| G1 Therapeutics, Inc. |
73462010101 |
COSELA (trilaciclib) for injection, 300mg |
2021-03-01 |
1417.0000 |
None |
1 |
21000 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Genentech USA |
50242007855 |
Susvimo, 10mg/0.1ml Vial with Initial Fill Needle |
2021-11-29 |
8000.0000 |
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 |
288 |
None |
None |
None |
None |
None |
None |
Estimated number of patients per year.
Susvimo Fill Needle was not acquired from a 3rd party. |
None |
| Genentech USA |
50242007812 |
Susvimo, 10mg/0.1ml Vial, Refill Needle |
2021-11-29 |
8000.0000 |
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 |
84 |
None |
None |
None |
None |
None |
None |
Estimated number of patients for Susvimo refill needle is per year.
Susvimo was not acquired from a 3rd party. |
None |
| Gilead Sciences, Inc. |
61958220501 |
EPCLUSA® (sofosbuvir 150mg/velpatasvir 37.5mg) oral pellets, 28 packets |
2021-10-18 |
24920.0000 |
None |
1 |
None |
None |
1 |
None |
None |
None |
None |
The information provided in this report is subject to general limitations and assumptions Gilead has shared with HCAI (previously known as OSHPD). The limitations and assumptions address gaps in guidance related to the definition and interpretation of various data elements within New Drug Reports. Additionally, consistent with the relevant statutes and regulations, the information provided in this report is limited to that which Gilead believes is in the public domain or otherwise publicly available.
EPCLUSA oral pellets were granted orphan drug status by the FDA since it is estimated that, for the product, less than 200,000 patients in the U.S. are affected by a condition that it may be used to treat. However, Gilead is not aware of publicly available information related to the estimated number of patients that may be treated with EPCLUSA oral pellets. Consistent with Section 127681(c) of the California Health and Safety Code, Gilead is unable to provide an estimated number of patients in its report.
Gilead has not provided a response to the drug acquisition related data fields for this drug product because Gilead developed this drug product. |
None |
| Gilead Sciences, Inc. |
61958220401 |
EPCLUSA® (sofosbuvir 200mg/velpatasvir 50mg) oral pellets, 28 packets |
2021-10-18 |
24920.0000 |
None |
1 |
None |
None |
1 |
None |
None |
None |
None |
The information provided in this report is subject to general limitations and assumptions Gilead has shared with HCAI (previously known as OSHPD). The limitations and assumptions address gaps in guidance related to the definition and interpretation of various data elements within New Drug Reports. Additionally, consistent with the relevant statutes and regulations, the information provided in this report is limited to that which Gilead believes is in the public domain or otherwise publicly available.
EPCLUSA oral pellets were granted orphan drug status by the FDA since it is estimated that, for the product, less than 200,000 patients in the U.S. are affected by a condition that it may be used to treat. However, Gilead is not aware of publicly available information related to the estimated number of patients that may be treated with EPCLUSA oral pellets. Consistent with Section 127681(c) of the California Health and Safety Code, Gilead is unable to provide an estimated number of patients in its report.
Gilead has not provided a response to the drug acquisition related data fields for this drug product because Gilead developed this drug product. |
None |
| GlaxoSmithKline |
00173089803 |
JEMPERLI INJ 500MG/10ML |
2021-04-23 |
10369.3800 |
None |
1 |
2663 |
1 |
1 |
None |
None |
None |
None |
Endometrial cancer is a main type of uterine cancer that forms in the inner lining of the uterus, known as the endometrium. Endometrial cancer can be classified as mismatch repair-deficient/microsatellite instability-high (dMMR/MSI-H) or mismatch repair-proficient/microsatellite stable. There are limited treatment options for women whose disease progresses on or after first-line therapy.? Nearly 60,000 new cases of endometrial cancer are expected in the US in 2021, making endometrial cancer the most common gynaecologic malignancy in the US. Approximately 25% of women with endometrial cancer will be diagnosed with advanced disease or will experience a recurrence. Of these, approximately 25% will be mismatch repair deficient with 71% or approximately 2,663 patients having progressed on prior platinum-based chemotherapy and therefore eligible for JEMPERLI. Diagnosed patients may or may not be prescribed JEMPERLI (NDC: 00173089803) depending on their known resistance to the medicines and other patient specific factors such as allergic reactions or other medical conditions that may preclude a patient's ability to be effectively treated with JEMPERLI (NDC: 00173089803).
GSK has not released JEMPERLI's (NDC: 00173089803) marketing or pricing plan information in the public domain and is limiting its response to that which is publicly available pursuant to California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c). |
None |
| Glenmark Pharmaceuticals Inc., USA |
68462037130 |
Topiramate Extended-Release Capsules USP, 200 mg |
2021-02-05 |
730.3800 |
None |
1 |
152914 |
None |
None |
None |
None |
None |
None |
Marketing/Pricing Plan not in the public domain or publically available. Estimated patients not known. However, IQVIA MAT data for the 12 months ending December 2020 is 152,914 total prescriptions. Acquisition fields left blank as drug was developed by Glenmark. |
None |
| Glenmark Pharmaceuticals Inc., USA |
68462071308 |
RUFINAMIDE TABS 200MG 120 |
2021-06-01 |
901.1400 |
None |
1 |
82125 |
None |
None |
None |
None |
None |
None |
Marketing/Pricing Plan not in the public domain or publically available. Estimated patients not known. However, IQVIA MAT data for the 12 months ending April 2021 is 82,125 total prescriptions. Acquisition fields left blank as drug was developed by Glenmark. |
None |
| Glenmark Pharmaceuticals Inc., USA |
68462071408 |
RUFINAMIDE TABS 400MG 120 |
2021-06-01 |
1802.2700 |
None |
1 |
82125 |
None |
None |
None |
None |
None |
None |
Marketing/Pricing Plan not in the public domain or publically available. Estimated patients not known. However, IQVIA MAT data for the 12 months ending April 2021 is 82,125 total prescriptions. Acquisition fields left blank as drug was developed by Glenmark. |
None |
| Glenmark Pharmaceuticals Inc., USA |
68462068401 |
Sirolimus Tablets 2 mg |
2021-06-03 |
2777.5400 |
None |
1 |
209827 |
None |
None |
None |
None |
None |
None |
Marketing/Pricing Plan not in the public domain or publically available. Estimated patients not known. However, IQVIA MAT data for the 12 months ending April 2021 is 209,827 prescriptions. Acquisition fields left blank as drug was developed by Glenmark. |
None |
| Glenmark Pharmaceuticals Inc., USA |
68462083365 |
Arformoterol Tartrate Inhalation Solution 15 mcg/2ml 60X2ml |
2021-06-23 |
1026.5400 |
None |
1 |
279013 |
None |
None |
None |
None |
None |
None |
Marketing/Pricing Plan not in the public domain or publically available. Estimated patients not known. However, IQVIA MAT data for the 12 months ending May 2021 is 279,013 total prescriptions. Acquisition fields left blank as drug was developed by Glenmark. |
None |
| Granules Pharmaceuticals Inc. |
70010049709 |
Metformin Hydrochloride Extended-Release Tablets, USP 1000MG |
2021-02-12 |
2625.0000 |
None |
1 |
1000 |
None |
None |
None |
None |
None |
None |
The dates mentioned here are accurate and the dates appear on NDC lookup and Medspan are tentative marketing dates given during Initial ANDA SPL submission. |
None |
| Granules Pharmaceuticals Inc. |
70010049601 |
Metformin Hydrochloride Extended-Release Tablets, USP 500MG |
2021-02-12 |
1615.0000 |
None |
1 |
1000 |
None |
None |
None |
None |
None |
None |
The dates mentioned here are accurate and the dates appear on NDC lookup and Medspan are tentative marketing dates given during Initial ANDA SPL submission. |
None |