| 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 |