| Accord BioPharma, Inc. |
69448001505 |
Hercessi Intravenous Solution Reconstituted 150 MG |
2025-01-03 |
1323.0000 |
None |
1 |
42268 |
None |
None |
None |
None |
None |
None |
"There are challenges with estimating the number of patients due to Hercessi’s multiple indications approved by the FDA. Accord estimates patients using US Population and an annual U.S. incidence rate which results in 37,000 estimated patients for Breast Cancer and 4,800 estimated patients for Gastric Cancer. The US Population is from the Neilsburg Research US population by Gender, July 2024. This incidence rate is derived from the National Cancer Institute Surveillance, Epidemiology, and End Results Program. Cancer Stat Facts: Female Breast Cancer. Available at: https://seer.cancer.gov/statfacts/html/breast.html. Accessed
January 15, 2024" |
None |
| Accord BioPharma, Inc. |
69448001611 |
Hercessi Intravenous Solution Reconstituted 420 MG |
2025-01-03 |
3704.4000 |
None |
1 |
42268 |
None |
None |
None |
None |
None |
None |
"There are challenges with estimating the number of patients due to Hercessi’s multiple indications approved by the FDA. Accord estimates patients using US Population and an annual U.S. incidence rate which results in 37,000 estimated patients for Breast Cancer and 4,800 estimated patients for Gastric Cancer. The US Population is from the Neilsburg Research US population by Gender, July 2024. This incidence rate is derived from the National Cancer Institute Surveillance, Epidemiology, and End Results Program. Cancer Stat Facts: Female Breast Cancer. Available at: https://seer.cancer.gov/statfacts/html/breast.html. Accessed
January 15, 2024" |
None |
| Akebia Therapeutics, Inc. |
59922064160 |
VAFSEO TABLETS 1 PACK 60 TABS 150 MG |
2025-01-09 |
1278.0000 |
The marketing plan for Vafseo is to highlight differentiation between Vafseo and the standard of care (including but not limited to its unique mechanism of action, stimulation of the body’s natural response to hypoxia, enhancing the body’s natural production of EPO, activating iron mobilization, controlling hemoglobin level over time, simple titration and few dose modifications, and convenient oral dosing).
The Vafseo wholesale acquisition cost (WAC) for a 30-day supply at the labeled starting dose, considers various qualitative and quantitative factors, including but not limited to the cost of bringing the therapy to market, the impact of the CMS TDAPA payment for innovative therapies during and post- the TDAPA period on dialysis organizations, and the value of addressing critical patient needs. |
None |
500000 |
None |
None |
None |
None |
None |
None |
U.S. Dialysis Patients Treated for Anemia approximately 500,000 Patients. Akebia does not expect to capture 100% of the eligible treatable patients, but the exact share of patients that will be treated with Vafseo is unknowable at this time. |
None |
| Akebia Therapeutics, Inc. |
59922064260 |
VAFSEO TABLETS 1 PACK 60 TABS 300 MG |
2025-01-09 |
2556.0000 |
The marketing plan for Vafseo is to highlight differentiation between Vafseo and the standard of care (including but not limited to its unique mechanism of action, stimulation of the body’s natural response to hypoxia, enhancing the body’s natural production of EPO, activating iron mobilization, controlling hemoglobin level over time, simple titration and few dose modifications, and convenient oral dosing).
The Vafseo wholesale acquisition cost (WAC) for a 30-day supply at the labeled starting dose, considers various qualitative and quantitative factors, including but not limited to the cost of bringing the therapy to market, the impact of the CMS TDAPA payment for innovative therapies during and post- the TDAPA period on dialysis organizations, and the value of addressing critical patient needs. |
None |
500000 |
None |
None |
None |
None |
None |
None |
U.S. Dialysis Patients Treated for Anemia approximately 500,000 Patients. Akebia does not expect to capture 100% of the eligible treatable patients, but the exact share of patients that will be treated with Vafseo is unknowable at this time. |
None |
| Amneal Pharmaceuticals |
60219227902 |
Everolimus Tablets for Oral Suspension 2mg |
2025-01-22 |
12894.9800 |
None |
1 |
967 |
None |
None |
None |
None |
None |
None |
This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house. |
None |
| Amneal Pharmaceuticals |
60219228002 |
Everolimus Tablets for Oral Suspension 3mg |
2025-01-22 |
13024.1400 |
None |
1 |
967 |
None |
None |
None |
None |
None |
None |
This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house. |
None |
| Amneal Pharmaceuticals |
60219228102 |
Everolimus Tablets for Oral Suspension 5mg |
2025-01-22 |
13555.5200 |
None |
1 |
967 |
None |
None |
None |
None |
None |
None |
This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house. |
None |
| Amneal Pharmaceuticals |
65162036018 |
Mesalamine Delayed-Release Tablets 800mg 180 ct |
2025-02-19 |
1335.4500 |
None |
1 |
32900 |
None |
None |
None |
None |
None |
None |
This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house. |
None |
| Amneal Pharmaceuticals |
70121271502 |
Methylene Blue Injection, USP 50mg/10mL |
2025-03-28 |
1980.0000 |
None |
1 |
228000 |
None |
None |
None |
None |
None |
None |
This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house. |
None |
| ANIP |
70954052210 |
INZIRQO - Powder, For Suspension - 10mg/ml - 80ml in 1 bottle |
2025-03-10 |
375.0000 |
Promotion will consist of awareness campaigns to pharmacies via mail and email. In addition, there will be physician promotion to Pediatric Nephrology, Pediatric Cardiology and select Geriatric physicians. |
None |
9758721 |
None |
None |
None |
None |
None |
None |
None |
None |
| Astellas Pharma US, Inc. |
00469442530 |
VYLOY® (zolbetuximab - clzb) 300mg vial |
2025-04-08 |
4800.0000 |
Astellas has not released the information requested (marketing/pricing plans) in the public domain. Further, Astellas does not believe this information is in the public domain or publicly available. As a result, Astellas is limiting its response to this reporting requirement pursuant to Cal. Health & Safety Code Section 127681(c). |
None |
6233 |
None |
None |
None |
None |
None |
None |
Astellas has not released the information requested in column 7 (estimated volume of patients that may be prescribed the drug) in the public domain. Further, Astellas does not believe this information is in the public domain or publicly available. As a result, Astellas is limiting its response to this reporting requirement pursuant to Cal. Health & Safety Code Section 127681(c). |
None |
| Aurobindo Pharma USA, Inc. |
59651058208 |
Pazopanib Tablets |
2025-04-01 |
6500.0000 |
Generic drug market pricing |
None |
2200 |
None |
None |
None |
None |
None |
None |
None |
https://reports.siera.hcai.ca.gov/api/report/drug-pricing/attachment?id=1056, https://reports.siera.hcai.ca.gov/api/report/drug-pricing/attachment?id=1057 |
| Aurobindo Pharma USA, Inc. |
59651084918 |
Rivaroxaban 2.5mg tablets - 180s |
2025-04-21 |
1435.3400 |
Generic drug, matched current generic approvals |
None |
30000 |
None |
None |
None |
None |
None |
None |
None |
https://reports.siera.hcai.ca.gov/api/report/drug-pricing/attachment?id=1058, https://reports.siera.hcai.ca.gov/api/report/drug-pricing/attachment?id=1059 |
| AvKare |
42291090328 |
Sunitinib Malate 37.5mg Capsule 28ct |
2025-01-08 |
12089.0400 |
None |
1 |
75000 |
None |
None |
None |
None |
None |
None |
While this drug was uploaded to the databanks back on 10/17/2023, this drug was not sold in the market until 01/08/2025. We were notified of this date of first sale in January 2025 and submitted the drug as soon as we were notified. |
None |
| Avyxa Pharma, LLC |
83831013101 |
AXTLE (pemetrexed) Injection 100 mg/vial, SDV |
2025-01-01 |
790.0000 |
Please refer to the "CA_Marketing and Pricing Plan_AXTLE" document. |
None |
25000 |
None |
None |
2024-07-01 |
None |
1 |
None |
None |
https://reports.siera.hcai.ca.gov/api/report/drug-pricing/attachment?id=1054 |
| Avyxa Pharma, LLC |
83831013201 |
AXTLE (pemetrexed) Injection 500 mg/vial, SDV |
2025-01-01 |
3950.0000 |
Please refer to the "CA_Marketing and Pricing Plan_AXTLE" document |
None |
21500 |
None |
None |
2024-07-01 |
None |
1 |
None |
None |
https://reports.siera.hcai.ca.gov/api/report/drug-pricing/attachment?id=1055 |
| Biocon Biologics Inc. |
83257002611 |
Yesintek 130 mg/26 mL (5 mg/mL) injection in an SDV |
2025-02-22 |
399.9900 |
None |
1 |
18831 |
None |
None |
None |
None |
None |
None |
None |
None |
| Biocon Biologics Inc. |
83257002341 |
Yesintek 45 mg/0.5 mL injection in a single-dose prefilled syringe |
2025-02-22 |
1499.9900 |
None |
1 |
10739 |
None |
None |
None |
None |
None |
None |
None |
None |
| Biocon Biologics Inc. |
83257002411 |
Yesintek 45 mg/0.5 mL injection in an SDV |
2025-02-22 |
1499.9900 |
None |
1 |
14199 |
None |
None |
None |
None |
None |
None |
None |
None |
| Biocon Biologics Inc. |
83257002541 |
Yesintek 90 mg/mL injection in a single-dose prefilled syringe |
2025-02-22 |
2999.9800 |
None |
1 |
96231 |
None |
None |
None |
None |
None |
None |
None |
None |
| Biocon Limited |
70377008711 |
Dasatinib Tablets 100mg 30ct |
2025-03-03 |
12480.4900 |
None |
1 |
66000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Biocon Limited |
70377008811 |
Dasatinib Tablets 140mg 30ct |
2025-03-03 |
12480.4900 |
None |
1 |
66000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Biocon Limited |
70377008311 |
Dasatinib Tablets 20mg 60ct |
2025-03-03 |
6924.6500 |
None |
1 |
66000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Biocon Limited |
70377008411 |
Dasatinib Tablets 50mg 60ct |
2025-03-03 |
13894.2700 |
None |
1 |
66000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Biocon Limited |
70377008511 |
Dasatinib Tablets 70mg 60ct |
2025-03-03 |
13894.2700 |
None |
1 |
66000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Biocon Limited |
70377008611 |
Dasatinib Tablets 80mg 30ct |
2025-03-03 |
12480.4900 |
None |
1 |
66000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Breckenridge Pharmaceutical |
51991099028 |
EVEROLIMUS TFOS 2MG 4X7 |
2025-02-01 |
12894.9800 |
No Marketing plan currently in place |
None |
37 |
None |
None |
None |
None |
None |
None |
None |
None |
| Breckenridge Pharmaceutical |
51991099128 |
EVEROLIMUS TFOS 3MG 4X7 |
2025-02-01 |
13024.1400 |
No Marketing plan currently in place |
None |
27 |
None |
None |
None |
None |
None |
None |
None |
None |
| Breckenridge Pharmaceutical |
51991099228 |
EVEROLIMUS TFOS 5MG 4X7 |
2025-02-01 |
13555.5200 |
No Marketing plan currently in place |
None |
52 |
None |
None |
None |
None |
None |
None |
None |
None |
| Bristol Myers Squibb |
00003612001 |
Opdivo Qvantig™ 600 mg-10,000 unit/5mL (VIAL (ML)) |
2025-01-02 |
7787.3300 |
We consider multiple factors when setting a list price for a medicine, including: (i) The benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. (ii) Market and business considerations, including: Ongoing research-investment costs; BMS invests more than 21% of its annual revenues in R&D, among the highest of any large company in any industry in the world; and Medical- and patient-service costs; this includes funding growing patient assistance programs; Inflationary and capital-investment costs associated with manufacturing, storage and supply. |
None |
840 |
None |
None |
None |
None |
None |
None |
Estimated number of patients reflects the 2025 average monthly total patients including new and continuing patients from prior months. |
None |
| Carnegie Pharmaceuticals LLC |
80005016108 |
E.E.S. 400 ORAL TABLET 400 MG |
2025-02-14 |
365.2100 |
None |
1 |
2138 |
None |
None |
2024-11-11 |
None |
1 |
The acquisition price is inclusive of all EES products on this submission and other erythromycin products not launched yet. |
None |
None |
| Carnegie Pharmaceuticals LLC |
80005015218 |
E.E.S. GRANULES ORAL SUSPENSION RECONSTITUTED 200 MG/5ML 100ML |
2025-02-14 |
376.2200 |
None |
1 |
7968 |
None |
None |
2024-11-11 |
None |
1 |
The acquisition price is inclusive of all EES products on this submission and other erythromycin products not launched yet. |
None |
None |
| Carnegie Pharmaceuticals LLC |
80005015334 |
E.E.S. GRANULES ORAL SUSPENSION RECONSTITUTED 200 MG/5ML 200ML |
2025-02-14 |
661.6300 |
None |
1 |
3194 |
None |
None |
2024-11-11 |
None |
1 |
The acquisition price is inclusive of all EES products on this submission and other erythromycin products not launched yet. |
None |
None |
| Carnegie Pharmaceuticals LLC |
80005015518 |
ERYPED 400 ORAL SUSPENSION RECONSTITUTED 400 MG/5ML 30 TABLETS |
2025-02-14 |
661.6200 |
None |
1 |
5003 |
None |
None |
2024-11-11 |
None |
1 |
The acquisition price is inclusive of all EES products on this submission and other erythromycin products not launched yet. |
None |
None |
| Celltrion USA, Inc. |
72606002901 |
STEQEYMA 130MG/26ML (5mg/mL) Injectable; Subcutaneous Vial |
2025-02-22 |
303.6800 |
Celltrion has used two consultant groups to collect market intel on the market space. Additionally, public media was used to understand how the payers and providers would perceive the biosimilar competition of this class due to multiple Ustekinumab biosimilars that were approved around the same time. One main factor to consider is how the originator delayed the biosimilar competition. |
None |
24000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Celltrion USA, Inc. |
72606002701 |
STEQEYMA 45MG/0.5ML Injectable; Subcutaneous Single-dose prefilled syringe with safety guard |
2025-02-22 |
2088.2100 |
Celltrion has used two consultant groups to collect market intel on the market space. Additionally, public media was used to understand how the payers and providers would perceive the biosimilar competition of this class due to multiple Ustekinumab biosimilars that were approved around the same time. One main factor to consider is how the originator delayed the biosimilar competition. |
None |
24000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Celltrion USA, Inc. |
72606002801 |
STEQEYMA 90MG/ML Injectable; Subcutaneous Single-dose prefilled syringe with safety guard |
2025-02-22 |
4176.4300 |
Celltrion has used two consultant groups to collect market intel on the market space. Additionally, public media was used to understand how the payers and providers would perceive the biosimilar competition of this class due to multiple Ustekinumab biosimilars that were approved around the same time. One main factor to consider is how the originator delayed the biosimilar competition. |
None |
24000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Celltrion USA, Inc. |
72606004006 |
ADALIMUMAB-AATY STARTER PACK 80 mg/0.8 ml |
2025-04-09 |
1557.0000 |
Adalimumab-aaty is a low WAC biosimilar product 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 the unbranded generic of Adalimumab-aaty, 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 generics 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. |
None |
398619 |
None |
None |
None |
None |
None |
None |
None |
None |
| Chartwell Rx LLC |
62135077423 |
Promethazine HCL Oral Solution 6.25mg/5mL 20 x 10mL UD |
2025-02-18 |
2011.4200 |
None |
1 |
81000000 |
None |
None |
2023-06-28 |
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. |
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. |
None |
| Chartwell Rx LLC |
62135077424 |
Promethazine HCL Oral Solution 6.25mg/5mL 20 x 5mL UD |
2025-02-18 |
1905.7100 |
None |
1 |
81000000 |
None |
None |
2023-06-28 |
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. |
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. |
None |
| Chartwell Rx LLC |
62135088523 |
Lacosamide Oral Solution USP C-V 10mg/ml 20x10UD |
2025-02-26 |
1950.0000 |
None |
1 |
198000 |
None |
None |
2023-09-21 |
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. |
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. |
None |
| Chartwell Rx LLC |
62135088524 |
Lacosamide Oral Solution USP C-V 10mg/ml 20x5UD |
2025-02-26 |
1925.0000 |
None |
1 |
198000 |
None |
None |
2023-09-21 |
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. |
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. |
None |
| Chartwell Rx LLC |
62135094324 |
Memantine HCl Oral Solution 2MG/ML 20x5ML UD |
2025-03-24 |
1908.3300 |
None |
1 |
6900000 |
None |
None |
2022-09-22 |
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. |
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. |
None |
| Chartwell Rx LLC |
62135080323 |
Acyclovir (Base) 200MG/5ML 20x20ML UD |
2025-03-26 |
1922.8300 |
None |
1 |
4000000 |
None |
None |
2023-08-04 |
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. |
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. |
None |
| Chartwell Rx LLC |
62135080324 |
Acyclovir (Base) 200MG/5ML 20x5ML UD |
2025-03-26 |
1905.7100 |
None |
1 |
4000000 |
None |
None |
2023-08-04 |
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. |
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. |
None |
| Chartwell Rx LLC |
62135018923 |
Albuterol (Sulfate) DAA Syrup Regular 2MG/5ML 20x20ML UD |
2025-04-07 |
1911.4200 |
None |
1 |
25000000 |
None |
None |
2020-11-25 |
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. |
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. |
None |
| Chartwell Rx LLC |
62135018924 |
Albuterol (Sulfate) DAA Syrup Regular 2MG/5ML 20x5ML UD |
2025-04-07 |
1852.8500 |
None |
1 |
25000000 |
None |
None |
2020-11-25 |
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. |
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. |
None |
| Chartwell Rx LLC |
62135070624 |
Lamivudine Oral Solution 10MG/ML 20x30ML UD |
2025-04-07 |
2000.0000 |
None |
1 |
2400000 |
None |
None |
2023-06-22 |
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. |
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. |
None |
| Chartwell Rx LLC |
62135054024 |
Citalopram (Hydrobromide) 10MG/5ML 20x10ML UD |
2025-04-22 |
1911.4200 |
None |
1 |
21000000 |
None |
None |
2022-09-21 |
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. |
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. |
None |
| Chartwell Rx LLC |
62135072924 |
Escitalopram Oxalate Oral Solution 5 MG/5ML 20x10ML UD |
2025-04-24 |
1975.0000 |
None |
1 |
68020000 |
None |
None |
2023-06-22 |
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. |
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. |
None |
| Chartwell Rx LLC |
62135052024 |
Oxybutynin Chloride Solution 5 MG/5ML 20x5ML UD |
2025-04-24 |
1905.7100 |
None |
1 |
33000000 |
None |
None |
2022-03-24 |
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. |
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. |
None |
| Chartwell Rx LLC |
62135096222 |
Phenobarbital Elixir 20MG/5ML 20x15ML UD |
2025-04-24 |
1985.4100 |
None |
1 |
3741100 |
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 did not assume marketing functions from prior owner, and did not receive any historical data from the sellers of the ANDAs. |
None |
| Chartwell Rx LLC |
62135096224 |
Phenobarbital Elixir 20MG/5ML 20x5ML UD |
2025-04-24 |
1895.1400 |
None |
1 |
3741100 |
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 did not assume marketing functions from prior owner, and did not receive any historical data from the sellers of the ANDAs. |
None |
| Chartwell Rx LLC |
62135096223 |
Phenobarbital Elixir 20MG/5ML 20x7.5ML UD |
2025-04-24 |
1942.7100 |
None |
1 |
3741100 |
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 did not assume marketing functions from prior owner, and did not receive any historical data from the sellers of the ANDAs. |
None |
| Chartwell Rx LLC |
62135043824 |
Tricitrates (Potassium Salt, Sodium Salt, Citric Acid) 550-500-334MG/5ML 20x5ML UD |
2025-04-30 |
1863.4200 |
None |
1 |
34010000 |
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 did not assume marketing functions from prior owner, and did not receive any historical data from the sellers of the ANDAs. |
None |
| Cintex Services LLC |
24470091740 |
ERGOTAMINE TARTRATE AND CAFFEINE (CAFFEINE; ERGOTAMINE TARTRATE) 100MG;1MG Oral Tablet, 40ct Bottle [Qty: 1] |
2025-03-27 |
980.0000 |
Cintex Services LLC determined the WAC by comparing it to the WAC pricing of other products currently available in the market for the same treatment. The WAC of Cintex Service's Ergotamine-Caffeine Oral Tablet 1-100 MG, 40ct bottle is priced 36.89% lower than branded comparator Ergomar NDC 70720-0120-20 marketed by Pangea Pharmaceuticals. Cintex Services LLC employs a tele-sales team to engage with neurology providers. Because the Cintex label already distributes a 100ct bottle of Ergotamine-Caffeine 1-100 MG Oral Tablets, there is an established market for this product. The 40-count bottle will enable pharmacies to dispense a single bottle, consistent with the approved indication and dosage for a one month supply. |
None |
39000000 |
None |
None |
None |
None |
None |
None |
US Patients Description: According to the National Institute of Neurological Disorders and Stroke (NINDS), an estimated 39 million Americans experience migraines each year. The American Academy of Neurology reported that 46% of patients were treated with prescription medicine. |
None |
| Daiichi Sankyo, Inc. |
65597080101 |
"DATROWAY® (datopotamab deruxtecan-dlnk)
One 100 mg single-dose vial" |
2025-01-27 |
4891.0700 |
None |
1 |
19224 |
None |
None |
None |
None |
None |
None |
None |
None |
| Deciphera Pharmaceuticals, LLC |
73207030440 |
Romvimza (vimseltinib) Capsule, 30 mg 1 Carton (8 count blister in wallet) |
2025-02-20 |
26128.0000 |
Marketing Plan in the U.S. - ROMVIMZA™ is a is a kinase inhibitor indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity. For additional information about Romvimza, please see the full Prescribing Information at www.romvimza.com. Romvimza will be marketed to healthcare professionals (HCPs) by a team of field-based professionals and its expenditures will include spending on the following areas. Deciphera's marketing initiatives will focus on raising awareness of tenosynovial giant cell tumor "TGCT", and its potential treatment. Supporting the launch of Romvimza may include comprehensive education that will be provided by Deciphera's employees to HCPs about the approved indication, dosing and administration, mechanism of action (MOA), and the efficacy and safety data consistent with the FDA approved label. Deciphera will have available and provide to HCPs various printed materials, patient brochures as well as offer peer to peer educational programs (in-person and virtual) describing both the TGCT disease state and the FDA-approved clinical profile of Romvimza. Additional activities may include the development of websites, webcasts, and other digital media offerings. Deciphera will participate in scientific meetings and congresses that will be attended by HCPs and may engage with HCPs through such attendance. Pricing Plan in the U.S. - Romvimza is currently only approved in the U.S. Deciphera is committed to ensuring patient access and the price for Romvimza was set after doing extensive research and understanding the value of Romvimza relative to other available treatments, as well as the unmet medical need, and disease burden of tenosynovial giant cell tumor "TGCT". Deciphera’s research also entailed evaluating the competitive landscape and payer environment, as well as business operational continuation needs. Deciphera is committed to supporting TGCT patients and removing barriers to access. As part of that commitment, Deciphera has established Deciphera AccessPoint, a patient support program that provides reimbursement and financial assistance programs for eligible patients. |
None |
20 |
None |
1 |
None |
None |
None |
None |
Currently, the exact population of tenosynovial giant cell tumor "TGCT" patients in the US is not clearly understood. It is estimated that there may be approximately 1,400 incident cases in the US annually. Romvimza may be used in a smaller subset of these patients per its label. The first sale of this package size occured on 2/20/2025. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598060330 |
Dasatinib 100mg Tablet, 30 |
2025-03-04 |
4561.5800 |
None |
1 |
450000 |
None |
None |
None |
None |
None |
None |
1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. The number of patients listed is based on the number of patients with leukemia in the US; 2) Product was not acquired; 3) The market introduction date is the date when the product was available for sale. For purchases of this product, the drug was not available for sale in California until this intro date. This was the same date that was filed in our 3-day reports, and the reports submitted to other states under their drug price transparency statutes, as well as the date for purposes of computing government price reporting. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598060430 |
Dasatinib 140mg Tablet, 30 |
2025-03-04 |
4561.5800 |
None |
1 |
450000 |
None |
None |
None |
None |
None |
None |
1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. The number of patients listed is based on the number of patients with leukemia in the US; 2) Product was not acquired; 3) The market introduction date is the date when the product was available for sale. For purchases of this product, the drug was not available for sale in California until this intro date. This was the same date that was filed in our 3-day reports, and the reports submitted to other states under their drug price transparency statutes, as well as the date for purposes of computing government price reporting. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598059960 |
Dasatinib 20mg Tablet, 60 |
2025-03-04 |
2530.9400 |
None |
1 |
450000 |
None |
None |
None |
None |
None |
None |
1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. The number of patients listed is based on the number of patients with leukemia in the US; 2) Product was not acquired; 3) The market introduction date is the date when the product was available for sale. For purchases of this product, the drug was not available for sale in California until this intro date. This was the same date that was filed in our 3-day reports, and the reports submitted to other states under their drug price transparency statutes, as well as the date for purposes of computing government price reporting. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598060060 |
Dasatinib 50mg Tablet, 60 |
2025-03-04 |
5061.8700 |
None |
1 |
450000 |
None |
None |
None |
None |
None |
None |
1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. The number of patients listed is based on the number of patients with leukemia in the US; 2) Product was not acquired; 3) The market introduction date is the date when the product was available for sale. For purchases of this product, the drug was not available for sale in California until this intro date. This was the same date that was filed in our 3-day reports, and the reports submitted to other states under their drug price transparency statutes, as well as the date for purposes of computing government price reporting. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598060160 |
Dasatinib 70mg Tablet, 60 |
2025-03-04 |
5061.8700 |
None |
1 |
450000 |
None |
None |
None |
None |
None |
None |
1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. The number of patients listed is based on the number of patients with leukemia in the US; 2) Product was not acquired; 3) The market introduction date is the date when the product was available for sale. For purchases of this product, the drug was not available for sale in California until this intro date. This was the same date that was filed in our 3-day reports, and the reports submitted to other states under their drug price transparency statutes, as well as the date for purposes of computing government price reporting. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598060230 |
Dasatinib 80mg Tablet, 30 |
2025-03-04 |
4561.5800 |
None |
1 |
450000 |
None |
None |
None |
None |
None |
None |
1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. The number of patients listed is based on the number of patients with leukemia in the US; 2) Product was not acquired; 3) The market introduction date is the date when the product was available for sale. For purchases of this product, the drug was not available for sale in California until this intro date. This was the same date that was filed in our 3-day reports, and the reports submitted to other states under their drug price transparency statutes, as well as the date for purposes of computing government price reporting. |
None |
| Fresenius Kabi USA LLC |
63323086502 |
Calcitonin Salmon Injection Solution Package Size 2ml Package Quantity 1 |
2025-01-13 |
800.0000 |
None |
1 |
90000 |
None |
None |
None |
None |
None |
None |
New Product Report is triggered based on 30-day course of therapy. |
None |
| Fresenius Kabi USA LLC |
65219082805 |
Otulfi® (ustekinumab-aauz) 130mg/26mL Vial for intravenous infusion Package Quantity 1 |
2025-03-17 |
1685.7100 |
None |
1 |
13123 |
None |
None |
None |
None |
None |
None |
None |
None |
| Fresenius Kabi USA LLC |
65219082401 |
Otulfi® (ustekinumab-aauz) 45mg/0.5 mL Prefilled Syringes Package Quantity 1 |
2025-03-17 |
1809.7900 |
None |
1 |
15826 |
None |
None |
None |
None |
None |
None |
None |
None |
| Fresenius Kabi USA LLC |
65219082626 |
Otulfi® (ustekinumab-aauz) 90mg/1mL Prefilled Syringes Package Quantity 1 |
2025-03-17 |
3619.5700 |
None |
1 |
105759 |
None |
None |
None |
None |
None |
None |
None |
None |
| Genentech USA |
50242020201 |
Evrysdi 5mg Tablets 30 Tablets |
2025-02-26 |
33653.0500 |
Marketing activities that support the launch of a new medicine are designed to raise awareness and understanding with healthcare providers and - in some cases - patients about the approved indication(s), efficacy and safety data contained within the medicine's FDA approved label. We take decisions related to the prices of our medicines very seriously. When determining pricing, we consider a number of factors including: how well the medicine works and how it compares to other available treatments; the financial resources required to continue discovering new medicines for people with serious diseases; and how to ensure that the price doesn’t prevent our medicines getting to people who need them. |
None |
8895 |
None |
None |
None |
None |
None |
None |
None |
None |
| Glenmark Pharmaceuticals Inc., USA |
68462075825 |
Phytonadione Injectable Emulsion 10 mg/mL 25 Vials |
2025-01-17 |
1069.1700 |
None |
1 |
3610240 |
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 Glenmark believes is in the public domain or publicly available. Acquisition fields left blank as drug was developed by Gland but being marketed by Glenmark. Marketing/Pricing Plan not in the public domain or publicly available. To provide its best estimate of U.S. patients who may be prescribed this drug product per year, Glenmark estimated patient populations for each indication of the drug. This product is indicated for coagulation disorders due to faulty formations of factors II, VII, IX and X. It is also given to newborns for prophylaxis treatment of hemorrhagic disease. We estimated potential patients that meet these criteria. For neonate estimated patients, we took the latest data on the number of births in the US (https://www.cdc.gov/nchs/products/databriefs/db507.htm) 3,596,017 for 2023 and rounded up to 3.6 MM. For coagulation disorders with Factor II,VII and X deficiencies, we used the incidents per person based on data from bleeding.org ( https://www.bleeding.org/bleeding-disorders-a-z) and applied to the latest US population data from the US census bureau (https://www.census.gov/library/stories/2024/12/new-year-population.html#:~:text=Population%20size%20(by%20single%20year,%2C%20Fertility%2C%20Mortality%20and%20Migration), Factor II - 1 in 2,000,000 when applied to total population of 341,150,000 (rounded) is 171 patients, Factor VII - 1 per 300,000 (low end of range) and applied to the population figure is 1,137 patients, Factor X - 1 per 500,000 (low end of range) and applied to the population figure is 682 patients. For coagulation disorder with Factor IX deficiency (Hemophilia B), we used the maximum number of persons with hemophilia based on data from bleeding.org ( https://www.bleeding.org/bleeding-disorders-a-z) 33,000 people and used their assumption that one quarter of this population has Hemophilia B or 8,250 patients. Total estimated patients who may be given this product is is 3,610,240. |
None |
| Hikma Pharmaceuticals USA Inc |
00054458249 |
Mercaptopurine Oral Suspension, 20mg/mL, 100 mL Bottle |
2025-02-26 |
1306.7900 |
This drug is a generic product; therefore, no marketing and pricing plans are available. This product is sold in the United States only. |
None |
115294 |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product.
Hikma has not evaluated the volume of patients in the USA. Mercaptopurine Oral Suspension is indicated as a therapy for patients with acute lymphocytic leukemia. According to the National Cancer Institute, there are approximately 115,294 people living with acute lymphocytic leukemia in the United States. |
None |
| INA Pharmaceutics Inc |
74157001390 |
Gabarone™ (Gabapentin) 100MG, 90 ct tabs |
2025-01-22 |
1500.0000 |
None |
1 |
2000 |
None |
None |
None |
None |
None |
None |
None |
None |
| INA Pharmaceutics Inc |
74157011190 |
Gabarone™ (Gabapentin) 400MG, 90 ct tabs |
2025-01-22 |
1500.0000 |
None |
1 |
2000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Incyte Corporation |
50881002311 |
Niktimvo (axatilimab-csfr) injection 22mg/0.44mL, for intravenous use, 1 vial |
2025-01-29 |
11550.0000 |
To market Niktimvo, Incyte designed activities to increase awareness and understanding with healthcare providers about the product. Marketing activities will include education and training provided by our sales force. Consumer-directed communications to educate patients on the disease state and Niktimvo are planned. At Incyte, we are driven by rigorous science and committed to ensuring patients have access to our innovative medicines. We responsibly price our drugs by balancing the value of the outcomes and innovation they bring to patients and the health care system within market and societal expectations. Niktimvo is indicated for 3L treatment of cGVHD. |
None |
3500 |
None |
1 |
2021-09-27 |
152000000.0000 |
None |
Terms of the Collaboration: Under the terms of the agreement, Incyte will lead global commercial activities for axatilimab across all indications. The companies will participate in a 50:50 profit share in the U.S., and Syndax will receive double-digit royalties on sales outside of the U.S. Syndax will retain the option to co-promote axatilimab for any approved indications in the U.S. In connection with the agreement, Syndax will receive an upfront payment of $117 million plus a $35 million equity investment, which will be purchased at $24.62 per share, a 30% premium to the volume weighted average price over the 10 days prior to September 24, 2021. Syndax will also be eligible to receive up to an additional $450 million in potential regulatory, development and commercial milestone payments. The companies will share development costs associated with global and U.S.-specific trials for all agreed upon trials at a rate of 55% (Incyte) and 45% (Syndax), with Incyte responsible for 100% of future development costs for trials that are specific to ex-U.S. countries. Syndax will fund the initial development of axatilimab in IPF and Incyte will have the option to co-fund late-stage development for this indication. |
None |
None |
| Incyte Corporation |
50881003412 |
Niktimvo (axatilimab-csfr) injection 9mg/0.18mL, for intravenous use, 1 Vial |
2025-01-29 |
4725.0000 |
To market Niktimvo, Incyte designed activities to increase awareness and understanding with healthcare providers about the product. Marketing activities will include education and training provided by our sales force. Consumer-directed communications to educate patients on the disease state and Niktimvo are planned. At Incyte, we are driven by rigorous science and committed to ensuring patients have access to our innovative medicines. We responsibly price our drugs by balancing the value of the outcomes and innovation they bring to patients and the health care system within market and societal expectations. Niktimvo is indicated for 3L treatment of cGVHD. |
None |
3500 |
None |
1 |
2021-09-27 |
152000000.0000 |
None |
Terms of the Collaboration: Under the terms of the agreement, Incyte will lead global commercial activities for axatilimab across all indications. The companies will participate in a 50:50 profit share in the U.S., and Syndax will receive double-digit royalties on sales outside of the U.S. Syndax will retain the option to co-promote axatilimab for any approved indications in the U.S. In connection with the agreement, Syndax will receive an upfront payment of $117 million plus a $35 million equity investment, which will be purchased at $24.62 per share, a 30% premium to the volume weighted average price over the 10 days prior to September 24, 2021. Syndax will also be eligible to receive up to an additional $450 million in potential regulatory, development and commercial milestone payments. The companies will share development costs associated with global and U.S.-specific trials for all agreed upon trials at a rate of 55% (Incyte) and 45% (Syndax), with Incyte responsible for 100% of future development costs for trials that are specific to ex-U.S. countries. Syndax will fund the initial development of axatilimab in IPF and Incyte will have the option to co-fund late-stage development for this indication. |
None |
None |
| Ingenus Pharmaceuticals, LLC |
50742055205 |
Fentanyl 50mcg/hr Transdermal Patch |
2025-01-06 |
65.0000 |
Ingenus is a generic pharmaceutical manufacturer and does not market to consumers or health care providers. The Fentanyl Transdermal system is sold primarily to wholesalers and then into the retail drug channel so all marketing efforts are at the wholesaler level.
Ingenus reviews several items in its pricing decisions for our products: competitive market and marketing for similar products, manufacturing costs and complexity to produce a high-quality product, and the ability to source a consistent, high-quality supply of the raw materials and components to manufacture the product. |
None |
6982 |
None |
None |
None |
None |
None |
None |
None |
None |
| Ingenus Pharmaceuticals, LLC |
50742055405 |
Fentanyl 75mcg/hr Transdermal Patch |
2025-01-06 |
75.0000 |
ngenus is a generic pharmaceutical manufacturer and does not market to consumers or health care providers. The Fentanyl Transdermal system is sold primarily to wholesalers and then into the retail drug channel so all marketing efforts are at the wholesaler level.
Ingenus reviews several items in its pricing decisions for our products: competitive market and marketing for similar products, manufacturing costs and complexity to produce a high-quality product, and the ability to source a consistent, high-quality supply of the raw materials and components to manufacture the product. |
None |
10473 |
None |
None |
None |
None |
None |
None |
None |
None |
| Ingenus Pharmaceuticals, LLC |
50742055605 |
Fentanyl 100mcg/hr Transdermal Patch |
2025-01-07 |
95.0000 |
ngenus is a generic pharmaceutical manufacturer and does not market to consumers or health care providers. The Fentanyl Transdermal system is sold primarily to wholesalers and then into the retail drug channel so all marketing efforts are at the wholesaler level.
Ingenus reviews several items in its pricing decisions for our products: competitive market and marketing for similar products, manufacturing costs and complexity to produce a high-quality product, and the ability to source a consistent, high-quality supply of the raw materials and components to manufacture the product. |
None |
13895 |
None |
None |
None |
None |
None |
None |
None |
None |
| Ingenus Pharmaceuticals, LLC |
50742055005 |
Fentanyl 25mcg/hr Transdermal Patch |
2025-01-22 |
35.0000 |
Ingenus is a generic pharmaceutical manufacturer and does not market to consumers or healthcare providers. The Fentanyl Transdermal system is sold primarily to wholesalers and then into the retail drug channel, so all marketing efforts are at the wholesaler level.
Ingenus reviews several items in its pricing decisions for our products. To establish a product's pricing, the company assesses the following: costs associated with product development, competitive market and marketing for similar products, manufacturing costs, the complexity of producing a high-quality product, and the ability to source a consistent, high-quality supply of the raw materials and components to manufacture the product. |
None |
3521 |
None |
None |
None |
None |
None |
None |
The WAC pricing entered is the WAC for a course of therapy. The package WAC of the 25mcg/hr. is $35.00 |
None |
| Ingenus Pharmaceuticals, LLC |
50742054905 |
Fentanyl 12mcg/hr. Transdermal Patch |
2025-01-30 |
55.0000 |
Ingenus is a generic pharmaceutical manufacturer and does not market to consumers or healthcare providers. The Fentanyl Transdermal system is sold primarily to wholesalers and then into the retail drug channel, so all marketing efforts are at the wholesaler level.
Ingenus reviews several items in its pricing decisions for our products. To establish the pricing on a product, the company assesses the following: costs associated with product development, competitive market and marketing for similar products, manufacturing costs and complexity to produce a high-quality product, and the ability to source a consistent, high-quality supply of the raw materials and components to manufacture the product. |
None |
675 |
None |
None |
None |
None |
None |
None |
None |
None |
| Ingenus Pharmaceuticals, LLC |
50742055105 |
Fentanyl 37.5mcg/hr Transdermal Patch |
2025-02-05 |
230.0000 |
Ingenus is a generic pharmaceutical manufacturer and does not market to consumers or healthcare providers. The Fentanyl Transdermal system is sold primarily to wholesalers and then into the retail drug channel, so all marketing efforts are at the wholesaler level.
Ingenus reviews several items in its pricing decisions for our products. To establish the pricing on a product, the company assesses the following: costs associated with product development, competitive market and marketing for similar products, manufacturing costs and complexity to produce a high-quality product, and the ability to source a consistent, high-quality supply of the raw materials and components to manufacture the product. |
None |
542 |
None |
None |
None |
None |
None |
None |
None |
None |
| Ingenus Pharmaceuticals, LLC |
50742055305 |
Fentanyl Transdermal Patch 62.5mcg/hr. |
2025-02-10 |
350.0000 |
Ingenus is a generic pharmaceutical manufacturer and does not market to consumers or healthcare providers. The Fentanyl Transdermal system is sold primarily to wholesalers and then into the retail drug channel, so all marketing efforts are at the wholesaler level.
Ingenus reviews several items in its pricing decisions for our products. To establish the pricing on a product, the company assesses the following: costs associated with product development, competitive market and marketing for similar products, manufacturing costs and complexity to produce a high-quality product, and the ability to source a consistent, high-quality supply of the raw materials and components to manufacture the product. |
None |
865 |
None |
None |
None |
None |
None |
None |
None |
None |
| Ingenus Pharmaceuticals, LLC |
50742055505 |
Fentanyl Transdermal Patch 87.5mcg/hr. |
2025-02-11 |
465.0000 |
Ingenus is a generic pharmaceutical manufacturer and does not market to consumers or healthcare providers. The Fentanyl Transdermal system is sold primarily to wholesalers and then into the retail drug channel, so all marketing efforts are at the wholesaler level.
Ingenus reviews several items in its pricing decisions for our products. To establish the pricing on a product, the company assesses the following: costs associated with product development, competitive market and marketing for similar products, manufacturing costs and complexity to produce a high-quality product, and the ability to source a consistent, high-quality supply of the raw materials and components to manufacture the product. |
None |
935 |
None |
None |
None |
None |
None |
None |
None |
None |
| Lumicell |
82292004010 |
Lumisight Intravenous Solution Reconstituted 39 MG, 1 Each, Unit-Dose, Vial Qty 10 |
2025-01-13 |
13800.0000 |
None |
1 |
180000 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Medexus Pharma, Inc |
59137036501 |
GRAFAPEX™ (treosulfan) for injection 5g/vial |
2025-02-24 |
3050.0000 |
None |
1 |
66 |
None |
None |
None |
None |
None |
None |
None |
None |
| Merck Sharp & Dohme LLC |
00006508501 |
PREVYMIS 120 mg/packet oral pellets 30 packets |
2025-01-15 |
2058.0000 |
Marketing Plan
•Promotional activities of PREVYMIS to physicians and other health professionals (HCPs) include detailing of all formulations of PREVYMIS by Merck sales representatives, print and digital educational resources, media placements, congress sponsorships and exhibit booths, and other related activities. In addition, Merck Medical Forums (educational speaker programs) for PREVYMIS will be available.
•Direct-to-consumer (DTC) promotional activities for PREVYMIS currently include a consumer website promoting the tablet and injection formulations of PREVYMIS. This is subject to change.
Pricing Plan
The new pellet formulation approved by the FDA on August 30, 2024, extends use to the pediatric population for previously approved adult indications based on age and weight parameters, allogeneic hematopoietic stem cell transplant (HSCT) ages 6mo-18yrs and kidney transplant (KT) recipients at high risk (donor CMV seropositive/recipient CMV seronegative [D+/R-]) ages 12-18 years old. The company has made the decision to maintain pricing parity for the new pellet formulation to the tablet on a per milligram basis. |
None |
2000 |
None |
1 |
None |
None |
None |
None |
Estimated number of Patients: Merck estimates that nationally there are approximately 2,000 patients annually who will undergo qualifying transplants that could potentially make them eligible to receive one of the oral pellet formulations of PREVYMIS, based on the latest publicly available data from Organ Procurement & Transplant Network’s databases. Merck does not know how many patients might be prescribed the drug as not all such patients may be a candidate for the oral pellet formulation of PREVYMIS. |
None |
| Merck Sharp & Dohme LLC |
00006508601 |
PREVYMIS 20 mg/packet pellets 30 packets |
2025-01-15 |
342.9000 |
Marketing Plan
•Promotional activities of PREVYMIS to physicians and other health professionals (HCPs) include detailing of all formulations of PREVYMIS by Merck sales representatives, print and digital educational resources, media placements, congress sponsorships and exhibit booths, and other related activities. In addition, Merck Medical Forums (educational speaker programs) for PREVYMIS will be available.
•Direct-to-consumer (DTC) promotional activities for PREVYMIS currently include a consumer website promoting the tablet and injection formulations of PREVYMIS. This is subject to change.
Pricing Plan
The new pellet formulation approved by the FDA on August 30, 2024, extends use to the pediatric population for previously approved adult indications based on age and weight parameters, allogeneic hematopoietic stem cell transplant (HSCT) ages 6mo-18yrs and kidney transplant (KT) recipients at high risk (donor CMV seropositive/recipient CMV seronegative [D+/R-]) ages 12-18 years old. The company has made the decision to maintain pricing parity for the new pellet formulation to the tablet on a per milligram basis. |
None |
2000 |
None |
1 |
None |
None |
None |
None |
Estimated number of Patients: Merck estimates that nationally there are approximately 2,000 patients annually who will undergo qualifying transplants that could potentially make them eligible to receive one of the oral pellet formulations of PREVYMIS, based on the latest publicly available data from Organ Procurement & Transplant Network’s databases. Merck does not know how many patients might be prescribed the drug as not all such patients may be a candidate for the oral pellet formulation of PREVYMIS. |
None |
| Mesoblast Inc. |
73648011101 |
Ryoncil (remestemcel-l-rknd) 1 Kit (1 Single Use Vial) Target 25 X 10^6 MSCs/ 3.8mL (6.68 x 10^6 MSCs/mL) for resuspension and infusion |
2025-03-17 |
194000.0000 |
RYONCIL™ is the first and only FDA-approved, allogeneic, off-the-shelf, bone marrow–derived mesenchymal stromal cell (MSC) therapy indicated for the treatment of pediatric patients aged 2 months and older, including adolescents and teenagers, with steroid-refractory acute graft-versus-host disease (SR-aGvHD), a life-threatening condition with high mortality rates (in patients with the most severe form of steroid-refractory acute GVD, mortality can be as high as 90% despite optimal standard of care). RYONCIL™ has the potential to be an effective and safe therapy to significantly improve survival outcomes in the most vulnerable population of children with severe forms of this disease. There are currently no FDA-approved treatments in the United States for children under 12 with steroid-refractory acute GVHD. Mesoblast is committed to providing, through the use of a professional sales team, educational materials that will assist healthcare providers in the treatment of their patient population affected by these complex diseases. Additional information for the support of patient assistance can be found at https://www.ryoncil.com/ entitled MyMesoblast™. This is a comprehensive, single-source support hub designed to help treatment centers and families successfully navigate the RYONCIL™ treatment journey. From early treatment consideration to investigating insurance coverage and addressing affordability concerns, MyMesoblast™ provides personalized support every step of the way, so patients can focus on what matters most. Mesoblast will participate in industry standard conferences where our dedicated sales teams will provide educational materials to healthcare providers. From time to time, speaker engagements will be utilized to further education to patients and their families of the lifesaving benefits of RYONCIL™. As part of the MyMesoblast™, dedicated Patient Access Specialists can enroll patients in Mesoblast's commercial co-pay assistance, patient assistance program, or provide referrals to alternate coverage resources for families. Mesoblast's pricing methodology for its cell therapy, RYONCIL™, for pediatric patients with steroid-refractory acute graft-versus-host disease (SR-aGvHD), is based on the economic value of the treatment, inclusive of extensive market research of this disease state by utilizing both highly trained internal and external resources. This pricing strategy aligns with emerging frameworks for cell therapies which are focused on the economic value of the treatment rather than solely on production costs. The pricing is determined by considering the cost of treating a child who dies of SR-aGvHD and the calculated total benefits of patient outcomes using RYONCIL™. |
None |
375 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Mesoblast Inc. |
73648011202 |
Ryoncil (remestemcel-l-rknd) 1 Kit (2 Single Use Vials) Target 25 X 10^6 MSCs/ 3.8mL (6.68 x 10^6 MSCs/mL) for resuspension and infusion |
2025-03-17 |
194000.0000 |
RYONCIL™ is the first and only FDA-approved, allogeneic, off-the-shelf, bone marrow–derived mesenchymal stromal cell (MSC) therapy indicated for the treatment of pediatric patients aged 2 months and older, including adolescents and teenagers, with steroid-refractory acute graft-versus-host disease (SR-aGvHD), a life-threatening condition with high mortality rates (in patients with the most severe form of steroid-refractory acute GVD, mortality can be as high as 90% despite optimal standard of care). RYONCIL™ has the potential to be an effective and safe therapy to significantly improve survival outcomes in the most vulnerable population of children with severe forms of this disease. There are currently no FDA-approved treatments in the United States for children under 12 with steroid-refractory acute GVHD. Mesoblast is committed to providing, through the use of a professional sales team, educational materials that will assist healthcare providers in the treatment of their patient population affected by these complex diseases. Additional information for the support of patient assistance can be found at https://www.ryoncil.com/ entitled MyMesoblast™. This is a comprehensive, single-source support hub designed to help treatment centers and families successfully navigate the RYONCIL™ treatment journey. From early treatment consideration to investigating insurance coverage and addressing affordability concerns, MyMesoblast™ provides personalized support every step of the way, so patients can focus on what matters most. Mesoblast will participate in industry standard conferences where our dedicated sales teams will provide educational materials to healthcare providers. From time to time, speaker engagements will be utilized to further education to patients and their families of the lifesaving benefits of RYONCIL™. As part of the MyMesoblast™, dedicated Patient Access Specialists can enroll patients in Mesoblast's commercial co-pay assistance, patient assistance program, or provide referrals to alternate coverage resources for families. Mesoblast's pricing methodology for its cell therapy, RYONCIL™, for pediatric patients with steroid-refractory acute graft-versus-host disease (SR-aGvHD), is based on the economic value of the treatment, inclusive of extensive market research of this disease state by utilizing both highly trained internal and external resources. This pricing strategy aligns with emerging frameworks for cell therapies which are focused on the economic value of the treatment rather than solely on production costs. The pricing is determined by considering the cost of treating a child who dies of SR-aGvHD and the calculated total benefits of patient outcomes using RYONCIL™. |
None |
375 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Mesoblast Inc. |
73648011303 |
Ryoncil (remestemcel-l-rknd) 1 Kit (3 Single Use Vials) Target 25 X 10^6 MSCs/ 3.8mL (6.68 x 10^6 MSCs/mL) for resuspension and infusion |
2025-03-17 |
194000.0000 |
RYONCIL™ is the first and only FDA-approved, allogeneic, off-the-shelf, bone marrow–derived mesenchymal stromal cell (MSC) therapy indicated for the treatment of pediatric patients aged 2 months and older, including adolescents and teenagers, with steroid-refractory acute graft-versus-host disease (SR-aGvHD), a life-threatening condition with high mortality rates (in patients with the most severe form of steroid-refractory acute GVD, mortality can be as high as 90% despite optimal standard of care). RYONCIL™ has the potential to be an effective and safe therapy to significantly improve survival outcomes in the most vulnerable population of children with severe forms of this disease. There are currently no FDA-approved treatments in the United States for children under 12 with steroid-refractory acute GVHD. Mesoblast is committed to providing, through the use of a professional sales team, educational materials that will assist healthcare providers in the treatment of their patient population affected by these complex diseases. Additional information for the support of patient assistance can be found at https://www.ryoncil.com/ entitled MyMesoblast™. This is a comprehensive, single-source support hub designed to help treatment centers and families successfully navigate the RYONCIL™ treatment journey. From early treatment consideration to investigating insurance coverage and addressing affordability concerns, MyMesoblast™ provides personalized support every step of the way, so patients can focus on what matters most. Mesoblast will participate in industry standard conferences where our dedicated sales teams will provide educational materials to healthcare providers. From time to time, speaker engagements will be utilized to further education to patients and their families of the lifesaving benefits of RYONCIL™. As part of the MyMesoblast™, dedicated Patient Access Specialists can enroll patients in Mesoblast's commercial co-pay assistance, patient assistance program, or provide referrals to alternate coverage resources for families. Mesoblast's pricing methodology for its cell therapy, RYONCIL™, for pediatric patients with steroid-refractory acute graft-versus-host disease (SR-aGvHD), is based on the economic value of the treatment, inclusive of extensive market research of this disease state by utilizing both highly trained internal and external resources. This pricing strategy aligns with emerging frameworks for cell therapies which are focused on the economic value of the treatment rather than solely on production costs. The pricing is determined by considering the cost of treating a child who dies of SR-aGvHD and the calculated total benefits of patient outcomes using RYONCIL™. |
None |
375 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Mesoblast Inc. |
73648011401 |
Ryoncil (remestemcel-l-rknd) 1 Kit (4 Single Use Vials) Target 25 X 10^6 MSCs/ 3.8mL (6.68 x 10^6 MSCs/mL) for resuspension and infusion |
2025-03-17 |
194000.0000 |
RYONCIL™ is the first and only FDA-approved, allogeneic, off-the-shelf, bone marrow–derived mesenchymal stromal cell (MSC) therapy indicated for the treatment of pediatric patients aged 2 months and older, including adolescents and teenagers, with steroid-refractory acute graft-versus-host disease (SR-aGvHD), a life-threatening condition with high mortality rates (in patients with the most severe form of steroid-refractory acute GVD, mortality can be as high as 90% despite optimal standard of care). RYONCIL™ has the potential to be an effective and safe therapy to significantly improve survival outcomes in the most vulnerable population of children with severe forms of this disease. There are currently no FDA-approved treatments in the United States for children under 12 with steroid-refractory acute GVHD. Mesoblast is committed to providing, through the use of a professional sales team, educational materials that will assist healthcare providers in the treatment of their patient population affected by these complex diseases. Additional information for the support of patient assistance can be found at https://www.ryoncil.com/ entitled MyMesoblast™. This is a comprehensive, single-source support hub designed to help treatment centers and families successfully navigate the RYONCIL™ treatment journey. From early treatment consideration to investigating insurance coverage and addressing affordability concerns, MyMesoblast™ provides personalized support every step of the way, so patients can focus on what matters most. Mesoblast will participate in industry standard conferences where our dedicated sales teams will provide educational materials to healthcare providers. From time to time, speaker engagements will be utilized to further education to patients and their families of the lifesaving benefits of RYONCIL™. As part of the MyMesoblast™, dedicated Patient Access Specialists can enroll patients in Mesoblast's commercial co-pay assistance, patient assistance program, or provide referrals to alternate coverage resources for families. Mesoblast's pricing methodology for its cell therapy, RYONCIL™, for pediatric patients with steroid-refractory acute graft-versus-host disease (SR-aGvHD), is based on the economic value of the treatment, inclusive of extensive market research of this disease state by utilizing both highly trained internal and external resources. This pricing strategy aligns with emerging frameworks for cell therapies which are focused on the economic value of the treatment rather than solely on production costs. The pricing is determined by considering the cost of treating a child who dies of SR-aGvHD and the calculated total benefits of patient outcomes using RYONCIL™. |
None |
375 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Mesoblast Inc. |
73648011502 |
Ryoncil (remestemcel-l-rknd) 1 Kit (5 Single Use Vials) Target 25 X 10^6 MSCs/ 3.8mL (6.68 x 10^6 MSCs/mL) for resuspension and infusion |
2025-03-17 |
194000.0000 |
RYONCIL™ is the first and only FDA-approved, allogeneic, off-the-shelf, bone marrow–derived mesenchymal stromal cell (MSC) therapy indicated for the treatment of pediatric patients aged 2 months and older, including adolescents and teenagers, with steroid-refractory acute graft-versus-host disease (SR-aGvHD), a life-threatening condition with high mortality rates (in patients with the most severe form of steroid-refractory acute GVD, mortality can be as high as 90% despite optimal standard of care). RYONCIL™ has the potential to be an effective and safe therapy to significantly improve survival outcomes in the most vulnerable population of children with severe forms of this disease. There are currently no FDA-approved treatments in the United States for children under 12 with steroid-refractory acute GVHD. Mesoblast is committed to providing, through the use of a professional sales team, educational materials that will assist healthcare providers in the treatment of their patient population affected by these complex diseases. Additional information for the support of patient assistance can be found at https://www.ryoncil.com/ entitled MyMesoblast™. This is a comprehensive, single-source support hub designed to help treatment centers and families successfully navigate the RYONCIL™ treatment journey. From early treatment consideration to investigating insurance coverage and addressing affordability concerns, MyMesoblast™ provides personalized support every step of the way, so patients can focus on what matters most. Mesoblast will participate in industry standard conferences where our dedicated sales teams will provide educational materials to healthcare providers. From time to time, speaker engagements will be utilized to further education to patients and their families of the lifesaving benefits of RYONCIL™. As part of the MyMesoblast™, dedicated Patient Access Specialists can enroll patients in Mesoblast's commercial co-pay assistance, patient assistance program, or provide referrals to alternate coverage resources for families. Mesoblast's pricing methodology for its cell therapy, RYONCIL™, for pediatric patients with steroid-refractory acute graft-versus-host disease (SR-aGvHD), is based on the economic value of the treatment, inclusive of extensive market research of this disease state by utilizing both highly trained internal and external resources. This pricing strategy aligns with emerging frameworks for cell therapies which are focused on the economic value of the treatment rather than solely on production costs. The pricing is determined by considering the cost of treating a child who dies of SR-aGvHD and the calculated total benefits of patient outcomes using RYONCIL™. |
None |
375 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Mesoblast Inc. |
73648011603 |
Ryoncil (remestemcel-l-rknd) 1 Kit (6 Single Use Vials) Target 25 X 10^6 MSCs/ 3.8mL (6.68 x 10^6 MSCs/mL) for resuspension and infusion |
2025-03-17 |
194000.0000 |
RYONCIL™ is the first and only FDA-approved, allogeneic, off-the-shelf, bone marrow–derived mesenchymal stromal cell (MSC) therapy indicated for the treatment of pediatric patients aged 2 months and older, including adolescents and teenagers, with steroid-refractory acute graft-versus-host disease (SR-aGvHD), a life-threatening condition with high mortality rates (in patients with the most severe form of steroid-refractory acute GVD, mortality can be as high as 90% despite optimal standard of care). RYONCIL™ has the potential to be an effective and safe therapy to significantly improve survival outcomes in the most vulnerable population of children with severe forms of this disease. There are currently no FDA-approved treatments in the United States for children under 12 with steroid-refractory acute GVHD. Mesoblast is committed to providing, through the use of a professional sales team, educational materials that will assist healthcare providers in the treatment of their patient population affected by these complex diseases. Additional information for the support of patient assistance can be found at https://www.ryoncil.com/ entitled MyMesoblast™. This is a comprehensive, single-source support hub designed to help treatment centers and families successfully navigate the RYONCIL™ treatment journey. From early treatment consideration to investigating insurance coverage and addressing affordability concerns, MyMesoblast™ provides personalized support every step of the way, so patients can focus on what matters most. Mesoblast will participate in industry standard conferences where our dedicated sales teams will provide educational materials to healthcare providers. From time to time, speaker engagements will be utilized to further education to patients and their families of the lifesaving benefits of RYONCIL™. As part of the MyMesoblast™, dedicated Patient Access Specialists can enroll patients in Mesoblast's commercial co-pay assistance, patient assistance program, or provide referrals to alternate coverage resources for families. Mesoblast's pricing methodology for its cell therapy, RYONCIL™, for pediatric patients with steroid-refractory acute graft-versus-host disease (SR-aGvHD), is based on the economic value of the treatment, inclusive of extensive market research of this disease state by utilizing both highly trained internal and external resources. This pricing strategy aligns with emerging frameworks for cell therapies which are focused on the economic value of the treatment rather than solely on production costs. The pricing is determined by considering the cost of treating a child who dies of SR-aGvHD and the calculated total benefits of patient outcomes using RYONCIL™. |
None |
375 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Mesoblast Inc. |
73648011704 |
Ryoncil (remestemcel-l-rknd) 1 Kit (7 Single Use Vials) Target 25 X 10^6 MSCs/ 3.8mL (6.68 x 10^6 MSCs/mL) for resuspension and infusion |
2025-03-17 |
194000.0000 |
RYONCIL™ is the first and only FDA-approved, allogeneic, off-the-shelf, bone marrow–derived mesenchymal stromal cell (MSC) therapy indicated for the treatment of pediatric patients aged 2 months and older, including adolescents and teenagers, with steroid-refractory acute graft-versus-host disease (SR-aGvHD), a life-threatening condition with high mortality rates (in patients with the most severe form of steroid-refractory acute GVD, mortality can be as high as 90% despite optimal standard of care). RYONCIL™ has the potential to be an effective and safe therapy to significantly improve survival outcomes in the most vulnerable population of children with severe forms of this disease. There are currently no FDA-approved treatments in the United States for children under 12 with steroid-refractory acute GVHD. Mesoblast is committed to providing, through the use of a professional sales team, educational materials that will assist healthcare providers in the treatment of their patient population affected by these complex diseases. Additional information for the support of patient assistance can be found at https://www.ryoncil.com/ entitled MyMesoblast™. This is a comprehensive, single-source support hub designed to help treatment centers and families successfully navigate the RYONCIL™ treatment journey. From early treatment consideration to investigating insurance coverage and addressing affordability concerns, MyMesoblast™ provides personalized support every step of the way, so patients can focus on what matters most. Mesoblast will participate in industry standard conferences where our dedicated sales teams will provide educational materials to healthcare providers. From time to time, speaker engagements will be utilized to further education to patients and their families of the lifesaving benefits of RYONCIL™. As part of the MyMesoblast™, dedicated Patient Access Specialists can enroll patients in Mesoblast's commercial co-pay assistance, patient assistance program, or provide referrals to alternate coverage resources for families. Mesoblast's pricing methodology for its cell therapy, RYONCIL™, for pediatric patients with steroid-refractory acute graft-versus-host disease (SR-aGvHD), is based on the economic value of the treatment, inclusive of extensive market research of this disease state by utilizing both highly trained internal and external resources. This pricing strategy aligns with emerging frameworks for cell therapies which are focused on the economic value of the treatment rather than solely on production costs. The pricing is determined by considering the cost of treating a child who dies of SR-aGvHD and the calculated total benefits of patient outcomes using RYONCIL™. |
None |
375 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Mesoblast Inc. |
73648011802 |
Ryoncil (remestemcel-l-rknd) 1 Kit (8 Single Use Vials) Target 25 X 10^6 MSCs/ 3.8mL (6.68 x 10^6 MSCs/mL) for resuspension and infusion |
2025-03-17 |
194000.0000 |
RYONCIL™ is the first and only FDA-approved, allogeneic, off-the-shelf, bone marrow–derived mesenchymal stromal cell (MSC) therapy indicated for the treatment of pediatric patients aged 2 months and older, including adolescents and teenagers, with steroid-refractory acute graft-versus-host disease (SR-aGvHD), a life-threatening condition with high mortality rates (in patients with the most severe form of steroid-refractory acute GVD, mortality can be as high as 90% despite optimal standard of care). RYONCIL™ has the potential to be an effective and safe therapy to significantly improve survival outcomes in the most vulnerable population of children with severe forms of this disease. There are currently no FDA-approved treatments in the United States for children under 12 with steroid-refractory acute GVHD. Mesoblast is committed to providing, through the use of a professional sales team, educational materials that will assist healthcare providers in the treatment of their patient population affected by these complex diseases. Additional information for the support of patient assistance can be found at https://www.ryoncil.com/ entitled MyMesoblast™. This is a comprehensive, single-source support hub designed to help treatment centers and families successfully navigate the RYONCIL™ treatment journey. From early treatment consideration to investigating insurance coverage and addressing affordability concerns, MyMesoblast™ provides personalized support every step of the way, so patients can focus on what matters most. Mesoblast will participate in industry standard conferences where our dedicated sales teams will provide educational materials to healthcare providers. From time to time, speaker engagements will be utilized to further education to patients and their families of the lifesaving benefits of RYONCIL™. As part of the MyMesoblast™, dedicated Patient Access Specialists can enroll patients in Mesoblast's commercial co-pay assistance, patient assistance program, or provide referrals to alternate coverage resources for families. Mesoblast's pricing methodology for its cell therapy, RYONCIL™, for pediatric patients with steroid-refractory acute graft-versus-host disease (SR-aGvHD), is based on the economic value of the treatment, inclusive of extensive market research of this disease state by utilizing both highly trained internal and external resources. This pricing strategy aligns with emerging frameworks for cell therapies which are focused on the economic value of the treatment rather than solely on production costs. The pricing is determined by considering the cost of treating a child who dies of SR-aGvHD and the calculated total benefits of patient outcomes using RYONCIL™. |
None |
375 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Mylan Pharmaceuticals Inc |
00378289520 |
Ferric Citrate 210mg |
2025-03-20 |
1411.7800 |
None |
1 |
5764480 |
None |
None |
None |
None |
None |
None |
Mylan’s Ferric Citrate product is an authorized generic of the Auryxia product. Ferric Citrate is indicated for the control of serum phosphorous levels in patients with chronic kidney disease on dialysis. Based on current literature, ~555,000 Americans are currently on dialysis. Of these patients, ~69% experience serum phosphorous levels above normal range (>4.5mg/dl). This means ~382,950 Americans undergoing dialysis for chronic kidney disease are eligible for prescription of Ferric Citrate to control serum phosphorous levels. Ferric Citrate is also indicated for the treatment of iron deficiency anemia in adults with chronic kidney disease not on dialysis. Given that only 555,000 of the ~35,000,000 Americans with chronic kidney disease are currently on dialysis, ~34,945,000 Americans living with chronic kidney disease are not on dialysis. Of these patients, ~15.4% are estimated to have anemia. Thia means ~5,381,530 Americans not undergoing dialysis for chronic kidney disease are eligible for prescription of Ferric Citrate to treat iron deficiency anemia. Altogether between these indications, ~5,764,480 Americans are eligible for prescription of Ferric Citrate 210mg. |
None |
| Neurelis |
72252051005 |
Valtoco 10 MG Dose Nasal Liquid 10 MG/0.1ML 5 per box |
2025-03-17 |
1829.6800 |
None |
1 |
180000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Neurelis |
72252051510 |
Valtoco 15 MG Dose Nasal Liquid Therapy Pack 2 x 7.5 MG/0.1ML 5 per box |
2025-03-17 |
1829.6800 |
None |
1 |
180000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Neurelis |
72252052010 |
Valtoco 20 MG Dose Nasal Liquid Therapy Pack 2 x 10 MG/0.1ML 5 per box |
2025-03-17 |
1829.6800 |
None |
1 |
180000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Neurelis |
72252050505 |
Valtoco 5 MG Dose Nasal Liquid 5 MG/0.1ML 5 per box |
2025-03-17 |
1829.6800 |
None |
1 |
180000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Neurotech Pharmaceuticals, Inc. |
82958050101 |
ENCELTO (revakinagene taroretcel-lwey, 82958-501-01), a single-dose implant that contains 200,000 to 440,000 allogeneic retinal pigment epithelial cells expressing rhCNTF for intravitreal surgical placement. Opaque semi-permeable capsule. |
2025-03-24 |
250000.0000 |
None |
1 |
165000 |
None |
1 |
None |
None |
None |
None |
None |
None |
| Novo |
00169208015 |
ALHEMO (concizumab-mtci) injection 150 mg/1.5 mL (100 mg/mL); 1.5 mL in 1 prefilled pen |
2025-02-19 |
25800.0000 |
At ALHEMO’s® launch on February 19, 2025, Novo Nordisk Inc. (NNI) intends to focus marketing efforts on pediatric and adult hematologists and their support staff primarily, who are likely to manage a significant population of patients that are likely to benefit from ALHEMO®. NNI also will market ALHEMO® for patients for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A (congenital factor VIII deficiency) with FVIII inhibitors and hemophilia B (congenital factor IX deficiency) with FIX inhibitors., as per ALHEMO® label.
NNI educates health care professionals (HCPs) about ALHEMO® through in-office detailing visits, educational programs, promotion at large conferences and conventions, and web-based mediums. NNI does not provide any gifts to health care professionals as such activity is strictly prohibited by company policy. NNI distributes educational materials to health care professionals regarding ALHEMO® which may include medical journal articles about the drug. NNI also offers product information as well as product starter kits through HCPs for patient use.
Novo Nordisk considers a range of financial and non-financial factors when setting prices for its products, including ALHEMO®. Those factors include:
Ensuring patient access through discounts, rebates, and fees provided to payers and purchasers: These factors, include, among other things, class of trade discounts in the distribution channel, rebates demanded by payers to maintain formulary access.
Operating costs and investment in research and development: The nature of medicine development makes costs very high and revenues from product sales allow the company to perform research and development, and to innovate. For every medicine that is approved and launched, there are significant financial resources expended on the many other drug candidates that do not progress and ultimately come to market. The company uses revenues to cover its various operating costs, including costs associated with education, disease awareness activities, medical information support, sales and marketing activities, patient affordability initiatives, and operating costs associated with compliance with legal and regulatory requirements.
Additional detail on the methodology used to establish the price of ALHEMO®: In general, Novo Nordisk conducts market research across payers, patients, and health care professionals when developing pricing for new products. That research includes evaluation of the factors identified above. For instance, when assessing the value of innovation specific to ALHEMO®, Novo Nordisk used the clinical evidence and the acceptance of treatment to help derive an appropriate price point that will optimize access for patients. The company also considered the clinical and economic value proposition, formulary access drivers, barriers for adoption and adherence, product differentiation, market dynamics, and treatment pathways and clinical guidelines. Novo Nordisk carefully balanced these factors to establish a price for ALHEMO®, rather than determining price from a specific insight or model. The company is committed to ensuring broad, affordable, unrestricted patient access for ALHEMO®. |
None |
33000 |
1 |
1 |
None |
None |
None |
None |
The U.S. Food and Drug Administration (FDA) granted Priority Review designation for ALHEMO® (concizumab-mtci) injection for prophylactic treatment of patients with hemophilia A and B with inhibitors. Because of the unmet medical needs in this population, and based on the Phase 2 clinicial trial results, the FDA granted Breakthrough Therapy designation for ALHEMO® in hemophilia B with inhibitors.
For the estimated patients per month requirement, Novo Nordisk utilizes product indication, targeted product profile, services, payer prior authorization requirements as well as the time factor to find the specialists managing undiagnosed patients and get them educated to estimate the number of patients who may be prescribed ALHEMO®. Novo Nordisk has estimated 2 patients per month or a total of 31 patients per year (approximately 25 HBwI patients and 6 HAwI patients) as the average number of patients who may be prescribed ALHEMO® each month in the United States. However, we note that the estimated prevalence of patients with hemophilia in the United States (US) is 33,000 between years 2012 and 2022 per the CDC. This includes both A and B subtypes. The prevalence of the two subtypes in hemophilia patients is approximately 20% have hemophilia B and 80% have hemophilia A. Overall, approximately 5% of each of these two cohorts will develop inhibitors. ALHEMO® is a tissue factor pathway inhibitor (TFPI) antagonist indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A (congenital factor VIII deficiency) with FVIII inhibitors and hemophilia B (congenital factor IX deficiency) with FIX inhibitors. The indication for hemophilia B with inhibitors (HBwI) represents a significant unmet need for the prophylactic treatment of this disease. Since there are limited treatment options and given the small number of total patients affected with HBwI (approximately 1% of the total hemophilia population), we estimate a higher volume of HBwI patients in the US to receive ALHEMO® than HAwI patients, who may have other prophylactic medication treatment options available. Therefore, the estimated number of hemophilia patients who may be prescribed ALHEMO® is much less than the prevalence.
The full prescribing information for ALHEMO® is available at https://www.novo-pi.com/alhemo.pdf |
None |
| Novo |
00169208415 |
ALHEMO (concizumab-mtci) injection 60 mg/1.5 mL (40 mg/mL); 1.5 mL in 1 prefilled pen |
2025-02-19 |
10320.0000 |
At ALHEMO’s® launch on February 19, 2025, Novo Nordisk Inc. (NNI) intends to focus marketing efforts on pediatric and adult hematologists and their support staff primarily, who are likely to manage a significant population of patients that are likely to benefit from ALHEMO®. NNI also will market ALHEMO® for patients for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A (congenital factor VIII deficiency) with FVIII inhibitors and hemophilia B (congenital factor IX deficiency) with FIX inhibitors., as per ALHEMO® label.
NNI educates health care professionals (HCPs) about ALHEMO® through in-office detailing visits, educational programs, promotion at large conferences and conventions, and web-based mediums. NNI does not provide any gifts to health care professionals as such activity is strictly prohibited by company policy. NNI distributes educational materials to health care professionals regarding ALHEMO® which may include medical journal articles about the drug. NNI also offers product information as well as product starter kits through HCPs for patient use.
Novo Nordisk considers a range of financial and non-financial factors when setting prices for its products, including ALHEMO®. Those factors include:
Ensuring patient access through discounts, rebates, and fees provided to payers and purchasers: These factors, include, among other things, class of trade discounts in the distribution channel, rebates demanded by payers to maintain formulary access.
Operating costs and investment in research and development: The nature of medicine development makes costs very high and revenues from product sales allow the company to perform research and development, and to innovate. For every medicine that is approved and launched, there are significant financial resources expended on the many other drug candidates that do not progress and ultimately come to market. The company uses revenues to cover its various operating costs, including costs associated with education, disease awareness activities, medical information support, sales and marketing activities, patient affordability initiatives, and operating costs associated with compliance with legal and regulatory requirements.
Additional detail on the methodology used to establish the price of ALHEMO®: In general, Novo Nordisk conducts market research across payers, patients, and health care professionals when developing pricing for new products. That research includes evaluation of the factors identified above. For instance, when assessing the value of innovation specific to ALHEMO®, Novo Nordisk used the clinical evidence and the acceptance of treatment to help derive an appropriate price point that will optimize access for patients. The company also considered the clinical and economic value proposition, formulary access drivers, barriers for adoption and adherence, product differentiation, market dynamics, and treatment pathways and clinical guidelines. Novo Nordisk carefully balanced these factors to establish a price for ALHEMO®, rather than determining price from a specific insight or model. The company is committed to ensuring broad, affordable, unrestricted patient access for ALHEMO®. |
None |
33000 |
1 |
1 |
None |
None |
None |
None |
The U.S. Food and Drug Administration (FDA) granted Priority Review designation for ALHEMO® (concizumab-mtci) injection for prophylactic treatment of patients with hemophilia A and B with inhibitors. Because of the unmet medical needs in this population, and based on the Phase 2 clinicial trial results, the FDA granted Breakthrough Therapy designation for ALHEMO® in hemophilia B with inhibitors.
For the estimated patients per month requirement, Novo Nordisk utilizes product indication, targeted product profile, services, payer prior authorization requirements as well as the time factor to find the specialists managing undiagnosed patients and get them educated to estimate the number of patients who may be prescribed ALHEMO®. Novo Nordisk has estimated 2 patients per month or a total of 31 patients per year (approximately 25 HBwI patients and 6 HAwI patients) as the average number of patients who may be prescribed ALHEMO® each month in the United States. However, we note that the estimated prevalence of patients with hemophilia in the United States (US) is 33,000 between years 2012 and 2022 per the CDC. This includes both A and B subtypes. The prevalence of the two subtypes in hemophilia patients is approximately 20% have hemophilia B and 80% have hemophilia A. Overall, approximately 5% of each of these two cohorts will develop inhibitors. ALHEMO® is a tissue factor pathway inhibitor (TFPI) antagonist indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A (congenital factor VIII deficiency) with FVIII inhibitors and hemophilia B (congenital factor IX deficiency) with FIX inhibitors. The indication for hemophilia B with inhibitors (HBwI) represents a significant unmet need for the prophylactic treatment of this disease. Since there are limited treatment options and given the small number of total patients affected with HBwI (approximately 1% of the total hemophilia population), we estimate a higher volume of HBwI patients in the US to receive ALHEMO® than HAwI patients, who may have other prophylactic medication treatment options available. Therefore, the estimated number of hemophilia patients who may be prescribed ALHEMO® is much less than the prevalence.
The full prescribing information for ALHEMO® is available at https://www.novo-pi.com/alhemo.pdf |
None |
| Novo |
00169208103 |
ALHEMO (concizumab-mtci) injection 300 mg/3 mL (100 mg/mL); 3 mL in 1 prefilled pen |
2025-03-24 |
51600.0000 |
At ALHEMO’s® launch on February 19, 2025, Novo Nordisk Inc. (NNI) intends to focus marketing efforts on pediatric and adult hematologists and their support staff primarily, who are likely to manage a significant population of patients that are likely to benefit from ALHEMO®. NNI also will market ALHEMO® for patients for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A (congenital factor VIII deficiency) with FVIII inhibitors and hemophilia B (congenital factor IX deficiency) with FIX inhibitors., as per ALHEMO® label.
NNI educates health care professionals (HCPs) about ALHEMO® through in-office detailing visits, educational programs, promotion at large conferences and conventions, and web-based mediums. NNI does not provide any gifts to health care professionals as such activity is strictly prohibited by company policy. NNI distributes educational materials to health care professionals regarding ALHEMO® which may include medical journal articles about the drug. NNI also offers product information as well as product starter kits through HCPs for patient use.
Novo Nordisk considers a range of financial and non-financial factors when setting prices for its products, including ALHEMO®. Those factors include:
Ensuring patient access through discounts, rebates, and fees provided to payers and purchasers: These factors, include, among other things, class of trade discounts in the distribution channel, rebates demanded by payers to maintain formulary access.
Operating costs and investment in research and development: The nature of medicine development makes costs very high and revenues from product sales allow the company to perform research and development, and to innovate. For every medicine that is approved and launched, there are significant financial resources expended on the many other drug candidates that do not progress and ultimately come to market. The company uses revenues to cover its various operating costs, including costs associated with education, disease awareness activities, medical information support, sales and marketing activities, patient affordability initiatives, and operating costs associated with compliance with legal and regulatory requirements.
Additional detail on the methodology used to establish the price of ALHEMO®: In general, Novo Nordisk conducts market research across payers, patients, and health care professionals when developing pricing for new products. That research includes evaluation of the factors identified above. For instance, when assessing the value of innovation specific to ALHEMO®, Novo Nordisk used the clinical evidence and the acceptance of treatment to help derive an appropriate price point that will optimize access for patients. The company also considered the clinical and economic value proposition, formulary access drivers, barriers for adoption and adherence, product differentiation, market dynamics, and treatment pathways and clinical guidelines. Novo Nordisk carefully balanced these factors to establish a price for ALHEMO®, rather than determining price from a specific insight or model. The company is committed to ensuring broad, affordable, unrestricted patient access for ALHEMO®. |
None |
33000 |
1 |
1 |
None |
None |
None |
None |
The U.S. Food and Drug Administration (FDA) granted Priority Review designation for ALHEMO® (concizumab-mtci) injection for prophylactic treatment of patients with hemophilia A and B with inhibitors. Because of the unmet medical needs in this population, and based on the Phase 2 clinicial trial results, the FDA granted Breakthrough Therapy designation for ALHEMO® in hemophilia B with inhibitors.
For the estimated patients per month requirement, Novo Nordisk utilizes product indication, targeted product profile, services, payer prior authorization requirements as well as the time factor to find the specialists managing undiagnosed patients and get them educated to estimate the number of patients who may be prescribed ALHEMO®. Novo Nordisk has estimated 2 patients per month or a total of 31 patients per year (approximately 25 HBwI patients and 6 HAwI patients) as the average number of patients who may be prescribed ALHEMO® each month in the United States. However, we note that the estimated prevalence of patients with hemophilia in the United States (US) is 33,000 between years 2012 and 2022 per the CDC. This includes both A and B subtypes. The prevalence of the two subtypes in hemophilia patients is approximately 20% have hemophilia B and 80% have hemophilia A. Overall, approximately 5% of each of these two cohorts will develop inhibitors. ALHEMO® is a tissue factor pathway inhibitor (TFPI) antagonist indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A (congenital factor VIII deficiency) with FVIII inhibitors and hemophilia B (congenital factor IX deficiency) with FIX inhibitors. The indication for hemophilia B with inhibitors (HBwI) represents a significant unmet need for the prophylactic treatment of this disease. Since there are limited treatment options and given the small number of total patients affected with HBwI (approximately 1% of the total hemophilia population), we estimate a higher volume of HBwI patients in the US to receive ALHEMO® than HAwI patients, who may have other prophylactic medication treatment options available. Therefore, the estimated number of hemophilia patients who may be prescribed ALHEMO® is much less than the prevalence.
The full prescribing information for ALHEMO® is available at https://www.novo-pi.com/alhemo.pdf |
None |
| Nuvaila US, LLC |
84612039901 |
AMJEVITA 20mg/0.2ml PREFILLED SYRINGE 1 Count |
2025-01-01 |
599.5000 |
Nuvaila’s marketing strategy will include a digital presence without direct marketing to prescribers or consumers. Nuvaila will maintain a global website as the primary information hub, provide a Co-pay program, and will create other compliant materials for use with PBMS, GPOs, distributors and pharmacies.
The prices of Nuvaila’s products reflect Nuvaila’s mission to provide lower-cost therapeutic alternatives for patients, the competitive landscape, and the price of the reference product.
Nuvaila's marketing and pricing is for the United States only. Nuvaila does not distribute the product internationally. |
None |
4000000 |
None |
None |
2024-07-08 |
None |
1 |
Amjevita is manufactured pursuant to a private label distribution agreement executed on July 8, 2024. The terms of the agreement are considered trade secrets and/or not otherwise in the public domain or publicly available. |
Estimated patients in the United States with a condition that may be prescribed the drug annually. An estimate is provided for the product family (AMJEVITA). |
None |
| Nuvaila US, LLC |
84612048202 |
AMJEVITA 40mg/0.4ml AUTOINJECTOR 2 Count |
2025-01-01 |
1199.0000 |
Nuvaila’s marketing strategy will include a digital presence without direct marketing to prescribers or consumers. Nuvaila will maintain a global website as the primary information hub, provide a Co-pay program, and will create other compliant materials for use with PBMS, GPOs, distributors and pharmacies.
The prices of Nuvaila’s products reflect Nuvaila’s mission to provide lower-cost therapeutic alternatives for patients, the competitive landscape, and the price of the reference product.
Nuvaila's marketing and pricing is for the United States only. Nuvaila does not distribute the product internationally. |
None |
4000000 |
None |
None |
2024-07-08 |
None |
1 |
Amjevita is manufactured pursuant to a private label distribution agreement executed on July 8, 2024. The terms of the agreement are considered trade secrets and/or not otherwise in the public domain or publicly available. |
Estimated patients in the United States with a condition that may be prescribed the drug annually. An estimate is provided for the product family (AMJEVITA). |
None |
| Nuvaila US, LLC |
84612047902 |
AMJEVITA 40mg/0.4ml PREFILLED SYRINGE 2 Count |
2025-01-01 |
1199.0000 |
Nuvaila’s marketing strategy will include a digital presence without direct marketing to prescribers or consumers. Nuvaila will maintain a global website as the primary information hub, provide a Co-pay program, and will create other compliant materials for use with PBMS, GPOs, distributors and pharmacies.
The prices of Nuvaila’s products reflect Nuvaila’s mission to provide lower-cost therapeutic alternatives for patients, the competitive landscape, and the price of the reference product.
Nuvaila's marketing and pricing is for the United States only. Nuvaila does not distribute the product internationally. |
None |
4000000 |
None |
None |
2024-07-08 |
None |
1 |
Amjevita is manufactured pursuant to a private label distribution agreement executed on July 8, 2024. The terms of the agreement are considered trade secrets and/or not otherwise in the public domain or publicly available. |
Estimated patients in the United States with a condition that may be prescribed the drug annually. An estimate is provided for the product family (AMJEVITA). |
None |
| Nuvaila US, LLC |
84612048102 |
AMJEVITA 80mg/0.8ml AUTOINJECTOR 2 Count |
2025-01-01 |
2398.0000 |
Nuvaila’s marketing strategy will include a digital presence without direct marketing to prescribers or consumers. Nuvaila will maintain a global website as the primary information hub, provide a Co-pay program, and will create other compliant materials for use with PBMS, GPOs, distributors and pharmacies.
The prices of Nuvaila’s products reflect Nuvaila’s mission to provide lower-cost therapeutic alternatives for patients, the competitive landscape, and the price of the reference product.
Nuvaila's marketing and pricing is for the United States only. Nuvaila does not distribute the product internationally. |
None |
4000000 |
None |
None |
2024-07-08 |
None |
1 |
Amjevita is manufactured pursuant to a private label distribution agreement executed on July 8, 2024. The terms of the agreement are considered trade secrets and/or not otherwise in the public domain or publicly available. |
Estimated patients in the United States with a condition that may be prescribed the drug annually. An estimate is provided for the product family (AMJEVITA). |
None |
| Nuvaila US, LLC |
84612006601 |
WEZLANA 130mg/26ml SINGLE DOSE VIAL 1 Count |
2025-01-01 |
1417.1600 |
Nuvaila’s marketing strategy will include a digital presence without direct marketing to prescribers or consumers. Nuvaila will maintain a global website as the primary information hub, provide a Co-pay program, and will create other compliant materials for use with PBMS, GPOs, distributors and pharmacies.
The prices of Nuvaila’s products reflect Nuvaila’s mission to provide lower-cost therapeutic alternatives for patients, the competitive landscape, and the price of the reference product. Additionally, Wezlana is offered at both a standard list price and low list price for certain formulations in alignment with the competitive landscape.
Nuvaila's marketing and pricing is for the United States only. Nuvaila does not distribute the product internationally. |
None |
3750000 |
None |
None |
2024-07-29 |
None |
1 |
Wezlana is manufactured pursuant to a private label distribution agreement executed on July 29, 2024. The terms of the agreement are considered trade secrets and/or not otherwise in the public domain or publicly available. |
Estimated patients in the United States with a condition that may be prescribed the drug annually. An estimate is provided for the product family (WEZLANA). |
None |
| Nuvaila US, LLC |
84612007601 |
WEZLANA 45mg/0.5ml PREFILLED SYRINGE 1 Count |
2025-01-01 |
2784.2900 |
Nuvaila’s marketing strategy will include a digital presence without direct marketing to prescribers or consumers. Nuvaila will maintain a global website as the primary information hub, provide a Co-pay program, and will create other compliant materials for use with PBMS, GPOs, distributors and pharmacies.
The prices of Nuvaila’s products reflect Nuvaila’s mission to provide lower-cost therapeutic alternatives for patients, the competitive landscape, and the price of the reference product. Additionally, Wezlana is offered at both a standard list price and low list price for certain formulations in alignment with the competitive landscape.
Nuvaila's marketing and pricing is for the United States only. Nuvaila does not distribute the product internationally. |
None |
3750000 |
None |
None |
2024-07-29 |
None |
1 |
Wezlana is manufactured pursuant to a private label distribution agreement executed on July 29, 2024. The terms of the agreement are considered trade secrets and/or not otherwise in the public domain or publicly available. |
Estimated patients in the United States with a condition that may be prescribed the drug annually. An estimate is provided for the product family (WEZLANA). |
None |
| Nuvaila US, LLC |
84612087601 |
WEZLANA 45mg/0.5ml PREFILLED SYRINGE 1 Count Standard |
2025-01-01 |
13782.2200 |
Nuvaila’s marketing strategy will include a digital presence without direct marketing to prescribers or consumers. Nuvaila will maintain a global website as the primary information hub, provide a Co-pay program, and will create other compliant materials for use with PBMS, GPOs, distributors and pharmacies.
The prices of Nuvaila’s products reflect Nuvaila’s mission to provide lower-cost therapeutic alternatives for patients, the competitive landscape, and the price of the reference product. Additionally, Wezlana is offered at both a standard list price and low list price for certain formulations in alignment with the competitive landscape.
Nuvaila's marketing and pricing is for the United States only. Nuvaila does not distribute the product internationally. |
None |
3750000 |
None |
None |
2024-07-29 |
None |
1 |
Wezlana is manufactured pursuant to a private label distribution agreement executed on July 29, 2024. The terms of the agreement are considered trade secrets and/or not otherwise in the public domain or publicly available. |
Estimated patients in the United States with a condition that may be prescribed the drug annually. An estimate is provided for the product family (WEZLANA). |
None |
| Nuvaila US, LLC |
84612005501 |
WEZLANA 45mg/0.5ml SINGLE DOSE VIAL 1 Count |
2025-01-01 |
2784.2900 |
Nuvaila’s marketing strategy will include a digital presence without direct marketing to prescribers or consumers. Nuvaila will maintain a global website as the primary information hub, provide a Co-pay program, and will create other compliant materials for use with PBMS, GPOs, distributors and pharmacies.
The prices of Nuvaila’s products reflect Nuvaila’s mission to provide lower-cost therapeutic alternatives for patients, the competitive landscape, and the price of the reference product. Additionally, Wezlana is offered at both a standard list price and low list price for certain formulations in alignment with the competitive landscape.
Nuvaila's marketing and pricing is for the United States only. Nuvaila does not distribute the product internationally. |
None |
3750000 |
None |
None |
2024-07-29 |
None |
1 |
Wezlana is manufactured pursuant to a private label distribution agreement executed on July 29, 2024. The terms of the agreement are considered trade secrets and/or not otherwise in the public domain or publicly available. |
Estimated patients in the United States with a condition that may be prescribed the drug annually. An estimate is provided for the product family (WEZLANA). |
None |
| Nuvaila US, LLC |
84612085501 |
WEZLANA 45mg/0.5ml SINGLE DOSE VIAL 1 Count Standard |
2025-01-01 |
13782.2200 |
Nuvaila’s marketing strategy will include a digital presence without direct marketing to prescribers or consumers. Nuvaila will maintain a global website as the primary information hub, provide a Co-pay program, and will create other compliant materials for use with PBMS, GPOs, distributors and pharmacies.
The prices of Nuvaila’s products reflect Nuvaila’s mission to provide lower-cost therapeutic alternatives for patients, the competitive landscape, and the price of the reference product. Additionally, Wezlana is offered at both a standard list price and low list price for certain formulations in alignment with the competitive landscape.
Nuvaila's marketing and pricing is for the United States only. Nuvaila does not distribute the product internationally. |
None |
3750000 |
None |
None |
2024-07-29 |
None |
1 |
Wezlana is manufactured pursuant to a private label distribution agreement executed on July 29, 2024. The terms of the agreement are considered trade secrets and/or not otherwise in the public domain or publicly available. |
Estimated patients in the United States with a condition that may be prescribed the drug annually. An estimate is provided for the product family (WEZLANA). |
None |
| Nuvaila US, LLC |
84612008901 |
WEZLANA 90mg/ml PREFILLED SYRINGE 1 Count |
2025-01-01 |
5568.5700 |
Nuvaila’s marketing strategy will include a digital presence without direct marketing to prescribers or consumers. Nuvaila will maintain a global website as the primary information hub, provide a Co-pay program, and will create other compliant materials for use with PBMS, GPOs, distributors and pharmacies.
The prices of Nuvaila’s products reflect Nuvaila’s mission to provide lower-cost therapeutic alternatives for patients, the competitive landscape, and the price of the reference product. Additionally, Wezlana is offered at both a standard list price and low list price for certain formulations in alignment with the competitive landscape.
Nuvaila's marketing and pricing is for the United States only. Nuvaila does not distribute the product internationally. |
None |
3750000 |
None |
None |
2024-07-29 |
None |
1 |
Wezlana is manufactured pursuant to a private label distribution agreement executed on July 29, 2024. The terms of the agreement are considered trade secrets and/or not otherwise in the public domain or publicly available. |
Estimated patients in the United States with a condition that may be prescribed the drug annually. An estimate is provided for the product family (WEZLANA). |
None |
| Nuvaila US, LLC |
84612088901 |
WEZLANA 90mg/ml PREFILLED SYRINGE 1 Count Standard |
2025-01-01 |
27564.4200 |
Nuvaila’s marketing strategy will include a digital presence without direct marketing to prescribers or consumers. Nuvaila will maintain a global website as the primary information hub, provide a Co-pay program, and will create other compliant materials for use with PBMS, GPOs, distributors and pharmacies.
The prices of Nuvaila’s products reflect Nuvaila’s mission to provide lower-cost therapeutic alternatives for patients, the competitive landscape, and the price of the reference product. Additionally, Wezlana is offered at both a standard list price and low list price for certain formulations in alignment with the competitive landscape.
Nuvaila's marketing and pricing is for the United States only. Nuvaila does not distribute the product internationally. |
None |
3750000 |
None |
None |
2024-07-29 |
None |
1 |
Wezlana is manufactured pursuant to a private label distribution agreement executed on July 29, 2024. The terms of the agreement are considered trade secrets and/or not otherwise in the public domain or publicly available. |
Estimated patients in the United States with a condition that may be prescribed the drug annually. An estimate is provided for the product family (WEZLANA). |
None |
| PureTek Corporation |
59088022407 |
VennGel II, Diclofenac Sodium 1% Topical Gel (100gm), Alcohol Pads, Large, 100ct box |
2025-02-20 |
2720.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
250000 |
None |
None |
None |
None |
None |
None |
Dispensed by prescription only |
None |
| PureTek Corporation |
59088020503 |
Fungizyl AL, Dimethyl Sulfoxide 2%, Miconazole Nitrate 2%(1fl oz) |
2025-02-26 |
1800.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
625000 |
None |
None |
None |
None |
None |
None |
Dispensed by prescription only |
None |
| PureTek Corporation |
59088001754 |
Flotrex chewable multivitamins with 0.25mg Fluoride, Vitamin A (as Retinyl Acetate) 750 mcg RAE
Vitamin C , Vitamin D3, Vitamin E, Thiamin , Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, 30ct |
2025-03-19 |
1604.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
1275000 |
None |
None |
None |
None |
None |
None |
Dispensed by prescription only |
None |
| Sagent Pharmaceuticals |
25021032401 |
Isoproterenol Hydrochloride Injection (0.2mg/ml, 1ml, 10x1ml) |
2025-03-14 |
1250.0000 |
Product is an off-patent generic injectable with multiple competitors. Plan is to be market competitive |
None |
28400 |
None |
None |
None |
None |
None |
None |
None |
None |
| Sagent Pharmaceuticals |
25021032405 |
Isoproterenol Hydrochloride Injection (0.2mg/ml, 5ml, 10x5ml) |
2025-03-18 |
1400.0000 |
Product is an off-patent generic injectable with multiple competitors. Plan is to be market competitive |
None |
86000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Sagent Pharmaceuticals |
25021032302 |
Procainamide Hydrochloride Injection (500mg/ml, 2ml, 10x2ml) |
2025-03-27 |
4500.0000 |
Product is an off-patent generic injectable with multiple competitors. Plan is to be market competitive |
None |
48140 |
None |
None |
None |
None |
None |
None |
None |
None |
| Sandoz Inc. |
61314032520 |
ADALIMUMAB 80MG/0.8ML 2LISY PE BI V1 US |
2025-01-15 |
2630.6000 |
Sandoz’s marketing plan for the introduction of Adalimumab will focus on educating health care professionals (HCPs) and patients (consumers) about the benefit of biosimilars and the approved use of Adalimumab. Sandoz does not plan to do any direct-to-consumer media advertisements on TV, in magazines, radio, billboards or blogs. Consumer engagement will include our patient website, patient education brochures and emails for those patients that opt into communications and enroll in patient support. Sandoz will offer a patient transition program to patients that transition from Humira to Adalimumab. HCP engagement will include the HCP website, printed resources, email blasts and other digital resources in line with the Hyrimoz prescribing information. There is no additional marketing spend for this product and none planned for this product family. |
None |
519999 |
None |
None |
None |
None |
None |
None |
Adalimumab is a tumor necrosis factor (TNF) blocker indicated for 9 disease states :
1. Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA.
2. Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older.
3. Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA.
4. Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS.
5. Crohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
6. Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers.
7. Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
8. Hidradenitis Suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.
9. Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. Source: Label from USFDA (Drugs@FDA). Link below label (fda.gov)
Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product. Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure. |
None |
| Sandoz Inc. |
00781352720 |
Edaravone 30MG/100ML 2LIBA US |
2025-01-30 |
1145.1800 |
Sandoz Inc. is contracting within the wholesaler and/or specialty pharmacy space. This is a generic drug and there is no actual or planned direct-to-consumer marketing or advertising for this product. The WAC is priced lower than the WAC of the reference product. |
None |
63 |
None |
None |
None |
None |
None |
None |
Amyotrophic Lateral Sclerosis (ALS): ALS is a progressive neurodegenerative disease that affects motor neurons in the brain and spinal cord, causing muscle weakness, severe disability, and eventually death. The condition affects approximately 15,000–21,000 people in the United States, according to the ALS Association. The average life expectancy of a person with ALS is about 2-5 years from the time of diagnosis, although some people can live with the disease for more than 5 years. Approximately 5000 people in the United States are diagnosed with ALS each year. There is an estimated 63 patients treated with Edaravone IV in the United States. Source : IQVIA, PIL (Drugs@FDA), Company Website
Acquistion date and Acquistion price not applicable as Sandoz did not acquire this product.
Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure. |
None |
| Sandoz Inc. |
61314065494 |
PYZCHIVA 130MG/26ML 26ML LIVI US |
2025-02-24 |
1564.7800 |
Sandoz’s marketing plan for the introduction of Pyzchiva will focus on educating health care professionals (HCPs) and patients (consumers) about the benefit of biosimilars and the approved use of Pyzchiva. Sandoz does not plan to do any direct-to-consumer media advertisements on TV, in magazines, radio, billboards or blogs. Consumer engagement will include our patient website, patient education brochures and emails for those patients that opt into communications and enroll in patient support. HCP engagement will include the HCP website, printed resources, email blasts and other digital resources in line with the Pyzchiva prescribing information. The WAC is priced lower than the WAC of the reference product. |
None |
26019 |
None |
None |
None |
None |
None |
None |
Pychiva is a human interleukin-12 and -23 antagonist indicated for a numer of treatment in Adults with:
1. Moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy
2. Active psoriatic arthritis (PsA)
3. Moderately to severely active Crohn’s disease (CD)
4. Moderately to severely active ulcerative colitis
B. Pediatric patients 6 years and older with :
1. Moderate to severe plaque psoriasis, who are candidates for phototherapy or systemic therapy
2. Active psoriatic arthritis (PsA)
There is an estimated 140,685 patients treated with Pychiva in the United States.
Source: Label (Drug@FDA, USFDA)
Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product. Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure. |
None |
| Sandoz Inc. |
61314065101 |
PYZCHIVA 45MG/0.5ML 0.5ML LISY US |
2025-02-24 |
2915.1500 |
Sandoz’s marketing plan for the introduction of Pyzchiva will focus on educating health care professionals (HCPs) and patients (consumers) about the benefit of biosimilars and the approved use of Pyzchiva. Sandoz does not plan to do any direct-to-consumer media advertisements on TV, in magazines, radio, billboards or blogs. Consumer engagement will include our patient website, patient education brochures and emails for those patients that opt into communications and enroll in patient support. HCP engagement will include the HCP website, printed resources, email blasts and other digital resources in line with the Pyzchiva prescribing information. The WAC is priced lower than the WAC of the reference product. |
None |
17096 |
None |
None |
None |
None |
None |
None |
Pychiva is a human interleukin-12 and -23 antagonist indicated for a numer of treatment in Adults with:
1. Moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy
2. Active psoriatic arthritis (PsA)
3. Moderately to severely active Crohn’s disease (CD)
4. Moderately to severely active ulcerative colitis
B. Pediatric patients 6 years and older with :
1. Moderate to severe plaque psoriasis, who are candidates for phototherapy or systemic therapy
2. Active psoriatic arthritis (PsA)
There is an estimated 140,685 patients treated with Pychiva in the United States.
Source: Label (Drug@FDA, USFDA)
Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product. Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure. |
None |
| Sandoz Inc. |
61314065201 |
PYZCHIVA 90MG/1ML 1ML LISY US |
2025-02-24 |
5830.2900 |
Sandoz’s marketing plan for the introduction of Pyzchiva will focus on educating health care professionals (HCPs) and patients (consumers) about the benefit of biosimilars and the approved use of Pyzchiva. Sandoz does not plan to do any direct-to-consumer media advertisements on TV, in magazines, radio, billboards or blogs. Consumer engagement will include our patient website, patient education brochures and emails for those patients that opt into communications and enroll in patient support. HCP engagement will include the HCP website, printed resources, email blasts and other digital resources in line with the Pyzchiva prescribing information. The WAC is priced lower than the WAC of the reference product. |
None |
97570 |
None |
None |
None |
None |
None |
None |
Pychiva is a human interleukin-12 and -23 antagonist indicated for a numer of treatment in Adults with:
1. Moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy
2. Active psoriatic arthritis (PsA)
3. Moderately to severely active Crohn’s disease (CD)
4. Moderately to severely active ulcerative colitis
B. Pediatric patients 6 years and older with :
1. Moderate to severe plaque psoriasis, who are candidates for phototherapy or systemic therapy
2. Active psoriatic arthritis (PsA)
There is an estimated 140,685 patients treated with Pychiva in the United States.
Source: Label (Drug@FDA, USFDA)
Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product. Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure. |
None |
| Solubiomix LLC |
73308043530 |
Ultramicrosize Griseofulvin, 165 mg, tablet, 30 count |
2025-03-03 |
992.1100 |
Sold through independent pharmacies |
None |
226 |
None |
None |
None |
None |
None |
None |
None |
None |
| SpringWorks Therapeutics |
82448013042 |
Gomekli (mirdametinib) 1mg Capsules, 42-ct bottle |
2025-02-18 |
8662.5000 |
Neurofibromatosis type 1 (NF1) is an incurable genetic condition affecting approximately 1 in 2500 newborns worldwide that is caused by a pathogenic variant in the NF1 tumor suppressor gene. Peripheral nerve sheath tumors called plexiform neurofibromas (PNs) are a common clinical manifestation of NF1. GOMEKLI (mirdametinib) is the first and only FDA-approved treatment for both adults and children 2 years of age and older with NF1 who have symptomatic PNs not amenable to complete resection. Despite advancements in NF1-PN treatment, unmet needs remain, and patients are in need of more options. GOMEKLI will be marketed to appropriate healthcare professionals in community neurology and oncology centers and NF1 centers of excellence in the U.S., as well as to appropriate patients in the U.S. with NF1-PNs. General marketing efforts will be focused on highlighting the approved indication, efficacy, safety and value that GOMEKLI may deliver to appropriate patients in need. Specific marketing plans used to launch the drug in the U.S. include, without limitation, use of print and digital media, patient and HCP websites, opt in email communications, media advertisements to both healthcare providers, patients, payers and population health decision makers, on platforms such as social media and other web-based mediums, professional detailing to healthcare providers, payers, and conference events, seminars and speaker programs. Patient support programs will also be offered to facilitate access to GOMEKLI for eligible patients who have been prescribed GOMEKLI, but these programs are not considered marketing or promotional activities.
With respect to its pricing plans for GOMEKLI in the U.S., SpringWorks conducted extensive qualitative and quantitative market research and analysis of several factors, including unmet medical need, disease severity, and patient burden of illness in this orphan population. Additionally, SpringWorks assessed current market pricing for comparable orphan rare disease and oncology drugs, which included broad-based physician, payer and population health decision maker feedback. Major financial and non-financial factors that influenced the decision to set the price of the drug at a level that exceeds the Medicare Part D threshold included: the unique clinical value that GOMEKLI offers as the first and only FDA-approved treatment for both adults and children 2 years of age and older with NF1 who have symptomatic PNs not amenable to complete resection; the safety and efficacy profile of the drug; patient access considerations, including the development and implementation of the SpringWorks CareConnections patient support program to support U.S. patients on their treatment journey with GOMEKLI; preclinical and ongoing clinical trials for the drug; anticipated discounts and other fees to be negotiated with supply chain partners, including wholesalers, specialty pharmacies, PBMs and group purchasing organizations; anticipated discounts, rebates and fees to various government programs; manufacturing and marketing costs; and past and ongoing investments in R&D (including resources, infrastructure and organization) to both support and build on the existing portfolio and develop new and innovative therapies for other rare indications.
SpringWorks does not currently market or sell GOMEKLI outside the U.S. |
None |
4587 |
None |
1 |
2017-08-18 |
229800000.0000 |
None |
In August 2017, SpringWorks entered into a license agreement with Pfizer, pursuant to which we acquired exclusive (including as to Pfizer) worldwide sublicensable rights to research, develop, manufacture and commercialize mirdametinib for the treatment of all diseases. Pursuant to the license agreement, SpringWorks is required to pay Pfizer up to an aggregate of $229.8 million upon achievement of certain commercial milestone events, and will pay Pfizer tiered royalties on sales of mirdametinib at percentages ranging from the mid-single digits to the low 20s, that may be subject to deductions for expiration of valid claims, amounts due under third-party licenses and generic competition |
None |
None |
| SpringWorks Therapeutics |
82448013442 |
Gomekli (mirdametinib) 1mg tablets, 42-ct bottle |
2025-02-18 |
8662.5000 |
Neurofibromatosis type 1 (NF1) is an incurable genetic condition affecting approximately 1 in 2500 newborns worldwide that is caused by a pathogenic variant in the NF1 tumor suppressor gene. Peripheral nerve sheath tumors called plexiform neurofibromas (PNs) are a common clinical manifestation of NF1. GOMEKLI (mirdametinib) is the first and only FDA-approved treatment for both adults and children 2 years of age and older with NF1 who have symptomatic PNs not amenable to complete resection. Despite advancements in NF1-PN treatment, unmet needs remain, and patients are in need of more options. GOMEKLI will be marketed to appropriate healthcare professionals in community neurology and oncology centers and NF1 centers of excellence in the U.S., as well as to appropriate patients in the U.S. with NF1-PNs. General marketing efforts will be focused on highlighting the approved indication, efficacy, safety and value that GOMEKLI may deliver to appropriate patients in need. Specific marketing plans used to launch the drug in the U.S. include, without limitation, use of print and digital media, patient and HCP websites, opt in email communications, media advertisements to both healthcare providers, patients, payers and population health decision makers, on platforms such as social media and other web-based mediums, professional detailing to healthcare providers, payers, and conference events, seminars and speaker programs. Patient support programs will also be offered to facilitate access to GOMEKLI for eligible patients who have been prescribed GOMEKLI, but these programs are not considered marketing or promotional activities.
With respect to its pricing plans for GOMEKLI in the U.S., SpringWorks conducted extensive qualitative and quantitative market research and analysis of several factors, including unmet medical need, disease severity, and patient burden of illness in this orphan population. Additionally, SpringWorks assessed current market pricing for comparable orphan rare disease and oncology drugs, which included broad-based physician, payer and population health decision maker feedback. Major financial and non-financial factors that influenced the decision to set the price of the drug at a level that exceeds the Medicare Part D threshold included: the unique clinical value that GOMEKLI offers as the first and only FDA-approved treatment for both adults and children 2 years of age and older with NF1 who have symptomatic PNs not amenable to complete resection; the safety and efficacy profile of the drug; patient access considerations, including the development and implementation of the SpringWorks CareConnections patient support program to support U.S. patients on their treatment journey with GOMEKLI; preclinical and ongoing clinical trials for the drug; anticipated discounts and other fees to be negotiated with supply chain partners, including wholesalers, specialty pharmacies, PBMs and group purchasing organizations; anticipated discounts, rebates and fees to various government programs; manufacturing and marketing costs; and past and ongoing investments in R&D (including resources, infrastructure and organization) to both support and build on the existing portfolio and develop new and innovative therapies for other rare indications.
SpringWorks does not currently market or sell GOMEKLI outside the U.S. |
None |
4587 |
None |
1 |
2017-08-18 |
229800000.0000 |
None |
In August 2017, SpringWorks entered into a license agreement with Pfizer, pursuant to which we acquired exclusive (including as to Pfizer) worldwide sublicensable rights to research, develop, manufacture and commercialize mirdametinib for the treatment of all diseases. Pursuant to the license agreement, SpringWorks is required to pay Pfizer up to an aggregate of $229.8 million upon achievement of certain commercial milestone events, and will pay Pfizer tiered royalties on sales of mirdametinib at percentages ranging from the mid-single digits to the low 20s, that may be subject to deductions for expiration of valid claims, amounts due under third-party licenses and generic competition |
None |
None |
| SpringWorks Therapeutics |
82448013484 |
Gomekli (mirdametinib) 1mg tablets, 84-ct bottle |
2025-02-18 |
17325.0000 |
Neurofibromatosis type 1 (NF1) is an incurable genetic condition affecting approximately 1 in 2500 newborns worldwide that is caused by a pathogenic variant in the NF1 tumor suppressor gene. Peripheral nerve sheath tumors called plexiform neurofibromas (PNs) are a common clinical manifestation of NF1. GOMEKLI (mirdametinib) is the first and only FDA-approved treatment for both adults and children 2 years of age and older with NF1 who have symptomatic PNs not amenable to complete resection. Despite advancements in NF1-PN treatment, unmet needs remain, and patients are in need of more options. GOMEKLI will be marketed to appropriate healthcare professionals in community neurology and oncology centers and NF1 centers of excellence in the U.S., as well as to appropriate patients in the U.S. with NF1-PNs. General marketing efforts will be focused on highlighting the approved indication, efficacy, safety and value that GOMEKLI may deliver to appropriate patients in need. Specific marketing plans used to launch the drug in the U.S. include, without limitation, use of print and digital media, patient and HCP websites, opt in email communications, media advertisements to both healthcare providers, patients, payers and population health decision makers, on platforms such as social media and other web-based mediums, professional detailing to healthcare providers, payers, and conference events, seminars and speaker programs. Patient support programs will also be offered to facilitate access to GOMEKLI for eligible patients who have been prescribed GOMEKLI, but these programs are not considered marketing or promotional activities.
With respect to its pricing plans for GOMEKLI in the U.S., SpringWorks conducted extensive qualitative and quantitative market research and analysis of several factors, including unmet medical need, disease severity, and patient burden of illness in this orphan population. Additionally, SpringWorks assessed current market pricing for comparable orphan rare disease and oncology drugs, which included broad-based physician, payer and population health decision maker feedback. Major financial and non-financial factors that influenced the decision to set the price of the drug at a level that exceeds the Medicare Part D threshold included: the unique clinical value that GOMEKLI offers as the first and only FDA-approved treatment for both adults and children 2 years of age and older with NF1 who have symptomatic PNs not amenable to complete resection; the safety and efficacy profile of the drug; patient access considerations, including the development and implementation of the SpringWorks CareConnections patient support program to support U.S. patients on their treatment journey with GOMEKLI; preclinical and ongoing clinical trials for the drug; anticipated discounts and other fees to be negotiated with supply chain partners, including wholesalers, specialty pharmacies, PBMs and group purchasing organizations; anticipated discounts, rebates and fees to various government programs; manufacturing and marketing costs; and past and ongoing investments in R&D (including resources, infrastructure and organization) to both support and build on the existing portfolio and develop new and innovative therapies for other rare indications.
SpringWorks does not currently market or sell GOMEKLI outside the U.S. |
None |
4587 |
None |
1 |
2017-08-18 |
229800000.0000 |
None |
In August 2017, SpringWorks entered into a license agreement with Pfizer, pursuant to which we acquired exclusive (including as to Pfizer) worldwide sublicensable rights to research, develop, manufacture and commercialize mirdametinib for the treatment of all diseases. Pursuant to the license agreement, SpringWorks is required to pay Pfizer up to an aggregate of $229.8 million upon achievement of certain commercial milestone events, and will pay Pfizer tiered royalties on sales of mirdametinib at percentages ranging from the mid-single digits to the low 20s, that may be subject to deductions for expiration of valid claims, amounts due under third-party licenses and generic competition |
None |
None |
| SpringWorks Therapeutics |
82448026042 |
Gomekli (mirdametinib) 2mg Capsules, 42-ct bottle |
2025-02-18 |
17325.0000 |
Neurofibromatosis type 1 (NF1) is an incurable genetic condition affecting approximately 1 in 2500 newborns worldwide that is caused by a pathogenic variant in the NF1 tumor suppressor gene. Peripheral nerve sheath tumors called plexiform neurofibromas (PNs) are a common clinical manifestation of NF1. GOMEKLI (mirdametinib) is the first and only FDA-approved treatment for both adults and children 2 years of age and older with NF1 who have symptomatic PNs not amenable to complete resection. Despite advancements in NF1-PN treatment, unmet needs remain, and patients are in need of more options. GOMEKLI will be marketed to appropriate healthcare professionals in community neurology and oncology centers and NF1 centers of excellence in the U.S., as well as to appropriate patients in the U.S. with NF1-PNs. General marketing efforts will be focused on highlighting the approved indication, efficacy, safety and value that GOMEKLI may deliver to appropriate patients in need. Specific marketing plans used to launch the drug in the U.S. include, without limitation, use of print and digital media, patient and HCP websites, opt in email communications, media advertisements to both healthcare providers, patients, payers and population health decision makers, on platforms such as social media and other web-based mediums, professional detailing to healthcare providers, payers, and conference events, seminars and speaker programs. Patient support programs will also be offered to facilitate access to GOMEKLI for eligible patients who have been prescribed GOMEKLI, but these programs are not considered marketing or promotional activities.
With respect to its pricing plans for GOMEKLI in the U.S., SpringWorks conducted extensive qualitative and quantitative market research and analysis of several factors, including unmet medical need, disease severity, and patient burden of illness in this orphan population. Additionally, SpringWorks assessed current market pricing for comparable orphan rare disease and oncology drugs, which included broad-based physician, payer and population health decision maker feedback. Major financial and non-financial factors that influenced the decision to set the price of the drug at a level that exceeds the Medicare Part D threshold included: the unique clinical value that GOMEKLI offers as the first and only FDA-approved treatment for both adults and children 2 years of age and older with NF1 who have symptomatic PNs not amenable to complete resection; the safety and efficacy profile of the drug; patient access considerations, including the development and implementation of the SpringWorks CareConnections patient support program to support U.S. patients on their treatment journey with GOMEKLI; preclinical and ongoing clinical trials for the drug; anticipated discounts and other fees to be negotiated with supply chain partners, including wholesalers, specialty pharmacies, PBMs and group purchasing organizations; anticipated discounts, rebates and fees to various government programs; manufacturing and marketing costs; and past and ongoing investments in R&D (including resources, infrastructure and organization) to both support and build on the existing portfolio and develop new and innovative therapies for other rare indications.
SpringWorks does not currently market or sell GOMEKLI outside the U.S. |
None |
4587 |
None |
1 |
2017-08-18 |
229800000.0000 |
None |
In August 2017, SpringWorks entered into a license agreement with Pfizer, pursuant to which we acquired exclusive (including as to Pfizer) worldwide sublicensable rights to research, develop, manufacture and commercialize mirdametinib for the treatment of all diseases. Pursuant to the license agreement, SpringWorks is required to pay Pfizer up to an aggregate of $229.8 million upon achievement of certain commercial milestone events, and will pay Pfizer tiered royalties on sales of mirdametinib at percentages ranging from the mid-single digits to the low 20s, that may be subject to deductions for expiration of valid claims, amounts due under third-party licenses and generic competition |
None |
None |
| SpringWorks Therapeutics |
82448026084 |
Gomekli (mirdametinib) 2mg Capsules, 84-ct bottle |
2025-02-18 |
34650.0000 |
Neurofibromatosis type 1 (NF1) is an incurable genetic condition affecting approximately 1 in 2500 newborns worldwide that is caused by a pathogenic variant in the NF1 tumor suppressor gene. Peripheral nerve sheath tumors called plexiform neurofibromas (PNs) are a common clinical manifestation of NF1. GOMEKLI (mirdametinib) is the first and only FDA-approved treatment for both adults and children 2 years of age and older with NF1 who have symptomatic PNs not amenable to complete resection. Despite advancements in NF1-PN treatment, unmet needs remain, and patients are in need of more options. GOMEKLI will be marketed to appropriate healthcare professionals in community neurology and oncology centers and NF1 centers of excellence in the U.S., as well as to appropriate patients in the U.S. with NF1-PNs. General marketing efforts will be focused on highlighting the approved indication, efficacy, safety and value that GOMEKLI may deliver to appropriate patients in need. Specific marketing plans used to launch the drug in the U.S. include, without limitation, use of print and digital media, patient and HCP websites, opt in email communications, media advertisements to both healthcare providers, patients, payers and population health decision makers, on platforms such as social media and other web-based mediums, professional detailing to healthcare providers, payers, and conference events, seminars and speaker programs. Patient support programs will also be offered to facilitate access to GOMEKLI for eligible patients who have been prescribed GOMEKLI, but these programs are not considered marketing or promotional activities.
With respect to its pricing plans for GOMEKLI in the U.S., SpringWorks conducted extensive qualitative and quantitative market research and analysis of several factors, including unmet medical need, disease severity, and patient burden of illness in this orphan population. Additionally, SpringWorks assessed current market pricing for comparable orphan rare disease and oncology drugs, which included broad-based physician, payer and population health decision maker feedback. Major financial and non-financial factors that influenced the decision to set the price of the drug at a level that exceeds the Medicare Part D threshold included: the unique clinical value that GOMEKLI offers as the first and only FDA-approved treatment for both adults and children 2 years of age and older with NF1 who have symptomatic PNs not amenable to complete resection; the safety and efficacy profile of the drug; patient access considerations, including the development and implementation of the SpringWorks CareConnections patient support program to support U.S. patients on their treatment journey with GOMEKLI; preclinical and ongoing clinical trials for the drug; anticipated discounts and other fees to be negotiated with supply chain partners, including wholesalers, specialty pharmacies, PBMs and group purchasing organizations; anticipated discounts, rebates and fees to various government programs; manufacturing and marketing costs; and past and ongoing investments in R&D (including resources, infrastructure and organization) to both support and build on the existing portfolio and develop new and innovative therapies for other rare indications.
SpringWorks does not currently market or sell GOMEKLI outside the U.S. |
None |
4587 |
None |
1 |
2017-08-18 |
229800000.0000 |
None |
In August 2017, SpringWorks entered into a license agreement with Pfizer, pursuant to which we acquired exclusive (including as to Pfizer) worldwide sublicensable rights to research, develop, manufacture and commercialize mirdametinib for the treatment of all diseases. Pursuant to the license agreement, SpringWorks is required to pay Pfizer up to an aggregate of $229.8 million upon achievement of certain commercial milestone events, and will pay Pfizer tiered royalties on sales of mirdametinib at percentages ranging from the mid-single digits to the low 20s, that may be subject to deductions for expiration of valid claims, amounts due under third-party licenses and generic competition |
None |
None |
| Stallergenes Greer USA |
22840011407 |
PALFORZIA - Each package contains 13 capsules:
(Level A) One 0.5 mg capsule
(Level B) One 1 mg capsule
(Level C) One 0.5 mg capsule; One 1 mg capsule
(Level D) Three 1 mg capsules
(Level E) Six 1 mg capsules |
2025-03-03 |
959.6400 |
"Marketing to Allergy HCPs that have capability to administer Oral Immunotherapy (OIT). Pricing to be equivalent to other Palforzia doses at time of introduction." |
None |
750 |
None |
None |
None |
None |
None |
None |
None |
None |
| Stallergenes Greer USA |
22840012615 |
PALFORZIA - Each package contains fifteen 1mg capsules |
2025-03-03 |
959.6400 |
"Marketing to Allergy HCPs that have capability to administer Oral Immunotherapy (OIT). Pricing to be equivalent to other Palforzia doses at time of introduction." |
None |
750 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
70095004001 |
Deflazacort Oral Tablets 6mg, 100ct |
2025-03-21 |
8185.5800 |
As this is a generic pharmaceutical product, Sun does not engage in marketing activities typically attendant to branded products. There are no direct-to-customer marketing activities of any kind, and no promotion of the product to physicians or other healthcare providers. Sun utilized appropriate pricing planning based on current and predicted market conditions. Utilizing only publicly available information, Sun determined to set its WAC at the same level as its competitor. It did not utilize the brand WAC in its calculations. |
None |
3100 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
70095004130 |
Deflazacort Oral Tablets, 18mg, 30ct |
2025-03-21 |
7367.2100 |
As this is a generic pharmaceutical product, Sun does not engage in marketing activities typically attendant to branded products. There are no direct-to-customer marketing activities of any kind, and no promotion of the product to physicians or other healthcare providers. Sun utilized appropriate pricing planning based on current and predicted market conditions. Utilizing only publicly available information, Sun determined to set its WAC at the same level as its competitor. It did not utilize the brand WAC in its calculations. |
None |
3100 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
70095004230 |
Deflazacort Oral Tablets, 30mg, 30ct |
2025-03-21 |
12279.3100 |
As this is a generic pharmaceutical product, Sun does not engage in marketing activities typically attendant to branded products. There are no direct-to-customer marketing activities of any kind, and no promotion of the product to physicians or other healthcare providers. Sun utilized appropriate pricing planning based on current and predicted market conditions. Utilizing only publicly available information, Sun determined to set its WAC at the same level as its competitor. It did not utilize the brand WAC in its calculations. |
None |
3100 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
70095004330 |
Deflazacort Oral Tablets, 36mg, 30ct |
2025-03-21 |
14214.6900 |
As this is a generic pharmaceutical product, Sun does not engage in marketing activities typically attendant to branded products. There are no direct-to-customer marketing activities of any kind, and no promotion of the product to physicians or other healthcare providers. Sun utilized appropriate pricing planning based on current and predicted market conditions. Utilizing only publicly available information, Sun determined to set its WAC at the same level as its competitor. It did not utilize the brand WAC in its calculations. |
None |
3100 |
None |
None |
None |
None |
None |
None |
None |
None |
| Syndax Pharmaceuticals, Inc. |
73555050000 |
REVUFORJ (revumenib) 25mg Package Quantity 30 Tablets |
2025-03-19 |
10000.0000 |
None |
1 |
2000 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Teva Pharmaceuticals USA |
51759052321 |
Simlandi Pre-Filled Syringe Kit 80mg/0.8mL |
2025-01-30 |
1038.0000 |
None |
1 |
14600000 |
None |
None |
None |
None |
None |
None |
Research suggests that there are a total of approximately 14,600,000 patients who suffer from the various conditions that Simlandi is indicated to treat |
None |
| Teva Pharmaceuticals USA |
51759038622 |
Simlandi (2 syringe) Pre-Filled Syringe Kit 20mg/0.2mL |
2025-01-30 |
1038.0000 |
None |
1 |
14600000 |
None |
None |
None |
None |
None |
None |
Research suggests that there are a total of approximately 14,600,000 patients who suffer from the various conditions that Simlandi is indicated to treat |
None |
| Teva Pharmaceuticals USA |
51759050532 |
SELARSDI Prefilled Syringe 45 mg/0.5 mL |
2025-02-24 |
2088.2100 |
None |
1 |
9688000 |
None |
None |
None |
None |
None |
None |
Research suggests that there are a total of approximately 9,688,000 patients who suffer from the various conditions that Simlandi is indicated to treat |
None |
| Teva Pharmaceuticals USA |
51759060732 |
SELARSDI Prefilled Syringe 90 mg/mL |
2025-02-24 |
4176.4300 |
None |
1 |
9688000 |
None |
None |
None |
None |
None |
None |
Research suggests that there are a total of approximately 9,688,000 patients who suffer from the various conditions that Simlandi is indicated to treat |
None |
| Teva Pharmaceuticals USA |
00480925708 |
OCTREOTIDE ACETATE INJ 10MG/VIAL KIT 1 |
2025-03-20 |
3044.2500 |
None |
1 |
9330 |
None |
1 |
None |
None |
None |
None |
Research suggests that as many as 9,330 Americans, in total, suffer from the conditions that this product is indicated to treat. Acquisition fields left blank; Teva developed the product. |
None |
| Teva Pharmaceuticals USA |
51759070813 |
SELARSDI Single Dose Vial 130mg/26mL |
2025-04-07 |
1400.0000 |
None |
1 |
9688000 |
None |
None |
None |
None |
None |
None |
Research suggests that there are a total of approximately 9,688,000 patients who suffer from the various conditions that Selarsdi is indicated to treat |
None |
| Tilde Sciences LLC |
83649055801 |
Vecamyl Oral Tablet 2.5 MG, 100 count bottle |
2025-03-24 |
6940.0000 |
None |
1 |
150 |
None |
None |
2023-09-22 |
650000.0000 |
None |
Drug was acquired with another asset in a bankruptcy. Price provided is inclusive of the other asset. Company was required to relabel drug prior to disribution. |
At the point of acquisition, the drug was in shortage. The company worked with the CDMO to identify a new API manufacturer and has been working with the FDA to provide stability data. At this time the company is waiting for FDA approval to relaunch the product. Approval is expected as early as 4/1/2025. |
None |
| Upsher-Smith Laboratories, LLC |
00832081530 |
Deflazacort 18mg tblt Btl 30ct |
2025-02-06 |
7367.2100 |
None |
1 |
10000 |
None |
1 |
None |
None |
None |
None |
None |
None |
| Upsher-Smith Laboratories, LLC |
00832081630 |
Deflazacort 30mg tblt Btl 30ct |
2025-02-06 |
12279.3100 |
None |
1 |
10000 |
None |
1 |
None |
None |
None |
None |
None |
None |
| Upsher-Smith Laboratories, LLC |
00832081730 |
Deflazacort 36mg tblt Btl 30ct |
2025-02-06 |
14214.6900 |
None |
1 |
10000 |
None |
1 |
None |
None |
None |
None |
None |
None |
| Upsher-Smith Laboratories, LLC |
00832081411 |
Deflazacort 6mg tblt Btl 100ct |
2025-02-06 |
8185.5800 |
None |
1 |
10000 |
None |
1 |
None |
None |
None |
None |
None |
None |
| Validus Pharmaceuticals |
30698045502 |
Trazodone Hydrochloride Oral Solution, 10mg/mL Raldesy TM 150ml HDPE Bottle Pack |
2025-03-17 |
386.0000 |
None |
1 |
3897 |
None |
None |
None |
None |
None |
None |
Raldesy is the only oral liquid formulation of trazodone hydrochloride |
None |
| Validus Pharmaceuticals |
30698045501 |
Trazodone Hydrochloride Oral Solution, 10mg/mL Raldesy TM 300ml HDPE Bottle Pack |
2025-03-17 |
486.0000 |
None |
1 |
5846 |
None |
None |
None |
None |
None |
None |
Raldesy is the only oral liquid formulation of trazodone hydrochloride |
None |
| Verrica Pharmaceuticals Inc. |
71349007011 |
YCANTH 0.7% (w/v) 1 applicator |
2025-01-21 |
685.0000 |
None |
1 |
40000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Vertex Pharmaceuticals Incorporated |
51167012101 |
ALYFTREK (vanzacaftor 10 mg/tezacaftor 50 mg/deutivacaftor 125 mg film-coated tablets) is supplied as a 56-count tablet carton (4 wallets, each wallet containing 14 tablets of vanzacaftor/tezacaftor/deutivacaftor). |
2025-01-13 |
28404.2200 |
Marketing Plan Description:
Vertex’s commercial field team in the United States is composed of a small number of individuals, and we focus our United States marketing activities for ALYFTREK™ towards a limited number of physicians and health care professionals who are located at Cystic Fibrosis (CF)-focused accredited centers (CF care centers) in the United States.
The objective of these activities is to raise awareness and understanding about the approved indication, dosing, efficacy and safety data that are consistent with ALYFTREK’s FDA approved label.
Specific activities related to physicians and health care professionals include print distribution by the commercial field team to CF care centers, digital advertising (e.g., ALYFTREK’s product website), and other educational programs.
Specific activities related to people living with CF and their caregivers include print distribution of patient materials to CF care centers and digital advertising (e.g., ALYFTREK’s product website and social media pages). Vertex does not engage in traditional direct-to-consumer advertising (e.g., television or mass media). While not part of Vertex’s marketing plan, Vertex also operates a comprehensive patient support program, known as Vertex Guidance & Patient Support (Vertex GPS™), which helps eligible patients who have been prescribed ALYTREK (vanzacaftor, tezacaftor, and deutivacaftor) access their medication and help them stay on track with treatment.
Pricing Plan Description:
Vertex is relentless in our pursuit of medical research to discover medicines that can prevent, cure or fundamentally change the outcomes of serious disease for patients and their families. Our pricing philosophy supports this mission and reflects the transformative clinical value of our medicines, our commitment to patient access and the investment required to bring new medicines to other serious diseases.
When determining our price, we consider a combination of factors, including clinical value and the benefit to patients, patient access, economic value and impact to healthcare systems, investment required for the ongoing discovery and development of new medicines for CF and other serious diseases with few or no treatment options.
ALYFTREK™ (vanzacaftor/tezacaftor/deutivacaftor) is a clinical advancement in the treatment of CF patients. It is a once-daily, next-in-class triple combination cystic fibrosis transmembrane conductance regulator (CFTR) modulator, that was studied in the most comprehensive Phase 3 pivotal program ever conducted in CF, including more than 1,000 patients, across more than 20 countries and more than 200 sites. Specifically, two randomized controlled trials (RCTs) versus TRIKAFTA™ (elexacaftor/tezacaftor/ivacaftor) in patients 12 years and older and a single-arm, open-label trial in patients 6-11 years of age. |
None |
28700 |
None |
1 |
None |
None |
None |
None |
Vertex estimates there are approximately 28,700 cystic fibrosis (CF) patients in the US with CF, ages 6 and older, who are eligible for ALYFTREK™ based on CF Registry data for 2024. Patients who are eligible for ALYFTREK have at least one F508del mutation, or another responsive mutation in the CFTR gene, and may also be eligible for other cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapies. |
None |
| Vertex Pharmaceuticals Incorporated |
51167013501 |
ALYFTREK (vanzacaftor 4 mg/tezacaftor 20 mg/deutivacaftor 50 mg film-coated tablets) is supplied as a 84-count tablet carton (4 wallets, each wallet containing 21 tablets of vanzacaftor/tezacaftor/deutivacaftor) |
2025-01-15 |
28404.2200 |
Marketing Plan Description:
Vertex’s commercial field team in the United States is composed of a small number of individuals, and we focus our United States marketing activities for ALYFTREK™ towards a limited number of physicians and health care professionals who are located at Cystic Fibrosis (CF)-focused accredited centers (CF care centers) in the United States.
The objective of these activities is to raise awareness and understanding about the approved indication, dosing, efficacy and safety data that are consistent with ALYFTREK’s FDA approved label.
Specific activities related to physicians and health care professionals include print distribution by the commercial field team to CF care centers, digital advertising (e.g., ALYFTREK’s product website), and other educational programs.
Specific activities related to people living with CF and their caregivers include print distribution of patient materials to CF care centers and digital advertising (e.g., ALYFTREK’s product website and social media pages). Vertex does not engage in traditional direct-to-consumer advertising (e.g., television or mass media). While not part of Vertex’s marketing plan, Vertex also operates a comprehensive patient support program, known as Vertex Guidance & Patient Support (Vertex GPS™), which helps eligible patients who have been prescribed ALYTREK (vanzacaftor, tezacaftor, and deutivacaftor) access their medication and help them stay on track with treatment.
Pricing Plan Description:
Vertex is relentless in our pursuit of medical research to discover medicines that can prevent, cure or fundamentally change the outcomes of serious disease for patients and their families. Our pricing philosophy supports this mission and reflects the transformative clinical value of our medicines, our commitment to patient access and the investment required to bring new medicines to other serious diseases.
When determining our price, we consider a combination of factors, including clinical value and the benefit to patients, patient access, economic value and impact to healthcare systems, investment required for the ongoing discovery and development of new medicines for CF and other serious diseases with few or no treatment options.
ALYFTREK™ (vanzacaftor/tezacaftor/deutivacaftor) is a clinical advancement in the treatment of CF patients. It is a once-daily, next-in-class triple combination cystic fibrosis transmembrane conductance regulator (CFTR) modulator, that was studied in the most comprehensive Phase 3 pivotal program ever conducted in CF, including more than 1,000 patients, across more than 20 countries and more than 200 sites. Specifically, two randomized controlled trials (RCTs) versus TRIKAFTA™ (elexacaftor/tezacaftor/ivacaftor) in patients 12 years and older and a single-arm, open-label trial in patients 6-11 years of age. |
None |
28700 |
None |
1 |
None |
None |
None |
None |
Vertex estimates there are approximately 28,700 cystic fibrosis (CF) patients in the US with CF, ages 6 and older, who are eligible for ALYFTREK™ based on CF Registry data for 2024. Patients who are eligible for ALYFTREK have at least one F508del mutation, or another responsive mutation in the CFTR gene, and may also be eligible for other cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapies. |
None |
| XGen Pharmaceuticals DJB |
39822065001 |
Nelarabine Injection 250mg/50mL Vial |
2025-02-17 |
350.0000 |
None |
1 |
500 |
None |
None |
None |
None |
None |
None |
None |
None |
| XGen Pharmaceuticals DJB |
39822065006 |
Nelarabine Injection 250mg/50mL x 6 |
2025-02-17 |
2100.0000 |
None |
1 |
500 |
None |
None |
None |
None |
None |
None |
None |
None |
| Zydus Pharmaceuticals (USA) Inc. |
83513001001 |
Beizray (Docet) Inj 80mg/4mL (160mg Kit) |
2025-03-03 |
7920.0000 |
None |
1 |
937639 |
None |
None |
None |
None |
None |
None |
Acquisition date and price are not applicable. Zydus has entered “937,639” in the “Estimated Number of Patients” column, however: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state nor nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4). Beizray is indicated for the treatment of patients with locally advanced or metastatic breast cancer, locally advanced or metastatic non-small cell lung cancer after failure or prior platinum based chemotherapy, for the tratment of patients with metastatic castration resistant prostate cancer, for the treatment of patients with advanced gastric adenocarcinoma and also for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck. The following websites were used to come up with our patient estimate - (https://www.cancer.gov/types/breast/hp/breast-treatment-pdq#:~:text=Incidence%20and%20Mortality,-Estimated%20new%20cases&text=Breast%20cancer%20is%20the%20most,section%20in%20Breast%20Cancer%20Screening.), (https://www.cdc.gov/united-states-cancer-statistics/publications/prostate-cancer-stat-bite.html#:~:text=What%20to%20know,males%20died%20from%20prostate%20cancer), (https://www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html#:~:text=Overall%2C%20the%20chance%20that%20a,the%20past%20decade%20in%20women.), (https://www.cancer.org/cancer/types/stomach-cancer/about/key-statistics.html#:~:text=About%2030%2C300%20new%20cases%20of,risk%20factors%20for%20stomach%20cancer), (https://www.cancer.gov/types/head-and-neck/head-neck-fact-sheet#:~:text=Researchers%20estimated%20that%20more%20than,cancer%20are%20much%20less%20common.) |
None |
| Zydus Pharmaceuticals (USA) Inc. |
70710174503 |
Dasatinib 100mg Tablets 30 Count |
2025-03-03 |
3120.1200 |
None |
1 |
70000 |
None |
None |
None |
None |
None |
None |
This is an AB rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has entered “70,000” in the “Estimated Number of Patients” column, however: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state nor nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4). Dasatinib is indicated for the treatment of newly diagnosed or previously treated Philadelphia chromosome positive chronic myeloid leukemia (Ph + CML). As per the Novartis Scemblix website (https://us.scemblix.com/about-ph-cml/ph-cml-chronic-phase) as of 2021, it was estimated that nearly 70,000 people in the United States were living with Ph+CML. For this reason we have put in a number of 70,000 in estimated number of patients. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
70710174603 |
Dasatinib 140mg Tablets 30 Count |
2025-03-03 |
3120.1200 |
None |
1 |
70000 |
None |
None |
None |
None |
None |
None |
This is an AB rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has entered “70,000” in the “Estimated Number of Patients” column, however: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state nor nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4). Dasatinib is indicated for the treatment of newly diagnosed or previously treated Philadelphia chromosome positive chronic myeloid leukemia (Ph + CML). As per the Novartis Scemblix website (https://us.scemblix.com/about-ph-cml/ph-cml-chronic-phase) as of 2021, it was estimated that nearly 70,000 people in the United States were living with Ph+CML. For this reason we have put in a number of 70,000 in estimated number of patients. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
70710174106 |
Dasatinib 20mg Tablets 30 Count |
2025-03-03 |
1731.1600 |
None |
1 |
70000 |
None |
None |
None |
None |
None |
None |
This is an AB rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has entered “70,000” in the “Estimated Number of Patients” column, however: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state nor nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4). Dasatinib is indicated for the treatment of newly diagnosed or previously treated Philadelphia chromosome positive chronic myeloid leukemia (Ph + CML). As per the Novartis Scemblix website (https://us.scemblix.com/about-ph-cml/ph-cml-chronic-phase) as of 2021, it was estimated that nearly 70,000 people in the United States were living with Ph+CML. For this reason we have put in a number of 70,000 in estimated number of patients. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
70710174206 |
Dasatinib 50mg Tablets 30 Count |
2025-03-03 |
3462.3200 |
None |
1 |
70000 |
None |
None |
None |
None |
None |
None |
This is an AB rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has entered “70,000” in the “Estimated Number of Patients” column, however: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state nor nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4). Dasatinib is indicated for the treatment of newly diagnosed or previously treated Philadelphia chromosome positive chronic myeloid leukemia (Ph + CML). As per the Novartis Scemblix website (https://us.scemblix.com/about-ph-cml/ph-cml-chronic-phase) as of 2021, it was estimated that nearly 70,000 people in the United States were living with Ph+CML. For this reason we have put in a number of 70,000 in estimated number of patients. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
70710174306 |
Dasatinib 70mg Tablets 30 Count |
2025-03-03 |
3462.3200 |
None |
1 |
70000 |
None |
None |
None |
None |
None |
None |
This is an AB rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has entered “70,000” in the “Estimated Number of Patients” column, however: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state nor nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4). Dasatinib is indicated for the treatment of newly diagnosed or previously treated Philadelphia chromosome positive chronic myeloid leukemia (Ph + CML). As per the Novartis Scemblix website (https://us.scemblix.com/about-ph-cml/ph-cml-chronic-phase) as of 2021, it was estimated that nearly 70,000 people in the United States were living with Ph+CML. For this reason we have put in a number of 70,000 in estimated number of patients. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
70710174403 |
Dasatinib 80mg Tablets 30 Count |
2025-03-03 |
3120.1200 |
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1 |
70000 |
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This is an AB rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has entered “70,000” in the “Estimated Number of Patients” column, however: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state nor nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4). Dasatinib is indicated for the treatment of newly diagnosed or previously treated Philadelphia chromosome positive chronic myeloid leukemia (Ph + CML). As per the Novartis Scemblix website (https://us.scemblix.com/about-ph-cml/ph-cml-chronic-phase) as of 2021, it was estimated that nearly 70,000 people in the United States were living with Ph+CML. For this reason we have put in a number of 70,000 in estimated number of patients. |
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