| 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 |