| GlaxoSmithKline |
00173089201 |
NUCALA INJ 100 MG/ML |
2019-06-17 |
2954.7300 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
Regarding estimated number of patients in the US that may be prescribed NUCALA (NDC: 00173089201) for severe eosinophilic asthma, GSK has not released this 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). Regarding estimated number of patients in the US that may be prescribed NUCALA (NDC: 00173089201) for its second indication, Eosinophilic Granulomatosis with Polyangiitis (EGPA), approximately five people out of every one million will be diagnosed with EGPA each year worldwide. Diagnosed patients may or may not be prescribed NUCALA (NDC: 00173089201) 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 NUCALA (NDC: 00173089201). GSK has not released NUCALA's (NDC: 00173089201) 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). NUCALA (NDC: 00173089201) was developed by GSK. |
None |
| GlaxoSmithKline |
00173089242 |
NUCALA INJ 100 MG/ML |
2019-06-17 |
2954.7300 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
Regarding estimated number of patients in the US that may be prescribed NUCALA (NDC: 00173089242) for severe eosinophilic asthma, GSK has not released this 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). Regarding estimated number of patients in the US that may be prescribed NUCALA (NDC: 00173089242) for its second indication, Eosinophilic Granulomatosis with Polyangiitis (EGPA), approximately five people out of every one million will be diagnosed with EGPA each year worldwide. Diagnosed patients may or may not be prescribed NUCALA (NDC: 00173089242) 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 NUCALA (NDC: 00173089242). GSK has not released NUCALA's (NDC: 00173089242) 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). NUCALA (NDC: 00173089242) was developed by GSK. |
None |
| Genentech USA |
50242014301 |
Actemra Pen - 162mg (0.9mL) |
2019-01-07 |
984.7200 |
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 |
None |
1 |
1 |
None |
None |
None |
None |
Genentech does not publicly disclose the estimated volume of patients who may be prescribed Actemra Pen - 162mg (0.9mL). |
None |
| Genentech USA |
50242091801 |
Tecentriq 840 mg (14mL) |
2019-03-23 |
6216.3800 |
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 |
0 |
None |
None |
None |
None |
None |
None |
Genentech does not publicly disclose the estimated volume of patients who may be prescribed Tecentriq – 840mg (14mL). Tecentriq – 840mg (14mL) was developed by Genentech. |
None |
| Genentech USA |
50242007701 |
Herceptin Hylecta - 600mg (5mL) Inject Sol |
2019-04-08 |
4675.2400 |
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 |
0 |
None |
None |
None |
None |
None |
None |
Genentech does not publicly disclose the estimated volume of patients who may be prescribed Herceptin Hylecta - 600mg (5mL) Inject Sol. Herceptin Hylecta - 600mg (5mL) Inject Sol. was developed by Genentech USA Inc. |
None |
| Genentech USA |
50242010501 |
Polivy 140mg Vial |
2019-06-10 |
15000.0000 |
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 |
0 |
1 |
1 |
None |
None |
None |
None |
Genentech does not publicly disclose the estimated volume of patients who may be prescribed Polivy 140mg Vial. Polivy 140mg Vial was developed on Genentech USA Inc |
None |
| Genentech USA |
50242009130 |
Rozlytrek 100 mg 30 capsules |
2019-08-22 |
5600.0000 |
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 |
0 |
1 |
1 |
None |
None |
None |
None |
Rozlytrek 100mg 30 capsules was not acquired from a third party. Genentech does not publicly disclose the estimated volume of patients who may be prescribed Rozlytrek 100mg 30 capsules. |
None |
| Genentech USA |
50242009490 |
Rozlytrek 200 mg 90 capsules |
2019-08-21 |
16800.0000 |
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 |
0 |
1 |
1 |
None |
None |
None |
None |
Rozlytrek 200mg 90 capsules was not acquired from a third party. Genentech does not publicly disclose the estimated volume of patients who may be prescribed Rozlytrek 200mg 90 capsules. |
None |
| Granules Pharmaceuticals Inc. |
70010004101 |
Amphetamine Sulfate Tablets USP 10 MG, 100 count |
2019-10-07 |
465.5000 |
None |
1 |
0 |
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 |
| Glenmark Pharmaceuticals Inc., USA |
68462042121 |
Atovaquone Oral Suspension USP |
2019-01-15 |
800.0000 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
Marketing/Pricing Plan not in the public domain or publically available. Estimated patients not known. Acquisition fields left blank as drug was developed by Glenmark. |
None |
| Glenmark Pharmaceuticals Inc., USA |
68462044626 |
Sevelamer Hydrochloride Tablets |
2019-02-08 |
1158.3200 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
Marketing/Pricing Plan not in the public domain or publically available. Estimated patients not known. Acquisition fields left blank as drug was developed by Glenmark. |
None |
| Glenmark Pharmaceuticals Inc., USA |
68462044718 |
Sevelamer Hydrochloride Tablets |
2019-02-08 |
1158.3200 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
Marketing/Pricing Plan not in the public domain or publically available. Estimated patients not known. Acquisition fields left blank as drug was developed by Glenmark. |
None |
| Glenmark Pharmaceuticals Inc., USA |
68462060994 |
Pimecrolimus Cream, 1% |
2019-09-24 |
845.4300 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
Marketing/Pricing Plan not in the public domain or publically available. Estimated patients not known, however IQVIA data for the 12 months ending August 2019 is 445,483 prescriptions for Pimecrolimus cream,1%. Acquisition fields left blank as drug was developed by Glenmark. |
None |
| Glenmark Pharmaceuticals Inc., USA |
68462031732 |
Fulvestrant Injection, 250 mg/5 mL (50 mg/mL) |
2019-11-04 |
1745.1500 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
Marketing/Pricing Plan not in the public domain or publically available. Estimated patients not known. However, according to the American Cancer Society’s Breast Cancer Facts & Figures 2019-2020 report, in 2019, an estimated 268,600 new cases of invasive breast cancer will be diagnosed among women. Acquisition fields left blank as drug was co-developed by Glenmark and Glenmark is the ANDA holder. |
None |
| Glenmark Pharmaceuticals Inc., USA |
68462052001 |
Metformin Hydrochloride Extended-Release Tablets USP 500 mg |
2019-12-27 |
1615.0000 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
Marketing/Pricing Plan not in the public domain or publically available. Estimated patients not known. However, however IQVIA data for the 12 months ending November 2019 is 170,821 prescriptions for Metformin Extended Release Tablets. Acquisition fields left blank as drug was developed by Glenmark. |
None |
| Glenmark Pharmaceuticals Inc., USA |
68462052190 |
Metformin Hydrochloride Extended-Release Tablets USP 1000 mg |
2019-12-27 |
2625.0000 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
Marketing/Pricing Plan not in the public domain or publically available. Estimated patients not known. However, however IQVIA data for the 12 months ending November 2019 is 170,821 prescriptions for Metformin Extended Release Tablets. Acquisition fields left blank as drug was developed by Glenmark. |
None |
| Grifols USA, LLC |
13553081005 |
Xembify immune globulin subcutaneous, human-klhw, 20% 1GM |
2019-11-12 |
171.0000 |
None |
1 |
500000 |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions. (1) |
Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Grifols believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Grifols has left the marketing and pricing plan description data field blank. (2) |
| Grifols USA, LLC |
13553081010 |
Xembify immune globulin subcutaneous, human-klhw, 20% 2GM |
2019-11-12 |
342.0000 |
None |
1 |
500000 |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions. (1) |
Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Grifols believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Grifols has left the marketing and pricing plan description data field blank. (2) |
| Grifols USA, LLC |
13553081020 |
Xembify immune globulin subcutaneous, human-klhw, 20% 4GM |
2019-11-12 |
684.0000 |
None |
1 |
500000 |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions. (1) |
Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Grifols believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Grifols has left the marketing and pricing plan description data field blank. (2) |
| Grifols USA, LLC |
13553081050 |
Xembify immune globulin subcutaneous, human-klhw, 20% 10GM |
2019-11-12 |
1710.0000 |
None |
1 |
500000 |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions. (1) |
Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Grifols believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Grifols has left the marketing and pricing plan description data field blank. (2) |
| Global Blood Therapeutics, Inc. |
72786010101 |
Oxbryta™ (voxelotor) 500 mg Tablets 90ct (recommended dosage of 1,500 mg/day) |
2019-12-04 |
10417.0000 |
None |
1 |
None |
1 |
1 |
None |
None |
None |
None |
California law provides that manufacturers may limit the information reported to that which is otherwise in the public domain or publicly available. Global Blood Therapeutics, Inc. (GBT) has publicly stated that it will not increase the list price of OXBRYTA for three years and that any future price increases will be tied to inflation. GBT’s marketing and pricing plans used in the launch of OXBRYTA are not otherwise in the public domain or publicly available. |
https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=332 |
| Granules Pharmaceuticals Inc. |
70010049101 |
Metformin Hydrochloride Extended-Release Tablets USP 500 MG, 100 count |
2019-03-21 |
4.7500 |
None |
1 |
0 |
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. |
70010049105 |
Metformin Hydrochloride Extended-Release Tablets USP 500 MG, 500 count |
2019-03-21 |
21.4500 |
None |
1 |
0 |
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. |
70010049201 |
Metformin Hydrochloride Extended-Release Tablets USP 750 MG, 100 count |
2019-03-21 |
7.2200 |
None |
1 |
0 |
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. |
70010049205 |
Metformin Hydrochloride Extended-Release Tablets USP 750 MG, 500 count |
2019-03-21 |
36.1200 |
None |
1 |
0 |
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. |
70010001201 |
Methylphenidate Hydrochloride Extended-Release Capsules 10 MG 100 count |
2019-09-19 |
305.0000 |
None |
1 |
0 |
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. |
70010001301 |
Methylphenidate Hydrochloride Extended-Release Capsules 20 MG 100 count |
2019-09-10 |
204.0200 |
None |
1 |
0 |
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. |
70010001401 |
Methylphenidate Hydrochloride Extended-Release Capsules 30 MG 100 count |
2019-09-16 |
208.9100 |
None |
1 |
0 |
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. |
70010001501 |
Methylphenidate Hydrochloride Extended-Release Capsules 40 MG 100 count |
2019-09-16 |
213.8100 |
None |
1 |
0 |
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. |
70010001603 |
Methylphenidate Hydrochloride Extended-Release Capsules 60 MG 30 count |
2019-09-19 |
322.9300 |
None |
1 |
0 |
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. |
70010004201 |
Methylphenidate Hydrochloride Extended-Release Tablets USP 10 MG 100 count |
2019-05-16 |
55.4400 |
None |
1 |
0 |
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. |
70010004301 |
Methylphenidate Hydrochloride Extended-Release Tablets USP 20 MG 100 count |
2019-05-16 |
57.1100 |
None |
1 |
0 |
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. |
70010004001 |
Amphetamine Sulfate Tablets USP 5 MG, 100 count |
2019-10-15 |
465.5000 |
None |
1 |
0 |
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 |