company”). The details of the company converted into a subsidiary (prior to the acquisition) are publicly available (News | Astellas Pharma Inc) and include:
• Stated Capital of US$137 thousand (as of December 31, 2022)
• Consolidated Stockholders’ equity of US$534,657 thousand (as of December 31, 2022)
• Number of Shares Outstanding 137,976,851 (as of May 30, 2023)
• Total Equity of US$534,657 (as of December 31, 2022)
• Total Assets US$666,823 (as of December 31, 2022)
• Equity per share (US $) 4.42 (as of December 31, 2022)
As a result of this acquisition Astellas also acquired Labeler Code (82829) and NDC (82829-002-01) associated with the IVERIC bio product IZERVAY™ (avacincaptad pegol intravitreal solution), which received U.S. Food and Drug Administration (FDA) approval following the acquisition on August 4, 2023 and has a Market Effective Date of August 29, 2023.
The acquisition amount (US$40 per share, approximately US$5.9 billion in the aggregate) includes the full amount required to purchase all outstanding options and restricted stock units. |
Regarding Estimated Number of Patients: The estimated number of patients living with GA is 1,000,000 patients, per Yates JR, Sepp T, Matharu BK, et al; Genetic Factors in AMD Study Group. Complement C3 variant and the risk of age-related macular degeneration. N Engl J Med. 2007;357(6):553-561.
Regarding Acquisition Price: The price is US$5.9 billion, but the CA portal will not allow me to enter the last zero. |
None |
| Janssen Biotech, Inc. |
57894046901 |
TALVEY™ (talquetamab) Strength: 3 mg Form: 1 single vial Package Size: 1 |
Brand |
FDA |
2023-08-10 |
777.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we plan to market in the US and promote to appropriate healthcare professionals who treat individuals diagnosed with relapsed/refractory multiple myeloma who have received four prior lines of therapy including a proteosome inhibitor, immunomodulatory agent, and CD-38 therapy. The pricing plan has WAC set for the 3 mg/1.5 mL vial at $777.00. The list price of TALVEY will also be discounted as required under the 340 B program, Federal Supply Schedule, and other government programs.
In July 2023, the European Commission (EC) granted conditional marketing authorisation (CMA) of TALVEY (Talquetamab) as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM). Patients must have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy. European approval allows Janssen to market TALVEY in all member states of the European Union and the European Economic Area. International pricing plans are based on ensuring compliance with local laws and processes. Member states pricing and reimbursement negotiations are ongoing and are based upon local funding choices |
None |
35730 |
1 |
1 |
None |
None |
None |
None |
There are 35,730 newly diagnosed patients with multiple myeloma each year. TALVEY is indicated for patients with relapsed refractory disease. Exact information for the TALVEY indicated population is not available in the public domain. |
None |
| Janssen Biotech, Inc. |
57894047001 |
TALVEY™ (talquetamab) Strength: 40 mg Form: 1 single vial Package Size: 1 |
Brand |
FDA |
2023-08-10 |
10360.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we plan to market in the US and promote to appropriate healthcare professionals who treat individuals diagnosed with relapsed/refractory multiple myeloma who have received four prior lines of therapy including a proteosome inhibitor, immunomodulatory agent, and CD-38 therapy. The pricing plan has WAC set for the 40 mg/1.0 mL vial at $10,360.00. The list price of TALVEY will also be discounted as required under the 340 B program, Federal Supply Schedule, and other government programs.
In July 2023, the European Commission (EC) granted conditional marketing authorisation (CMA) of TALVEY (Talquetamab) as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM). Patients must have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy. European approval allows Janssen to market TALVEY in all member states of the European Union and the European Economic Area. International pricing plans are based on ensuring compliance with local laws and processes. Member states pricing and reimbursement negotiations are ongoing and are based upon local funding choices |
None |
35730 |
1 |
1 |
None |
None |
None |
None |
There are 35,730 newly diagnosed patients with multiple myeloma each year. TALVEY is indicated for patients with relapsed refractory disease. Exact information for the TALVEY indicated population is not available in the public domain. |
None |
| Janssen Biotech, Inc. |
57894010060 |
AKEEGA™ (niraparib and abiraterone acetate)Strength: 100mg/500mg Form: Tablet Package Size: 60 |
Brand |
FDA |
2023-08-15 |
18750.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we plan to market in the US and promote to appropriate healthcare professionals who treat individuals diagnosed with BRCA+ mCRPC. The pricing plan has monthly WAC set for both AKEEGA NDCs to be $18,750. The list price of AKEEGA will also be discounted as required under the 340B program, Federal Supply Schedule, and other government programs.
In April 2023, the European Commission (EC) granted marketing authorisation for AKEEGA (niraparib and abiraterone acetate [AA]), in the form of a dual action tablet (DAT), given with prednisone for treatment of adults with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated.
European approval allows Janssen to market AKEEGA in all member states of the European Union and the European Economic Area. International pricing plans are based on ensuring compliance with local laws and processes. Member states pricing and reimbursement negotiations are ongoing and are based upon local funding choices |
None |
35000 |
1 |
1 |
None |
None |
None |
None |
Estimate of 35,000 patients based on who will be treated for mCRPC specifically for Line 1. Exact usage of AKEEGA based on indicated population is not available in the public domain |
None |
| Janssen Biotech, Inc. |
57894005060 |
AKEEGA™ (niraparib and abiraterone acetate)Strength: 50mg/500mg Form: Tablet Package Size: 60 |
Brand |
FDA |
2023-08-15 |
18750.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we plan to market in the US and promote to appropriate healthcare professionals who treat individuals diagnosed with BRCA+ mCRPC. The pricing plan has monthly WAC set for both AKEEGA NDCs to be $18,750. The list price of AKEEGA will also be discounted as required under the 340B program, Federal Supply Schedule, and other government programs.
In April 2023, the European Commission (EC) granted marketing authorisation for AKEEGA (niraparib and abiraterone acetate [AA]), in the form of a dual action tablet (DAT), given with prednisone for treatment of adults with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated.
European approval allows Janssen to market AKEEGA in all member states of the European Union and the European Economic Area. International pricing plans are based on ensuring compliance with local laws and processes. Member states pricing and reimbursement negotiations are ongoing and are based upon local funding choices |
None |
35000 |
1 |
1 |
None |
None |
None |
None |
Estimate of 35,000 patients based on who will be treated for mCRPC specifically for Line 1. Exact usage of AKEEGA based on indicated population is not available in the public domain |
None |
| Kesin Pharma Corporation |
81033006620 |
Metronidazole Oral Suspension 500mg/5mL - 200mL Bottle |
Brand |
FDA |
2023-10-16 |
545.0000 |
LIKMEZ will be promoted by our commercial field team to healthcare professionals to educate them on our product. We will use various means of promotion including in-office visits, virtual meetings, ad campaigns, and digital marketing. Kesin conducted extensive market research and analysis, including the competitive landscape, product development expenses, and operational costs forecasted to reach our determination of the launch pricing. |
None |
72000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Krystal Biotech, Inc. |
82194051002 |
Vyjuvek Gel 5x10^9 PFU/mL |
Brand |
FDA |
2023-07-07 |
24250.0000 |
Marketing plans: HCP and Patient websites, HCP detailing, conferences/seminars, journal reprints. Pricing methodology: Krystal Biotech developed Vyjuvek based on a need to address a treatment for a rare genetic disease; dystrophic epidermolysis bullosa (“DEB”). DEB affects approximately 3,000 patients in the US and over time, in patients with DEB, repeated blistering and fibrosis can lead to squamous-cell carcinoma, life-threatening infections and limb deformities. Development of this drug product led to the FDA granting the following designations: Orphan Drug, Fast Track, Regenerative Medicine Advance Therapy, Rare Pediatric Disease Priority Review and Priority Review designations. Considerable efforts were expended in drug development and research, as Vyjuvek is the first and only treatment that addresses the genetic cause of DEB. Given the rarity of the condition Vyjuvek treats, Krystal Biotech employed methodologies based on research and development costs, as well as the value this product brings to the limited patient population that is affected by DEB. The clinical research costs (past and future), the cost of manufacturing, distribution to the marketplace including administrative requirements, patient availability and access were all contributing factors that shaped Krystal Biotech determination of Vyjuvek's pricing. |
None |
1000 |
None |
1 |
None |
None |
None |
None |
None |
None |
| La Jolla Pharmaceutical Company |
68547011110 |
Xacduro For IV Soln 1-1 GM, 3 Each, Unit-Dose, Box |
Brand |
FDA |
2023-08-15 |
475.0000 |
In support of the launch of XACDURO, La Jolla is highly focused on HCP promotion to HCPs in Hospital Settings. This promotion will begin on September 18, 2023. There will be no Direct-to-Consumer advertising. We engaged a trusted, independent pharmaceutical compliance consulting firm to conduct pricing primary market research with target HCPs. This included value-based pricing surveys and HCP feedback which indicated an acceptable price range for XACDURO on-label usage based on average patient day of therapy. This comprehensive evaluation included other life-saving antibiotics and we compared that analysis with pharmacoeconomics to determine the ultimate value of XACDURO. |
None |
19000 |
None |
1 |
None |
None |
None |
None |
None |
None |
| Mayne Pharma Inc |
68308066830 |
Doxycycline 40mg Capsules 30 count |
Generic |
FDA |
2023-02-23 |
782.6200 |
None |
1 |
17000 |
None |
None |
None |
None |
None |
None |
The 17,000 estimated number of patients is per month and on a national level. |
None |
| Mayne Pharma Inc |
68308066510 |
Calcitriol Ointment 3mcg/g 100g |
Generic |
FDA |
2023-07-27 |
823.3100 |
None |
1 |
1800 |
None |
None |
2023-07-18 |
0.0000 |
1 |
There was no upfront cost for the license of this product. |
The 1800 estimated number of patients is per month and on a national level. |
None |
| Mayne Pharma Inc |
68308076950 |
Halobetasol Propionate Topical Foam, 0.05% 50g |
Generic |
FDA |
2023-12-08 |
828.5200 |
None |
1 |
6700000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Meitheal Pharmaceuticals, Inc. |
71288013951 |
Mitomycin for Injection, USP 40mg 100mL SDV |
Generic |
FDA |
2023-03-14 |
1263.9600 |
Meitheal markets generic Mitomycin for Injection 40mg as a therapeutic equivalent to the innovator (brand) drug in the U.S. As such, Meitheal relies on the safety and efficacy findings of the FDA with respect to the innovator drug. Meitheal markets to group purchasing organizations (GPOs), Integrated Delivery Networks (IDNs), and hospital/alternate site (own use) customers based solely on price and availability and therefore does not engage in direct-to-consumer, direct-to-physician, or prescriber marketing. Meitheal does not market based on any aspects of the drug itself, nor does Meitheal aim to treat a certain number of patients. Rather, Meitheal evaluates the size of the total market for a particular drug and strives to achieve a certain market share for that product. |
None |
90550 |
None |
None |
None |
None |
None |
None |
Since Mitomycin for Injection is a generic product that has a few alternative options available, Meitheal Pharmaceuticals does not track the number of patients that are prescribed Mitomycin for Injection. Mitomycin for Injection is primarily used for the treatment of cancer of the stomach or pancreas that has spread to other parts of the body and has not improved or worsened after treatment with other medications, surgery, or radiation therapy. The website Cancer.org states a patient population of 90,550 stomach or pancreas cancer patients on an annual basis. |
https://reports.siera.hcai.ca.gov/api/report/drug-pricing/attachment?id=672 |
| Meitheal Pharmaceuticals, Inc. |
71288010320 |
Bendamustine HCl for Injection, USP 100 mg 20 mL SDV |
Generic |
FDA |
2023-06-14 |
1600.0000 |
Meitheal markets generic Bendamustine HCl as a therapeutic equivalent to Cephalon's NDA# 022249 Treanda for Injection (marketed by Teva). As such, Meitheal relies on the safety and efficacy findings of the FDA with respect to the reference listed drug. Meitheal markets to group purchasing organizations (GPOs), Integrated Delivery Networks (IDNs), and hospital/alternate site (own use) customers based solely on price and availability and therefore does not engage in direct-to-consumer, direct-to-physician, or prescriber marketing. Meitheal does not market based on any aspects of the drug itself, nor does Meitheal aim to treat a certain number of patients. Rather, Meitheal evaluates the size of the total market for a particular drug and strives to achieve a certain market share for that product. |
None |
18740 |
None |
None |
None |
None |
None |
None |
As Bendamustine is a generic product and there are a number of alternative options available, Meitheal Pharmaceuticals does not track the number of patients that are prescribed Bendamustine. As such, given Bendamustine primary use for the treatment of chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen, Meitheal's best estimate regarding a patient population is 18,740 new cases of CLL and 80,550 people diagnosed with NHL in the US per American Cancer Society's estimates for the US in 2023. |
https://reports.siera.hcai.ca.gov/api/report/drug-pricing/attachment?id=683 |
| Meitheal Pharmaceuticals, Inc. |
71288015501 |
Plerixafor Injection, 24 mg per 1.2 mL (20mg/mL) SDV |
Generic |
FDA |
2023-07-26 |
1490.5000 |
Meitheal markets generic Plerixafor Injection as a therapeutic equivalent to Genzyme's NDA#022311 Mozobil (marketed by Sanofi). As such, Meitheal relies on the safety and efficacy findings of the FDA with respect to the reference listed drug. Meitheal markets to group purchasing organizations (GPOs), Integrated Delivery Networks (IDNs), and hospital/alternate site (own use) customers based solely on price and availability and therefore does not engage in direct-to-consumer, direct-to-physician, or prescriber marketing. Meitheal does not market based on any aspects of the drug itself, nor does Meitheal aim to treat a certain number of patients. Rather, Meitheal evaluates the size of the total market for a particular drug and strives to achieve a certain market share for that product. |
None |
22827 |
None |
None |
None |
None |
None |
None |
As Plerixafor product is a generic product and there are a number of alternative options available, Meitheal Pharmaceuticals does not track the number of patients that are prescribed Plerixafor. As such, given Plerixafor injection is used in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells (HSC) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin lymphoma (NHL) or multiple myeloma, Meitheal's best estimate regarding a patient population is 7,722 transplants for multiple myeloma and 3,184 transplants for NHL per Center for International Blood and Marrow Transplant Research (CIBMTR). |
None |
| Melinta Therapeutics, LLC |
70842024001 |
REZZAYO packaged with 1 VIAL in 1 CARTON / one 200 MG INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
Brand |
FDA |
2023-07-31 |
1950.0000 |
None |
1 |
200000 |
None |
1 |
2022-07-27 |
0.0000 |
1 |
The information is not publicly available. |
Rezzayo was granted Orphan Drug status by the FDA. To qualify for Orphan Drug designation, the number of people affected by the disease or condition for which the drug is to be developed is fewer than 200,000 persons. |
None |
| Mylan Pharmaceuticals Inc |
00378193501 |
Lenalidomide 2.5mg Oral capsule, 100 |
Generic |
FDA |
2023-03-07 |
71990.6200 |
None |
1 |
70792 |
None |
None |
None |
None |
None |
None |
The Product was not the result of a product acquisition.
Lenalidomide is indicated for the treatment of patients with multiple myeloma, transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities, mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, follicular lymphoma, and marginal zone lymphoma. Based on the literature, an estimated 34,470 adults in the United States will be diagnosed with multiple myeloma (https://www.cancer.net/cancer-types/multiple-myeloma/statistics), and approximately 10,000 people in the United States are diagnosed with MDS each year (https://www.cancer.net/cancer-types/myelodysplastic-syndromes-mds/statistics). In 2020, about 77,240 new cases of non-Hodgkin lymphoma (NHL) were expected to be diagnosed in the US. MCL patients represent about 3 to 8 percent of all new cases of NHL (https://www.lls.org/sites/default/files/2021-09/FS4_Mantle_Cell_Facts_0921Rev.pdf). Follicular lymphoma has an annual incidence of about 15,000 cases/year in the United States (https://www.lls.org/research/follicular-lymphoma-fl). In 2016, there were an estimated 7,460 newly diagnosed patients with marginal zone lymphoma (MZL) in the US (https://aol.amegroups.com/article/view/6993/html).Therefore, an estimated (using available data) 70,792 patients in the United States could potentially use this product during the current year. |
None |
| Mylan Pharmaceuticals Inc |
00378193528 |
Lenalidomide 2.5mg Oral capsule, 28 |
Generic |
FDA |
2023-03-07 |
20157.3600 |
None |
1 |
70792 |
None |
None |
None |
None |
None |
None |
The Product was not the result of a product acquisition.
Lenalidomide is indicated for the treatment of patients with multiple myeloma, transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities, mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, follicular lymphoma, and marginal zone lymphoma. Based on the literature, an estimated 34,470 adults in the United States will be diagnosed with multiple myeloma (https://www.cancer.net/cancer-types/multiple-myeloma/statistics), and approximately 10,000 people in the United States are diagnosed with MDS each year (https://www.cancer.net/cancer-types/myelodysplastic-syndromes-mds/statistics). In 2020, about 77,240 new cases of non-Hodgkin lymphoma (NHL) were expected to be diagnosed in the US. MCL patients represent about 3 to 8 percent of all new cases of NHL (https://www.lls.org/sites/default/files/2021-09/FS4_Mantle_Cell_Facts_0921Rev.pdf). Follicular lymphoma has an annual incidence of about 15,000 cases/year in the United States (https://www.lls.org/research/follicular-lymphoma-fl). In 2016, there were an estimated 7,460 newly diagnosed patients with marginal zone lymphoma (MZL) in the US (https://aol.amegroups.com/article/view/6993/html).Therefore, an estimated (using available data) 70,792 patients in the United States could potentially use this product during the current year. |
None |
| Mylan Pharmaceuticals Inc |
00378194201 |
Lenalidomide 20mg Oral capsule, 100 |
Generic |
FDA |
2023-03-07 |
71990.6200 |
None |
1 |
70792 |
None |
None |
None |
None |
None |
None |
The Product was not the result of a product acquisition.
Lenalidomide is indicated for the treatment of patients with multiple myeloma, transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities, mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, follicular lymphoma, and marginal zone lymphoma. Based on the literature, an estimated 34,470 adults in the United States will be diagnosed with multiple myeloma (https://www.cancer.net/cancer-types/multiple-myeloma/statistics), and approximately 10,000 people in the United States are diagnosed with MDS each year (https://www.cancer.net/cancer-types/myelodysplastic-syndromes-mds/statistics). In 2020, about 77,240 new cases of non-Hodgkin lymphoma (NHL) were expected to be diagnosed in the US. MCL patients represent about 3 to 8 percent of all new cases of NHL (https://www.lls.org/sites/default/files/2021-09/FS4_Mantle_Cell_Facts_0921Rev.pdf). Follicular lymphoma has an annual incidence of about 15,000 cases/year in the United States (https://www.lls.org/research/follicular-lymphoma-fl). In 2016, there were an estimated 7,460 newly diagnosed patients with marginal zone lymphoma (MZL) in the US (https://aol.amegroups.com/article/view/6993/html).Therefore, an estimated (using available data) 70,792 patients in the United States could potentially use this product during the current year. |
None |
| Mylan Pharmaceuticals Inc |
00378194221 |
Lenalidomide 20mg Oral capsule, 21 |
Generic |
FDA |
2023-03-07 |
15118.0400 |
None |
1 |
70792 |
None |
None |
None |
None |
None |
None |
The Product was not the result of a product acquisition.
Lenalidomide is indicated for the treatment of patients with multiple myeloma, transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities, mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, follicular lymphoma, and marginal zone lymphoma. Based on the literature, an estimated 34,470 adults in the United States will be diagnosed with multiple myeloma (https://www.cancer.net/cancer-types/multiple-myeloma/statistics), and approximately 10,000 people in the United States are diagnosed with MDS each year (https://www.cancer.net/cancer-types/myelodysplastic-syndromes-mds/statistics). In 2020, about 77,240 new cases of non-Hodgkin lymphoma (NHL) were expected to be diagnosed in the US. MCL patients represent about 3 to 8 percent of all new cases of NHL (https://www.lls.org/sites/default/files/2021-09/FS4_Mantle_Cell_Facts_0921Rev.pdf). Follicular lymphoma has an annual incidence of about 15,000 cases/year in the United States (https://www.lls.org/research/follicular-lymphoma-fl). In 2016, there were an estimated 7,460 newly diagnosed patients with marginal zone lymphoma (MZL) in the US (https://aol.amegroups.com/article/view/6993/html).Therefore, an estimated (using available data) 70,792 patients in the United States could potentially use this product during the current year. |
None |
| Mylan Pharmaceuticals Inc |
49502038102 |
Hulio®(CF) (adalimumab-fkjp) Injection 20 mg/0.4 mL Syringe |
Generic |
FDA |
2023-07-06 |
6576.4900 |
None |
1 |
12957128 |
None |
1 |
None |
None |
None |
None |
HULIO injections are indicated for reducing signs and symptoms in adult patients with moderate to severe rheumatoid arthritis (RA). Based on trusted literature, an estimated 1.3 million adults in the United States have moderate to severe RA (https://www.medicalnewstoday.com/articles/rheumatoid-arthritis-prevalence#causes). Therefore, using available data, approximately 1.3 million patients with RA in the United States could be eligible for use of HULIO.
HULIO injections are indicated for reducing signs and symptoms of moderate to severe juvenile idiopathic arthritis (JIA). JIA is the most common chronic rheumatologic disorder amongst juveniles in the United States (https://www.arthritis.org/diseases/juvenile-idiopathic-arthritis). Based on trusted literature, the prevalence of JIA ranges from 16-50 cases/100,000 individuals in the United States (https://posna.org/physician-education/study-guide/juvenile-idiopathic-arthritis). Therefore, there is an estimated total of 294,000 juveniles affected by moderate to severe JIA in the United States that could be eligible for use of HULIO.
HULIO injections are indicated for reducing signs and symptoms in adult patients with active psoriatic arthritis. Based on trusted literature, an estimated 1.5 million adults in the United States have active psoriatic arthritis (https://www.hopkinsarthritis.org/arthritis-info/psoriatic-arthritis/). It is estimated that about one in three adults with the skin disease psoriasis will get psoriatic arthritis. Therefore, using available data, approximately 1.5 million adult patients with psoriatic arthritis in the United States could be eligible for use of HULIO.
HULIO injections are indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS). Based on trusted literature, the prevalence of active AS in the United States is approximately 0.2 – 0.5% (https://www.hopkinsarthritis.org/arthritis-info/ankylosing-spondylitis/#:~:text=Epidemiology,14%20per%20100%2C000%20person%2Dyears.). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, approximately to 670,256 to 1.67 million Americans with active AS could be eligible for use of HULIO.
HULIO injections are indicated for the treatment of moderate to severe active Crohn’s disease in adults and pediatric patients 6 years of age or older. Based on trusted literature, there are an estimated 565,000 Americans living with moderate to severe Crohn’s disease (https://pubmed.ncbi.nlm.nih.gov/22926499/). Therefore, approximately 565,000 people in the United States with active Crohn’s disease could be eligible for use of HULIO.
HULIO injections are indicated for the treatment of moderate to severe active ulcerative colitis in adult patients. Based on trusted literature, there are an estimated 593,000 Americans living with moderate to severe ulcerative colitis (https://pubmed.ncbi.nlm.nih.gov/22926499/). Therefore, approximately 593,000 people in the United States with active ulcerative colitis could be eligible for use of HULIO.
HULIO injections are indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis. Based on trusted literature, an estimated range of 1-2% of the American population lives with moderate to severe plaque psoriasis (https://emedicine.medscape.com/article/1108072-overview). Plaque psoriasis is the most common form of psoriasis and affects 80-90% of psoriasis patients (https://my.clevelandclinic.org/health/diseases/22842-plaque-psoriasis#:~:text=How%20common%20is%20plaque%20psoriasis,with%20psoriasis%20have%20plaque%20psoriasis.). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, approximately 3.35 to 6.7 million people in the United States with chronic plaque psoriasis could be eligible for use of HULIO.
HULIO injections are indicated for the treatment of moderate to severe hidradenitis suppurativa (HS) in adult patients. Based on trusted literature, an estimated .1% of the American population is affected by moderate to severe HS (https://pubmed.ncbi.nlm.nih.gov/28492923/). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, an estimated 335,128 people in the United States with moderate to severe HS could be eligible for use of HULIO.
Therefore, an estimated (using available data) 12,957,128 patients in the United States could potentially use this product during the current year.
The Products were not the result of a product acquisition; however, on November 29, 2022, Viatris announced that it has closed its transaction with Biocon Biologics Limited ("Biocon Biologics"), creating what Viatris expects to be a unique fully vertically integrated global biosimilars leader. Viatris and Biocon Biologics have entered a Transition Services Agreement (TSA) pursuant to which Viatris will provide commercialization and certain |
None |
| Mylan Pharmaceuticals Inc |
49502038202 |
Hulio®(CF) (adalimumab-fkjp) Injection 40 mg/0.8 mL Syringe |
Generic |
FDA |
2023-07-06 |
6576.4900 |
None |
1 |
12957128 |
None |
1 |
None |
None |
None |
None |
HULIO injections are indicated for reducing signs and symptoms in adult patients with moderate to severe rheumatoid arthritis (RA). Based on trusted literature, an estimated 1.3 million adults in the United States have moderate to severe RA (https://www.medicalnewstoday.com/articles/rheumatoid-arthritis-prevalence#causes). Therefore, using available data, approximately 1.3 million patients with RA in the United States could be eligible for use of HULIO.
HULIO injections are indicated for reducing signs and symptoms of moderate to severe juvenile idiopathic arthritis (JIA). JIA is the most common chronic rheumatologic disorder amongst juveniles in the United States (https://www.arthritis.org/diseases/juvenile-idiopathic-arthritis). Based on trusted literature, the prevalence of JIA ranges from 16-50 cases/100,000 individuals in the United States (https://posna.org/physician-education/study-guide/juvenile-idiopathic-arthritis). Therefore, there is an estimated total of 294,000 juveniles affected by moderate to severe JIA in the United States that could be eligible for use of HULIO.
HULIO injections are indicated for reducing signs and symptoms in adult patients with active psoriatic arthritis. Based on trusted literature, an estimated 1.5 million adults in the United States have active psoriatic arthritis (https://www.hopkinsarthritis.org/arthritis-info/psoriatic-arthritis/). It is estimated that about one in three adults with the skin disease psoriasis will get psoriatic arthritis. Therefore, using available data, approximately 1.5 million adult patients with psoriatic arthritis in the United States could be eligible for use of HULIO.
HULIO injections are indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS). Based on trusted literature, the prevalence of active AS in the United States is approximately 0.2 – 0.5% (https://www.hopkinsarthritis.org/arthritis-info/ankylosing-spondylitis/#:~:text=Epidemiology,14%20per%20100%2C000%20person%2Dyears.). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, approximately to 670,256 to 1.67 million Americans with active AS could be eligible for use of HULIO.
HULIO injections are indicated for the treatment of moderate to severe active Crohn’s disease in adults and pediatric patients 6 years of age or older. Based on trusted literature, there are an estimated 565,000 Americans living with moderate to severe Crohn’s disease (https://pubmed.ncbi.nlm.nih.gov/22926499/). Therefore, approximately 565,000 people in the United States with active Crohn’s disease could be eligible for use of HULIO.
HULIO injections are indicated for the treatment of moderate to severe active ulcerative colitis in adult patients. Based on trusted literature, there are an estimated 593,000 Americans living with moderate to severe ulcerative colitis (https://pubmed.ncbi.nlm.nih.gov/22926499/). Therefore, approximately 593,000 people in the United States with active ulcerative colitis could be eligible for use of HULIO.
HULIO injections are indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis. Based on trusted literature, an estimated range of 1-2% of the American population lives with moderate to severe plaque psoriasis (https://emedicine.medscape.com/article/1108072-overview). Plaque psoriasis is the most common form of psoriasis and affects 80-90% of psoriasis patients (https://my.clevelandclinic.org/health/diseases/22842-plaque-psoriasis#:~:text=How%20common%20is%20plaque%20psoriasis,with%20psoriasis%20have%20plaque%20psoriasis.). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, approximately 3.35 to 6.7 million people in the United States with chronic plaque psoriasis could be eligible for use of HULIO.
HULIO injections are indicated for the treatment of moderate to severe hidradenitis suppurativa (HS) in adult patients. Based on trusted literature, an estimated .1% of the American population is affected by moderate to severe HS (https://pubmed.ncbi.nlm.nih.gov/28492923/). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, an estimated 335,128 people in the United States with moderate to severe HS could be eligible for use of HULIO.
Therefore, an estimated (using available data) 12,957,128 patients in the United States could potentially use this product during the current year.
The Products were not the result of a product acquisition; however, on November 29, 2022, Viatris announced that it has closed its transaction with Biocon Biologics Limited ("Biocon Biologics"), creating what Viatris expects to be a unique fully vertically integrated global biosimilars leader. Viatris and Biocon Biologics have entered a Transition Services Agreement (TSA) pursuant to which Viatris will provide commercialization and certain |
None |
| Mylan Pharmaceuticals Inc |
49502038002 |
Hulio®(CF) (adalimumab-fkjp) Pen Injection 40 mg/0.8 mL |
Generic |
FDA |
2023-07-06 |
6576.4900 |
None |
1 |
12957128 |
None |
1 |
None |
None |
None |
None |
HULIO injections are indicated for reducing signs and symptoms in adult patients with moderate to severe rheumatoid arthritis (RA). Based on trusted literature, an estimated 1.3 million adults in the United States have moderate to severe RA (https://www.medicalnewstoday.com/articles/rheumatoid-arthritis-prevalence#causes). Therefore, using available data, approximately 1.3 million patients with RA in the United States could be eligible for use of HULIO.
HULIO injections are indicated for reducing signs and symptoms of moderate to severe juvenile idiopathic arthritis (JIA). JIA is the most common chronic rheumatologic disorder amongst juveniles in the United States (https://www.arthritis.org/diseases/juvenile-idiopathic-arthritis). Based on trusted literature, the prevalence of JIA ranges from 16-50 cases/100,000 individuals in the United States (https://posna.org/physician-education/study-guide/juvenile-idiopathic-arthritis). Therefore, there is an estimated total of 294,000 juveniles affected by moderate to severe JIA in the United States that could be eligible for use of HULIO.
HULIO injections are indicated for reducing signs and symptoms in adult patients with active psoriatic arthritis. Based on trusted literature, an estimated 1.5 million adults in the United States have active psoriatic arthritis (https://www.hopkinsarthritis.org/arthritis-info/psoriatic-arthritis/). It is estimated that about one in three adults with the skin disease psoriasis will get psoriatic arthritis. Therefore, using available data, approximately 1.5 million adult patients with psoriatic arthritis in the United States could be eligible for use of HULIO.
HULIO injections are indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS). Based on trusted literature, the prevalence of active AS in the United States is approximately 0.2 – 0.5% (https://www.hopkinsarthritis.org/arthritis-info/ankylosing-spondylitis/#:~:text=Epidemiology,14%20per%20100%2C000%20person%2Dyears.). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, approximately to 670,256 to 1.67 million Americans with active AS could be eligible for use of HULIO.
HULIO injections are indicated for the treatment of moderate to severe active Crohn’s disease in adults and pediatric patients 6 years of age or older. Based on trusted literature, there are an estimated 565,000 Americans living with moderate to severe Crohn’s disease (https://pubmed.ncbi.nlm.nih.gov/22926499/). Therefore, approximately 565,000 people in the United States with active Crohn’s disease could be eligible for use of HULIO.
HULIO injections are indicated for the treatment of moderate to severe active ulcerative colitis in adult patients. Based on trusted literature, there are an estimated 593,000 Americans living with moderate to severe ulcerative colitis (https://pubmed.ncbi.nlm.nih.gov/22926499/). Therefore, approximately 593,000 people in the United States with active ulcerative colitis could be eligible for use of HULIO.
HULIO injections are indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis. Based on trusted literature, an estimated range of 1-2% of the American population lives with moderate to severe plaque psoriasis (https://emedicine.medscape.com/article/1108072-overview). Plaque psoriasis is the most common form of psoriasis and affects 80-90% of psoriasis patients (https://my.clevelandclinic.org/health/diseases/22842-plaque-psoriasis#:~:text=How%20common%20is%20plaque%20psoriasis,with%20psoriasis%20have%20plaque%20psoriasis.). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, approximately 3.35 to 6.7 million people in the United States with chronic plaque psoriasis could be eligible for use of HULIO.
HULIO injections are indicated for the treatment of moderate to severe hidradenitis suppurativa (HS) in adult patients. Based on trusted literature, an estimated .1% of the American population is affected by moderate to severe HS (https://pubmed.ncbi.nlm.nih.gov/28492923/). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, an estimated 335,128 people in the United States with moderate to severe HS could be eligible for use of HULIO.
Therefore, an estimated (using available data) 12,957,128 patients in the United States could potentially use this product during the current year.
The Products were not the result of a product acquisition; however, on November 29, 2022, Viatris announced that it has closed its transaction with Biocon Biologics Limited ("Biocon Biologics"), creating what Viatris expects to be a unique fully vertically integrated global biosimilars leader. Viatris and Biocon Biologics have entered a Transition Services Agreement (TSA) pursuant to which Viatris will provide commercialization and certain |
None |
| Mylan Pharmaceuticals Inc |
49502041702 |
Adalimumab-fkjp(CF) Injection 20 mg/0.4 mL Syringe |
Generic |
FDA |
2023-07-07 |
995.0000 |
None |
1 |
12957128 |
None |
None |
None |
None |
None |
None |
Adalimumab injections are indicated for reducing signs and symptoms in adult patients with moderate to severe rheumatoid arthritis (RA). Based on trusted literature, an estimated 1.3 million adults in the United States have moderate to severe RA (https://www.medicalnewstoday.com/articles/rheumatoid-arthritis-prevalence#causes). In the United States, there are currently 258 million adults over the age of 18, meaning an estimated .6% to 1% of the American adult population has moderate to severe RA. Therefore, using available data, approximately 1.3 million patients with RA in the United States could be eligible for use of Adalimumab.
Adalimumab injections are indicated for reducing signs and symptoms of moderate to severe juvenile idiopathic arthritis (JIA). JIA is the most common chronic rheumatologic disorder amongst juveniles in the United States (https://www.arthritis.org/diseases/juvenile-idiopathic-arthritis). Based on trusted literature, the prevalence of JIA ranges from 16-50 cases/100,000 individuals in the United States (https://posna.org/physician-education/study-guide/juvenile-idiopathic-arthritis). Therefore, there is an estimated total of 294,000 juveniles affected by moderate to severe JIA in the United States that could be eligible for use of Adalimumab.
Adalimumab injections are indicated for reducing signs and symptoms in adult patients with active psoriatic arthritis. Based on trusted literature, an estimated 1.5 million adults in the United States have active psoriatic arthritis (https://www.hopkinsarthritis.org/arthritis-info/psoriatic-arthritis/). It is estimated that about one in three adults with the skin disease psoriasis will get psoriatic arthritis. Therefore, using available data, approximately 1.5 million adult patients with psoriatic arthritis in the United States could be eligible for use of Adalimumab.
Adalimumab injections are indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS). Based on trusted literature, the prevalence of active AS in the United States is approximately 0.2 – 0.5% (https://www.hopkinsarthritis.org/arthritis-info/ankylosing-spondylitis/#:~:text=Epidemiology,14%20per%20100%2C000%20person%2Dyears.). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, approximately to 670,256 to 1.67 million Americans with active AS could be eligible for use of Adalimumab.
Adalimumab injections are indicated for the treatment of moderate to severe active Crohn’s disease in adults and pediatric patients 6 years of age or older. Based on trusted literature, there are an estimated 565,000 Americans living with moderate to severe Crohn’s disease (https://pubmed.ncbi.nlm.nih.gov/22926499/). Therefore, approximately 565,000 people in the United States with active Crohn’s disease could be eligible for use of Adalimumab.
Adalimumab injections are indicated for the treatment of moderate to severe active ulcerative colitis in adult patients. Based on trusted literature, there are an estimated 593,000 Americans living with moderate to severe ulcerative colitis (https://pubmed.ncbi.nlm.nih.gov/22926499/). Therefore, approximately 593,000 people in the United States with active ulcerative colitis could be eligible for use of Adalimumab.
Adalimumab injections are indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis. Based on trusted literature, an estimated range of 1-2% of the American population lives with moderate to severe plaque psoriasis (https://emedicine.medscape.com/article/1108072-overview). Plaque psoriasis is the most common form of psoriasis and affects 80-90% of psoriasis patients (https://my.clevelandclinic.org/health/diseases/22842-plaque-psoriasis#:~:text=How%20common%20is%20plaque%20psoriasis,with%20psoriasis%20have%20plaque%20psoriasis.). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, approximately 3.35 to 6.7 million people in the United States with chronic plaque psoriasis could be eligible for use of Adalimumab.
Adalimumab injections are indicated for the treatment of moderate to severe hidradenitis suppurativa (HS) in adult patients. Based on trusted literature, an estimated .1% of the American population is affected by moderate to severe HS (https://pubmed.ncbi.nlm.nih.gov/28492923/). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, an estimated 335,128 people in the United States with moderate to severe HS could be eligible for use of Adalimumab.
Therefore, an estimated (using available data) 12,957,128 patients in the United States could potentially use this product during the current year.
The Products were not the result of a product acquisition; however, on November 29, 2022, Viatris announced that it has closed its transaction with Biocon Biologics Limited ("Biocon Biologic |
None |
| Mylan Pharmaceuticals Inc |
49502041802 |
Adalimumab-fkjp(CF) Injection 40 mg/0.8 mL Syringe |
Generic |
FDA |
2023-07-07 |
995.0000 |
None |
1 |
12957128 |
None |
None |
None |
None |
None |
None |
Adalimumab injections are indicated for reducing signs and symptoms in adult patients with moderate to severe rheumatoid arthritis (RA). Based on trusted literature, an estimated 1.3 million adults in the United States have moderate to severe RA (https://www.medicalnewstoday.com/articles/rheumatoid-arthritis-prevalence#causes). In the United States, there are currently 258 million adults over the age of 18, meaning an estimated .6% to 1% of the American adult population has moderate to severe RA. Therefore, using available data, approximately 1.3 million patients with RA in the United States could be eligible for use of Adalimumab.
Adalimumab injections are indicated for reducing signs and symptoms of moderate to severe juvenile idiopathic arthritis (JIA). JIA is the most common chronic rheumatologic disorder amongst juveniles in the United States (https://www.arthritis.org/diseases/juvenile-idiopathic-arthritis). Based on trusted literature, the prevalence of JIA ranges from 16-50 cases/100,000 individuals in the United States (https://posna.org/physician-education/study-guide/juvenile-idiopathic-arthritis). Therefore, there is an estimated total of 294,000 juveniles affected by moderate to severe JIA in the United States that could be eligible for use of Adalimumab.
Adalimumab injections are indicated for reducing signs and symptoms in adult patients with active psoriatic arthritis. Based on trusted literature, an estimated 1.5 million adults in the United States have active psoriatic arthritis (https://www.hopkinsarthritis.org/arthritis-info/psoriatic-arthritis/). It is estimated that about one in three adults with the skin disease psoriasis will get psoriatic arthritis. Therefore, using available data, approximately 1.5 million adult patients with psoriatic arthritis in the United States could be eligible for use of Adalimumab.
Adalimumab injections are indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS). Based on trusted literature, the prevalence of active AS in the United States is approximately 0.2 – 0.5% (https://www.hopkinsarthritis.org/arthritis-info/ankylosing-spondylitis/#:~:text=Epidemiology,14%20per%20100%2C000%20person%2Dyears.). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, approximately to 670,256 to 1.67 million Americans with active AS could be eligible for use of Adalimumab.
Adalimumab injections are indicated for the treatment of moderate to severe active Crohn’s disease in adults and pediatric patients 6 years of age or older. Based on trusted literature, there are an estimated 565,000 Americans living with moderate to severe Crohn’s disease (https://pubmed.ncbi.nlm.nih.gov/22926499/). Therefore, approximately 565,000 people in the United States with active Crohn’s disease could be eligible for use of Adalimumab.
Adalimumab injections are indicated for the treatment of moderate to severe active ulcerative colitis in adult patients. Based on trusted literature, there are an estimated 593,000 Americans living with moderate to severe ulcerative colitis (https://pubmed.ncbi.nlm.nih.gov/22926499/). Therefore, approximately 593,000 people in the United States with active ulcerative colitis could be eligible for use of Adalimumab.
Adalimumab injections are indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis. Based on trusted literature, an estimated range of 1-2% of the American population lives with moderate to severe plaque psoriasis (https://emedicine.medscape.com/article/1108072-overview). Plaque psoriasis is the most common form of psoriasis and affects 80-90% of psoriasis patients (https://my.clevelandclinic.org/health/diseases/22842-plaque-psoriasis#:~:text=How%20common%20is%20plaque%20psoriasis,with%20psoriasis%20have%20plaque%20psoriasis.). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, approximately 3.35 to 6.7 million people in the United States with chronic plaque psoriasis could be eligible for use of Adalimumab.
Adalimumab injections are indicated for the treatment of moderate to severe hidradenitis suppurativa (HS) in adult patients. Based on trusted literature, an estimated .1% of the American population is affected by moderate to severe HS (https://pubmed.ncbi.nlm.nih.gov/28492923/). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, an estimated 335,128 people in the United States with moderate to severe HS could be eligible for use of Adalimumab.
Therefore, an estimated (using available data) 12,957,128 patients in the United States could potentially use this product during the current year.
The Products were not the result of a product acquisition; however, on November 29, 2022, Viatris announced that it has closed its transaction with Biocon Biologics Limited ("Biocon Biologic |
None |
| Mylan Pharmaceuticals Inc |
49502041602 |
Adalimumab-fkjp(CF) Pen Injection 40 mg/0.8 mL |
Generic |
FDA |
2023-07-07 |
995.0000 |
None |
1 |
12957128 |
None |
None |
None |
None |
None |
None |
Adalimumab injections are indicated for reducing signs and symptoms in adult patients with moderate to severe rheumatoid arthritis (RA). Based on trusted literature, an estimated 1.3 million adults in the United States have moderate to severe RA (https://www.medicalnewstoday.com/articles/rheumatoid-arthritis-prevalence#causes). In the United States, there are currently 258 million adults over the age of 18, meaning an estimated .6% to 1% of the American adult population has moderate to severe RA. Therefore, using available data, approximately 1.3 million patients with RA in the United States could be eligible for use of Adalimumab.
Adalimumab injections are indicated for reducing signs and symptoms of moderate to severe juvenile idiopathic arthritis (JIA). JIA is the most common chronic rheumatologic disorder amongst juveniles in the United States (https://www.arthritis.org/diseases/juvenile-idiopathic-arthritis). Based on trusted literature, the prevalence of JIA ranges from 16-50 cases/100,000 individuals in the United States (https://posna.org/physician-education/study-guide/juvenile-idiopathic-arthritis). Therefore, there is an estimated total of 294,000 juveniles affected by moderate to severe JIA in the United States that could be eligible for use of Adalimumab.
Adalimumab injections are indicated for reducing signs and symptoms in adult patients with active psoriatic arthritis. Based on trusted literature, an estimated 1.5 million adults in the United States have active psoriatic arthritis (https://www.hopkinsarthritis.org/arthritis-info/psoriatic-arthritis/). It is estimated that about one in three adults with the skin disease psoriasis will get psoriatic arthritis. Therefore, using available data, approximately 1.5 million adult patients with psoriatic arthritis in the United States could be eligible for use of Adalimumab.
Adalimumab injections are indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS). Based on trusted literature, the prevalence of active AS in the United States is approximately 0.2 – 0.5% (https://www.hopkinsarthritis.org/arthritis-info/ankylosing-spondylitis/#:~:text=Epidemiology,14%20per%20100%2C000%20person%2Dyears.). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, approximately to 670,256 to 1.67 million Americans with active AS could be eligible for use of Adalimumab.
Adalimumab injections are indicated for the treatment of moderate to severe active Crohn’s disease in adults and pediatric patients 6 years of age or older. Based on trusted literature, there are an estimated 565,000 Americans living with moderate to severe Crohn’s disease (https://pubmed.ncbi.nlm.nih.gov/22926499/). Therefore, approximately 565,000 people in the United States with active Crohn’s disease could be eligible for use of Adalimumab.
Adalimumab injections are indicated for the treatment of moderate to severe active ulcerative colitis in adult patients. Based on trusted literature, there are an estimated 593,000 Americans living with moderate to severe ulcerative colitis (https://pubmed.ncbi.nlm.nih.gov/22926499/). Therefore, approximately 593,000 people in the United States with active ulcerative colitis could be eligible for use of Adalimumab.
Adalimumab injections are indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis. Based on trusted literature, an estimated range of 1-2% of the American population lives with moderate to severe plaque psoriasis (https://emedicine.medscape.com/article/1108072-overview). Plaque psoriasis is the most common form of psoriasis and affects 80-90% of psoriasis patients (https://my.clevelandclinic.org/health/diseases/22842-plaque-psoriasis#:~:text=How%20common%20is%20plaque%20psoriasis,with%20psoriasis%20have%20plaque%20psoriasis.). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, approximately 3.35 to 6.7 million people in the United States with chronic plaque psoriasis could be eligible for use of Adalimumab.
Adalimumab injections are indicated for the treatment of moderate to severe hidradenitis suppurativa (HS) in adult patients. Based on trusted literature, an estimated .1% of the American population is affected by moderate to severe HS (https://pubmed.ncbi.nlm.nih.gov/28492923/). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, an estimated 335,128 people in the United States with moderate to severe HS could be eligible for use of Adalimumab.
Therefore, an estimated (using available data) 12,957,128 patients in the United States could potentially use this product during the current year.
The Products were not the result of a product acquisition; however, on November 29, 2022, Viatris announced that it has closed its transaction with Biocon Biologics Limited ("Biocon Biologic |
None |
| Mylan Pharmaceuticals Inc |
00378381601 |
Clozapine Orally Disintegrating Tablets, 150mg, 100 PKG |
Generic |
FDA |
2023-08-16 |
1726.3200 |
None |
1 |
167686 |
None |
None |
None |
None |
None |
None |
Clozapine orally disintegrating tablets are indicated for the treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Based on trusted literature, an estimated 1% of Americans are affected by schizophrenia (https://www.hopkinsmedicine.org/health/wellness-and-prevention/mental-health-disorder-statistics). In the United States, there are currently 335,371,100 people (https://www.census.gov/popclock/). Thus, an estimated 3,353,711 Americans are affected by schizophrenia. According to literature, treatment-resistant schizophrenia occurs in up to 34% of patients with schizophrenia (https://www.nature.com/articles/s41537-019-0090-z#:~:text=Treatment-resistant%20schizophrenia%20(TRS)%20has%20been%20defined%20). Therefore, approximately 1,140,262 patients living with treatment-resistant schizophrenia could be eligible for use of clozapine orally disintegrating tablets.
Clozapine orally disintegrating tablets are indicated for reducing the risk of recurrent suicidal behavior in patients with schizophrenia who are judged to be at chronic risk of re-experiencing suicidal behavior. Based on trusted literature, an estimated 1% of Americans are affected by schizophrenia (https://www.hopkinsmedicine.org/health/wellness-and-prevention/mental-health-disorder-statistics). In the United States, there are currently 335,371,100 people (https://www.census.gov/popclock/). Thus, an estimated 3,353,711 Americans are affected by schizophrenia. According to literature, the risk of suicidal behavior among individuals with schizophrenia is estimated at 5% (https://www.treatmentadvocacycenter.org/evidence-and-research/learn-more-about/3632-schizophrenia-bipolar-disorder-and-suicide). Therefore, approximately 167,686 patients with recurrent suicidal behavior could be eligible for use of clozapine orally disintegrating tablets. |
None |
| Mylan Pharmaceuticals Inc |
00378381701 |
Clozapine Orally Disintegrating Tablets, 200mg, 100 PKG |
Generic |
FDA |
2023-08-16 |
2301.7700 |
None |
1 |
167686 |
None |
None |
None |
None |
None |
None |
Clozapine orally disintegrating tablets are indicated for the treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Based on trusted literature, an estimated 1% of Americans are affected by schizophrenia (https://www.hopkinsmedicine.org/health/wellness-and-prevention/mental-health-disorder-statistics). In the United States, there are currently 335,371,100 people (https://www.census.gov/popclock/). Thus, an estimated 3,353,711 Americans are affected by schizophrenia. According to literature, treatment-resistant schizophrenia occurs in up to 34% of patients with schizophrenia (https://www.nature.com/articles/s41537-019-0090-z#:~:text=Treatment-resistant%20schizophrenia%20(TRS)%20has%20been%20defined%20). Therefore, approximately 1,140,262 patients living with treatment-resistant schizophrenia could be eligible for use of clozapine orally disintegrating tablets.
Clozapine orally disintegrating tablets are indicated for reducing the risk of recurrent suicidal behavior in patients with schizophrenia who are judged to be at chronic risk of re-experiencing suicidal behavior. Based on trusted literature, an estimated 1% of Americans are affected by schizophrenia (https://www.hopkinsmedicine.org/health/wellness-and-prevention/mental-health-disorder-statistics). In the United States, there are currently 335,371,100 people (https://www.census.gov/popclock/). Thus, an estimated 3,353,711 Americans are affected by schizophrenia. According to literature, the risk of suicidal behavior among individuals with schizophrenia is estimated at 5% (https://www.treatmentadvocacycenter.org/evidence-and-research/learn-more-about/3632-schizophrenia-bipolar-disorder-and-suicide). Therefore, approximately 167,686 patients with recurrent suicidal behavior could be eligible for use of clozapine orally disintegrating tablets. |
None |
| Novartis |
00078116147 |
Mekinist® (trametinib) for oral solution 4.7MG |
Brand |
FDA |
2023-05-16 |
1548.9800 |
Novartis considered many factors in determining the price of Mekinist. Tafinlar + Mekinist, the worldwide targeted therapy leader in BRAF/MEK-inhibition, is the first and only therapy to be approved with a tumor-agnostic indication for adult and pediatric patients with solid tumors that have a BRAF V600E mutation. We priced in parity to other branded treatments in this therapeutic area and are focused on access to Mekinist for this patient population. |
None |
400 |
1 |
1 |
None |
None |
None |
None |
Novartis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Novartis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Novartis or any of its affiliates now or in the future. Novartis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Novartis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all Novartis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure. |
None |
| Novartis |
00078115421 |
Tafinlar® (dabrafenib) tablets for oral suspension 10MG 210 |
Brand |
FDA |
2023-05-16 |
3663.2700 |
Novartis considered many factors in determining the price of Tafinlar. Tafinlar + Mekinist, the worldwide targeted therapy leader in BRAF/MEK-inhibition, is the first and only therapy to be approved with a tumor-agnostic indication for adult and pediatric patients with solid tumors that have a BRAF V600E mutation. We priced in parity to other branded treatments in this therapeutic area and are focused on access to Tafinlar for this patient population. |
None |
400 |
1 |
1 |
None |
None |
None |
None |
Novartis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Novartis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Novartis or any of its affiliates now or in the future. Novartis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Novartis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all Novartis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure. |
None |
| Novartis |
00078107068 |
COSENTYX SYRINGE 300MG/2ML |
Brand |
FDA |
2023-08-07 |
6924.2600 |
Novartis considered many factors in determining the price of Cosentyx. Cosentyx® (secukinumab) is the first new biologic treatment for hidradenitis suppurativa (HS) in nearly a decade, offering clinically meaningful results across the most debilitating symptoms. An international Phase IIIb study showed treatment with Cosentyx® (secukinumab) 300 mg in a 2 mL autoinjector (UnoReady® pen) resulted in high efficacy and convenient administration in adults with moderate to severe plaque psoriasis. Novartis patient support is a comprehensive support program designed to help patients get started on Cosentyx and stay on treatment. Cosentyx was priced to the healthcare value provided by this innovative medicine. |
None |
30673 |
None |
None |
None |
None |
None |
None |
Novartis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Novartis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Novartis or any of its affiliates now or in the future. Novartis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Novartis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all Novartis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure. |
None |
| Novartis |
00078116861 |
COSENTYX VIAL 125MG/5ML |
Brand |
FDA |
2023-10-25 |
2115.0000 |
Novartis considered many factors in determining the price of Cosentyx IV. To arrive at a fair price recommendation, the US team assessed several considerations, including patient accessibility and insurance/health plan coverage as well as the market basket of branded and biosimilar agents. Recommended price aligns with clinical value Cos IV brings as the 1st IV IL-17 available, filling unmet needs for patients & health professionals. The marketing for Cosentyx IV includes promotion of the drug to physicians or other health professionals, as well as patient promotional activities. |
None |
45000 |
None |
None |
None |
None |
None |
None |
Novartis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Novartis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Novartis or any of its affiliates now or in the future. Novartis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Novartis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all Novartis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure. |
None |
| Novartis |
00078118920 |
FABHALTA HGC 200MG 60 |
Brand |
FDA |
2023-12-08 |
45205.4800 |
Novartis considered many factors in determining the price of Fabhalta (Iptacopan). Fabhalta is an efficacious treatment for adults with paroxysmal nocturnal hemoglobinuria (PNH) and the first and only oral monotherapy to become available for patients. Fabhalta, now available for both previously treated and treatment-naive patients, is the only FDA-approved Factor B inhibitor of the immune system's complement pathway, which drives complement-mediated hemolysis in PNH. The price for FABHALTA reflects the benefits it may provide people living with PNH and also considers the overall value FABHALTA may provide to the healthcare system compared to currently available therapies. The branded therapies used for reference were Ultomiris and Soliris from Alexion and Empaveli from Apellis. The marketing for Fabhalta includes education and promotion to physicians, direct to consumer promotions, other types of marketing (e.g., online platforms and education). |
None |
6 |
1 |
1 |
None |
None |
None |
None |
Novartis provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Novartis does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Novartis or any of its affiliates now or in the future. Novartis, on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Novartis related information herein is confidential and proprietary, commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that the confidentiality of this submission and of all Novartis’ related information herein be maintained to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that Novartis is notified of the request and afforded the opportunity to submit objections to disclosure. |
None |
| Novo |
00169203011 |
Sogroya® 10 mg/1.5 mL (6.7 mg/mL) pen; 1.5mL in 1 prefilled syringe |
Brand |
FDA |
2023-06-09 |
2635.8000 |
None |
1 |
33000 |
None |
None |
None |
None |
None |
None |
"Sogroya® is a human growth hormone analog indicated for:
Pediatric Patients: Treatment of pediatric patients aged 2.5 years and older who have growth failure due to inadequate secretion of endogenous growth hormone (GH) (1).
Adults Patients: Replacement of endogenous growth hormone in adults with growth hormone deficiency (1).
The full Prescribing Information for Sogroya® is available at https://www.novo-pi.com/sogroya.pdf.
According to Komodo’s longitudinal claims data in 2023 there are approximately 33,000 GHD patients, on average, who could potentially use Sogroya® in any one-month period. For the estimated patients per month requirement, Novo Nordisk utilizes the number of estimated patients on pharmacotherapy who could potentially use Sogroya®. However, we note that the total number of patients diagnosed with GHD is roughly 1 in 5,000 adults and 1 in 4,000 to 6,000 pediatric. Please note, this is not an estimate of prescriptions that might be written for Sogroya® or each available dose of Sogroya®. Sogroya® will represent a portion of the broader market for growth hormone therapies
Sogroya® was developed by Novo Nordisk. " |
None |
| Novo |
00169203711 |
Sogroya® 15 mg/1.5 mL (10 mg/mL) pen; 1.5mL in 1 prefilled syringe |
Brand |
FDA |
2023-06-09 |
3953.7000 |
None |
1 |
33000 |
None |
None |
None |
None |
None |
None |
"Sogroya® is a human growth hormone analog indicated for:
Pediatric Patients: Treatment of pediatric patients aged 2.5 years and older who have growth failure due to inadequate secretion of endogenous growth hormone (GH) (1).
Adults Patients: Replacement of endogenous growth hormone in adults with growth hormone deficiency (1).
The full Prescribing Information for Sogroya® is available at https://www.novo-pi.com/sogroya.pdf.
According to Komodo’s longitudinal claims data in 2023 there are approximately 33,000 GHD patients, on average, who could potentially use Sogroya® in any one-month period. For the estimated patients per month requirement, Novo Nordisk utilizes the number of estimated patients on pharmacotherapy who could potentially use Sogroya®. However, we note that the total number of patients diagnosed with GHD is roughly 1 in 5,000 adults and 1 in 4,000 to 6,000 pediatric. Please note, this is not an estimate of prescriptions that might be written for Sogroya® or each available dose of Sogroya®. Sogroya® will represent a portion of the broader market for growth hormone therapies
Sogroya® was developed by Novo Nordisk. " |
None |
| Novo |
00169203511 |
Sogroya® 5 mg/1.5 mL (3.3 mg/mL) pen; 1.5mL in 1 prefilled syringe |
Brand |
FDA |
2023-06-09 |
1317.9000 |
None |
1 |
33000 |
None |
None |
None |
None |
None |
None |
"Sogroya® is a human growth hormone analog indicated for:
Pediatric Patients: Treatment of pediatric patients aged 2.5 years and older who have growth failure due to inadequate secretion of endogenous growth hormone (GH) (1).
Adults Patients: Replacement of endogenous growth hormone in adults with growth hormone deficiency (1).
The full Prescribing Information for Sogroya® is available at https://www.novo-pi.com/sogroya.pdf.
According to Komodo’s longitudinal claims data in 2023 there are approximately 33,000 GHD patients, on average, who could potentially use Sogroya® in any one-month period. For the estimated patients per month requirement, Novo Nordisk utilizes the number of estimated patients on pharmacotherapy who could potentially use Sogroya®. However, we note that the total number of patients diagnosed with GHD is roughly 1 in 5,000 adults and 1 in 4,000 to 6,000 pediatric. Please note, this is not an estimate of prescriptions that might be written for Sogroya® or each available dose of Sogroya®. Sogroya® will represent a portion of the broader market for growth hormone therapies
Sogroya® was developed by Novo Nordisk. " |
None |
| Organon |
78206018701 |
Hadlima Carton two singledose autoinjector pens 40 mg/0.4 ml |
Brand |
FDA |
2023-07-01 |
1038.0000 |
None |
1 |
400000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Organon |
78206018401 |
Hadlima Carton two singledose autoinjector pens 40 mg/0.8 ml |
Brand |
FDA |
2023-07-01 |
1038.0000 |
None |
1 |
400000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Organon |
78206018601 |
Hadlima Carton two singledose prefilled syringes 40 mg/0.4 ml |
Brand |
FDA |
2023-07-01 |
1038.0000 |
None |
1 |
400000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Organon |
78206018301 |
Hadlima Carton two singledose prefilled syringes 40 mg/0.8 ml |
Brand |
FDA |
2023-07-01 |
1038.0000 |
None |
1 |
400000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Orphalan |
81802000108 |
CUVRIOR, 300mg, tablet, 8 tablets per blister pack |
Brand |
FDA |
2023-04-01 |
1528.0000 |
None |
1 |
9000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Orphalan |
81802000172 |
CUVRIOR, 300mg, tablet, 8 tablets per blister pack, 9 blister packs total |
Brand |
FDA |
2023-04-01 |
13752.0000 |
None |
1 |
9000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Otsuka America Pharmaceutical, Inc. |
59148010280 |
Abilify Asimtufii® 720mg Kit (aripiprazole) |
Brand |
FDA |
2023-06-05 |
4078.8400 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Otsuka America Pharmaceutical, Inc. |
59148011480 |
Abilify Asimtufii® 960mg Kit (aripiprazole) |
Brand |
FDA |
2023-06-05 |
5438.4600 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Padagis US LLC |
45802043601 |
Tazarotene Gel 0.05% 100g |
Generic |
FDA |
2023-06-05 |
1316.7100 |
Product is be priced to deliver value to the market as compared to the Brand referenced drug. |
None |
655 |
None |
1 |
None |
None |
None |
None |
"As a generic manufacturer, Padagis does not have information available to accurately determinate the number of patients that could potentially have a condition for which the drug may be prescribed. Padagis neither collects nor uses estimated patient information and does not believe there is publicly available data that accurately represents the number of patients for all indications.
Based on IQVIA data available to Padagis, Padagis estimates that approximately 655 prescriptions were filled for the gel in the past 12 months, but number of prescriptions filled should not be misinterpreted as an accurate estimate of the number of patients with a condition for which the new drug may be prescribed, as dosage and therapy may vary across individual patients." |
None |
| Padagis US LLC |
45802044201 |
Tazarotene Gel 0.1% 100g |
Generic |
FDA |
2023-06-05 |
1399.0700 |
Product is be priced to deliver value to the market as compared to the Brand referenced drug. |
None |
1657 |
None |
1 |
None |
None |
None |
None |
"As a generic manufacturer, Padagis does not have information available to accurately determinate the number of patients that could potentially have a condition for which the drug may be prescribed. Padagis neither collects nor uses estimated patient information and does not believe there is publicly available data that accurately represents the number of patients for all indications.
Based on IQVIA data available to Padagis, Padagis estimates that approximately 1,657 prescriptions were filled for the gel in the past 12 months, but number of prescriptions filled should not be misinterpreted as an accurate estimate of the number of patients with a condition for which the new drug may be prescribed, as dosage and therapy may vary across individual patients." |
None |
| Padagis US LLC |
00574113316 |
Spironolactone Oral Suspension 25 mg/5 mL 473 mL |
Generic |
FDA |
2023-10-31 |
1498.5000 |
Product is be priced to deliver value to the market as compared to the Brand referenced drug. |
None |
6125 |
None |
None |
None |
None |
None |
None |
"As a generic manufacturer, Padagis does not have information available to accurately determinate the number of patients that could potentially have a condition for which the drug may be prescribed. Padagis neither collects nor uses estimated patient information and does not believe there is publicly available data that accurately represents the number of patients for all indications.
Based on IQVIA data available to Padagis, Padagis estimates that approximately 6,125 Total Units were sold for this drug in the past 12 months, but number of units sold should not be misinterpreted as an accurate estimate of the number of patients with a condition for which the new drug may be prescribed, as dosage and therapy may vary across individual patients." |
None |
| Par Pharmaceutical |
10370036801 |
Topiramate ER Caps 200mg 100s |
Generic |
FDA |
2023-03-24 |
3472.9200 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions.
Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Moreover, Par notes that because this product will compete in an established space, Par did not consider, nor did it identify, the estimated patient population in determining market need for the product.
Par notes Topiramate extended-release capsules are indicated:
1) As initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older.
2) As adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 6 years of age and older.
3) For the preventive treatment of migraine in patients 12 years of age and older.
The Centers for Disease Control and Prevention (“CDC”) estimates that 3.4 million people in the United States had active epilepsy in 2015. This CDC did not further break out how many children ages 6-17 had active epilepsy as compared to children ages 0-5. ( https://www.cdc.gov/epilepsy/about/fast-facts.htm#:~:text=Active%20Epilepsy&text=This%20is%20about%203.4%20million,million%20adults%20and%20470%2C000%20children.&text=According%20to%20the%20latest%20estimates,17%20years%20have%20active%20epilepsy.&text=Think%20of%20a%20school%20with,of%20them%20could%20have%20epilepsy )
The National Institutes of Health (“NIH”) estimates that migraines affect about 12% of the population. (https://www.ncbi.nlm.nih.gov/books/NBK560787/ )
Par has not independently verified this information.
Because Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to accurately provide an estimate of the average number of patients that will be prescribed this product each month.
Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s product because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states:
“Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at:
https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market.
Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank.
2) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank.
3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank. |
None |
| Par Pharmaceutical |
10370036811 |
Topiramate ER Caps 200mg 30s |
Generic |
FDA |
2023-03-24 |
1041.8900 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions.
Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Moreover, Par notes that because this product will compete in an established space, Par did not consider, nor did it identify, the estimated patient population in determining market need for the product.
Par notes Topiramate extended-release capsules are indicated:
1) As initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older.
2) As adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 6 years of age and older.
3) For the preventive treatment of migraine in patients 12 years of age and older.
The Centers for Disease Control and Prevention (“CDC”) estimates that 3.4 million people in the United States had active epilepsy in 2015. This CDC did not further break out how many children ages 6-17 had active epilepsy as compared to children ages 0-5. ( https://www.cdc.gov/epilepsy/about/fast-facts.htm#:~:text=Active%20Epilepsy&text=This%20is%20about%203.4%20million,million%20adults%20and%20470%2C000%20children.&text=According%20to%20the%20latest%20estimates,17%20years%20have%20active%20epilepsy.&text=Think%20of%20a%20school%20with,of%20them%20could%20have%20epilepsy )
The National Institutes of Health (“NIH”) estimates that migraines affect about 12% of the population. (https://www.ncbi.nlm.nih.gov/books/NBK560787/ )
Par has not independently verified this information.
Because Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to accurately provide an estimate of the average number of patients that will be prescribed this product each month.
Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s product because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states:
“Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at:
https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market.
Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank.
2) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank.
3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank. |
None |
| Par Pharmaceutical |
49884015802 |
Everolimus Tablets 0.25mg 60s |
Generic |
FDA |
2023-03-27 |
445.1100 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions.
(1) Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Moreover, Par notes that because this product will compete in an established space, Par did not consider, nor did it identify, the estimated patient population in determining market need for the product.
Accordingly, Par is unable to provide an estimate of the average number of patients who may be treated by this product beyond publicly available data.
Par notes this product indicated for the prophylaxis of organ rejection in adult patients who have had kidney or liver transplants.
The Centers for Disease Control and Prevention (“CDC”) states that 20,167 patients had a kidney transplant in the United States in 2017. ( https://nccd.cdc.gov/ckd/detail.aspx?Qnum=Q234 )
The National Institutes of Health (“NIH”) states that about 7,100 liver transplants were performed in the United States in 2015. ( https://www.niddk.nih.gov/health-information/liver-disease/liver-transplant/definition-facts )
Par has not independently verified this information.
Further, Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to accurately provide an estimate of the average number of patients that will be prescribed this product each month.
Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s product because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states:
“Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at:
https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market.
Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank.
(2) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank.
(3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank. |
None |
| Par Pharmaceutical |
49884015902 |
Everolimus Tablets 0.5mg 60s |
Generic |
FDA |
2023-03-27 |
890.2300 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions.
(1) Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Moreover, Par notes that because this product will compete in an established space, Par did not consider, nor did it identify, the estimated patient population in determining market need for the product.
Accordingly, Par is unable to provide an estimate of the average number of patients who may be treated by this product beyond publicly available data.
Par notes this product indicated for the prophylaxis of organ rejection in adult patients who have had kidney or liver transplants.
The Centers for Disease Control and Prevention (“CDC”) states that 20,167 patients had a kidney transplant in the United States in 2017. ( https://nccd.cdc.gov/ckd/detail.aspx?Qnum=Q234 )
The National Institutes of Health (“NIH”) states that about 7,100 liver transplants were performed in the United States in 2015. ( https://www.niddk.nih.gov/health-information/liver-disease/liver-transplant/definition-facts )
Par has not independently verified this information.
Further, Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to accurately provide an estimate of the average number of patients that will be prescribed this product each month.
Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s product because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states:
“Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at:
https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market.
Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank.
(2) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank.
(3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank. |
None |
| Par Pharmaceutical |
10370036701 |
Topiramate Extended-Release Capsules 100mg 100s |
Generic |
FDA |
2023-05-24 |
2538.8200 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions.
Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Moreover, Par notes that because this product will compete in an established space, Par did not consider, nor did it identify, the estimated patient population in determining market need for the product.
Par notes Topiramate extended-release capsules are indicated:
1) As initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older.
2) As adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 6 years of age and older.
3) For the preventive treatment of migraine in patients 12 years of age and older.
The Centers for Disease Control and Prevention (“CDC”) estimates that 3.4 million people in the United States had active epilepsy in 2015. This CDC did not further break out how many children ages 6-17 had active epilepsy as compared to children ages 0-5. ( https://www.cdc.gov/epilepsy/about/fast-facts.htm#:~:text=Active%20Epilepsy&text=This%20is%20about%203.4%20million,million%20adults%20and%20470%2C000%20children.&text=According%20to%20the%20latest%20estimates,17%20years%20have%20active%20epilepsy.&text=Think%20of%20a%20school%20with,of%20them%20could%20have%20epilepsy )
The National Institutes of Health (“NIH”) estimates that migraines affect about 12% of the population. (https://www.ncbi.nlm.nih.gov/books/NBK560787/ )
Par has not independently verified this information.
Because Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to accurately provide an estimate of the average number of patients that will be prescribed this product each month.
Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s product because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states:
“Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at:
https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market.
Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank.
2) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank.
3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank. |
None |
| Par Pharmaceutical |
10370036711 |
Topiramate Extended-Release Capsules 100mg 30s |
Generic |
FDA |
2023-05-24 |
761.6400 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions.
Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Moreover, Par notes that because this product will compete in an established space, Par did not consider, nor did it identify, the estimated patient population in determining market need for the product.
Par notes Topiramate extended-release capsules are indicated:
1) As initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older.
2) As adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 6 years of age and older.
3) For the preventive treatment of migraine in patients 12 years of age and older.
The Centers for Disease Control and Prevention (“CDC”) estimates that 3.4 million people in the United States had active epilepsy in 2015. This CDC did not further break out how many children ages 6-17 had active epilepsy as compared to children ages 0-5. ( https://www.cdc.gov/epilepsy/about/fast-facts.htm#:~:text=Active%20Epilepsy&text=This%20is%20about%203.4%20million,million%20adults%20and%20470%2C000%20children.&text=According%20to%20the%20latest%20estimates,17%20years%20have%20active%20epilepsy.&text=Think%20of%20a%20school%20with,of%20them%20could%20have%20epilepsy )
The National Institutes of Health (“NIH”) estimates that migraines affect about 12% of the population. (https://www.ncbi.nlm.nih.gov/books/NBK560787/ )
Par has not independently verified this information.
Because Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to accurately provide an estimate of the average number of patients that will be prescribed this product each month.
Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s product because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states:
“Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at:
https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market.
Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank.
2) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank.
3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank. |
None |
| Par Pharmaceutical |
10370036501 |
Topiramate Extended-Release Capsules 25mg 100s |
Generic |
FDA |
2023-05-24 |
983.7100 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions.
Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Moreover, Par notes that because this product will compete in an established space, Par did not consider, nor did it identify, the estimated patient population in determining market need for the product.
Par notes Topiramate extended-release capsules are indicated:
1) As initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older.
2) As adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 6 years of age and older.
3) For the preventive treatment of migraine in patients 12 years of age and older.
The Centers for Disease Control and Prevention (“CDC”) estimates that 3.4 million people in the United States had active epilepsy in 2015. This CDC did not further break out how many children ages 6-17 had active epilepsy as compared to children ages 0-5. ( https://www.cdc.gov/epilepsy/about/fast-facts.htm#:~:text=Active%20Epilepsy&text=This%20is%20about%203.4%20million,million%20adults%20and%20470%2C000%20children.&text=According%20to%20the%20latest%20estimates,17%20years%20have%20active%20epilepsy.&text=Think%20of%20a%20school%20with,of%20them%20could%20have%20epilepsy )
The National Institutes of Health (“NIH”) estimates that migraines affect about 12% of the population. (https://www.ncbi.nlm.nih.gov/books/NBK560787/ )
Par has not independently verified this information.
Because Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to accurately provide an estimate of the average number of patients that will be prescribed this product each month.
Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s product because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states:
“Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at:
https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market.
Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank.
2) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank.
3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank. |
None |
| Par Pharmaceutical |
10370036511 |
Topiramate Extended-Release Capsules 25mg 30s |
Generic |
FDA |
2023-05-24 |
295.1100 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions.
Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Moreover, Par notes that because this product will compete in an established space, Par did not consider, nor did it identify, the estimated patient population in determining market need for the product.
Par notes Topiramate extended-release capsules are indicated:
1) As initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older.
2) As adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 6 years of age and older.
3) For the preventive treatment of migraine in patients 12 years of age and older.
The Centers for Disease Control and Prevention (“CDC”) estimates that 3.4 million people in the United States had active epilepsy in 2015. This CDC did not further break out how many children ages 6-17 had active epilepsy as compared to children ages 0-5. ( https://www.cdc.gov/epilepsy/about/fast-facts.htm#:~:text=Active%20Epilepsy&text=This%20is%20about%203.4%20million,million%20adults%20and%20470%2C000%20children.&text=According%20to%20the%20latest%20estimates,17%20years%20have%20active%20epilepsy.&text=Think%20of%20a%20school%20with,of%20them%20could%20have%20epilepsy )
The National Institutes of Health (“NIH”) estimates that migraines affect about 12% of the population. (https://www.ncbi.nlm.nih.gov/books/NBK560787/ )
Par has not independently verified this information.
Because Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to accurately provide an estimate of the average number of patients that will be prescribed this product each month.
Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s product because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states:
“Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at:
https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market.
Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank.
2) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank.
3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank. |
None |
| Par Pharmaceutical |
10370036601 |
Topiramate Extended-Release Capsules 50mg 100s |
Generic |
FDA |
2023-05-25 |
1281.3800 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions.
Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Moreover, Par notes that because this product will compete in an established space, Par did not consider, nor did it identify, the estimated patient population in determining market need for the product.
Par notes Topiramate extended-release capsules are indicated:
1) As initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older.
2) As adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 6 years of age and older.
3) For the preventive treatment of migraine in patients 12 years of age and older.
The Centers for Disease Control and Prevention (“CDC”) estimates that 3.4 million people in the United States had active epilepsy in 2015. This CDC did not further break out how many children ages 6-17 had active epilepsy as compared to children ages 0-5. ( https://www.cdc.gov/epilepsy/about/fast-facts.htm#:~:text=Active%20Epilepsy&text=This%20is%20about%203.4%20million,million%20adults%20and%20470%2C000%20children.&text=According%20to%20the%20latest%20estimates,17%20years%20have%20active%20epilepsy.&text=Think%20of%20a%20school%20with,of%20them%20could%20have%20epilepsy )
The National Institutes of Health (“NIH”) estimates that migraines affect about 12% of the population. (https://www.ncbi.nlm.nih.gov/books/NBK560787/ )
Par has not independently verified this information.
Because Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to accurately provide an estimate of the average number of patients that will be prescribed this product each month.
Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s product because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states:
“Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at:
https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market.
Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank.
2) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank.
3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank. |
None |
| Par Pharmaceutical |
10370036611 |
Topiramate Extended-Release Capsules 50mg 30s |
Generic |
FDA |
2023-05-25 |
384.4100 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions.
Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Moreover, Par notes that because this product will compete in an established space, Par did not consider, nor did it identify, the estimated patient population in determining market need for the product.
Par notes Topiramate extended-release capsules are indicated:
1) As initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older.
2) As adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 6 years of age and older.
3) For the preventive treatment of migraine in patients 12 years of age and older.
The Centers for Disease Control and Prevention (“CDC”) estimates that 3.4 million people in the United States had active epilepsy in 2015. This CDC did not further break out how many children ages 6-17 had active epilepsy as compared to children ages 0-5. ( https://www.cdc.gov/epilepsy/about/fast-facts.htm#:~:text=Active%20Epilepsy&text=This%20is%20about%203.4%20million,million%20adults%20and%20470%2C000%20children.&text=According%20to%20the%20latest%20estimates,17%20years%20have%20active%20epilepsy.&text=Think%20of%20a%20school%20with,of%20them%20could%20have%20epilepsy )
The National Institutes of Health (“NIH”) estimates that migraines affect about 12% of the population. (https://www.ncbi.nlm.nih.gov/books/NBK560787/ )
Par has not independently verified this information.
Because Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to accurately provide an estimate of the average number of patients that will be prescribed this product each month.
Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s product because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states:
“Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at:
https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market.
Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank.
2) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank.
3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank. |
None |
| Par Pharmaceutical |
00254301255 |
Alvimopan Caps 12mg 30s |
Generic |
FDA |
2023-06-27 |
4713.2900 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions.
1) Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Moreover, Par notes that because this product will compete in an established space, Par did not consider, nor did it identify, the estimated patient population in determining market need for the product.
Par notes Alvimopan capsules are indicated to accelerate the time to upper and lower gastrointestinal recovery following surgeries that include partial bowel resection with primary anastomosis.
The National Institutes of Health (“NIH”) estimates that in the United States, there are more than 300,000 operations for diseases of the colon each year. ( https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5380454/ )
Par has not independently verified this information.
Because Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to accurately provide an estimate of the average number of patients that will be prescribed this product each month.
Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s product because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states:
“Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at:
https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market.
Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank.
2) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank.
3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank. |
None |
| Par Pharmaceutical |
42023019501 |
Posaconazole Inj 18mg/mL 1vial |
Generic |
FDA |
2023-06-28 |
530.4500 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions.
Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Moreover, Par notes that because this product will compete in an established space, Par did not consider, nor did it identify, the estimated patient population in determining market need for the product.
Par notes Posaconazole Injection are indicated for:
1) the treatment of invasive aspergillosis in adults and pediatric patients 13 years of age and older.
2) the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised
The Centers for Disease Control and Prevention (“CDC”) estimates 15,000 aspergillosis-associated hospitalizations occurred in the United States in 2014. The CDC further notes “because aspergillosis is not a reportable infection in the United States, the exact number of cases is difficult to determine.” (https://www.cdc.gov/fungal/diseases/aspergillosis/statistics.html )
The CDC estimates that approximately 25,000 cases of candidemia occur nationwide each year. ( https://www.cdc.gov/fungal/diseases/candidiasis/invasive/statistics.html )
Par has not independently verified this information.
Because Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to accurately provide an estimate of the average number of patients that will be prescribed this product each month.
Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s product because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states:
“Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at:
https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market.
Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank.
2) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank.
3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank. |
None |
| Pfizer |
00069350002 |
ZAVZPRET 10mg Nasal Spray 1x6 GVL |
Brand |
FDA |
2023-05-25 |
1100.0000 |
None |
1 |
6500000 |
1 |
None |
2022-10-03 |
1285800000.0000 |
None |
Pfizer Inc. acquired Biohaven, the maker of Nurtec ODT/Vydura (rimegepant), on October 3, 2022, an innovative therapy approved for both acute treatment of migraine and prevention of episodic migraine in adults. The transaction includes the acquisition of Biohaven’s CGRP programs, including rimegepant, zavegepant and a portfolio of five pre-clinical CGRP assets. Under the terms of the agreement, we acquired all outstanding common shares of Biohaven not already owned by us for $148.50 per share, in cash, for payments of approximately $11.5 billion, plus repayment of third-party debt of $863 million and redemption of Biohaven’s redeemable preferred stock for $495 million. Effective immediately prior to the closing of the acquisition, Biohaven completed the spin-off of Biohaven Ltd. (NYSE: BHVN), distributing Biohaven Ltd.’s shares to Biohaven shareholders. Biohaven Ltd. is a new publicly traded company that retained Biohaven’s non-CGRP development stage pipeline compounds. Pfizer, a Biohaven shareholder, received a pro rata portion of Biohaven Ltd.’s shares in the distribution and owns approximately 1.5% of Biohaven Ltd. as of December 31, 2022. |
Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pfizer estimates that there are approximately 6.5M patients in the United States that could potentially receive ZAVZPRET™, an innovative therapy approved for the acute treatment of migraine. Comment regarding Fields 8-9: ZAVZPRET™ did not receive breakthrough status and did not receive priority review; therefore, Columns 8-9 are intentionally left blank. Comment regarding Field 11 - The acquisition price is $12,858,000,000. The system would not allow us to enter the full acquisition price. |
None |
| Pfizer |
00069103130 |
TALZENNA 0.1mg Capsule 1x30 Bottle |
Brand |
FDA |
2023-06-21 |
17514.0700 |
None |
1 |
12000 |
None |
1 |
2016-09-28 |
1430000000.0000 |
None |
On September 28, 2016, Pfizer Inc. acquired Medivation for approximately $14.3 billion in cash ($13.9 billion, net of cash acquired). |
Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pfizer estimates that in total, approximately 12,000 patients in the U.S. could potentially receive TALZENNA™ in HRR-gene mutated metastatic castration-resistant prostate cancer. Comment regarding Field 8 - TALZENNA™ did not receive breakthrough status; therefore, Column 8 is intentionally left blank. Comment regarding Field 11 - The acquisition price is $14,300,000,000. The system would not allow us to enter the full acquisition price. |
None |
| Pfizer |
00069123530 |
TALZENNA 0.35mg Capsule 1x30 Bottle |
Brand |
FDA |
2023-06-21 |
17514.0700 |
None |
1 |
12000 |
None |
1 |
2016-09-28 |
1430000000.0000 |
None |
On September 28, 2016, Pfizer Inc. acquired Medivation for approximately $14.3 billion in cash ($13.9 billion, net of cash acquired). |
Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pfizer estimates that in total, approximately 12,000 patients in the U.S. could potentially receive TALZENNA™ in HRR-gene mutated metastatic castration-resistant prostate cancer. Comment regarding Field 8 - TALZENNA™ did not receive breakthrough status; therefore, Column 8 is intentionally left blank. Comment regarding Field 11 - The acquisition price is $14,300,000,000. The system would not allow us to enter the full acquisition price. |
None |
| Pfizer |
00069033428 |
LITFULO 50MG CAP 1X28 BTL US |
Brand |
FDA |
2023-07-06 |
3769.2300 |
None |
1 |
500000 |
None |
None |
None |
None |
None |
None |
Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pfizer estimates that there are approximately 0.5M patients in the United States that could potentially receive LITFULO™ in 2023 for the treatment of alopecia areata, an autoimmune disease. Comment regarding Fields 8-9: LITFULO™ did not receive breakthrough status and did not receive priority review; therefore, Columns 8-9 are intentionally left blank. Comment regarding Fields 10-13: LITFULO™ was not acquired; therefore, Columns 10-13 are intentionally left blank. |
None |
| Pfizer |
00069050502 |
NGENLA 24mg SSOL 1x1.2mL PFP US |
Brand |
FDA |
2023-07-31 |
1992.0000 |
None |
1 |
70000 |
None |
None |
None |
None |
None |
None |
Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pfizer estimates that there are approximately 70,000 patients in the United States that could potentially receive NGENLA® for the long-term treatment of pediatric growth hormone deficiency. Comment regarding Fields 8-9: NGENLA™ did not receive breakthrough status and did not receive priority review; therefore, Columns 8-9 are intentionally left blank. Comment regarding Fields 10-13: NGENLA™ was not acquired; therefore, Columns 10-13 are intentionally left blank. |
None |
| Pfizer |
00069052002 |
NGENLA 60mg SSOL 1x1.2mL PFP US |
Brand |
FDA |
2023-07-31 |
4980.0000 |
None |
1 |
70000 |
None |
None |
None |
None |
None |
None |
Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pfizer estimates that there are approximately 70,000 patients in the United States that could potentially receive NGENLA® for the long-term treatment of pediatric growth hormone deficiency. Comment regarding Fields 8-9: NGENLA™ did not receive breakthrough status and did not receive priority review; therefore, Columns 8-9 are intentionally left blank. Comment regarding Fields 10-13: NGENLA™ was not acquired; therefore, Columns 10-13 are intentionally left blank. |
None |
| Pfizer |
00069252202 |
ELREXFIO 44 mg/1.1 mL (40 mg/mL) in a Single-Dose Vial |
Brand |
FDA |
2023-08-15 |
7555.6800 |
None |
1 |
1200 |
1 |
1 |
None |
None |
None |
None |
Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pfizer estimates that there are approximately 1,200 patients in the United States that could potentially receive ELREXFIO™ for the treatment of adult patients with RRMM who have received at least four prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Comment regarding Fields 10-13: ELREXFIO™ was not acquired; therefore, Columns 10-13 are intentionally left blank. |
None |
| Pfizer |
00069449402 |
ELREXFIO 76 mg/1.9 mL (40 mg/mL) in a Single-Dose Vial |
Brand |
FDA |
2023-08-15 |
13050.7200 |
None |
1 |
1200 |
1 |
1 |
None |
None |
None |
None |
Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pfizer estimates that there are approximately 1,200 patients in the United States that could potentially receive ELREXFIO™ for the treatment of adult patients with RRMM who have received at least four prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Comment regarding Fields 10-13: ELREXFIO™ was not acquired; therefore, Columns 10-13 are intentionally left blank. |
None |
| Pfizer |
00069033302 |
ABRILADA 20mg/0.4ml SSOL 1x2 PFS US |
Generic |
FDA |
2023-10-18 |
6576.4900 |
None |
1 |
100000 |
None |
None |
None |
None |
None |
None |
Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pfizer estimates that there are approximately 100,000 patients in the United States that could potentially receive ABRILADA™ for the treatment of all approved indications. Comment regarding Field 8 - ABRILADA™ did not receive breakthrough status; therefore, Column 8 is intentionally left blank. Comment regarding Field 9 - ABRILADA™ did not receive priority review; therefore, Column 9 is intentionally left blank. Comment regarding Fields 10-13: ABRILADA™ was not acquired; therefore, Columns 10-13 are intentionally left blank. |
None |
| Pfizer |
00069032501 |
ABRILADA 40mg/0.8ml SSOL 1x1 PFP US |
Generic |
FDA |
2023-10-18 |
3288.2500 |
None |
1 |
100000 |
None |
None |
None |
None |
None |
None |
Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pfizer estimates that there are approximately 100,000 patients in the United States that could potentially receive ABRILADA™ for the treatment of all approved indications. Comment regarding Field 8 - ABRILADA™ did not receive breakthrough status; therefore, Column 8 is intentionally left blank. Comment regarding Field 9 - ABRILADA™ did not receive priority review; therefore, Column 9 is intentionally left blank. Comment regarding Fields 10-13: ABRILADA™ was not acquired; therefore, Columns 10-13 are intentionally left blank. |
None |
| Pfizer |
00069032502 |
ABRILADA 40mg/0.8ml SSOL 1x2 PFP US |
Generic |
FDA |
2023-10-18 |
6576.4900 |
None |
1 |
100000 |
None |
None |
None |
None |
None |
None |
Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pfizer estimates that there are approximately 100,000 patients in the United States that could potentially receive ABRILADA™ for the treatment of all approved indications. Comment regarding Field 8 - ABRILADA™ did not receive breakthrough status; therefore, Column 8 is intentionally left blank. Comment regarding Field 9 - ABRILADA™ did not receive priority review; therefore, Column 9 is intentionally left blank. Comment regarding Fields 10-13: ABRILADA™ was not acquired; therefore, Columns 10-13 are intentionally left blank. |
None |
| Pfizer |
00069032802 |
ABRILADA 40mg/0.8ml SSOL 1x2 PFS US |
Generic |
FDA |
2023-10-18 |
6576.4900 |
None |
1 |
100000 |
None |
None |
None |
None |
None |
None |
Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pfizer estimates that there are approximately 100,000 patients in the United States that could potentially receive ABRILADA™ for the treatment of all approved indications. Comment regarding Field 8 - ABRILADA™ did not receive breakthrough status; therefore, Column 8 is intentionally left blank. Comment regarding Field 9 - ABRILADA™ did not receive priority review; therefore, Column 9 is intentionally left blank. Comment regarding Fields 10-13: ABRILADA™ was not acquired; therefore, Columns 10-13 are intentionally left blank. |
None |
| Pfizer |
00069531720 |
PAXLOVID (nirmatrelvir tablets and ritonavir tablets) 150 mg/100 mg Dose Pack |
Brand |
FDA |
2023-10-18 |
1390.0000 |
None |
1 |
34000000 |
None |
1 |
None |
None |
None |
None |
Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pfizer estimates that there are approximately 34M patients in the United States that could potentially receive PAXLOVID™ to treat mild-to-moderate coronavirus disease 2019 (COVID 19) in adults who are at high risk for progression to severe COVID 19, including hospitalization or death. Comment regarding Field 8 - PAXLOVID™ did not receive breakthrough status; therefore, Column 8 is intentionally left blank. Comment regarding Fields 10-13: PAXLOVID™ was not acquired; therefore, Columns 10-13 are intentionally left blank. |
None |
| Pfizer |
00069532130 |
PAXLOVID (nirmatrelvir tablets and ritonavir tablets) 300 mg/100 mg Dose Pack |
Brand |
FDA |
2023-10-18 |
1390.0000 |
None |
1 |
34000000 |
None |
1 |
None |
None |
None |
None |
Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pfizer estimates that there are approximately 34M patients in the United States that could potentially receive PAXLOVID™ to treat mild-to-moderate coronavirus disease 2019 (COVID 19) in adults who are at high risk for progression to severe COVID 19, including hospitalization or death. Comment regarding Field 8 - PAXLOVID™ did not receive breakthrough status; therefore, Column 8 is intentionally left blank. Comment regarding Fields 10-13: PAXLOVID™ was not acquired; therefore, Columns 10-13 are intentionally left blank. |
None |
| Pfizer |
00069027430 |
VELSIPITY 2MG TFC 1X30 PBTL US |
Brand |
FDA |
2023-10-19 |
6164.3800 |
None |
1 |
633000 |
None |
None |
2022-03-11 |
670000000.0000 |
None |
On March 11, 2022, we acquired Arena, a clinical stage company, for $100 per share in cash. The total fair value of the consideration transferred was $6.6 billion ($6.2 billion, net of cash acquired). In addition, $138 million in payments to Arena employees for the fair value of previously unvested long-term incentive awards was recognized as post-closing compensation expense and recorded in Restructuring charges and certain acquisition-related costs. |
Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pfizer estimates that there are approximately 415,000 patients in the United States that could potentially receive VELSIPTY™ for the treatment of moderate to severe ulcerative colitis. Comment regarding Fields 8-9: VELSIPTY™ did not receive breakthrough status and did not receive priority review; therefore, Columns 8-9 are intentionally left blank. Comment regarding Field 11 - The acquisition price is $6,700,000,000. The system would not allow us to enter the full acquisition price. |
None |
| Pfizer |
00069150060 |
XALKORI 150mg CAP 1x60 BTL US |
Brand |
FDA |
2023-11-20 |
15868.4800 |
None |
1 |
100 |
1 |
None |
None |
None |
None |
None |
Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pfizer estimates that there are approximately 100 new patients annually in the United States that could potentially receive the pellet formulation of XALKORI. This includes pediatric patients receiving XALKORI for the treatment of ALK+ ALCL and ALK+ IMT and adult patients receiving treatment for ROS1 and ALK+ mNSCLC who cannot swallow. Comment regarding Field 9 - XALKORI® did not receive priority review; therefore, Column 9 is intentionally left blank. Comment regarding Fields 10-13: XALKORI® was not acquired; therefore, Columns 10-13 are intentionally left blank. |
None |
| Pfizer |
00069025160 |
XALKORI 20mg CAP 1x60 BTL US |
Brand |
FDA |
2023-11-20 |
2242.7400 |
None |
1 |
100 |
1 |
None |
None |
None |
None |
None |
Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pfizer estimates that there are approximately 100 new patients annually in the United States that could potentially receive the pellet formulation of XALKORI. This includes pediatric patients receiving XALKORI for the treatment of ALK+ ALCL and ALK+ IMT and adult patients receiving treatment for ROS1 and ALK+ mNSCLC who cannot swallow. Comment regarding Field 9 - XALKORI® did not receive priority review; therefore, Column 9 is intentionally left blank. Comment regarding Fields 10-13: XALKORI® was not acquired; therefore, Columns 10-13 are intentionally left blank. |
None |
| Pfizer |
00069050760 |
XALKORI 50mg CAP 1x60 BTL US |
Brand |
FDA |
2023-11-20 |
5289.4900 |
None |
1 |
100 |
1 |
None |
None |
None |
None |
None |
Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pfizer estimates that there are approximately 100 new patients annually in the United States that could potentially receive the pellet formulation of XALKORI. This includes pediatric patients receiving XALKORI for the treatment of ALK+ ALCL and ALK+ IMT and adult patients receiving treatment for ROS1 and ALK+ mNSCLC who cannot swallow. Comment regarding Field 9 - XALKORI® did not receive priority review; therefore, Column 9 is intentionally left blank. Comment regarding Fields 10-13: XALKORI® was not acquired; therefore, Columns 10-13 are intentionally left blank. |
None |
| Pharmaceutical Associates, Inc |
00121494800 |
Potassium Chloride Oral Solution USP 10% Rx - 20mEq/15mL 100/cs |
Generic |
FDA |
2023-03-17 |
1205.0000 |
None |
1 |
13000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Pharmaceutical Associates, Inc |
00121189600 |
Potassium Chloride Oral Solution USP 10% Rx - 40mEq/30mL 100/cs |
Generic |
FDA |
2023-03-17 |
1849.0000 |
None |
1 |
13000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Pharming Healthcare Inc |
71274017060 |
Joenja 70mg Tablets 60 Count Bottle |
Brand |
FDA |
2023-04-03 |
45000.0000 |
None |
1 |
400 |
None |
1 |
2019-08-13 |
20000000.0000 |
None |
None |
None |
None |
| Piramal Critical Care |
66794023741 |
Doxycycline for Injection, USP, 20 mL vial, 100mg, Single use vial, 1 carton of 10 vials |
Generic |
FDA |
2023-06-16 |
251.0000 |
"For Doxycycline, Piramal conducts the following marketing activities; telemarketing and direct to HCP’s notifications via email and sales representatives visits conducting calls on HCP’s where sell sheets are provided. Piramal marketing activities are minimal since this is a generic product; and the spend on marketing activities on an annual basis is the following amounts: Direct to consumer was $0; Direct to physician (HCPs) was $3,250.00.
Piramal conducts market research utilizing IQVIA data to determine the competitive landscape for any new product launch. We review this information and determine how many generic manufacturers are in the market and determine a market share position based on this approach. We establish our WAC pricing by reviewing IQVIA data and setting our WAC at a competitive rate by researching all competitive WAC pricing for both brand and generic competitors and then we establish a commercial contract price of 70% below current Average Manufacturer Selling Price (AMSP). WAC was set at 1% below Average WAC Price (AWP) of the existing market. Additionally, multiple factors are considered for selecting a product beyond the pricing; such as the difficulties in producing the product, distribution cost for speciality products, administrative costs related to contracts, chargeback management, as well as the value this product would bring to patients. " |
None |
1596000 |
None |
None |
None |
None |
None |
None |
None |
None |
| PureTek Corporation |
59088043510 |
Diclofenac Sodium Topical Solution 1.5%, w/w 5fl oz (150ml) |
Generic |
FDA |
2023-01-16 |
1308.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
750000 |
None |
None |
None |
None |
None |
None |
Dispensed by prescription only |
None |
| PureTek Corporation |
59088073000 |
Triasil, Triamcinolone Acetonide Ointment USP, 0.025%, 80g+ Gauze pads, sterile, 20ct + silicon Tape roll (1ct) |
Brand |
Medispan |
2023-01-20 |
2888.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
250000 |
None |
None |
None |
None |
None |
None |
Dispensed by prescription only |
None |
| PureTek Corporation |
59088069816 |
Urea 39.5% Cream (8oz) |
Generic |
Medispan |
2023-01-20 |
1581.2000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
1500000 |
None |
None |
None |
None |
None |
None |
Dispensed by prescription only |
None |
| PureTek Corporation |
59088064354 |
Dexatran Multivitamin (30ct), Vit C 200mg, Thiamin 10 mg, Riboflavin 6 mg, Niacin 30 mg, Vitamin B6 5 mg, Folate 1667 mcg DFE, Vitamin B12 15 mcg, Pantothenic Acid 10 mg, Iron 18 mg, Magnesium 6.9 mg, Zinc 18.2 mg, Copper 0.8 mg, Manganese 1.3 mg |
Brand |
Medispan |
2023-02-20 |
1800.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
725000 |
None |
None |
None |
None |
None |
None |
Dispensed by prescription only |
None |
| PureTek Corporation |
59088021016 |
Urea 39.5% + 2% Salicylic Acid Cream (8oz)_ Urea 39.5%_ Salicylic Acid 2% |
Brand |
Medispan |
2023-03-24 |
3370.4000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
500000 |
None |
None |
None |
None |
None |
None |
Dispensed by prescription only |
None |
| PureTek Corporation |
59088020903 |
Hydroxym Gel (1oz), Hydrocortisone 2% |
Brand |
Medispan |
2023-07-14 |
1158.4000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
250000 |
None |
None |
None |
None |
None |
None |
Dispensed by prescription only |
None |
| PureTek Corporation |
59088090554 |
Lidocan (30ct), Lidocaine Patch 5%, Lidocaine 700mg (50mg per gram adhesive) in an aqueous base. |
Generic |
FDA |
2023-07-19 |
1540.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
700000 |
None |
None |
None |
None |
None |
None |
Dispensed by prescription only |
None |
| PureTek Corporation |
59088073100 |
Xyliderm, Lidocan (30ct), Alcohol Prep Pads Sterile (200ct), Xrylix Sheets (30ct) |
Brand |
Medispan |
2023-07-19 |
2560.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
200000 |
None |
None |
None |
None |
None |
None |
Dispensed by prescription only |
None |
| PureTek Corporation |
59088080100 |
Lextol,Penetral Cream (Capsaicin 0.025%), Diclofenac Sodium Topical Solution (1.5% w/w, 5fl oz./ 150ml) |
Brand |
Medispan |
2023-08-30 |
2349.6000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
275000 |
None |
None |
None |
None |
None |
None |
RX |
None |
| PureTek Corporation |
59088064003 |
Micomitin Antifungal Liquid (1fl oz), Tolnaftate 1% |
Brand |
Medispan |
2023-08-30 |
1800.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
325000 |
None |
None |
None |
None |
None |
None |
Dispensed by prescription only |
None |
| PureTek Corporation |
59088030803 |
Lidotral 5% with Menthol Spray (1fl oz/ 30 ml), Lidocaine HCI 5%, Menthol 3% |
Brand |
Medispan |
2023-10-11 |
1704.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
725000 |
None |
None |
None |
None |
None |
None |
RX, Dispensed by prescription only |
None |
| PureTek Corporation |
59088021403 |
Salicate Serum, Salicylic Acid 10% |
Brand |
Medispan |
2023-10-13 |
1581.2000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
650000 |
None |
None |
None |
None |
None |
None |
RX, Dispensed by prescription only |
None |
| PureTek Corporation |
59088090754 |
Lidocan III (30ct), Lidocaine Patch 5%, Lidocaine 700mg (50mg per gram adhesive) in an aqueous base |
Generic |
FDA |
2023-10-17 |
828.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
795000 |
None |
None |
None |
None |
None |
None |
RX, Dispensed by prescription only |
None |
| PureTek Corporation |
59088044301 |
Mycozyl AL (10ml), Miconatate 1% antifungal liquid |
Brand |
Medispan |
2023-10-17 |
917.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
675000 |
None |
None |
None |
None |
None |
None |
RX, Dispensed by prescription only |
None |
| PureTek Corporation |
59088090854 |
Lidocan II Patch (30ct), Lidocaine 5% patch (30ct) |
Brand |
Medispan |
2023-10-23 |
1540.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
825000 |
None |
None |
None |
None |
None |
None |
RX, Dispensed by prescription only |
None |
| PureTek Corporation |
59088020207 |
Menticam Cream (3oz), Camphor 4% Menthol 7.5% Methyl salicylate 10% |
Brand |
Medispan |
2023-10-26 |
828.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
625000 |
None |
None |
None |
None |
None |
None |
RX, Dispensed by prescription only |
None |
| PureTek Corporation |
59088020307 |
Menticam Gel (3.5oz), Camphor 4% Menthol 7.5% Methyl salicylate 10% |
Brand |
Medispan |
2023-10-26 |
828.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
625000 |
None |
None |
None |
None |
None |
None |
RX, Dispensed by prescription only |
None |
| PureTek Corporation |
59088015854 |
Davimet M (30ct) chewable tablets, Vit A 750 mcg RAE, Vit C 60mg, Vit D3 10 mcg, Vit E 10mg, Thiamin 1.05mg, Riboflavin 1.2mg, Niacin 13.5 mg, Vit B6 1.05mg, Folate 1700 mcg DFE, B12 4.5 mcg |
Brand |
Medispan |
2023-11-30 |
828.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
825000 |
None |
None |
None |
None |
None |
None |
RX, Dispensed by prescription only |
None |
| PureTek Corporation |
59088030154 |
Folixate (30ct) tablets, Folate 1700 mcg DFE, Vit D3 125 mcg |
Brand |
Medispan |
2023-12-05 |
828.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
875000 |
None |
None |
None |
None |
None |
None |
RX, Dispensed by prescription only |
None |
| PureTek Corporation |
59088000454 |
Bolsitol Capsules (30ct), Lactobacillus Plantarum 299V, 10 billion CFU |
Brand |
Medispan |
2023-12-06 |
828.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
675000 |
None |
None |
None |
None |
None |
None |
RX, Dispensed by prescription only |
None |
| PureTek Corporation |
59088022705 |
Salycim Cream (2oz), Salicylic Acid 6% |
Brand |
Medispan |
2023-12-06 |
828.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
575000 |
None |
None |
None |
None |
None |
None |
RX, Dispensed by prescription only |
None |
| PureTek Corporation |
59088026403 |
Mycozyl HC (1fl oz), Tolnaftate 1%, Hydrocortisone 0.667% |
Brand |
Medispan |
2023-12-11 |
828.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
1250000 |
None |
None |
None |
None |
None |
None |
RX, Dispensed by prescription only |
None |
| PureTek Corporation |
59088065931 |
Livita Liquid Multivitamin for Adults (480ml), Vit A, Vit C, Vit D3, Vit E, Thiamin, Riboflavin, Niacin, Vit B6, Folate, Vit b12, Biotin, Pantothenic Acid, Choline, Calcium, Magnesium, Zinc |
Brand |
Medispan |
2023-12-15 |
1680.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
1500000 |
None |
None |
None |
None |
None |
None |
RX, Dispensed by prescription only |
None |
| PureTek Corporation |
59088066016 |
Livita Liquid Multivitamin for Children |
Brand |
Medispan |
2023-12-15 |
1500.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
1500000 |
None |
None |
None |
None |
None |
None |
RX, Dispensed by prescription only |
None |
| PureTek Corporation |
59088015654 |
Menatrol (30ct) capsules, |
Brand |
Medispan |
2023-12-18 |
828.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
2500000 |
None |
None |
None |
None |
None |
None |
RX, Dispensed by prescription only |
None |
| Reata Pharmaceuticals, Inc. |
73179025090 |
Skyclarys 50 mg 90 count |
Brand |
FDA |
2023-06-28 |
30833.3300 |
Because there has been no FDA-approved drug for Friedrich's ataxia (FA) until SKYCLARYS, most patients seek routine care by their local neurologist or primary care physician.? Important commercial launch targets include CCRN centers, or Collaborative Clinical Research Network sites, ataxia centers and HCPs with FA patients linked to their practice. Through the evaluation of ICD-10 claims data, we've identified healthcare providers treating patients with Friedrich's ataxia today.???
We also have marketing outreach efforts through digital, social, email, and print to reach additional practicing neurologists to raise awareness of SKYCLARYS’ approval as newly diagnosed patients are identified and others return to their neurologist for treatment.?
With SKYCLARYS approval, our commercial team began to inform the FA network of patients, caregivers, and healthcare providers. Omni-channel outreach efforts started with the launch of our brand websites, online search, social media, and digital campaigns that went live upon drug approval.??
Our sales organization consists of a team of region business directors and neurology account managers responsible for educating HCPs. Our field access team consists of national account directors focused on SKYCLARYS coverage by national and regional payers, and the patient access liaisons team hired to support practice level access needs.??
We offer Reata REACH or the Reata Education, Access, and Care Helpline as an integrated, exclusive specialty pharmacy and patient services program. It will serve as the single point of contact for HCPs prescribing SKYCLARYS, FA patients receiving drug and their caregivers. REACH is designed to create a simple and positive experience through new patient start process, insurance navigation, therapy adherence, and access.
A WAC price of $30,833.33 per bottle (30 day supply) was established for SKYCLARYS. |
None |
4500 |
None |
1 |
None |
None |
None |
None |
acquisition price is N/A |
None |
| Regeneron Pharmaceuticals, Inc. |
61755005001 |
EYLEA® HD (aflibercept) Injection 8mg Vial Kit |
Brand |
FDA |
2023-08-21 |
2625.0000 |
Marketing
Planned marketing activities that will support the approval of EYLEA® HD (aflibercept) Injection 8mg include raising awareness about the extended dosing regimens while maintaining noninferior BCVA-ETDRS letter gains to EYLEA® (aflibercept) Injection 2mg at week 48, with a safety form consistent to EYLEA for the treatment of wet age related macular degeneration and diabetic macular edema, and EYLEA® HD (aflibercept) Injection 8mg among healthcare professionals through physician-focused product and disease education websites, other digital media, print media, and use of sales representatives to promote the FDA-approved indications. Anticipated direct-to-consumer marketing activities include a consumer-focused product website and other digital media.
Pricing
Regeneron approaches pricing with fairness, affordability and access at the forefront. Our pricing philosophy is guided by several principles.
First, medicines should be priced fairly. We take a value-based pricing approach that reflects their benefit to patients, society and the healthcare system. We consider the long-term investment and risk inherent in science and technology innovation, which is required to bring novel medicines to patients.
Second, medicines are only useful if patients in need can access and afford them. We are committed to supporting patients’ access by providing financial assistance for eligible patients.
Third, our growth is driven by scientific innovation, not pricing. Any price changes Regeneron makes is designed to keep pace with the medicine’s value and our costs, and in careful consideration of commercial competitiveness.
Regeneron also seeks to work collaboratively with other stakeholders in the healthcare system and welcome their input on fair and cost-effective pricing. These principles taken together help to ensure advancing our goal of setting fair, value-based prices for our medicines and breaking down barriers to patient access. |
None |
600000 |
None |
1 |
None |
None |
None |
None |
All information submitted by Regeneron Pharmaceuticals, Inc. to the California Office of Statewide Health Planning and Development under Cal. Code. Regs. Tit. 22, § 96076, including all information contained in this submission, is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act. Regeneron requests that the confidentiality of this submission and of all Regeneron’s related information herein be maintained to the maximum extent permitted by law. To the extent that any of this designated information is requested, whether under the California Public Records Act or otherwise, Regeneron requests that it be notified of the request and afforded an opportunity to submit objections to disclosure.” |
None |
| Regeneron Pharmaceuticals, Inc. |
61755001401 |
VEOPOZ™ (pozelimab-bbfg) 400 mg/2 mL (200 mg/mL) |
Brand |
FDA |
2023-09-01 |
34615.3800 |
Marketing
Planned marketing activities that will support the approval of VEOPOZ™ (pozelimab-bbfg) include raising awareness about CD55-deficient protein losing enteropathy (also known as CHAPLE disease) and VEOPOZ™ among healthcare professionals through physician-focused product website and other digital media to promote the FDA-approved indication. Anticipated direct-to-consumer marketing activities include a consumer-focused disease awareness website and other digital media.
Pricing
Regeneron approaches pricing with fairness, affordability and access at the forefront. Our pricing philosophy is guided by several principles.
First, medicines should be priced fairly. We take a value-based pricing approach that reflects their benefit to patients, society and the healthcare system. We consider the long-term investment and risk inherent in science and technology innovation, which is required to bring novel medicines to patients.
Second, medicines are only useful if patients in need can access and afford them. We are committed to supporting patients’ access by providing financial assistance for eligible patients.
Third, our growth is driven by scientific innovation, not pricing. Any price changes Regeneron makes is designed to keep pace with the medicine’s value and our costs, and in careful consideration of commercial competitiveness.
Regeneron also seeks to work collaboratively with other stakeholders in the healthcare system and welcome their input on fair and cost-effective pricing. These principles taken together help to ensure advancing our goal of setting fair, value-based prices for our medicines and breaking down barriers to patient access. |
None |
3 |
None |
1 |
None |
None |
None |
None |
All information submitted by Regeneron Pharmaceuticals, Inc. to the California Office of Statewide Health Planning and Development under Cal. Code. Regs. Tit. 22, § 96076, including all information contained in this submission, is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act. Regeneron requests that the confidentiality of this submission and of all Regeneron’s related information herein be maintained to the maximum extent permitted by law. To the extent that any of this designated information is requested, whether under the California Public Records Act or otherwise, Regeneron requests that it be notified of the request and afforded an opportunity to submit objections to disclosure.
VEOPOZ™ (pozelimab-bbfg) Injection is approved for the treatment of CHAPLE disease, an ultra-rare disease for which there are no reliable estimates on prevalence in the United States. The response provided in Column 7 herein reflects Regeneron’s good faith attempt to estimate the patient population such disease in the United States.” |
None |
| RISING PHARMA HOLDINGS, INC. |
64980058851 |
Edetate Calcium Disodium injection, USP 5 mL single-dose vial (NDC 64980-588-05) containing 200 mg of edetate calcium disodium per mL (1000 mg per vial), in boxes containing 5 vials (NDC 64980-588-51). |
Generic |
FDA |
2023-07-15 |
32609.0000 |
None |
1 |
400 |
None |
None |
None |
None |
None |
None |
None |
None |
| RISING PHARMA HOLDINGS, INC. |
16571081205 |
TRIENTINE CAP 500 MG 50CT |
Generic |
FDA |
2023-09-29 |
19166.8000 |
The product is an additional strength to an already existing 250mg Trientine in the market that is highly generic. We do not have a field sales force and do not market directly to Physicians. Pricing was also recently reduced by 50%. |
None |
300 |
None |
None |
None |
None |
None |
None |
None |
None |
| Sagent Pharmaceuticals |
25021082902 |
Fomepizole Injection (1.5gm/1.5ml, 1.5ml, 1x1.5ml) |
Generic |
FDA |
2023-12-11 |
985.0000 |
Competitive pricing to match competition. Pricing methodology to price in market higher than the 2nd market leader. |
None |
6739 |
None |
None |
None |
None |
None |
None |
None |
None |
| Sandoz Inc. |
00781215832 |
PIRFENIDONE 267MG 270HGC BO US |
Generic |
FDA |
2023-01-09 |
9130.5700 |
This launch is specific to the U.S. Sandoz Inc. is contracting within the wholesaler and/or specialty pharmacy space. The WAC is priced lower than the WAC of the reference product. |
None |
100000 |
None |
None |
None |
None |
None |
None |
According to Cortellis data from July 2021, IPF is rare disease, with an estimated prevalence of 44,000 to 135,000 cases and an incidence of 21,000 new cases per year in the U.S.
Source: https://insights.decisionresourcesgroup.com/disease/idiopathic-pulmonary-fibrosis.
Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product.
Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure. |
None |
| Sandoz Inc. |
00781402822 |
CHLORPROMAZINE 100MG/ML 240ML |
Generic |
FDA |
2023-03-31 |
2160.0000 |
This launch is specific to the U.S. Sandoz Inc. is contracting within the wholesaler and/or specialty pharmacy space. The WAC is priced equal to the previous manufacturer. |
None |
139710 |
None |
None |
2022-12-14 |
1400000.0000 |
None |
Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure. |
Chlorpromazine Oral Soultion is indicated for the treatment of multiple conditions including but not limited to the following: the management of manifestations of psychotic disorders, the treatment of schizophrenia, to control nausea and vomiting.
For relief of restlessness and apprehension before surgery, for acute intermittent porphyria, as an adjunct in the treatment of tetanus.
To control the manifestations of the manic type of manic-depressive illness, for relief of intractable hiccups, for the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability and poor frustration tolerance. There is an estimated 139,710 patients treated with Chlorpromazine Oral Solution in the United States. Source: DailyMEd, FDA label Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure. |
None |
| Sandoz Inc. |
61314032764 |
Adalimumab 40MG/0.4ML 2LISY BI US |
Generic |
FDA |
2023-07-05 |
1315.3000 |
Sandoz’s marketing plan for the introduction of Hyrimoz will focus on educating health care professionals (HCPs) and patients (consumers) about the benefit of biosimilars and the approved use of Hyrimoz. Sandoz does not plan to do any direct-to-consumer media advertisements on TV, in magazines, radio, billboards or blogs. Consumer engagement will include our patient website, patient education brochures and emails for those patients that opt into communications and enroll in patient support. Sandoz will offer a patient transition program to patients that transition from Humira to Hyrimoz. HCP engagement will include the HCP website, printed resources, email blasts and other digital resources in line with the Hyrimoz prescribing information. We will provide samples to physician offices but will not provide gifts or sponsor continuing education programs for HCPs. The WAC is priced lower than the WAC of the reference product. |
None |
33782 |
None |
None |
None |
None |
None |
None |
Hyrimoz is a tumor necrosis factor (TNF) blocker indicated for 9 disease states :
1. Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA.
2. Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older.
3. Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA.
4. Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS.
5. Crohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
6. Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers.
7. Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
8. Hidradenitis Suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.
9. Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. There are an estimated 475,350 patients that could be treated with Hyrimoz in the United States. Source: Label from USFDA (Drugs@FDA). Link: label (fda.gov)
Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product. Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure. |
None |
| Sandoz Inc. |
61314032720 |
Adalimumab 40MG/0.4ML 2LISY PE BI US |
Generic |
FDA |
2023-07-05 |
1315.3000 |
Sandoz’s marketing plan for the introduction of Hyrimoz will focus on educating health care professionals (HCPs) and patients (consumers) about the benefit of biosimilars and the approved use of Hyrimoz. Sandoz does not plan to do any direct-to-consumer media advertisements on TV, in magazines, radio, billboards or blogs. Consumer engagement will include our patient website, patient education brochures and emails for those patients that opt into communications and enroll in patient support. Sandoz will offer a patient transition program to patients that transition from Humira to Hyrimoz. HCP engagement will include the HCP website, printed resources, email blasts and other digital resources in line with the Hyrimoz prescribing information. We will provide samples to physician offices but will not provide gifts or sponsor continuing education programs for HCPs. The WAC is priced lower than the WAC of the reference product. |
None |
376201 |
None |
None |
None |
None |
None |
None |
Hyrimoz is a tumor necrosis factor (TNF) blocker indicated for 9 disease states :
1. Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA.
2. Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older.
3. Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA.
4. Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS.
5. Crohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
6. Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers.
7. Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
8. Hidradenitis Suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.
9. Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. There are an estimated 475,350 patients that could be treated with Hyrimoz in the United States. Source: Label from USFDA (Drugs@FDA). Link: label (fda.gov)
Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product. Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure. |
None |
| Sandoz Inc. |
61314050964 |
HYRIMOZ 10MG/0.1ML 2LISY BI US |
Generic |
FDA |
2023-07-05 |
6576.4900 |
Sandoz’s marketing plan for the introduction of Hyrimoz will focus on educating health care professionals (HCPs) and patients (consumers) about the benefit of biosimilars and the approved use of Hyrimoz. Sandoz does not plan to do any direct-to-consumer media advertisements on TV, in magazines, radio, billboards or blogs. Consumer engagement will include our patient website, patient education brochures and emails for those patients that opt into communications and enroll in patient support. Sandoz will offer a patient transition program to patients that transition from Humira to Hyrimoz. HCP engagement will include the HCP website, printed resources, email blasts and other digital resources in line with the Hyrimoz prescribing information. We will provide samples to physician offices but will not provide gifts or sponsor continuing education programs for HCPs. The WAC is priced lower than the WAC of the reference product. |
None |
202 |
None |
None |
None |
None |
None |
None |
Hyrimoz is a tumor necrosis factor (TNF) blocker indicated for 9 disease states :
1. Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA.
2. Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older.
3. Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA.
4. Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS.
5. Crohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
6. Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers.
7. Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
8. Hidradenitis Suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.
9. Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. There are an estimated 475,350 patients that could be treated with Hyrimoz in the United States. Source: Label from USFDA (Drugs@FDA). Link: label (fda.gov)
Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product. Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure. |
None |
| Sandoz Inc. |
61314047664 |
HYRIMOZ 20MG/0.2ML 2LISY BI US |
Generic |
FDA |
2023-07-05 |
6576.4900 |
Sandoz’s marketing plan for the introduction of Hyrimoz will focus on educating health care professionals (HCPs) and patients (consumers) about the benefit of biosimilars and the approved use of Hyrimoz. Sandoz does not plan to do any direct-to-consumer media advertisements on TV, in magazines, radio, billboards or blogs. Consumer engagement will include our patient website, patient education brochures and emails for those patients that opt into communications and enroll in patient support. Sandoz will offer a patient transition program to patients that transition from Humira to Hyrimoz. HCP engagement will include the HCP website, printed resources, email blasts and other digital resources in line with the Hyrimoz prescribing information. We will provide samples to physician offices but will not provide gifts or sponsor continuing education programs for HCPs. The WAC is priced lower than the WAC of the reference product. |
None |
2630 |
None |
None |
None |
None |
None |
None |
Hyrimoz is a tumor necrosis factor (TNF) blocker indicated for 9 disease states :
1. Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA.
2. Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older.
3. Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA.
4. Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS.
5. Crohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
6. Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers.
7. Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
8. Hidradenitis Suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.
9. Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. There are an estimated 475,350 patients that could be treated with Hyrimoz in the United States. Source: Label from USFDA (Drugs@FDA). Link: label (fda.gov)
Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product. Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure. |
None |
| Sandoz Inc. |
61314047364 |
HYRIMOZ 40MG/0.4ML 2LISY BI US |
Generic |
FDA |
2023-07-05 |
6576.4900 |
Sandoz’s marketing plan for the introduction of Hyrimoz will focus on educating health care professionals (HCPs) and patients (consumers) about the benefit of biosimilars and the approved use of Hyrimoz. Sandoz does not plan to do any direct-to-consumer media advertisements on TV, in magazines, radio, billboards or blogs. Consumer engagement will include our patient website, patient education brochures and emails for those patients that opt into communications and enroll in patient support. Sandoz will offer a patient transition program to patients that transition from Humira to Hyrimoz. HCP engagement will include the HCP website, printed resources, email blasts and other digital resources in line with the Hyrimoz prescribing information. We will provide samples to physician offices but will not provide gifts or sponsor continuing education programs for HCPs. The WAC is priced lower than the WAC of the reference product. |
None |
33782 |
None |
None |
None |
None |
None |
None |
Hyrimoz is a tumor necrosis factor (TNF) blocker indicated for 9 disease states :
1. Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA.
2. Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older.
3. Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA.
4. Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS.
5. Crohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
6. Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers.
7. Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
8. Hidradenitis Suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.
9. Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. There are an estimated 475,350 patients that could be treated with Hyrimoz in the United States. Source: Label from USFDA (Drugs@FDA). Link: label (fda.gov)
Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product. Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure. |
None |
| Sandoz Inc. |
61314047320 |
HYRIMOZ 40MG/0.4ML 2LISY PE BI US |
Generic |
FDA |
2023-07-05 |
6576.4900 |
Sandoz’s marketing plan for the introduction of Hyrimoz will focus on educating health care professionals (HCPs) and patients (consumers) about the benefit of biosimilars and the approved use of Hyrimoz. Sandoz does not plan to do any direct-to-consumer media advertisements on TV, in magazines, radio, billboards or blogs. Consumer engagement will include our patient website, patient education brochures and emails for those patients that opt into communications and enroll in patient support. Sandoz will offer a patient transition program to patients that transition from Humira to Hyrimoz. HCP engagement will include the HCP website, printed resources, email blasts and other digital resources in line with the Hyrimoz prescribing information. We will provide samples to physician offices but will not provide gifts or sponsor continuing education programs for HCPs. The WAC is priced lower than the WAC of the reference product. |
None |
376201 |
None |
None |
None |
None |
None |
None |
Hyrimoz is a tumor necrosis factor (TNF) blocker indicated for 9 disease states :
1. Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA.
2. Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older.
3. Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA.
4. Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS.
5. Crohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
6. Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers.
7. Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
8. Hidradenitis Suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.
9. Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. There are an estimated 475,350 patients that could be treated with Hyrimoz in the United States. Source: Label from USFDA (Drugs@FDA). Link: label (fda.gov)
Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product. Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure. |
None |
| Sandoz Inc. |
61314051736 |
HYRIMOZ 80+40MG 3 KIT PE BI US |
Generic |
FDA |
2023-07-05 |
13153.0100 |
Sandoz’s marketing plan for the introduction of Hyrimoz will focus on educating health care professionals (HCPs) and patients (consumers) about the benefit of biosimilars and the approved use of Hyrimoz. Sandoz does not plan to do any direct-to-consumer media advertisements on TV, in magazines, radio, billboards or blogs. Consumer engagement will include our patient website, patient education brochures and emails for those patients that opt into communications and enroll in patient support. Sandoz will offer a patient transition program to patients that transition from Humira to Hyrimoz. HCP engagement will include the HCP website, printed resources, email blasts and other digital resources in line with the Hyrimoz prescribing information. We will provide samples to physician offices but will not provide gifts or sponsor continuing education programs for HCPs. The WAC is priced lower than the WAC of the reference product. |
None |
14213 |
None |
None |
None |
None |
None |
None |
Hyrimoz is a tumor necrosis factor (TNF) blocker indicated for 9 disease states :
1. Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA.
2. Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older.
3. Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA.
4. Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS.
5. Crohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
6. Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers.
7. Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
8. Hidradenitis Suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.
9. Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. There are an estimated 475,350 patients that could be treated with Hyrimoz in the United States. Source: Label from USFDA (Drugs@FDA). Link: label (fda.gov)
Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product. Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure. |
None |
| Sandoz Inc. |
61314045420 |
HYRIMOZ 80MG/0.8ML 2LISY PE BI US |
Generic |
FDA |
2023-07-05 |
13153.0100 |
Sandoz’s marketing plan for the introduction of Hyrimoz will focus on educating health care professionals (HCPs) and patients (consumers) about the benefit of biosimilars and the approved use of Hyrimoz. Sandoz does not plan to do any direct-to-consumer media advertisements on TV, in magazines, radio, billboards or blogs. Consumer engagement will include our patient website, patient education brochures and emails for those patients that opt into communications and enroll in patient support. Sandoz will offer a patient transition program to patients that transition from Humira to Hyrimoz. HCP engagement will include the HCP website, printed resources, email blasts and other digital resources in line with the Hyrimoz prescribing information. We will provide samples to physician offices but will not provide gifts or sponsor continuing education programs for HCPs. The WAC is priced lower than the WAC of the reference product. |
None |
12896 |
None |
None |
None |
None |
None |
None |
Hyrimoz is a tumor necrosis factor (TNF) blocker indicated for 9 disease states :
1. Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA.
2. Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older.
3. Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA.
4. Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS.
5. Crohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
6. Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers.
7. Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
8. Hidradenitis Suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.
9. Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. There are an estimated 475,350 patients that could be treated with Hyrimoz in the United States. Source: Label from USFDA (Drugs@FDA). Link: label (fda.gov)
Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product. Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure. |
None |
| Sandoz Inc. |
61314045468 |
HYRIMOZ 80MG/0.8ML 3LISY BI US |
Generic |
FDA |
2023-07-05 |
19729.5400 |
Sandoz’s marketing plan for the introduction of Hyrimoz will focus on educating health care professionals (HCPs) and patients (consumers) about the benefit of biosimilars and the approved use of Hyrimoz. Sandoz does not plan to do any direct-to-consumer media advertisements on TV, in magazines, radio, billboards or blogs. Consumer engagement will include our patient website, patient education brochures and emails for those patients that opt into communications and enroll in patient support. Sandoz will offer a patient transition program to patients that transition from Humira to Hyrimoz. HCP engagement will include the HCP website, printed resources, email blasts and other digital resources in line with the Hyrimoz prescribing information. We will provide samples to physician offices but will not provide gifts or sponsor continuing education programs for HCPs. The WAC is priced lower than the WAC of the reference product. |
None |
273 |
None |
None |
None |
None |
None |
None |
Hyrimoz is a tumor necrosis factor (TNF) blocker indicated for 9 disease states :
1. Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA.
2. Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older.
3. Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA.
4. Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS.
5. Crohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
6. Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers.
7. Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
8. Hidradenitis Suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.
9. Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. There are an estimated 475,350 patients that could be treated with Hyrimoz in the United States. Source: Label from USFDA (Drugs@FDA). Link: label (fda.gov)
Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product. Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure. |
None |
| Sandoz Inc. |
61314045436 |
HYRIMOZ 80MG/0.8ML 3LISY PE BI US |
Generic |
FDA |
2023-07-05 |
19729.5400 |
Sandoz’s marketing plan for the introduction of Hyrimoz will focus on educating health care professionals (HCPs) and patients (consumers) about the benefit of biosimilars and the approved use of Hyrimoz. Sandoz does not plan to do any direct-to-consumer media advertisements on TV, in magazines, radio, billboards or blogs. Consumer engagement will include our patient website, patient education brochures and emails for those patients that opt into communications and enroll in patient support. Sandoz will offer a patient transition program to patients that transition from Humira to Hyrimoz. HCP engagement will include the HCP website, printed resources, email blasts and other digital resources in line with the Hyrimoz prescribing information. We will provide samples to physician offices but will not provide gifts or sponsor continuing education programs for HCPs. The WAC is priced lower than the WAC of the reference product. |
None |
34745 |
None |
None |
None |
None |
None |
None |
Hyrimoz is a tumor necrosis factor (TNF) blocker indicated for 9 disease states :
1. Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA.
2. Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older.
3. Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA.
4. Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS.
5. Crohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
6. Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers.
7. Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
8. Hidradenitis Suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.
9. Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. There are an estimated 475,350 patients that could be treated with Hyrimoz in the United States. Source: Label from USFDA (Drugs@FDA). Link: label (fda.gov)
Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product. Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure. |
None |
| Sandoz Inc. |
61314053164 |
HYRIOZ 80+40MG 2KIT MP BI US |
Generic |
FDA |
2023-07-05 |
9864.7600 |
Sandoz’s marketing plan for the introduction of Hyrimoz will focus on educating health care professionals (HCPs) and patients (consumers) about the benefit of biosimilars and the approved use of Hyrimoz. Sandoz does not plan to do any direct-to-consumer media advertisements on TV, in magazines, radio, billboards or blogs. Consumer engagement will include our patient website, patient education brochures and emails for those patients that opt into communications and enroll in patient support. Sandoz will offer a patient transition program to patients that transition from Humira to Hyrimoz. HCP engagement will include the HCP website, printed resources, email blasts and other digital resources in line with the Hyrimoz prescribing information. We will provide samples to physician offices but will not provide gifts or sponsor continuing education programs for HCPs. The WAC is priced lower than the WAC of the reference product. |
None |
407 |
None |
None |
None |
None |
None |
None |
Hyrimoz is a tumor necrosis factor (TNF) blocker indicated for 9 disease states :
1. Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA.
2. Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older.
3. Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA.
4. Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS.
5. Crohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
6. Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers.
7. Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
8. Hidradenitis Suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.
9. Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. There are an estimated 475,350 patients that could be treated with Hyrimoz in the United States. Source: Label from USFDA (Drugs@FDA). Link: label (fda.gov)
Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product. Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure. |
None |
| Sanofi |
71104098101 |
ALTUVIIIO™, efanesoctocog alfa, [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl], 1000 IU nominally, Single Dose Vial in a Kit |
Brand |
FDA |
2023-03-27 |
5.1100 |
In the US, marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by HCPs most likely to manage patients with hemophilia A patients, materials to be used by sales representatives to educate about hemophilia A and to share information on ALTUVIIIO with HCPs, and materials to educate patients about hemophilia A and ALTUVIIIO. Direct to Consumer (DTC) outreach for ALTUVIIIO will include printed materials, search, website, email, and online ad placements. DTC initiatives are not expected to include any TV, radio or national magazine advertising.
Ex-US, marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by HCPs most likely to manage patients with Hemophilia A, materials to be used by sales representatives to share information on ALTUVIIIO with HCPs
At Sanofi, we work passionately to prevent, treat, and cure illness and disease, understand and solve health care needs of people across the world, and transform the practice of medicine. Sanofi has a longstanding commitment to promote health care systems that make our treatments accessible and affordable to patients in need.
Sanofi understands and shares concerns about the affordability of medicines for patients while also recognizing that we are only one of many stakeholders in the health care system. In order to maintain an environment that will continue to bring new health care solutions to patients, we must encourage a transition to a value-driven health care system that provides incentives for the highest-quality care. This evolution will enable both affordable access to treatment and continued investment in medical innovation. Sanofi is committed to helping address this challenge. While many factors, including decisions affecting patient out-of-pocket spending and insurance coverage, are controlled by other stakeholders in the health care system, we believe we have a responsibility to be a leader in solving issues of patient access and system viability. For our part, we price our medicines according to their value, while contributing to broader solutions that improve patient outcomes and support affordability within the U.S. health care system.
When we set the price of a new medicine, we hold ourselves to a rigorous and structured process that includes consultation with external stakeholders and considers a holistic assessment of value through clinical, economic and societal lens; similar treatment options, affordability and unique factors specific to the medicine at time of launch (i.e., longer-term outcome studies, sophisticated patient support tools, etc.). |
None |
25000 |
1 |
1 |
None |
None |
None |
None |
Hemophilia A, also called factor VIII (8) deficiency or classic hemophilia, is a genetic disorder caused by missing or defective factor VIII (FVIII), a clotting protein. Although it is passed down from parents to children, about 1/3 of cases found have no previous family history. Hemophilia is an inherited bleeding disorder primarily affecting males—but females can also have hemophilia. Patients are classified as mild, moderate, or severe hemophilia. More than half of people diagnosed with hemophilia A have the severe form. Hemophilia A is four times as common as hemophilia B. Hemophilia affects all races and ethnic groups.
ALTUVIIIO is approved for the treatment of Hemophilia A patients regardless of gender, age, or disease severity, and it is indicated for use for prophylaxis, on-demand, and perioperative use. Currently, there are an estimated 25,000 patients in the US with hemophilia A across all severity levels, including men and women with the rare blood disorder. Approximately 13,000 are treated and have the potential to be prescribed ALTUVIIIO. |
None |
| Sanofi |
71104098201 |
ALTUVIIIO™, efanesoctocog alfa, [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl], 2000 IU nominally, Single Dose Vial in a Kit |
Brand |
FDA |
2023-03-27 |
5.1100 |
In the US, marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by HCPs most likely to manage patients with hemophilia A patients, materials to be used by sales representatives to educate about hemophilia A and to share information on ALTUVIIIO with HCPs, and materials to educate patients about hemophilia A and ALTUVIIIO. Direct to Consumer (DTC) outreach for ALTUVIIIO will include printed materials, search, website, email, and online ad placements. DTC initiatives are not expected to include any TV, radio or national magazine advertising.
Ex-US, marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by HCPs most likely to manage patients with Hemophilia A, materials to be used by sales representatives to share information on ALTUVIIIO with HCPs
At Sanofi, we work passionately to prevent, treat, and cure illness and disease, understand and solve health care needs of people across the world, and transform the practice of medicine. Sanofi has a longstanding commitment to promote health care systems that make our treatments accessible and affordable to patients in need.
Sanofi understands and shares concerns about the affordability of medicines for patients while also recognizing that we are only one of many stakeholders in the health care system. In order to maintain an environment that will continue to bring new health care solutions to patients, we must encourage a transition to a value-driven health care system that provides incentives for the highest-quality care. This evolution will enable both affordable access to treatment and continued investment in medical innovation. Sanofi is committed to helping address this challenge. While many factors, including decisions affecting patient out-of-pocket spending and insurance coverage, are controlled by other stakeholders in the health care system, we believe we have a responsibility to be a leader in solving issues of patient access and system viability. For our part, we price our medicines according to their value, while contributing to broader solutions that improve patient outcomes and support affordability within the U.S. health care system.
When we set the price of a new medicine, we hold ourselves to a rigorous and structured process that includes consultation with external stakeholders and considers a holistic assessment of value through clinical, economic and societal lens; similar treatment options, affordability and unique factors specific to the medicine at time of launch (i.e., longer-term outcome studies, sophisticated patient support tools, etc.). |
None |
25000 |
1 |
1 |
None |
None |
None |
None |
Hemophilia A, also called factor VIII (8) deficiency or classic hemophilia, is a genetic disorder caused by missing or defective factor VIII (FVIII), a clotting protein. Although it is passed down from parents to children, about 1/3 of cases found have no previous family history. Hemophilia is an inherited bleeding disorder primarily affecting males—but females can also have hemophilia. Patients are classified as mild, moderate, or severe hemophilia. More than half of people diagnosed with hemophilia A have the severe form. Hemophilia A is four times as common as hemophilia B. Hemophilia affects all races and ethnic groups.
ALTUVIIIO is approved for the treatment of Hemophilia A patients regardless of gender, age, or disease severity, and it is indicated for use for prophylaxis, on-demand, and perioperative use. Currently, there are an estimated 25,000 patients in the US with hemophilia A across all severity levels, including men and women with the rare blood disorder. Approximately 13,000 are treated and have the potential to be prescribed ALTUVIIIO. |
None |
| Sanofi |
71104097801 |
ALTUVIIIO™, efanesoctocog alfa, [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl], 250 IU nominally, Single Dose Vial in a Kit |
Brand |
FDA |
2023-03-27 |
5.1100 |
In the US, marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by HCPs most likely to manage patients with hemophilia A patients, materials to be used by sales representatives to educate about hemophilia A and to share information on ALTUVIIIO with HCPs, and materials to educate patients about hemophilia A and ALTUVIIIO. Direct to Consumer (DTC) outreach for ALTUVIIIO will include printed materials, search, website, email, and online ad placements. DTC initiatives are not expected to include any TV, radio or national magazine advertising.
Ex-US, marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by HCPs most likely to manage patients with Hemophilia A, materials to be used by sales representatives to share information on ALTUVIIIO with HCPs
At Sanofi, we work passionately to prevent, treat, and cure illness and disease, understand and solve health care needs of people across the world, and transform the practice of medicine. Sanofi has a longstanding commitment to promote health care systems that make our treatments accessible and affordable to patients in need.
Sanofi understands and shares concerns about the affordability of medicines for patients while also recognizing that we are only one of many stakeholders in the health care system. In order to maintain an environment that will continue to bring new health care solutions to patients, we must encourage a transition to a value-driven health care system that provides incentives for the highest-quality care. This evolution will enable both affordable access to treatment and continued investment in medical innovation. Sanofi is committed to helping address this challenge. While many factors, including decisions affecting patient out-of-pocket spending and insurance coverage, are controlled by other stakeholders in the health care system, we believe we have a responsibility to be a leader in solving issues of patient access and system viability. For our part, we price our medicines according to their value, while contributing to broader solutions that improve patient outcomes and support affordability within the U.S. health care system.
When we set the price of a new medicine, we hold ourselves to a rigorous and structured process that includes consultation with external stakeholders and considers a holistic assessment of value through clinical, economic and societal lens; similar treatment options, affordability and unique factors specific to the medicine at time of launch (i.e., longer-term outcome studies, sophisticated patient support tools, etc.). |
None |
25000 |
1 |
1 |
None |
None |
None |
None |
Hemophilia A, also called factor VIII (8) deficiency or classic hemophilia, is a genetic disorder caused by missing or defective factor VIII (FVIII), a clotting protein. Although it is passed down from parents to children, about 1/3 of cases found have no previous family history. Hemophilia is an inherited bleeding disorder primarily affecting males—but females can also have hemophilia. Patients are classified as mild, moderate, or severe hemophilia. More than half of people diagnosed with hemophilia A have the severe form. Hemophilia A is four times as common as hemophilia B. Hemophilia affects all races and ethnic groups.
ALTUVIIIO is approved for the treatment of Hemophilia A patients regardless of gender, age, or disease severity, and it is indicated for use for prophylaxis, on-demand, and perioperative use. Currently, there are an estimated 25,000 patients in the US with hemophilia A across all severity levels, including men and women with the rare blood disorder. Approximately 13,000 are treated and have the potential to be prescribed ALTUVIIIO. |
None |
| Sanofi |
71104098301 |
ALTUVIIIO™, efanesoctocog alfa, [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl], 3000 IU nominally, Single Dose Vial in a Kit |
Brand |
FDA |
2023-03-27 |
5.1100 |
In the US, marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by HCPs most likely to manage patients with hemophilia A patients, materials to be used by sales representatives to educate about hemophilia A and to share information on ALTUVIIIO with HCPs, and materials to educate patients about hemophilia A and ALTUVIIIO. Direct to Consumer (DTC) outreach for ALTUVIIIO will include printed materials, search, website, email, and online ad placements. DTC initiatives are not expected to include any TV, radio or national magazine advertising.
Ex-US, marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by HCPs most likely to manage patients with Hemophilia A, materials to be used by sales representatives to share information on ALTUVIIIO with HCPs
At Sanofi, we work passionately to prevent, treat, and cure illness and disease, understand and solve health care needs of people across the world, and transform the practice of medicine. Sanofi has a longstanding commitment to promote health care systems that make our treatments accessible and affordable to patients in need.
Sanofi understands and shares concerns about the affordability of medicines for patients while also recognizing that we are only one of many stakeholders in the health care system. In order to maintain an environment that will continue to bring new health care solutions to patients, we must encourage a transition to a value-driven health care system that provides incentives for the highest-quality care. This evolution will enable both affordable access to treatment and continued investment in medical innovation. Sanofi is committed to helping address this challenge. While many factors, including decisions affecting patient out-of-pocket spending and insurance coverage, are controlled by other stakeholders in the health care system, we believe we have a responsibility to be a leader in solving issues of patient access and system viability. For our part, we price our medicines according to their value, while contributing to broader solutions that improve patient outcomes and support affordability within the U.S. health care system.
When we set the price of a new medicine, we hold ourselves to a rigorous and structured process that includes consultation with external stakeholders and considers a holistic assessment of value through clinical, economic and societal lens; similar treatment options, affordability and unique factors specific to the medicine at time of launch (i.e., longer-term outcome studies, sophisticated patient support tools, etc.). |
None |
25000 |
1 |
1 |
None |
None |
None |
None |
Hemophilia A, also called factor VIII (8) deficiency or classic hemophilia, is a genetic disorder caused by missing or defective factor VIII (FVIII), a clotting protein. Although it is passed down from parents to children, about 1/3 of cases found have no previous family history. Hemophilia is an inherited bleeding disorder primarily affecting males—but females can also have hemophilia. Patients are classified as mild, moderate, or severe hemophilia. More than half of people diagnosed with hemophilia A have the severe form. Hemophilia A is four times as common as hemophilia B. Hemophilia affects all races and ethnic groups.
ALTUVIIIO is approved for the treatment of Hemophilia A patients regardless of gender, age, or disease severity, and it is indicated for use for prophylaxis, on-demand, and perioperative use. Currently, there are an estimated 25,000 patients in the US with hemophilia A across all severity levels, including men and women with the rare blood disorder. Approximately 13,000 are treated and have the potential to be prescribed ALTUVIIIO. |
None |
| Sanofi |
71104098401 |
ALTUVIIIO™, efanesoctocog alfa, [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl], 4000 IU nominally, Single Dose Vial in a Kit |
Brand |
FDA |
2023-03-27 |
5.1100 |
In the US, marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by HCPs most likely to manage patients with hemophilia A patients, materials to be used by sales representatives to educate about hemophilia A and to share information on ALTUVIIIO with HCPs, and materials to educate patients about hemophilia A and ALTUVIIIO. Direct to Consumer (DTC) outreach for ALTUVIIIO will include printed materials, search, website, email, and online ad placements. DTC initiatives are not expected to include any TV, radio or national magazine advertising.
Ex-US, marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by HCPs most likely to manage patients with Hemophilia A, materials to be used by sales representatives to share information on ALTUVIIIO with HCPs
At Sanofi, we work passionately to prevent, treat, and cure illness and disease, understand and solve health care needs of people across the world, and transform the practice of medicine. Sanofi has a longstanding commitment to promote health care systems that make our treatments accessible and affordable to patients in need.
Sanofi understands and shares concerns about the affordability of medicines for patients while also recognizing that we are only one of many stakeholders in the health care system. In order to maintain an environment that will continue to bring new health care solutions to patients, we must encourage a transition to a value-driven health care system that provides incentives for the highest-quality care. This evolution will enable both affordable access to treatment and continued investment in medical innovation. Sanofi is committed to helping address this challenge. While many factors, including decisions affecting patient out-of-pocket spending and insurance coverage, are controlled by other stakeholders in the health care system, we believe we have a responsibility to be a leader in solving issues of patient access and system viability. For our part, we price our medicines according to their value, while contributing to broader solutions that improve patient outcomes and support affordability within the U.S. health care system.
When we set the price of a new medicine, we hold ourselves to a rigorous and structured process that includes consultation with external stakeholders and considers a holistic assessment of value through clinical, economic and societal lens; similar treatment options, affordability and unique factors specific to the medicine at time of launch (i.e., longer-term outcome studies, sophisticated patient support tools, etc.). |
None |
25000 |
1 |
1 |
None |
None |
None |
None |
Hemophilia A, also called factor VIII (8) deficiency or classic hemophilia, is a genetic disorder caused by missing or defective factor VIII (FVIII), a clotting protein. Although it is passed down from parents to children, about 1/3 of cases found have no previous family history. Hemophilia is an inherited bleeding disorder primarily affecting males—but females can also have hemophilia. Patients are classified as mild, moderate, or severe hemophilia. More than half of people diagnosed with hemophilia A have the severe form. Hemophilia A is four times as common as hemophilia B. Hemophilia affects all races and ethnic groups.
ALTUVIIIO is approved for the treatment of Hemophilia A patients regardless of gender, age, or disease severity, and it is indicated for use for prophylaxis, on-demand, and perioperative use. Currently, there are an estimated 25,000 patients in the US with hemophilia A across all severity levels, including men and women with the rare blood disorder. Approximately 13,000 are treated and have the potential to be prescribed ALTUVIIIO. |
None |
| Sanofi |
71104097901 |
ALTUVIIIO™, efanesoctocog alfa, [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl], 500 IU nominally, Single Dose Vial in a Kit |
Brand |
FDA |
2023-03-27 |
5.1100 |
In the US, marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by HCPs most likely to manage patients with hemophilia A patients, materials to be used by sales representatives to educate about hemophilia A and to share information on ALTUVIIIO with HCPs, and materials to educate patients about hemophilia A and ALTUVIIIO. Direct to Consumer (DTC) outreach for ALTUVIIIO will include printed materials, search, website, email, and online ad placements. DTC initiatives are not expected to include any TV, radio or national magazine advertising.
Ex-US, marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by HCPs most likely to manage patients with Hemophilia A, materials to be used by sales representatives to share information on ALTUVIIIO with HCPs
At Sanofi, we work passionately to prevent, treat, and cure illness and disease, understand and solve health care needs of people across the world, and transform the practice of medicine. Sanofi has a longstanding commitment to promote health care systems that make our treatments accessible and affordable to patients in need.
Sanofi understands and shares concerns about the affordability of medicines for patients while also recognizing that we are only one of many stakeholders in the health care system. In order to maintain an environment that will continue to bring new health care solutions to patients, we must encourage a transition to a value-driven health care system that provides incentives for the highest-quality care. This evolution will enable both affordable access to treatment and continued investment in medical innovation. Sanofi is committed to helping address this challenge. While many factors, including decisions affecting patient out-of-pocket spending and insurance coverage, are controlled by other stakeholders in the health care system, we believe we have a responsibility to be a leader in solving issues of patient access and system viability. For our part, we price our medicines according to their value, while contributing to broader solutions that improve patient outcomes and support affordability within the U.S. health care system.
When we set the price of a new medicine, we hold ourselves to a rigorous and structured process that includes consultation with external stakeholders and considers a holistic assessment of value through clinical, economic and societal lens; similar treatment options, affordability and unique factors specific to the medicine at time of launch (i.e., longer-term outcome studies, sophisticated patient support tools, etc.). |
None |
25000 |
1 |
1 |
None |
None |
None |
None |
Hemophilia A, also called factor VIII (8) deficiency or classic hemophilia, is a genetic disorder caused by missing or defective factor VIII (FVIII), a clotting protein. Although it is passed down from parents to children, about 1/3 of cases found have no previous family history. Hemophilia is an inherited bleeding disorder primarily affecting males—but females can also have hemophilia. Patients are classified as mild, moderate, or severe hemophilia. More than half of people diagnosed with hemophilia A have the severe form. Hemophilia A is four times as common as hemophilia B. Hemophilia affects all races and ethnic groups.
ALTUVIIIO is approved for the treatment of Hemophilia A patients regardless of gender, age, or disease severity, and it is indicated for use for prophylaxis, on-demand, and perioperative use. Currently, there are an estimated 25,000 patients in the US with hemophilia A across all severity levels, including men and women with the rare blood disorder. Approximately 13,000 are treated and have the potential to be prescribed ALTUVIIIO. |
None |
| Sarepta Therapeutics Inc |
60923050110 |
Delandistrogene Moxeparvovec 10 Vial 100 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923050211 |
Delandistrogene Moxeparvovec 11 Vial 110 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923050312 |
Delandistrogene Moxeparvovec 12 Vial 120 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923050413 |
Delandistrogene Moxeparvovec 13 Vial 130 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923050514 |
Delandistrogene Moxeparvovec 14 Vial 140 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923050615 |
Delandistrogene Moxeparvovec 15 Vial 150 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923050716 |
Delandistrogene Moxeparvovec 16 Vial 160 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923050817 |
Delandistrogene Moxeparvovec 17 Vial 170 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923050918 |
Delandistrogene Moxeparvovec 18 Vial 180 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923051019 |
Delandistrogene Moxeparvovec 19 Vial 190 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923051120 |
Delandistrogene Moxeparvovec 20 Vial 200 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923051221 |
Delandistrogene Moxeparvovec 21 Vial 210 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923051322 |
Delandistrogene Moxeparvovec 22 Vial 220 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923051423 |
Delandistrogene Moxeparvovec 23 Vial 230 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923051524 |
Delandistrogene Moxeparvovec 24 Vial 240 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923051625 |
Delandistrogene Moxeparvovec 25 Vial 250 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923051726 |
Delandistrogene Moxeparvovec 26 Vial 260 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923051827 |
Delandistrogene Moxeparvovec 27 Vial 270 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923051928 |
Delandistrogene Moxeparvovec 28 Vial 280 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923052029 |
Delandistrogene Moxeparvovec 29 Vial 290 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923052130 |
Delandistrogene Moxeparvovec 30 Vial 300 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923052231 |
Delandistrogene Moxeparvovec 31 Vial 310 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923052332 |
Delandistrogene Moxeparvovec 32 Vial 320 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923052433 |
Delandistrogene Moxeparvovec 33 Vial 330 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923052534 |
Delandistrogene Moxeparvovec 34 Vial 340 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923052635 |
Delandistrogene Moxeparvovec 35 Vial 350 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923052736 |
Delandistrogene Moxeparvovec 36 Vial 360 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923052837 |
Delandistrogene Moxeparvovec 37 Vial 370 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923052938 |
Delandistrogene Moxeparvovec 38 Vial 380 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923053039 |
Delandistrogene Moxeparvovec 39 Vial 390 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923053140 |
Delandistrogene Moxeparvovec 40 Vial 400 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923053241 |
Delandistrogene Moxeparvovec 41 Vial 410 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923053342 |
Delandistrogene Moxeparvovec 42 Vial 420 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923053443 |
Delandistrogene Moxeparvovec 43 Vial 430 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923053544 |
Delandistrogene Moxeparvovec 44 Vial 440 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923053645 |
Delandistrogene Moxeparvovec 45 Vial 450 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923053746 |
Delandistrogene Moxeparvovec 46 Vial 460 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923053847 |
Delandistrogene Moxeparvovec 47 Vial 470 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923053948 |
Delandistrogene Moxeparvovec 48 Vial 480 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923054049 |
Delandistrogene Moxeparvovec 49 Vial 490 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923054150 |
Delandistrogene Moxeparvovec 50 Vial 500 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923054251 |
Delandistrogene Moxeparvovec 51 Vial 510 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923054352 |
Delandistrogene Moxeparvovec 52 Vial 520 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923054453 |
Delandistrogene Moxeparvovec 53 Vial 530 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923054554 |
Delandistrogene Moxeparvovec 54 Vial 540 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923054655 |
Delandistrogene Moxeparvovec 55 Vial 550 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923054756 |
Delandistrogene Moxeparvovec 56 Vial 560 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923054857 |
Delandistrogene Moxeparvovec 57 Vial 570 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923054958 |
Delandistrogene Moxeparvovec 58 Vial 580 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923055059 |
Delandistrogene Moxeparvovec 59 Vial 590 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923055160 |
Delandistrogene Moxeparvovec 60 Vial 600 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923055261 |
Delandistrogene Moxeparvovec 61 Vial 610 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923055362 |
Delandistrogene Moxeparvovec 62 Vial 620 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923055463 |
Delandistrogene Moxeparvovec 63 Vial 630 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923055564 |
Delandistrogene Moxeparvovec 64 Vial 640 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923055665 |
Delandistrogene Moxeparvovec 65 Vial 650 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923055766 |
Delandistrogene Moxeparvovec 66 Vial 660 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923055867 |
Delandistrogene Moxeparvovec 67 Vial 670 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923055968 |
Delandistrogene Moxeparvovec 68 Vial 680 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923056069 |
Delandistrogene Moxeparvovec 69 Vial 690 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923056170 |
Delandistrogene Moxeparvovec 70 Vial 700 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Shorla Oncology |
81927011106 |
NELARABINE (NELARABINE) 250MG/50ML (5MG/ML) 6 x 50 ML VIAL |
Generic |
FDA |
2023-05-16 |
3960.0000 |
Nelarabine is a generic physician administered oncology product. Shorla Oncology will be marketing the product to pharmacists and oncologists and will be pricing the product at parity to the market/competitors |
None |
555 |
None |
1 |
None |
None |
None |
None |
None |
None |
| Shorla Oncology |
81927020401 |
JYLAMVO ORAL SOLUTION 1 BOTTLE 60 ML 120 MG |
Brand |
FDA |
2023-12-18 |
876.4700 |
Jylamvo is a branded oral liquid formulation of methtrexate for adult patients with rheumatoid and oncologic diseases who have difficulty swallowing pills. It will be marketed as an alternative to compounding, pill splitting and pill crushing. Shorla Oncology will be marketing the product to pharmacists, rheumatologists and oncologists through a virtual sales team. |
None |
29900 |
None |
None |
None |
None |
None |
None |
None |
None |
| Slayback Pharma LLC |
71225014001 |
Baclofen Oral Suspension, 25mg/5mL, 250 mL in one bottle in one carton. |
Generic |
FDA |
2023-06-28 |
1361.2300 |
None |
1 |
2600 |
None |
None |
None |
None |
None |
None |
This is a newly approved drug in production. The first lots should be ready for market in the coming days or within two weeks. This was not an acquired drug. The total number of monthly patients has been estimated as we are not sure as to the amount of sales we will have the first year and competition is strong as there are more that 100 manufacturers with labeled Baclofen vying for market share. |
None |
| Somerset Pharma LLC |
70069072820 |
Calcium Gluconate Injection USP, 10,000 mg/100 mL |
Generic |
FDA |
2023-10-20 |
1078.2000 |
None |
1 |
75527 |
None |
None |
None |
None |
None |
None |
This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house. |
None |
| Somerset Pharma LLC |
70069072725 |
Calcium Gluconate Injection, USP 5,000mg/50mL |
Generic |
FDA |
2023-10-20 |
673.5000 |
None |
1 |
61790 |
None |
None |
None |
None |
None |
None |
This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house. |
None |
| SpringWorks Therapeutics |
82448005018 |
OGSIVEO (Nirogacestat) 50mg tablets, 180-ct bottle |
Brand |
FDA |
2023-12-04 |
29000.0000 |
Desmoid tumors are a rare, devastating disease, with a potentially significant burden of illness on patients. OGSIVEOTM (nirogacestat) is the first and only FDA-approved treatment indicated for adult patients with progressing desmoid tumors who require systemic treatment. Patients afflicted with desmoid tumors often have significant unmet need. OGSIVEO will be marketed to appropriate healthcare professionals in both community oncology and sarcoma centers of excellence in the U.S., as well as adult patients in the U.S. with desmoid tumors. General marketing efforts will be focused on highlighting the approved indication, efficacy, safety and value that OGSIVEO may deliver to appropriate patients in need. Specific marketing plans used to launch the drug in the U.S. include, without limitation, use of print and digital media, patient and HCP websites, opt in email communications, media advertisements to both healthcare providers and patients on platforms such as social media and other web-based mediums, professional detailing to healthcare providers, and conference events, seminars and speaker programs. Patient support programs will also be offered to facilitate access to OGSIVEO for eligible patients who have been prescribed OGSIVEO, but these programs are not considered marketing or promotional activities.
With respect to its pricing plans for OGSIVEO in the U.S., SpringWorks conducted extensive qualitative and quantitative market research and analysis of several factors, including unmet medical need, disease severity, and patient burden of illness in this orphan population. Additionally, SpringWorks assessed current market pricing for comparable orphan rare disease and oncology drugs, which included broad-based physician, payer and population health decision maker feedback. Additional financial and non-financial factors were considered in establishing the wholesale acquisition cost for OGSIVEO, including: the unique clinical value that OGSIVEO offers as the first and only FDA-approved gamma secretase inhibitor indicated for adult patients with progressing desmoid tumors who require systemic treatment; the safety and efficacy profile of the drug; patient access considerations, including the development and implementation of the SpringWorks CareConnections patient support program to support U.S. patients on their treatment journey with OGSIVEO; preclinical and ongoing clinical trials for the drug; anticipated discounts and other fees to be negotiated with supply chain partners, including wholesalers, specialty pharmacies, and group purchasing organizations; anticipated discounts, rebates and fees to various government programs; manufacturing and marketing costs; and past and ongoing investments in R&D (including resources, infrastructure and organization) to both support and build on the existing portfolio and develop new and innovative therapies for other rare indications.
SpringWorks does not currently market or sell OGSIVEO outside the U.S. |
None |
1311 |
1 |
1 |
2017-08-18 |
232500000.0000 |
None |
In August 2017, SpringWorks entered into a license agreement with Pfizer, pursuant to which we acquired exclusive (including as to Pfizer) worldwide sublicensable rights to research, develop and manufacture nirogacestat for the treatment, diagnosis and prevention of all diseases and commercialize nirogacestat for the treatment, diagnosis and prevention of all diseases other than Alzheimer’s disease, breast cancer and prostate cancer. Pursuant to the license agreement, SpringWorks is required to pay Pfizer up to an aggregate of $232.5 million upon achievement of certain commercial milestone events, and will pay Pfizer tiered royalties on sales of nirogacestat at percentages ranging from the mid-single digits to the low 20s, that may be subject to deductions for expiration of valid claims, amounts due under third-party licenses and generic competition. |
None |
None |
| Stemline Therapeutics |
72187010203 |
ORDERDU 345 MG tablet, 30 ct |
Brand |
FDA |
2023-02-03 |
21369.0000 |
When pricing Ordersu, Stemline considered a variety of factors, including the benefit to the patients, patient assistance programs, reinvestment to support lifecycle development of the compound, as well as development of new therapies, supply chain and other factors. Orserdu is the first oral estrogen receptor antagonist (commonly referred to as a SERD) and the first FDA approved therapy for appropriate mBC patients with ESR1 mutations. |
None |
13000 |
None |
1 |
2020-07-23 |
30000000.0000 |
None |
Stemline's parent company, the Menarini Group, licensed Ordersdu from Radius Health, Inc. with an upfront payment of $30 million and potential additional payments of up to $320 million based on the successful achievement of future development and sales milestones. Menarini Group will make tiered, low to mid-teen percentage royalty payments to Radius Health, Inc. on global net sales. |
In reference to Estimated Patients: While the overall incidence of ESR1 mutations is uncertain and reported only from small patient cohorts, it is estimated to affect ~13,000 patients with mBC in the US. We do not anticipate that Orserdu will be prescribed for that entire patient population. Orserdu is the first oral estrogen receptor antagonist (commonly referred to as a SERD) and the first FDA approved therapy for appropriate mBC patients with ESR1 mutations. Orserdu is an estrogen receptor agonist (commonly referred to as a SERD) indicated for the treatment of postmenopausal women or adult men with ER+/HER2- , ESR1 mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. Orserdu is the first FDA approved therapy for these patients. In 2022, the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) Program estimated that there would be 287,850 new cases of breast cancer diagnosed in the United States (US) (Siegel 2022). Approximately 6% of women have mBC at the time of their initial diagnosis and 20% to 40% of women initially diagnosed with localized or regional breast cancers will develop metastatic disease (SEER 2022; Vera-Llonch 2011). Approximately 68% of breast cancers diagnosed in women are ER/PR-positive and HER2- negative (SEER Cancer Stat Facts: Female Breast Cancer Subtypes. National Cancer Institute. Cyclin dependent kinase 4/6 (CDK4/6) inhibitors, combined with either an aromatase inhibitor or fulvestrant has since become the mainstay for first-line management of postmenopausal women with ER/PR-positive, HER2-negative mBC (Finn 2016b; Hortobagyi 2018; Goetz 2017; Tripathy 2018; Burstein 2021; NCCN v2.2023). However, tumors eventually develop endocrine resistance, often through the development of an estrogen receptor 1 gene (ESR1) mutation. Development of an acquired mutation in ESR1 is one of the key mechanisms of endocrine therapy resistance. The prevalence of ESR1 mutations in patients depends on prior duration and setting of endocrine therapy. ESR1 mutations have been reported in up to 39% of patients with ER/PR-positive, HER2 negative advanced or mBC who have received prior treatment with an aromatase inhibitor in the metastatic setting (Reinert 2017). |
None |
| Stemline Therapeutics |
72187010103 |
ORSERDU 86 MG tablets, 30 ct |
Brand |
FDA |
2023-02-03 |
7123.0000 |
When pricing Ordersu, Stemline considered a variety of factors, including the benefit to the patients, patient assistance programs, reinvestment to support lifecycle development of the compound, as well as development of new therapies, supply chain and other factors. Orserdu is the first oral estrogen receptor antagonist (commonly referred to as a SERD) and the first FDA approved therapy for appropriate mBC patients with ESR1 mutations. |
None |
13000 |
None |
1 |
2020-07-23 |
30000000.0000 |
None |
Stemline's parent company, the Menarini Group, licensed Ordersdu from Radius Health, Inc. with an upfront payment of $30 million and potential additional payments of up to $320 million based on the successful achievement of future development and sales milestones. Menarini Group will make tiered, low to mid-teen percentage royalty payments to Radius Health, Inc. on global net sales. |
In reference to Estimated Patients: While the overall incidence of ESR1 mutations is uncertain and reported only from small patient cohorts, it is estimated to affect ~13,000 patients with mBC in the US. We do not anticipate that Orserdu will be prescribed for that entire patient population. Orserdu is the first oral estrogen receptor antagonist (commonly referred to as a SERD) and the first FDA approved therapy for appropriate mBC patients with ESR1 mutations. Orserdu is an estrogen receptor agonist (commonly referred to as a SERD) indicated for the treatment of postmenopausal women or adult men with ER+/HER2- , ESR1 mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. Orserdu is the first FDA approved therapy for these patients. In 2022, the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) Program estimated that there would be 287,850 new cases of breast cancer diagnosed in the United States (US) (Siegel 2022). Approximately 6% of women have mBC at the time of their initial diagnosis and 20% to 40% of women initially diagnosed with localized or regional breast cancers will develop metastatic disease (SEER 2022; Vera-Llonch 2011). Approximately 68% of breast cancers diagnosed in women are ER/PR-positive and HER2- negative (SEER Cancer Stat Facts: Female Breast Cancer Subtypes. National Cancer Institute. Cyclin dependent kinase 4/6 (CDK4/6) inhibitors, combined with either an aromatase inhibitor or fulvestrant has since become the mainstay for first-line management of postmenopausal women with ER/PR-positive, HER2-negative mBC (Finn 2016b; Hortobagyi 2018; Goetz 2017; Tripathy 2018; Burstein 2021; NCCN v2.2023). However, tumors eventually develop endocrine resistance, often through the development of an estrogen receptor 1 gene (ESR1) mutation. Development of an acquired mutation in ESR1 is one of the key mechanisms of endocrine therapy resistance. The prevalence of ESR1 mutations in patients depends on prior duration and setting of endocrine therapy. ESR1 mutations have been reported in up to 39% of patients with ER/PR-positive, HER2 negative advanced or mBC who have received prior treatment with an aromatase inhibitor in the metastatic setting (Reinert 2017). |
None |
| SUN PHARMACEUTICALS |
63304004327 |
Lenalidomide Caps 10Mg 28ct |
Generic |
FDA |
2023-03-20 |
20157.3600 |
None |
1 |
235000 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
63304004422 |
Lenalidomide Caps 15Mg 21ct |
Generic |
FDA |
2023-03-20 |
15118.0400 |
None |
1 |
235000 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
63304004127 |
Lenalidomide Caps 2.5Mg 28ct |
Generic |
FDA |
2023-03-20 |
20157.3600 |
None |
1 |
235000 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
63304004522 |
Lenalidomide Caps 20Mg 21ct |
Generic |
FDA |
2023-03-20 |
15118.0400 |
None |
1 |
235000 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
63304004622 |
Lenalidomide Caps 25Mg 21ct |
Generic |
FDA |
2023-03-20 |
15118.0400 |
None |
1 |
235000 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
63304004227 |
Lenalidomide Caps 5Mg 28ct |
Generic |
FDA |
2023-03-20 |
20157.3600 |
None |
1 |
235000 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
57664004688 |
LISDEXAMFETAMINE DIMESYLATE CAPSULE 10mg |
Generic |
FDA |
2023-08-24 |
527.6000 |
As this is a generic pharmaceutical product, Sun does not engage in marketing activities typically attendant to branded products. There are no direct-to-customer marketing activities of any kind, and no promotion of the product to physicians or other healthcare providers. Sun utilized appropriate pricing planning based on current and predicted market conditions. We have discussions with potential customers to determine and agree upon pricing since there are multiple generic competitors within the market for this product. |
None |
1600000 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
57664004788 |
LISDEXAMFETAMINE DIMESYLATE CAPSULE 20mg |
Generic |
FDA |
2023-08-24 |
527.6000 |
As this is a generic pharmaceutical product, Sun does not engage in marketing activities typically attendant to branded products. There are no direct-to-customer marketing activities of any kind, and no promotion of the product to physicians or other healthcare providers. Sun utilized appropriate pricing planning based on current and predicted market conditions. We have discussions with potential customers to determine and agree upon pricing since there are multiple generic competitors within the market for this product. |
None |
1600000 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
57664004888 |
LISDEXAMFETAMINE DIMESYLATE CAPSULE 30mg |
Generic |
FDA |
2023-08-24 |
527.6000 |
As this is a generic pharmaceutical product, Sun does not engage in marketing activities typically attendant to branded products. There are no direct-to-customer marketing activities of any kind, and no promotion of the product to physicians or other healthcare providers. Sun utilized appropriate pricing planning based on current and predicted market conditions. We have discussions with potential customers to determine and agree upon pricing since there are multiple generic competitors within the market for this product. |
None |
1600000 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
57664004988 |
LISDEXAMFETAMINE DIMESYLATE CAPSULE 40mg |
Generic |
FDA |
2023-08-24 |
527.6000 |
As this is a generic pharmaceutical product, Sun does not engage in marketing activities typically attendant to branded products. There are no direct-to-customer marketing activities of any kind, and no promotion of the product to physicians or other healthcare providers. Sun utilized appropriate pricing planning based on current and predicted market conditions. We have discussions with potential customers to determine and agree upon pricing since there are multiple generic competitors within the market for this product. |
None |
1600000 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
57664005088 |
LISDEXAMFETAMINE DIMESYLATE CAPSULE 50mg |
Generic |
FDA |
2023-08-24 |
527.6000 |
As this is a generic pharmaceutical product, Sun does not engage in marketing activities typically attendant to branded products. There are no direct-to-customer marketing activities of any kind, and no promotion of the product to physicians or other healthcare providers. Sun utilized appropriate pricing planning based on current and predicted market conditions. We have discussions with potential customers to determine and agree upon pricing since there are multiple generic competitors within the market for this product. |
None |
1600000 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
57664005188 |
LISDEXAMFETAMINE DIMESYLATE CAPSULE 60mg |
Generic |
FDA |
2023-08-24 |
527.6000 |
As this is a generic pharmaceutical product, Sun does not engage in marketing activities typically attendant to branded products. There are no direct-to-customer marketing activities of any kind, and no promotion of the product to physicians or other healthcare providers. Sun utilized appropriate pricing planning based on current and predicted market conditions. We have discussions with potential customers to determine and agree upon pricing since there are multiple generic competitors within the market for this product. |
None |
1600000 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
57664005288 |
LISDEXAMFETAMINE DIMESYLATE CAPSULE 70mg |
Generic |
FDA |
2023-08-24 |
527.6000 |
As this is a generic pharmaceutical product, Sun does not engage in marketing activities typically attendant to branded products. There are no direct-to-customer marketing activities of any kind, and no promotion of the product to physicians or other healthcare providers. Sun utilized appropriate pricing planning based on current and predicted market conditions. We have discussions with potential customers to determine and agree upon pricing since there are multiple generic competitors within the market for this product. |
None |
1600000 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
57664008388 |
LISDEXAMFETAMINE DIMESYLATE TAB CHEW 10mg |
Generic |
FDA |
2023-08-24 |
1107.9500 |
As this is a generic pharmaceutical product, Sun does not engage in marketing activities typically attendant to branded products. There are no direct-to-customer marketing activities of any kind, and no promotion of the product to physicians or other healthcare providers. Sun utilized appropriate pricing planning based on current and predicted market conditions. We have discussions with potential customers to determine and agree upon pricing since there are multiple generic competitors within the market for this product. |
None |
1600000 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
57664008488 |
LISDEXAMFETAMINE DIMESYLATE TAB CHEW 20mg |
Generic |
FDA |
2023-08-24 |
1107.9500 |
As this is a generic pharmaceutical product, Sun does not engage in marketing activities typically attendant to branded products. There are no direct-to-customer marketing activities of any kind, and no promotion of the product to physicians or other healthcare providers. Sun utilized appropriate pricing planning based on current and predicted market conditions. We have discussions with potential customers to determine and agree upon pricing since there are multiple generic competitors within the market for this product. |
None |
1600000 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
57664008588 |
LISDEXAMFETAMINE DIMESYLATE TAB CHEW 30mg |
Generic |
FDA |
2023-08-24 |
1107.9500 |
As this is a generic pharmaceutical product, Sun does not engage in marketing activities typically attendant to branded products. There are no direct-to-customer marketing activities of any kind, and no promotion of the product to physicians or other healthcare providers. Sun utilized appropriate pricing planning based on current and predicted market conditions. We have discussions with potential customers to determine and agree upon pricing since there are multiple generic competitors within the market for this product. |
None |
1600000 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
57664008688 |
LISDEXAMFETAMINE DIMESYLATE TAB CHEW 40mg |
Generic |
FDA |
2023-08-24 |
1107.9500 |
As this is a generic pharmaceutical product, Sun does not engage in marketing activities typically attendant to branded products. There are no direct-to-customer marketing activities of any kind, and no promotion of the product to physicians or other healthcare providers. Sun utilized appropriate pricing planning based on current and predicted market conditions. We have discussions with potential customers to determine and agree upon pricing since there are multiple generic competitors within the market for this product. |
None |
1600000 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
57664008788 |
LISDEXAMFETAMINE DIMESYLATE TAB CHEW 50mg |
Generic |
FDA |
2023-08-24 |
1107.9500 |
As this is a generic pharmaceutical product, Sun does not engage in marketing activities typically attendant to branded products. There are no direct-to-customer marketing activities of any kind, and no promotion of the product to physicians or other healthcare providers. Sun utilized appropriate pricing planning based on current and predicted market conditions. We have discussions with potential customers to determine and agree upon pricing since there are multiple generic competitors within the market for this product. |
None |
1600000 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
57664008888 |
LISDEXAMFETAMINE DIMESYLATE TAB CHEW 60mg |
Generic |
FDA |
2023-08-24 |
1107.9500 |
As this is a generic pharmaceutical product, Sun does not engage in marketing activities typically attendant to branded products. There are no direct-to-customer marketing activities of any kind, and no promotion of the product to physicians or other healthcare providers. Sun utilized appropriate pricing planning based on current and predicted market conditions. We have discussions with potential customers to determine and agree upon pricing since there are multiple generic competitors within the market for this product. |
None |
1600000 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
63304011613 |
Pazopanib Tablets 200mg 120ct |
Generic |
FDA |
2023-10-19 |
15021.1700 |
Pricing plan: Brand WAC minus 11%. As this is a generic pharmaceutical product, Sun does not engage in marketing activities typically attendant to branded products. There are no direct-to-customer marketing activities of any kind, and no promotion of the product to physicians or other healthcare providers. Sun utilized appropriate pricing planning based on current and predicted market conditions. We have discussions with potential customers to determine and agree upon pricing since there are multiple generic competitors within the market for this product. |
None |
628355 |
None |
None |
None |
None |
None |
None |
None |
None |
| Taiho Oncology, Inc. |
64842012004 |
Lytgobi tablets, 12MG (3 tablets); 4MG 21 tablet count DosePak |
Brand |
FDA |
2023-02-10 |
5835.0000 |
None |
1 |
1 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Taiho Oncology, Inc. |
64842012005 |
Lytgobi tablets, 16MG (4 tablets); 4MG 28 tablet count DosePak |
Brand |
FDA |
2023-02-10 |
5835.0000 |
None |
1 |
1 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Taiho Oncology, Inc. |
64842012006 |
Lytgobi tablets, 20MG (5 tablets); 4MG 35 tablet count DosePak |
Brand |
FDA |
2023-02-10 |
5835.0000 |
None |
1 |
1 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Takeda Pharmaceuticals America, Inc. |
63020021021 |
FRUZAQLA™ (fruquintinib) 1mg capsules |
Brand |
FDA |
2023-11-09 |
6300.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we do plan to market FRUZAQLA in the US through print and digital media materials created to be used by sales representatives to share information on FRUZAQLA with prescribers and through the use of print and digital materials made available to educate patients about FRUZAQLA. We will also promote FRUZAQLA to appropriate healthcare professionals, who treat individuals diagnosed with metastatic colorectal cancer (CRC), through engagement at scientific meetings and conferences. Takeda considers a number of factors when deciding the price at which to set its prescription drugs, including, but not limited to: (i) the value medicine brings to patients and society; (ii) access to medicines; and (iii) providing a thoughtful approach that allows us to continue to deliver innovative medicines. CRC is a cancer that starts in either the colon or rectum. According to the International Agency for Research on Cancer, CRC is the third most prevalent cancer worldwide, associated with 935,000 deaths in 2020. In the U.S., it is estimated that 153,000 patients will be diagnosed with CRC and 53,000 deaths from the disease will occur in 2023. Although early-stage CRC can be surgically resected, metastatic CRC remains an area of high unmet need with poor outcomes and limited treatment options. FRUZAQLA is a highly selective and potent inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, -2 and -3 for the treatment of adult patients with previously treated metastatic colorectal cancer (CRC). FRUZAQLA will be the first and only highly selective inhibitor of all three VEGF receptors approved in the U.S. for previously treated metastatic CRC. In establishing WAC, Takeda also evaluated the access landscape for metastatic CRC patients, including the current treatment landscape and associated costs, likelihood of payor coverage, and options for patients without coverage. In addition, Takeda considered its ability to continue to fund the discovery of future oncology innovations and the resources needed to bring new therapies to market. |
None |
743 |
None |
1 |
2023-03-14 |
400000000.0000 |
None |
Upfront payment, additional milestone payments may be due in the future. Total possible payment (upfront and milestones) $730 million. |
The estimated number of patients in any given state in the United States (U.S.) with a condition for which FRUZAQLA may be prescribed each month is not known but it is expected that FRUZAQLA will be able to be prescribed to approximately 7% of all patients diagnosed with CRC in the U.S., or about 10,621 patients. |
None |
| Takeda Pharmaceuticals America, Inc. |
63020022521 |
FRUZAQLA™ (fruquintinib) 5mg capsules |
Brand |
FDA |
2023-11-09 |
25200.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we do plan to market FRUZAQLA in the US through print and digital media materials created to be used by sales representatives to share information on FRUZAQLA with prescribers and through the use of print and digital materials made available to educate patients about FRUZAQLA. We will also promote FRUZAQLA to appropriate healthcare professionals, who treat individuals diagnosed with metastatic colorectal cancer (CRC), through engagement at scientific meetings and conferences. Takeda considers a number of factors when deciding the price at which to set its prescription drugs, including, but not limited to: (i) the value medicine brings to patients and society; (ii) access to medicines; and (iii) providing a thoughtful approach that allows us to continue to deliver innovative medicines. CRC is a cancer that starts in either the colon or rectum. According to the International Agency for Research on Cancer, CRC is the third most prevalent cancer worldwide, associated with 935,000 deaths in 2020. In the U.S., it is estimated that 153,000 patients will be diagnosed with CRC and 53,000 deaths from the disease will occur in 2023. Although early-stage CRC can be surgically resected, metastatic CRC remains an area of high unmet need with poor outcomes and limited treatment options. FRUZAQLA is a highly selective and potent inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, -2 and -3 for the treatment of adult patients with previously treated metastatic colorectal cancer (CRC). FRUZAQLA will be the first and only highly selective inhibitor of all three VEGF receptors approved in the U.S. for previously treated metastatic CRC. In establishing WAC, Takeda also evaluated the access landscape for metastatic CRC patients, including the current treatment landscape and associated costs, likelihood of payor coverage, and options for patients without coverage. In addition, Takeda considered its ability to continue to fund the discovery of future oncology innovations and the resources needed to bring new therapies to market. |
None |
9878 |
None |
1 |
2023-03-14 |
400000000.0000 |
None |
Upfront payment, additional milestone payments may be due in the future. Total possible payment (upfront and milestones) $730 million. |
The estimated number of patients in any given state in the United States (U.S.) with a condition for which FRUZAQLA may be prescribed each month is not known but it is expected that FRUZAQLA will be able to be prescribed to approximately 7% of all patients diagnosed with CRC in the U.S., or about 10,621 patients. |
None |
| Takeda Pharmaceuticals America, Inc. |
64764014505 |
ADZYNMA Intravenous Solution Reconstituted 1500 Unit |
Brand |
FDA |
2023-11-29 |
3.2800 |
Takeda’s marketing plans, including the spending associated with Takeda’s marketing tactics, are confidential and proprietary, and not available in the public domain. However, marketing to support product launch will include print and digital media materials, including emails, a website for healthcare professionals, detailing materials for sales representatives to share information about Adzynma with appropriate prescribers, including for patient education, and attendance at professional congresses. Takeda used a value-based pricing methodology in setting the launch price of ADZYNMA, and considered several factors including, but not limited to: (i) the value the medicine brings to patients and society; (ii) the ability of patients to access our medicines; and (iii) our mission of continuing to develop, research, and market new medicines to address patients’ unmet needs. For more information, please see Takeda's Pricing Philosophy. |
None |
1 |
1 |
1 |
None |
None |
None |
None |
For the estimated number of patients, we included '1' simply because we are required to enter a number into this field. We offer the following additional explanation. ADZYNMA (ADAMTS13, recombinant-krhn), an orphan drug, is indicated for prophylactic or on-demand enzyme replacement therapy in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP). cTTP is an ultra-rare, chronic and debilitating blood clotting disorder. Due to the nature of the disease for which ADZYNMA is indicated, Takeda has not determined a specific volume of patients for whom ADZYNMA may be prescribed, and therefore an estimated volume of patients in the US for whom ADZYNMA may be prescribed is not available in the public domain. The International Society on Thrombosis and Haemostasis (ISTH) diagnostic guidelines cite the annual incidence of thrombotic thrombocytopenic purpura (TTP) as two to six cases per million per year globally. Because the inherited form of the disease, cTTP, is ultra-rare, its incidence is uncertain, but studies suggest that it accounts for between 3-5% of patients with TTP.
ADZYNMA (rADAMTS13) is supplied in a single-dose vial and contains nominally 500 IU or 1500 IU of rADAMTS13. Each vial is labeled with the specific number of units of ADAMTS13 potency expressed in IU, and the price of a vial is the price per IU multiplied by the specific number of units in that vial. The WAC price at introduction is $3.28 per IU but has been reported at a nominal package level. |
None |
| Takeda Pharmaceuticals America, Inc. |
64764014005 |
ADZYNMA Intravenous Solution Reconstituted 500 Unit |
Brand |
FDA |
2023-11-29 |
3.2800 |
Takeda’s marketing plans, including the spending associated with Takeda’s marketing tactics, are confidential and proprietary, and not available in the public domain. However, marketing to support product launch will include print and digital media materials, including emails, a website for healthcare professionals, detailing materials for sales representatives to share information about Adzynma with appropriate prescribers, including for patient education, and attendance at professional congresses. Takeda used a value-based pricing methodology in setting the launch price of ADZYNMA, and considered several factors including, but not limited to: (i) the value the medicine brings to patients and society; (ii) the ability of patients to access our medicines; and (iii) our mission of continuing to develop, research, and market new medicines to address patients’ unmet needs. For more information, please see Takeda's Pricing Philosophy. |
None |
1 |
1 |
1 |
None |
None |
None |
None |
For the estimated number of patients, we included '1' simply because we are required to enter a number into this field. We offer the following additional explanation. ADZYNMA (ADAMTS13, recombinant-krhn), an orphan drug, is indicated for prophylactic or on-demand enzyme replacement therapy in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP). cTTP is an ultra-rare, chronic and debilitating blood clotting disorder. Due to the nature of the disease for which ADZYNMA is indicated, Takeda has not determined a specific volume of patients for whom ADZYNMA may be prescribed, and therefore an estimated volume of patients in the US for whom ADZYNMA may be prescribed is not available in the public domain. The International Society on Thrombosis and Haemostasis (ISTH) diagnostic guidelines cite the annual incidence of thrombotic thrombocytopenic purpura (TTP) as two to six cases per million per year globally. Because the inherited form of the disease, cTTP, is ultra-rare, its incidence is uncertain, but studies suggest that it accounts for between 3-5% of patients with TTP.
ADZYNMA (rADAMTS13) is supplied in a single-dose vial and contains nominally 500 IU or 1500 IU of rADAMTS13. Each vial is labeled with the specific number of units of ADAMTS13 potency expressed in IU, and the price of a vial is the price per IU multiplied by the specific number of units in that vial. The WAC price at introduction is $3.28 per IU but has been reported at a nominal package level. |
None |
| Tarsus Pharmaceuticals, Inc. |
81942012501 |
XDEMVY™, Lotilaner Ophthalmic Solution 0.25%, 10 mL bottle |
Brand |
FDA |
2023-08-24 |
1850.0000 |
None |
1 |
7000000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Teva Neuroscience, Inc. |
68546047156 |
AUSTEDO XR® 12mg (30ct) |
Brand |
FDA |
2023-05-08 |
4720.5000 |
None |
1 |
533000 |
None |
None |
None |
None |
None |
None |
Research suggests that the diagnosed prevelance for Huntington's is about 33,000. Tardive dyskinesia affects about 500,000 individuals in the United States; Teva developed this product. |
None |
| Teva Neuroscience, Inc. |
68546047256 |
AUSTEDO XR® 24mg (30ct) |
Brand |
FDA |
2023-05-08 |
7080.7000 |
None |
1 |
533000 |
None |
None |
None |
None |
None |
None |
Research suggests that the diagnosed prevelance for Huntington's is about 33,000. Tardive dyskinesia affects about 500,000 individuals in the United States; Teva developed this product. |
None |
| Teva Neuroscience, Inc. |
68546047056 |
AUSTEDO XR® 6mg (30ct) |
Brand |
FDA |
2023-05-08 |
2360.2500 |
None |
1 |
533000 |
None |
None |
None |
None |
None |
None |
Research suggests that the diagnosed prevelance for Huntington's is about 33,000. Tardive dyskinesia affects about 500,000 individuals in the United States; Teva developed this product. |
None |
| Teva Neuroscience, Inc. |
51759052010 |
UZEDY ER Inj. 100mg/0.28 ML |
Brand |
FDA |
2023-05-17 |
2464.0000 |
None |
1 |
3300000 |
None |
None |
None |
None |
None |
None |
Research suggests there are 3,300,000 schizophrenia patients in the US. Acquisition fields left blank; Teva developed this product. |
None |
| Teva Neuroscience, Inc. |
51759063010 |
UZEDY ER Inj. 125mg/0.35 ML |
Brand |
FDA |
2023-05-17 |
3080.0000 |
None |
1 |
3300000 |
None |
None |
None |
None |
None |
None |
Research suggests there are 3,300,000 schizophrenia patients in the US. Acquisition fields left blank; Teva developed this product. |
None |
| Teva Neuroscience, Inc. |
51759074010 |
UZEDY ER Inj. 150mg/0.42 ML |
Brand |
FDA |
2023-05-17 |
3696.0000 |
None |
1 |
3300000 |
None |
None |
None |
None |
None |
None |
Research suggests there are 3,300,000 schizophrenia patients in the US. Acquisition fields left blank; Teva developed this product. |
None |
| Teva Neuroscience, Inc. |
51759085010 |
UZEDY ER Inj. 200mg/0.56 ML |
Brand |
FDA |
2023-05-17 |
4928.0000 |
None |
1 |
3300000 |
None |
None |
None |
None |
None |
None |
Research suggests there are 3,300,000 schizophrenia patients in the US. Acquisition fields left blank; Teva developed this product. |
None |
| Teva Neuroscience, Inc. |
51759096010 |
UZEDY ER Inj. 250mg/0.70 ML |
Brand |
FDA |
2023-05-17 |
6160.0000 |
None |
1 |
3300000 |
None |
None |
None |
None |
None |
None |
Research suggests there are 3,300,000 schizophrenia patients in the US. Acquisition fields left blank; Teva developed this product. |
None |
| Teva Neuroscience, Inc. |
51759030510 |
UZEDY ER Inj. 50mg/0.14 ML |
Brand |
FDA |
2023-05-17 |
1232.0000 |
None |
1 |
3300000 |
None |
None |
None |
None |
None |
None |
Research suggests there are 3,300,000 schizophrenia patients in the US. Acquisition fields left blank; Teva developed this product. |
None |
| Teva Neuroscience, Inc. |
51759041010 |
UZEDY ER Inj. 75mg/0.21 ML |
Brand |
FDA |
2023-05-17 |
1848.0000 |
None |
1 |
3300000 |
None |
None |
None |
None |
None |
None |
Research suggests there are 3,300,000 schizophrenia patients in the US. Acquisition fields left blank; Teva developed this product. |
None |
| Teva Neuroscience, Inc. |
68546049052 |
AUSTEDO® XR Patient Titration Kit |
Brand |
FDA |
2023-08-01 |
6608.6800 |
None |
1 |
533000 |
None |
None |
None |
None |
None |
None |
Research suggests that the diagnosed prevelance for Huntington's is about 33,000. Tardive dyskinesia affects about 500,000 individuals in the United States; Teva developed this product. |
None |
| Teva Pharmaceuticals USA |
00480542589 |
SORAFENIB TOSYLATE TABLET 200MG 120 |
Generic |
FDA |
2023-01-03 |
10874.4700 |
None |
1 |
50000 |
None |
None |
None |
None |
None |
None |
Research suggests that there are roughly 50,000 patients in the US whose conditions match the product’s approved indications and, thus, are candidates to take the product. Acquisition fields left blank; Teva developed the product. |
None |
| Teva Pharmaceuticals USA |
00480124128 |
LENALIDOMIDE CAPSULE 2.5MG 28 |
Generic |
FDA |
2023-03-08 |
20157.3600 |
None |
1 |
70000 |
None |
None |
None |
None |
None |
None |
Research suggests that there are as many as 70,000 patients in the US whose conditions match the product’s approved indications and, thus, are candidates to take the product. Acquisition fields left blank; Teva developed this product, in partnership with Natco Pharma. |
None |
| Teva Pharmaceuticals USA |
00480124521 |
LENALIDOMIDE CAPSULE 20MG 21 |
Generic |
FDA |
2023-03-08 |
15118.0400 |
None |
1 |
70000 |
None |
None |
None |
None |
None |
None |
Research suggests that there are as many as 70,000 patients in the US whose conditions match the product’s approved indications and, thus, are candidates to take the product. Acquisition fields left blank; Teva developed this product, in partnership with Natco Pharma. |
None |
| Teva Pharmaceuticals USA |
00480235901 |
TOPIRAMATE ER CAPSULE 200MG 100 |
Generic |
FDA |
2023-03-31 |
3750.7500 |
None |
1 |
21300000 |
None |
1 |
None |
None |
None |
None |
Research suggests that as many as 21.3 million Americans, in total, suffer from the conditions that this product is indicated to treat. Acquisition fields left blank; Teva developed the product. |
None |
| Teva Pharmaceuticals USA |
00480235956 |
TOPIRAMATE ER CAPSULE 200MG 30 |
Generic |
FDA |
2023-03-31 |
1125.2400 |
None |
1 |
21300000 |
None |
1 |
None |
None |
None |
None |
Research suggests that as many as 21.3 million Americans, in total, suffer from the conditions that this product is indicated to treat. Acquisition fields left blank; Teva developed the product. |
None |
| Teva Pharmaceuticals USA |
00480235801 |
TOPIRAMATE ER CAPSULE 100MG 100 |
Generic |
FDA |
2023-05-03 |
2741.9200 |
None |
1 |
21300000 |
None |
1 |
None |
None |
None |
None |
Research suggests that as many as 21.3 million Americans, in total, suffer from the conditions that this product is indicated to treat. Acquisition fields left blank; Teva developed the product. |
None |
| Teva Pharmaceuticals USA |
00480235601 |
TOPIRAMATE ER CAPSULE 25MG 100 |
Generic |
FDA |
2023-05-03 |
1062.4100 |
None |
1 |
21300000 |
None |
1 |
None |
None |
None |
None |
Research suggests that as many as 21.3 million Americans, in total, suffer from the conditions that this product is indicated to treat. Acquisition fields left blank; Teva developed the product. |
None |
| Teva Pharmaceuticals USA |
00480235701 |
TOPIRAMATE ER CAPSULE 50MG 100 |
Generic |
FDA |
2023-05-03 |
1383.9000 |
None |
1 |
21300000 |
None |
1 |
None |
None |
None |
None |
Research suggests that as many as 21.3 million Americans, in total, suffer from the conditions that this product is indicated to treat. Acquisition fields left blank; Teva developed the product. |
None |
| Teva Pharmaceuticals USA |
00480405356 |
GEFITINIB TABLET 250MG 30 |
Generic |
FDA |
2023-06-21 |
4439.6600 |
None |
1 |
80000 |
None |
None |
None |
None |
None |
None |
Research suggests that as many as 80,000 Americans, in total, suffer from the condition that this product is indicated to treat. Acquisition fields left blank; Teva developed the product. |
None |
| Teva Pharmaceuticals USA |
00480432001 |
PLERIXAFOR INJ 24MG/1.2ML (20MG/ML) 1 |
Generic |
FDA |
2023-07-28 |
1200.0000 |
None |
1 |
285000 |
None |
None |
None |
None |
None |
None |
Research suggests that as many as 285,000 Americans, in total, suffer from the condition that this product is indicated to treat. Acquisition fields left blank; Teva developed the product. |
None |
| Teva Pharmaceuticals USA |
00480368501 |
AMPHETAMINE MIX SALT ER CAPS 37.5MG 100 |
Generic |
FDA |
2023-10-10 |
975.8100 |
None |
1 |
4500000 |
None |
1 |
None |
None |
None |
None |
Research suggests that as many as $4.5 million Americans, in total, suffer from the condition that this product is indicated to treat. Acquisition fields left blank; Teva developed the product. |
None |
| Teva Pharmaceuticals USA |
00480368301 |
AMPHETAMINE MIX SALTS ER CAPS 12.5MG 100 |
Generic |
FDA |
2023-10-10 |
975.8100 |
None |
1 |
4500000 |
None |
1 |
None |
None |
None |
None |
Research suggests that as many as $4.5 million Americans, in total, suffer from the condition that this product is indicated to treat. Acquisition fields left blank; Teva developed the product. |
None |
| Teva Pharmaceuticals USA |
00480368401 |
AMPHETAMINE MIX SALTS ER CAPS 25MG 100 |
Generic |
FDA |
2023-10-10 |
975.8100 |
None |
1 |
4500000 |
None |
1 |
None |
None |
None |
None |
Research suggests that as many as $4.5 million Americans, in total, suffer from the condition that this product is indicated to treat. Acquisition fields left blank; Teva developed the product. |
None |
| Teva Pharmaceuticals USA |
00480368601 |
AMPHETAMINE MIX SALTS ER CAPS 50MG 100 |
Generic |
FDA |
2023-10-10 |
975.8100 |
None |
1 |
4500000 |
None |
1 |
None |
None |
None |
None |
Research suggests that as many as $4.5 million Americans, in total, suffer from the condition that this product is indicated to treat. Acquisition fields left blank; Teva developed the product. |
None |
| Teva Pharmaceuticals USA |
00480418489 |
PAZOPANIB HCL TABLET 200MG 120 |
Generic |
FDA |
2023-10-20 |
11294.2300 |
None |
1 |
580000 |
None |
None |
None |
None |
None |
None |
Research suggests that as many as 580,000 Americans, in total, suffer from the conditions that this product is indicated to treat. Acquisition fields left blank; Teva developed the product. |
None |
| Teva Pharmaceuticals USA |
00093776924 |
EVEROLIMUS TABLETS 10MG 28 (7X4) |
Generic |
FDA |
2023-10-23 |
933.3300 |
None |
1 |
930000 |
None |
None |
None |
None |
None |
None |
Research suggests that as many as 930,000 Americans, in total, suffer from the conditions that this product is indicated to treat. Acquisition fields left blank; Teva developed the product. |
None |
| Teva Pharmaceuticals USA |
00591474030 |
DEFERASIROX GRANULE 360MG 30 |
Generic |
FDA |
2023-11-10 |
1333.1800 |
None |
1 |
5000000 |
None |
None |
None |
None |
None |
None |
Research suggests that as many as 5 million patients receive blood transfusions annually in the US and, thus, may be eligible to take this product. Acquisition fields left blank; Teva developed the product. |
None |
| Teva Pharmaceuticals USA |
00480145308 |
RISPERIDONE SR INJ 50MG 2ML KIT |
Generic |
FDA |
2023-12-11 |
1062.0400 |
None |
1 |
7000000 |
None |
None |
None |
None |
None |
None |
Research suggests that as many as 7 million Americans, in total, suffer from the conditions that this product is indicated to treat. Acquisition fields left blank; Teva developed the product. |
None |
| Teva Pharmaceuticals USA |
00093110616 |
TERIPARATIDE INJ PEN 0.25MG/ML 2.4ML 1 |
Generic |
FDA |
2023-12-18 |
2896.3000 |
None |
1 |
283000000 |
None |
1 |
None |
None |
None |
None |
Research suggests that as many as 283 million Americans, in total, suffer from the conditions that this product is indicated to treat. Acquisition fields left blank; Teva developed the product. |
None |
| TG Therapeutics, Inc. |
73150015006 |
BRIUMVI (ublituximab-xiiy) 150 mg/6 mL Vial |
Brand |
FDA |
2023-01-26 |
9833.3300 |
Marketing Plan:
BRIUMVI was approved on 12/28/22 as a CD20-directed cytolytic antibody indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. TG Therapeutics has designed marketing activities to raise awareness and understanding with Healthcare Providers, Patients and Care Partners about the approved indications, efficacy, safety and patient support services offerings available.
TG Therapeutics will take a very targeted approach to paid advertising to both Healthcare Providers, Patients and Care Partners. TG is not planning on executing DTC advertising via TV executions at this time, instead there will be a focus on leveraging digital platforms such as banner, social media, paid search, etc. We will, however, have a patient-facing website that provides information about BRIUMVI, the diseases it is approved to treat, and the BRIUMVI Patient Support Program.
At launch TG will not offer coupons or free trials or other promotional incentives. However, at launch TG will offer copayment assistance to commercially insured patients through the BRIUMVI Patient Support Program. Information about the BRIUMVI Patient Support Program, including the commercial co-pay program, will be provided to healthcare providers (“HCPs”) by our sales representatives and via an HCP website, and to patients via a patient-facing website.
In preparation for launch over the 2022 calendar year, promotional spend was focused on creating content for HCPs to raise awareness of TG Therapeutics, including medical congress activities and unbranded speaker programs. From a branded perspective promotional spend was focused on developing content in anticipation for the launch of BRIUMVI, including non-personal promotion (branded website and in office resources).
Pricing Plans:
TG Therapeutics was founded with one broad mission: to develop novel and valuable treatment options for patients with B-cell diseases. Our commitment to patients, however, goes beyond science. We believe that access is essential in ensuring advances are available to patients who are in need of treatment options. This is why we created a unique approach to our decision-making around access and pricing anchored on the clinical value of our products and guided by three core pillars: fiercely focused on patients, access and solutions. TG Therapeutics is committed to responsible pricing and partnership across the healthcare system and we listened carefully to the MS community, including neurologists, patients, payers and advocacy groups to ensure that we priced BRIUMVI to optimize access for patients. |
None |
70000 |
None |
None |
2012-01-30 |
None |
1 |
TG Therapeutics does not believe the acquisition price is in the public domain or publicly available. Accordingly, TG Therapeutics is limiting its response to this item pursuant to California Health & Safety Code § 127681(c). |
Comment regarding number of Estimated Patients field: There are currently 900,000 – 1,000,000 patients diagnosed with MS in the US, with ~350,000 receiving an MS DMT in any given year. Each year there are approximately 80,000 – 90,000 patients in the US who are in need of a new MS treatment. Approximately ~85% of MS patients fall within our FDA labelled indications (Relapsing MS). |
None |
| Tolmar Inc |
62935046150 |
ELIGARD® 45mg (leuprolide acetate for injectable suspension) 6 months of therapy |
Brand |
FDA |
2023-03-08 |
2710.1300 |
Marketing activities that support the launch of a new medicine are designed to raise awareness and understanding with healthcare providers, patients, and caregivers about the approved indication, efficacy and safety data contained within the medicine's FDA approved label. Generally, Tolmar markets in the US at medical conferences in the urology and oncology community, as well as promoting to appropriate healthcare professionals, patients, and caregivers |
None |
45000 |
None |
None |
None |
None |
None |
None |
As part of Tolmar’s commitment to advancing science and patient care, Tolmar has launched a new Eligard®(leuprolide acetate) for injectable suspension. The new Eligard is designed to streamline the mixing and administration process by providing the product in a single, pre-connected unit |
None |
| Tolmar Inc |
62935016360 |
FENSOLVI® 45mg (leuprolide acetate for injectable suspension) 6 months of therapy |
Brand |
FDA |
2023-04-01 |
24891.6800 |
Marketing activities that support the launch of a new medicine are designed to raise awareness and understanding with healthcare providers, patients, and caregivers about the approved indication, efficacy and safety data contained within the medicine's FDA approved label. Generally, Tolmar markets in the US at medical conferences in the pediatric Endocrinology community, as well as promoting to appropriate healthcare professionals, patients, and caregivers |
None |
1200 |
None |
None |
None |
None |
None |
None |
As part of Tolmar’s commitment to advancing science and patient care, Tolmar has launched a new Fensolvi®(leuprolide acetate) for injectable suspension. The new Fensolvi® is designed to streamline the mixing and administration process by providing the product in a single, pre-connected unit |
None |
| Tolmar Inc |
62935022710 |
ELIGARD® 22.5 MG (leuprolide acetate for injectable suspension) 3 months of therapy |
Brand |
FDA |
2023-12-01 |
1355.0700 |
Marketing activities that support the launch of a new medicine are designed to raise awareness and understanding with healthcare providers, patients, and caregivers about the approved indication, efficacy and safety data contained within the medicine's FDA approved label. Generally, Tolmar markets in the US at medical conferences in the urology and oncology community, as well as promoting to appropriate healthcare professionals, patients, and caregivers |
None |
45000 |
None |
None |
None |
None |
None |
None |
As part of Tolmar’s commitment to advancing science and patient care, Tolmar has launched a new Eligard®(leuprolide acetate) for injectable suspension. The new Eligard is designed to streamline the mixing and administration process by providing the product in a single, pre-connected unit |
None |
| Travere Therapeutics, Inc. |
68974020030 |
Filspari (sparsentan) Oral tablets, 200mg, 30 tablets |
Brand |
FDA |
2023-02-28 |
9900.0000 |
Our marketing and market access teams, supported by third-party agencies with rare disease experience, drives our commercialization and disease awareness efforts in the United States. Specifically, we implement a variety of industry accepted programs to educate physicians, including direct-to-physician contact by sales representatives, peer-to-peer educational programs, and participation in targeted medical convention programs.
We plan to distribute FILSPARI through three direct to patient pharmacies, and operate Travere TotalCare, pursuant to which we will provide our comprehensive patient support services. This patient support program for FILSPARI in the United States will provide services, assistance and resources that will help patients understand IgAN, manage the insurance process, fill their prescriptions and initiate treatment. Travere has a long-standing commitment to setting prices responsibly based on the value our medicines bring to patients, society and healthcare systems. Our approach reflects our commitment to continued transparency in how we price our prescription medicines in the United States while minimizing our contribution to health system spending.
When we set the price of a new medicine, we hold ourselves to a rigorous and structured process that includes consultation with external stakeholders and considers the following factors
1) Clinical value and outcomes, or the benefit the medicine delivers to patients, and how well it works compared to a standard of care;
2) Economic value, or how the medicine reduces the need—and therefore costs—of other healthcare interventions
3) Social value, or how the medicine contributes to quality of life, and productivity. |
None |
1500 |
None |
1 |
None |
None |
None |
None |
None |
None |
| Travere Therapeutics, Inc. |
68974040030 |
Filspari (sparsentan) Oral tablets, 400mg, 30 tablets |
Brand |
FDA |
2023-03-01 |
9900.0000 |
Our marketing and market access teams, supported by third-party agencies with rare disease experience, drives our commercialization and disease awareness efforts in the United States. Specifically, we implement a variety of industry accepted programs to educate physicians, including direct-to-physician contact by sales representatives, peer-to-peer educational programs, and participation in targeted medical convention programs.
We plan to distribute FILSPARI through three direct to patient pharmacies, and operate Travere TotalCare, pursuant to which we will provide our comprehensive patient support services. This patient support program for FILSPARI in the United States will provide services, assistance and resources that will help patients understand IgAN, manage the insurance process, fill their prescriptions and initiate treatment. Travere has a long-standing commitment to setting prices responsibly based on the value our medicines bring to patients, society and healthcare systems. Our approach reflects our commitment to continued transparency in how we price our prescription medicines in the United States while minimizing our contribution to health system spending.
When we set the price of a new medicine, we hold ourselves to a rigorous and structured process that includes consultation with external stakeholders and considers the following factors
1) Clinical value and outcomes, or the benefit the medicine delivers to patients, and how well it works compared to a standard of care;
2) Economic value, or how the medicine reduces the need—and therefore costs—of other healthcare interventions
3) Social value, or how the medicine contributes to quality of life, and productivity. |
None |
1500 |
None |
1 |
None |
None |
None |
None |
None |
None |
| TruPharma, LLC |
52817061516 |
Tramadol 5mg/mL Solution, Oral 473mL |
Generic |
FDA |
2023-01-27 |
471.0500 |
This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only. |
None |
48790 |
None |
None |
None |
None |
None |
None |
None |
None |
| TruPharma, LLC |
52817062008 |
Baclofen Solution, Oral 10mg/5mL 273mL |
Generic |
FDA |
2023-11-10 |
661.5000 |
This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only. |
None |
7596 |
None |
None |
None |
None |
None |
None |
None |
None |
| UCB, Inc |
50474098079 |
RYSTIGGO 140 MG/ML 2 ML VIAL |
Brand |
FDA |
2023-06-27 |
6050.0000 |
None |
1 |
176 |
1 |
1 |
None |
None |
None |
None |
UCB estimates that the average number of patients in the USA who may be prescribed Rystiggo for calendar year 2023 is approximately 176 and for calendar year 2024 is 563. The foregoing estimates are based on UCB analysis of the estimated number of generalized myasthenia gravis (gMG) patients that are (i) anti-acetylcholine receptor antibody-positive (AChR+) with low to moderate restrictiveness, or (ii) muscle-specific tyrosine kinase antibody seropositive with low restrictiveness. UCB used the following sources for the foregoing analysis: IQVIA Pharmetrics, IQVIA LAAD, Symphony Health data and Komodo Heath data |
None |
| UCB, Inc |
50474078185 |
BIMZELX - 160MG/ML 2AINJ US |
Brand |
FDA |
2023-11-13 |
14400.0000 |
None |
1 |
10481 |
None |
None |
None |
None |
None |
None |
UCB estimates that 184 patients on average may be prescribed Bimzelx for the remainder of 2023 and 10,481 patients on average may be prescribed Bimzelx for calendar year 2024. The foregoing estimates are based on UCB analysis of the estimated number of moderate to severe psoriasis patients to be treated with biologics and/or advanced oral products from data received from various internal and external industry data sources. |
None |
| UCB, Inc |
50474078079 |
BIMZELX 160MG/ML 2 - PFS SAFETY SYRINGE |
Brand |
FDA |
2023-11-13 |
14400.0000 |
None |
1 |
10481 |
None |
None |
None |
None |
None |
None |
UCB estimates that 184 patients on average may be prescribed Bimzelx for the remainder of 2023 and 10,481 patients on average may be prescribed Bimzelx for calendar year 2024. The foregoing estimates are based on UCB analysis of the estimated number of moderate to severe psoriasis patients to be treated with biologics and/or advanced oral products from data received from various internal and external industry data sources. |
None |
| United Therapeutics |
66302030002 |
Orenitram 0.125MG Tab 10 ct. Blister Pack |
Brand |
FDA |
2023-03-01 |
66.2000 |
United Therapeutics considers multiple factors when setting a list price for a medicine, including: benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. Market and business considerations, including: Ongoing research-investment costs, Medical- and patient-service costs (which may or may not include patient assistance programs and capital-investment costs associated with manufacturing, storage and supply).
Orenitram is an FDA approved treatment which affects a number of patients in the US annually. United Therapeutic's approach will focus on educating healthcare providers on how to identify and diagnose potential patients to provide relief from symptoms as early as possible - the education will provide information about treatment. |
None |
2180 |
None |
None |
None |
None |
None |
None |
Estimated patients is confidential and proprietary, and not publicly available or within the public domain. |
None |
| United Therapeutics |
66302030202 |
Orenitram 0.25MG Tab 10 ct. Blister Pack |
Brand |
FDA |
2023-03-01 |
132.3800 |
United Therapeutics considers multiple factors when setting a list price for a medicine, including: benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. Market and business considerations, including: Ongoing research-investment costs, Medical- and patient-service costs (which may or may not include patient assistance programs and capital-investment costs associated with manufacturing, storage and supply).
Orenitram is an FDA approved treatment which affects a number of patients in the US annually. United Therapeutic's approach will focus on educating healthcare providers on how to identify and diagnose potential patients to provide relief from symptoms as early as possible - the education will provide information about treatment. |
None |
2180 |
None |
None |
None |
None |
None |
None |
Estimated patients is confidential and proprietary, and not publicly available or within the public domain. |
None |
| United Therapeutics |
66302031002 |
Orenitram 1.0MG Tab 10 ct. Blister Pack |
Brand |
FDA |
2023-03-01 |
529.5700 |
United Therapeutics considers multiple factors when setting a list price for a medicine, including: benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. Market and business considerations, including: Ongoing research-investment costs, Medical- and patient-service costs (which may or may not include patient assistance programs and capital-investment costs associated with manufacturing, storage and supply).
Orenitram is an FDA approved treatment which affects a number of patients in the US annually. United Therapeutic's approach will focus on educating healthcare providers on how to identify and diagnose potential patients to provide relief from symptoms as early as possible - the education will provide information about treatment. |
None |
2180 |
None |
None |
None |
None |
None |
None |
Estimated patients is confidential and proprietary, and not publicly available or within the public domain. |
None |
| United Therapeutics |
66302032502 |
Orenitram 2.5MG Tab 10 ct. Blister Pack |
Brand |
FDA |
2023-03-01 |
1323.9100 |
United Therapeutics considers multiple factors when setting a list price for a medicine, including: benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. Market and business considerations, including: Ongoing research-investment costs, Medical- and patient-service costs (which may or may not include patient assistance programs and capital-investment costs associated with manufacturing, storage and supply).
Orenitram is an FDA approved treatment which affects a number of patients in the US annually. United Therapeutic's approach will focus on educating healthcare providers on how to identify and diagnose potential patients to provide relief from symptoms as early as possible - the education will provide information about treatment. |
None |
2180 |
None |
None |
None |
None |
None |
None |
Estimated patients is confidential and proprietary, and not publicly available or within the public domain. |
None |
| United Therapeutics |
66302035002 |
Orenitram 5MG Tab 10 ct. Blister Pack |
Brand |
FDA |
2023-03-01 |
2647.8300 |
United Therapeutics considers multiple factors when setting a list price for a medicine, including: benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. Market and business considerations, including: Ongoing research-investment costs, Medical- and patient-service costs (which may or may not include patient assistance programs and capital-investment costs associated with manufacturing, storage and supply).
Orenitram is an FDA approved treatment which affects a number of patients in the US annually. United Therapeutic's approach will focus on educating healthcare providers on how to identify and diagnose potential patients to provide relief from symptoms as early as possible - the education will provide information about treatment. |
None |
2180 |
None |
None |
None |
None |
None |
None |
Estimated patients is confidential and proprietary, and not publicly available or within the public domain. |
None |
| United Therapeutics |
66302036384 |
Orenitram Titration Kit 7-Blister Card Pack 0.125mg and 0.25mg and 1 mg Month 3 |
Brand |
FDA |
2023-03-01 |
5838.8400 |
United Therapeutics considers multiple factors when setting a list price for a medicine, including: benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. Market and business considerations, including: Ongoing research-investment costs, Medical- and patient-service costs (which may or may not include patient assistance programs and capital-investment costs associated with manufacturing, storage and supply).
Orenitram is an FDA approved treatment which affects a number of patients in the US annually. United Therapeutic's approach will focus on educating healthcare providers on how to identify and diagnose potential patients to provide relief from symptoms as early as possible - the education will provide information about treatment. |
None |
2180 |
None |
None |
None |
None |
None |
None |
Estimated patients is confidential and proprietary, and not publicly available or within the public domain. |
None |
| United Therapeutics |
66302036128 |
Orenitram Titration Kit 7-Blister Card Pack 0.125mg and 0.25mg Month 1 |
Brand |
FDA |
2023-03-01 |
1390.2000 |
United Therapeutics considers multiple factors when setting a list price for a medicine, including: benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. Market and business considerations, including: Ongoing research-investment costs, Medical- and patient-service costs (which may or may not include patient assistance programs and capital-investment costs associated with manufacturing, storage and supply).
Orenitram is an FDA approved treatment which affects a number of patients in the US annually. United Therapeutic's approach will focus on educating healthcare providers on how to identify and diagnose potential patients to provide relief from symptoms as early as possible - the education will provide information about treatment. |
None |
2180 |
None |
None |
None |
None |
None |
None |
Estimated patients is confidential and proprietary, and not publicly available or within the public domain. |
None |
| United Therapeutics |
66302036256 |
Orenitram Titration Kit 7-Blister Card Pack 0.125mg and 0.25mg Month 2 |
Brand |
FDA |
2023-03-01 |
3614.5200 |
United Therapeutics considers multiple factors when setting a list price for a medicine, including: benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. Market and business considerations, including: Ongoing research-investment costs, Medical- and patient-service costs (which may or may not include patient assistance programs and capital-investment costs associated with manufacturing, storage and supply).
Orenitram is an FDA approved treatment which affects a number of patients in the US annually. United Therapeutic's approach will focus on educating healthcare providers on how to identify and diagnose potential patients to provide relief from symptoms as early as possible - the education will provide information about treatment. |
None |
2180 |
None |
None |
None |
None |
None |
None |
Estimated patients is confidential and proprietary, and not publicly available or within the public domain. |
None |
| Upsher-Smith Laboratories, LLC |
00245600111 |
VIGADRONE® Tablets contain the antiepileptic agent vigabatrin in a strength of 500 mg and are indicated for certain patients with infantile spasms and refractory complex partial seizures. |
Generic |
FDA |
2023-07-28 |
14929.0000 |
• The Marketing Plan is to focus on providing patients and providers with a low cost alternative to the brand Sabril, and to provide education about the services Upsher-Smith offers through a specialty pharmacy to help parents and patients manage side effects, provide speed to therapy via rapid shipments, offer bridge supply during insurance interruption, manage transitions from powder dosage form to tablet dosage form & to provide education about the disease state. The marketing activities include a web site, email activities, attending medical conferences, and supporting a small account management team that focuses on centers of excellence. |
None |
11 |
None |
None |
None |
None |
None |
None |
There are ~114 new Vigabatrin patients enrolled in the REMS program each month; 10-15% of those patients are vigabatrin tablet patients |
None |
| USAntibiotics |
81964000354 |
AUGMENTIN ES-600- amoxicillin and clavulanate potassium for suspension |
Brand |
FDA |
2023-04-29 |
915.3600 |
None |
1 |
251100000 |
None |
None |
None |
None |
None |
None |
number of patients represents number of annual patients in US receiving anitibiotic prescriptions |
None |
| Vericel Corporation |
69866200503 |
NexoBrid (anacaulase-bcdb) For topical gel - 4.85 g anacaulase-bcdb in 5 g lyophilized powder. For Topical Use Only. |
Brand |
FDA |
2023-01-16 |
3150.0000 |
None |
1 |
25500 |
None |
None |
2019-05-07 |
17500000.0000 |
None |
The agreement states an upfront payment of $17.5 million, with an additional $7.5 million payment contingent upon U.S. approval and up to $125 million contingent upon meeting certain annual sales milestones. |
None |
None |
| Verrica Pharmaceuticals Inc. |
71349007001 |
YCANTH 0.7% (w/v) |
Brand |
FDA |
2023-08-24 |
685.0000 |
Verrica is targeting health care professionals in the pediatric and dermatology disciplines as well as direct to consumer marketing in the U.S. At Verrica, we are committed to ensuring patients have access to our innovative medicines while preserving our ability to develop future groundbreaking treatments and cures. Verrica considers numerous factors in determining the price of its drugs, including research and development costs; manufacturing supply considerations; patient population; nature of payer for the relevant product; contracts and relationships with customers; and legal considerations, including compliance with rules and regulations governing sales to government and institutional purchasers. |
None |
70000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Verrica Pharmaceuticals Inc. |
71349007012 |
YCANTH 0.7% (w/v) 12 applicators |
Brand |
FDA |
2023-08-24 |
8220.0000 |
Verrica is targeting health care professionals in the pediatric and dermatology disciplines as well as direct to consumer marketing in the U.S. At Verrica, we are committed to ensuring patients have access to our innovative medicines while preserving our ability to develop future groundbreaking treatments and cures. Verrica considers numerous factors in determining the price of its drugs, including research and development costs; manufacturing supply considerations; patient population; nature of payer for the relevant product; contracts and relationships with customers; and legal considerations, including compliance with rules and regulations governing sales to government and institutional purchasers. |
None |
70000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Verrica Pharmaceuticals Inc. |
71349007006 |
YCANTH 0.7% (w/v) 6 applicators |
Brand |
FDA |
2023-08-24 |
4110.0000 |
Verrica is targeting health care professionals in the pediatric and dermatology disciplines as well as direct to consumer marketing in the U.S. At Verrica, we are committed to ensuring patients have access to our innovative medicines while preserving our ability to develop future groundbreaking treatments and cures. Verrica considers numerous factors in determining the price of its drugs, including research and development costs; manufacturing supply considerations; patient population; nature of payer for the relevant product; contracts and relationships with customers; and legal considerations, including compliance with rules and regulations governing sales to government and institutional purchasers. |
None |
70000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Vertex Pharmaceuticals Incorporated |
51167029009 |
CASGEVY (exagamglogene autotemcel), suspension for intravenous infusion |
Brand |
FDA |
2023-12-08 |
2200000.0000 |
Marketing Plan Description
Vertex’s commercial field team in the United States is composed of a small number of individuals, and we focus our United States marketing activities for CASGEVY towards a limited number of physicians and health care professionals who are located at Authorized Treatment Centers (ATCs) in the United States.
The objective of these activities is to raise awareness and understanding about the approved indication, dosing, efficacy and safety data that are consistent with CASGEVY’s FDA approved label.
Specific activities related to physicians and health care professionals include print distribution by the commercial field team to ATCs, digital advertising (e.g., CASGEVY’s product website), and other educational programs.
Specific activities related to people living with sickle cell disease (SCD) and their caregivers include print distribution of patient materials to ATCs care centers and digital advertising (e.g., CASGEVY’s product website and social media pages). Vertex does not engage in traditional direct-to-consumer advertising (e.g., television or mass media). While not part of Vertex’s marketing plan, the company also operates a patient support program, known as Vertex Connects™, that provides educational resources, communications, and support to eligible patients who have been prescribed CASGEVY.
Pricing Plan Description
When determining the price of CASGEVY, we applied a value-based approach that recognizes the holistic value of a one-time therapy:
• Lifetime clinical benefit of CASGEVY as a one-time treatment for patients with SCD facing significant early mortality
• Enables access for all eligible patients regardless of payer type without excessive hurdles to therapy
• Reduced economic impact of lifelong health care expenses and long-term value delivered across healthcare systems and society
• Investment required for ongoing discovery and development of new medicines
The list price of CASGEVY reflects the transformative clinical and economic value that a one-time treatment that eliminates severe vaso-occlusive crises (VOCs) brings to patients and their families, as well as the resulting long-term value delivered across the healthcare ecosystem and society.
• In clinical trials, 93.5% of patients with SCD achieved the primary efficacy endpoint of freedom from VOCs for at least 12 consecutive months.
• List price is within the range of traditional cost-effectiveness thresholds based on external economic modeling. |
None |
16000 |
None |
1 |
None |
None |
None |
None |
There are approximately 120,000 prevalent cases of Sickle Cell Disease (SCD) in the US. Among prevalent cases of SCD, approximately 16,000 have severe disease defined by recurrent vaso-occlusive crises, meet key age criteria, and would be considered for gene therapy.
The acquisition fields are left blank because the product was developed by Vertex in collaboration with CRISPR and not acquired from a third party. |
None |
| XGen Pharmaceuticals DJB |
39822303002 |
Pentamidine for Inhalation 300mg/vial |
Generic |
FDA |
2023-07-01 |
90.0000 |
None |
1 |
7800 |
None |
None |
None |
None |
None |
None |
The marketing date for this item has been updated with a marketing launch date of 6/30/2023 in the CMS date bank (and other databanks as needed). |
None |
| XGen Pharmaceuticals DJB |
39822305002 |
Pentamidine for Injection 300mg/vial x10 |
Generic |
FDA |
2023-07-01 |
900.0000 |
None |
1 |
5364 |
None |
None |
None |
None |
None |
None |
The marketing date for this item has been updated with a marketing launch date of 6/30/2023 in the CMS date bank (and other databanks as needed). |
None |
| Zydus Pharmaceuticals (USA) Inc. |
68382076906 |
Topiramate ER Capsules 100mg 30ct |
Generic |
FDA |
2023-01-04 |
822.2600 |
None |
1 |
42400000 |
None |
None |
None |
None |
None |
None |
This is an AB rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has entered “42,400,000” in the “Estimated Number of Patients” column, however: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state nor nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4). Topiramate ER Capsules is indicated for the treatment of epileptic seizures and for the treatment of migraines. As per the CDC link "Frequently asked questions about Epilepsy" (https://www.cdc.gov/epilepsy/about/faq.htm?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fepilepsy%2Fbasics%2Ffaq.htm) about 3.4 million people in the United States have active epilepsy. Also, as per the link "How Common is Migraine?" (https://migraine.com/migraine-statistics) roughly 39 million people in the United States have migraine. For this reason we have put in a number of 42.4 million in estimated number of patients. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
70710103007 |
Lenalidomide 2.5mg Capsule (28 CAPS) |
Generic |
FDA |
2023-03-06 |
20157.3600 |
None |
1 |
60000 |
None |
None |
None |
None |
None |
None |
This is an AB rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has entered “60,000” in the “Estimated Number of Patients” column, however: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state nor nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4). Lenalidomide is indicated for the treatment of Multiple Myeloma. As per the University of California San Francisco link (https://www.ucsfhealth.org/conditions/multiple-myeloma#) about 60,000 people have this disease and 20,000 new cases are diagnosed each year in the United States. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
70710103408 |
Lenalidomide 20mg Capsule (21 CAPS) |
Generic |
FDA |
2023-03-06 |
15118.0400 |
None |
1 |
60000 |
None |
None |
None |
None |
None |
None |
This is an AB rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has entered “60,000” in the “Estimated Number of Patients” column, however: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state nor nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4). Lenalidomide is indicated for the treatment of Multiple Myeloma. As per the University of California San Francisco link (https://www.ucsfhealth.org/conditions/multiple-myeloma#) about 60,000 people have this disease and 20,000 new cases are diagnosed each year in the United States. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
68382035201 |
Sirolimus 2mg Tablets (100 ct) |
Generic |
FDA |
2023-03-23 |
1186.3400 |
None |
1 |
25000 |
None |
None |
None |
None |
None |
None |
This is an AB rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has entered “25,000” in the “Estimated Number of Patients” column, however: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state nor nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4). Sirolimus is indicated to prevent rejction of a kidney transplant. As per Organ Procurement & Transplantation Network (OPTN) link (https://optn.transplant.hrsa.gov/news/2022-organ-transplants-again-set-annual-records-organ-donation-from-deceased-donors-continues-12-year-record-setting-trend/) upwards of 25,000 people in the United States had first time kidney transplants in 2022. For this reason we are estimating approximately 25,000 patients. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
70710189506 |
Arsenic Trioxide Injection (NovaPlus N+) 10mg/10ml |
Generic |
FDA |
2023-04-24 |
3790.5000 |
None |
1 |
5000 |
None |
None |
None |
None |
None |
None |
This is an AP rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has entered “5,000” in the “Estimated Number of Patients” column, however: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state nor nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4). Arsenic Trioxide is indicated for the treatment of acute promyelocytic leukemia (APL). As per NIH GARD (Genetic and Rare Diseases Information Center) link (https://rarediseases.info.nih.gov/diseases/538/acute-promyelocytic-leukemia) fewer than 5,000 people in the United States have this disease. For this reason we are estimating approximately 5,000 patients. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
70710189606 |
Arsenic Trioxide Injection (NovaPlus N+) 12mg/6ml |
Generic |
FDA |
2023-04-24 |
5388.7700 |
None |
1 |
5000 |
None |
None |
None |
None |
None |
None |
This is an AP rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has entered “5,000” in the “Estimated Number of Patients” column, however: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state nor nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4). Arsenic Trioxide is indicated for the treatment of acute promyelocytic leukemia (APL). As per NIH GARD (Genetic and Rare Diseases Information Center) link (https://rarediseases.info.nih.gov/diseases/538/acute-promyelocytic-leukemia) fewer than 5,000 people in the United States have this disease. For this reason we are estimating approximately 5,000 patients. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
70710120801 |
Plerixafor Inj. 24mg/1.2mL (1X1.2mL) |
Generic |
FDA |
2023-07-26 |
1200.0000 |
None |
1 |
20000 |
None |
None |
None |
None |
None |
None |
This is an AP rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has entered “20,000” in the “Estimated Number of Patients” column, however: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state nor nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4). Plerixafor is indicated for the peripheral mobilization of hematopoietic stem cells for those patients with certain types of cancer (non-Hodgkin's lymphoma-NHL, multiple myeloma-MM) to prepare them for stem cell transplant. As per NIH LIbrary of Medicine National Center for Biotechnology Information link regarding the Prevalence of Hemtopoietic Cell Transplant Survivors in the United States (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3779514/#) approximately 20,000 patients receive HCT (hematopoietic cell transplantation) each year in the USA. For this reason we are estimating approximately 20,000 patients. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
70710185207 |
Indomethacin Suppositories 50mg |
Generic |
FDA |
2023-08-03 |
10314.2900 |
None |
1 |
1300000 |
None |
None |
None |
None |
None |
None |
This is an AB rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has entered “1,300,000” in the “Estimated Number of Patients” column, however: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state nor nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4). Indomethacin Suppository is indicated for for moderate to severe ankylosing spondylitis, osteoarthritis, rheumatoid arthritis or gouty arthritis in adults and children older than 14 years of age. As per NIH LIbrary of Medicine National Center for Biotechnology Information link regarding the Prevalence Trend and Disparities in Rheumatoid Arthritis amound US Adults 2005-2018 (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8348893/#) approximately 1.3 million adults suffer from RA, representing 0.6% to 1% of the adult population. For this reason we are estimating approximately 1.3 million patients. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
70710192601 |
Sodium Phenylacetate and Sodium Benzoate 10%-10% Inj. 20ml (1 vial) |
Generic |
FDA |
2023-09-25 |
2500.0000 |
None |
1 |
2396 |
None |
None |
None |
None |
None |
None |
This is an AP rated generic product that is distributed by Zydus. Acquisition date and price are not applicable. Zydus has entered “2,396” in the “Estimated Number of Patients” column, however: (1). Zydus’ role as generic distributor is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state nor nationally. Sales volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4). Sodium Phenylacetate and Sodium Benzoate is indicated for the treatment of acute hyperammonemia and associated encephalopathy in pediatric and adult patients with deficiences in enzymes of the urea cycle. As per NIH LIbrary of Medicine National Center for Biotechnology Information link regarding Hyperammonemia ( https://www.ncbi.nlm.nih.gov/books/NBK557504/#), its prevalence is estimated to be 1:140000. Based on the USA population counter clock dated September 27, 2023, the US population is 335,491,897 which was divided by 140,000 to arrive at the 2,396 patients. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
68382048116 |
Pitavastatin Calcium 1mg Tablets |
Generic |
FDA |
2023-11-02 |
828.7400 |
None |
1 |
93000000 |
None |
None |
None |
None |
None |
None |
This is an AB rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has entered “93,000,000” in the “Estimated Number of Patients” column, however: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state nor nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4).Pitavastatin Calcium is indicated for hyperlipidemia (or high cholesterol). As per the Cleveland Clink link regarding Hyperlipidemia (https://my.clevelandclinic.org/health/diseases/21656-hyperlipidemia) approximately 93 million adults age 20 and older have a total cholesterol count above the recommended limit of 200mg/dL. For this reason we are estimating approximately 93 million patients. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
68382048216 |
Pitavastatin Calcium 2mg Tablets |
Generic |
FDA |
2023-11-02 |
828.7400 |
None |
1 |
93000000 |
None |
None |
None |
None |
None |
None |
This is an AB rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has entered “93,000,000” in the “Estimated Number of Patients” column, however: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state nor nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4).Pitavastatin Calcium is indicated for hyperlipidemia (or high cholesterol). As per the Cleveland Clink link regarding Hyperlipidemia (https://my.clevelandclinic.org/health/diseases/21656-hyperlipidemia) approximately 93 million adults age 20 and older have a total cholesterol count above the recommended limit of 200mg/dL. For this reason we are estimating approximately 93 million patients. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
68382048316 |
Pitavastatin Calcium 4mg Tablets |
Generic |
FDA |
2023-11-02 |
828.7400 |
None |
1 |
93000000 |
None |
None |
None |
None |
None |
None |
This is an AB rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has entered “93,000,000” in the “Estimated Number of Patients” column, however: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state nor nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4).Pitavastatin Calcium is indicated for hyperlipidemia (or high cholesterol). As per the Cleveland Clink link regarding Hyperlipidemia (https://my.clevelandclinic.org/health/diseases/21656-hyperlipidemia) approximately 93 million adults age 20 and older have a total cholesterol count above the recommended limit of 200mg/dL. For this reason we are estimating approximately 93 million patients. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
70710183805 |
Methylene Blue 50mg/10mL Solution for injection (5 x 10ml) |
Generic |
FDA |
2023-12-07 |
1171.9400 |
None |
1 |
3000 |
None |
None |
None |
None |
None |
None |
This is an AP rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has entered “3,000” in the “Estimated Number of Patients” column, however: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state nor nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4).Methylene Blue Solution for Injection is indicated for methemoglobinemia. As per the Jama Network link regarding Risk of Topical Anesthetic Induced Methemoglobinemia (https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/1673755#) as many as 3,000 cases of methemoglobinemia overall may occur annually in the United States. For this reason we are estimating approximately 3,000 patients. |
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| Zydus Pharmaceuticals (USA) Inc. |
68382035806 |
Topiramate ER Capsules 200mg 30ct TK |
Generic |
FDA |
2023-12-12 |
1125.2400 |
None |
1 |
42400000 |
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This is an AB rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has entered “42,400,000” in the “Estimated Number of Patients” column, however: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state nor nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4). Topiramate ER Capsules is indicated for the treatment of epileptic seizures and for the treatment of migraines. As per the CDC link "Frequently asked questions about Epilepsy" (https://www.cdc.gov/epilepsy/about/faq.htm?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fepilepsy%2Fbasics%2Ffaq.htm) about 3.4 million people in the United States have active epilepsy. Also, as per the link "How Common is Migraine?" (https://migraine.com/migraine-statistics) roughly 39 million people in the United States have migraine. For this reason we have put in a number of 42.4 million in estimated number of patients. |
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