| Sagent Pharmaceuticals |
25021018984 |
Foscarnet Sodium Injection (24mg/ml, 250ml, 10x250ml) |
2021-07-01 |
4727.7000 |
Target vial users to convert to generic bags. No increases expected price competitive to tyye vials |
None |
1000 |
None |
None |
None |
None |
None |
None |
New Gx Entry |
None |
| Sandoz Inc. |
00781347432 |
CARMUSTINE 100MG/VL 1LYVI |
2021-06-17 |
1714.3000 |
This launch is specific to the U.S. Sandoz Inc. is contracting within the oncology and hospital space. Resources are available for hospital buyers. The WAC is priced lower than the WAC of the reference product. |
None |
169626 |
None |
None |
None |
None |
None |
None |
Carmustine for Injection, USP is indicated as palliative therapy as a single agent or in established combination therapy in the following: Brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors. Multiple myeloma in combination with prednisone. Relapsed or refractory Hodgkin's lymphoma in combination with other approved drugs. Relapsed or refractory Non-Hodgkin's lymphomas in combination with other approved drugs. Based on 2020 Kantar Health data, the prevalence of brain tumors and multiple myeloma (the two most common indications for this product) in the U.S. is approximately 169,626 individuals.
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. |
00781315401 |
FERUMOXYTOL INJ 510MG/17ML 1LIVI |
2021-07-15 |
869.1400 |
This launch is specific to the U.S. Sandoz Inc. is contracting within the oncology and hospital space. Resources are available for hospital buyers. The WAC is priced lower than the WAC of the reference product. |
None |
3000000 |
None |
None |
None |
None |
None |
None |
According to the National Heart, Lung, and Blood Institute, an estimated 3 million individuals suffer from anemia in the U.S. Increasing prevalence of target diseases, such as rheumatoid arthritis, autoimmune diseases, kidney conditions, cancer, liver disorders, thyroid diseases, and inflammatory bowel diseases, is a major factor facilitating the growth of the market for intravenous iron drugs. Some of the most common forms of anemia are iron and vitamin deficiency, a plastic, hemolytic, and sickle cell. Some of the common causes of anemia are iron, vitamin A and B12, and folate deficiencies. Source: https://www.grandviewresearch.com/industry-analysis/intravenous-iron-drugs-market
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 |
| Sanofi |
58468042601 |
NEXVIAZYME™ (avalglucosidase alfa-ngpt) |
2021-08-17 |
1714.9000 |
Marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by HCPs most likely to manage patients with Pompe disease, materials to be used by sales representatives to share information on NEXVIAZYME with prescribers, and materials to educate patients about Pompe and NEXVIAZYME. Direct to Consumer (DTC) outreach for NEXVIAZYME will include search, website, and online ad placements. DTC initiatives are not expected to include any TV, radio, or national magazine advertising.
Sanofi’s commitment to pricing rests on three principles: a holistic assessment of value when setting launch prices, year-over-year price increases that are limited to National Health Expenditure projections, and disclosure of our aggregate gross and net prices changes to provide greater transparency about the pricing of our medicines. These comprehensive principles were drafted to address questions around the price of medicines in the United States. Our goal is to make our medicines accessible and affordable to all patients. We share concerns about the affordability of medicines, and we believe deeply in the important role we play in providing treatments for serious illnesses. We are determined to do our part in pricing our medicines with greater transparency and according to their value, while continuing to advance scientific knowledge and bringing life-saving treatments to patients worldwide. As part of our commitment to ensure treatment access and affordability for innovative therapies, Sanofi has decided to price NEXVIAZYME the same as alglucosidase alfa, the only other FDA-approved therapy for the treatment of Pompe disease and the comparator arm in the pivotal study. |
None |
3500 |
1 |
1 |
None |
None |
None |
None |
Pompe disease is a rare, degenerative muscle disorder that can impact an individual’s ability to move and breathe. It affects an estimated 3,500 people in the United States (US) and can manifest at any age from infancy to late adulthood. |
https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=552 |
| Sarepta Therapeutics Inc |
60923022702 |
AMONDYS45 Casimersen 100MG/2mL injection vial in carton |
2021-02-25 |
1600.0000 |
Consistent with Section 127681(c) of the California Health and Safety Code, Sarepta is limiting its response to that which is otherwise in the public domain or publicly available. Sarepta’s marketing and pricing plans for AMONDYS 45 are neither in the public domain nor publicly available. |
None |
None |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": AMONDYS 45 is an antisense oligonucleotide from Sarepta’s phosphorodiamidate morpholino oligomer platform, indicated for the treatment of Duchenne muscular dystrophy in patients with a confirmed mutation amenable to exon 45 skipping. Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) |
None |
| Seattle Genetics, Inc. |
51144000301 |
TIVDAK™ (Tisotumab vedotin - tftv ) For injection, for intravenous use. 40mg vial |
2021-09-20 |
5885.0000 |
With regard to marketing plans, efforts to ensure that healthcare providers with appropriate patients are aware of Tivdak™ include customary digital and print media campaigns, oncology account managers sharing information with healthcare providers, and engagement of healthcare providers at congresses.
With regard to pricing plans, Seagen Inc has a passion for helping patients, and that passion includes ensuring that we reach as many of the patients with cancers that our products treat as we can. Our pricing considerations are informed by that passion, and we incorporate diverse perspectives of stakeholders in the healthcare system. We also consistently seek to balance rewarding innovation while providing appropriate access for patients. Finally, we consider the clinical value our products deliver to patients, the severity of the cancers we treat, availability of alternative treatments, market dynamics, our continued ability to deliver new state-of-the-art innovations in response to other deadly cancers, and the meaningful impact we make on patient’s lives. |
None |
0 |
1 |
1 |
None |
None |
None |
None |
Seagen Inc does not believe the estimated number of patients in the United States with a condition for which this product may be prescribed is in the public domain. Thus, consistent with 22 C.C.R. §96076(c), Seagen Inc has inserted zero in order to ensure report submission. Seagen Inc notes this product is indicated for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy, and we are able to provide the following publicly available information on cervical cancer more generally. Specifically, in 2020, there were 13,800 people diagnosed with cervical cancer in the United States. According to SEER statistics and published literature, 5,237 (out of the 13,800 incident CC patients in 2020) became eligible for 1L r/mCC treatment, among whom 2,619 (50% of 5,237) became eligible for 2L treatment. |
None |
| SK Life Science, Inc. |
71699010456 |
XCOPRI® Cenobamate Tablets 100mg(28)+150mg(28) |
2021-05-03 |
1029.3300 |
While specific marketing and pricing plans are not available in the public domain, generally, marketing activities that support the launch of a new medicine are designed to give healthcare providers and appropriate patients information about the new medicine, its approved indication(s), efficacy and safety data in accordance with the FDA approved label, this can be done through in-person promotion as well as digital and print advertising. When determining pricing of our medicines, we consider factors such as: how well the medicine works, particularly in comparison to other available treatments; the costs associated with discovering new medicines; and carefully consider how we can ensure that our medicine is available to people who need it. SK Life Science, Inc. does not market XCOPRI outside the US. |
None |
1800000 |
None |
None |
None |
None |
None |
None |
While SKLSI's estimated volume of patients who may be prescribed XCOPRI is not available in the public domain, XCOPRI is approved specifically for the treatment of adult patients with partial-onset seizures. The total number of partial-onset seizure patients in the US with this condition is estimated at 1.8 million. XCOPRI was developed by SK Life Sciences. XCOPRI® is a registered trademark of SK Biopharmaceuticals, Co., Ltd.” |
None |
| Sobi Inc |
66658050101 |
Gamifant10 mg/2 mL (5 mg/mL)SINGLE DOSE VIAL |
2021-01-01 |
6679.8000 |
continuing to perform same approach as we do for the NDC Label code it is replacing 72171 501-01 |
None |
12 |
1 |
1 |
None |
None |
None |
None |
1 vial 10mg- this is not commercial active yet as we are awaiting for NDC 72171-501-01 to be exhausted out of market place that will be circa May 2021 onwards. This is part of original BLA 761107. This NDC is replacing NDC 72171-501-01. There is no price difference of these same products different NDCs |
https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=467 |
| Sobi Inc |
66658050501 |
Gamifant50 mg/10 mL (5 mg/mL) SINGLE DOSE VIAL |
2021-01-01 |
16885.0500 |
continuing to perform same approach as we do for the NDC Label code it is replacing 72171 505-01 |
None |
10 |
1 |
1 |
None |
None |
None |
None |
1 vial 50mg- this is not commercial active yet as we are awaiting for NDC 72171-505-01 to be exhausted out of market place that will be circa February 2021 onwards. This is part of original BLA 761107. this new NDC is replacing NDC 72171-505-01. There is no price difference of these same products different NDCs |
https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=468 |
| Sobi Inc |
66658051001 |
Gamifant100 mg/20 mL (5 mg/mL)SINGLE DOSE VIAL |
2021-01-11 |
33770.1000 |
continuing to perform same approach as we do for the Gamifant Label that has and is currently approved. this is just a new strength drug to the product |
None |
6 |
1 |
1 |
None |
None |
None |
None |
1 vial 10mg- this is new NDC to part of original BLA 761107 Supplemental approval letter (BLA 761107/S-004) |
https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=469 |
| Solaris Pharma Corporation |
73473030275 |
Clindamycin Phosphate External Gel 1 %™ (clindamycin phosphate) 75mL per Bottle |
2021-09-17 |
888.6300 |
None |
1 |
45000000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Stratatech Corporation |
73612020001 |
StrataGraft® (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen - dsat) |
2021-10-22 |
4000.0000 |
In accordance with Mallinckrodt’s drug pricing pledge, we price our innovative drugs to reflect the value to patients, providers, and the healthcare system as a whole. StrataGraft is a highly specialized product used in the hospital setting for the treatment of deep partial thickness burns. The product will only be directly marketed to healthcare practitioners, including surgeons, operating in approximately 115 burn centers across the US. |
None |
10000 |
None |
1 |
None |
None |
None |
None |
According to the American Burn Association Fact Sheet (https://ameriburn.org/who-we-are/media/burn-incidence-fact-sheet/) on Burn Incidence, there are approximately 486,000 burn injuries that receive medical treatment on an annual basis. Of those, approximately 40,000 patients are hospitalized for their burns on an annual basis and approximately 25 percent of these patients receive an autograft during their stay and could potentially be eligible to receive Stratagraft. Stratagraft is only indicated for deep partial thickness burn treatment, and only a limited subset of patients would be eligible for treatment with this product. |
None |
| Strides Pharma, Inc. |
42543088904 |
Efavirenz Tablets 600mg |
2021-03-26 |
894.3200 |
This product is marketed in the generic multisource space, and therefore marketing of the product is not based on any aspects of the product itself, but its price and availability. For these reasons, Strides Pharma Inc.("Strides")does not interact with healthcare providers including physicians, hospital groups, group purchasing organizations, or other entities to promote Strides' products.
The methodology that Strides uses to set the wholesale acquisition price("WAC") was to discount the reference drug price or match the lowest generic WACs available at the time of the product launch. Strides uses a subscription-based service, Medi-Span Price Rx, in obtaining this information to reflect a discount off of the Reference Drug listed by the FDA. Therefore, Cost-based, quality-adjusted, or value-based pricing were not used to establish WAC for this product. |
None |
1200000 |
None |
None |
None |
None |
None |
None |
The reason for leaving the acquisition-related fields blank was because Strides developed the drug. The source for the estimated patients is Hiv.gov, an official US government website managed by the US Department of Health & Human Services. |
None |
| Strides Pharma, Inc. |
42543071904 |
Emtricitabine & Tenofovir Disoproxil Fumarate Tablets 200/300mg |
2021-03-26 |
1455.4000 |
This product is marketed in the generic multisource space, and therefore marketing of the product is not based on any aspects of the product itself, but its price and availability. For these reasons, Strides Pharma Inc.("Strides")does not interact with healthcare providers including physicians, hospital groups, group purchasing organizations, or other entities to promote Strides' products.
The methodology that Strides uses to set the wholesale acquisition price("WAC") was to discount the reference drug price or match the lowest generic WACs available at the time of the product launch. Strides uses a subscription-based service, Medi-Span Price Rx, in obtaining this information to reflect a discount off of the Reference Drug listed by the FDA. Therefore, Cost-based, quality-adjusted, or value-based pricing were not used to establish WAC for this product. |
None |
1200000 |
None |
None |
None |
None |
None |
None |
The reason for leaving the acquisition-related fields blank was because Strides developed the drug. The source for the estimated patients is Hiv.gov, an official US government website managed by the US Department of Health & Human Services. |
None |
| SUN PHARMACEUTICALS |
63304008690 |
Droxidopa Caps 100mg 90ct |
2021-02-19 |
740.0000 |
This product is being marketed in the generic, multisource space. This product is priced to reflect a discount off of the Reference Drug listed by the FDA. Sun representatives, who are responsible for generic sales, do not promote to health care providers. |
None |
0 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
63304010490 |
Droxidopa Caps 200mg 90ct |
2021-02-19 |
1080.0000 |
This product is being marketed in the generic, multisource space. This product is priced to reflect a discount off of the Reference Drug listed by the FDA. Sun representatives, who are responsible for generic sales, do not promote to health care providers. |
None |
0 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
63304011290 |
Droxidopa Caps 300mg 90ct |
2021-02-19 |
1440.0000 |
This product is being marketed in the generic, multisource space. This product is priced to reflect a discount off of the Reference Drug listed by the FDA. Sun representatives, who are responsible for generic sales, do not promote to health care providers. |
None |
0 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
57664002597 |
Isotretinoin Capsules 40mg 3 x 10 Packs |
2021-04-27 |
915.1300 |
• ABSORICA LD is the only isotretinoin formulation to feature Sun Pharma’s micronization technology, which utilizes micronized particles to optimize absorption at a 20% lower dose. ABSORICA LD can be taken with or without food removing uncertainty surrounding timing of dosing and making absorption more predictable • ABSORICA LD also delivers twice the level of absorption of ABSORICA in a fasted state, with a comparable safety profile. ABSORICA LD is not substitutable with any other currently available isotretinoin. |
None |
10000000 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
57664002097 |
Isotretinoin Capsules 10mg 3 x 10 Packs |
2021-04-29 |
850.5400 |
• ABSORICA LD is the only isotretinoin formulation to feature Sun Pharma’s micronization technology, which utilizes micronized particles to optimize absorption at a 20% lower dose. ABSORICA LD can be taken with or without food removing uncertainty surrounding timing of dosing and making absorption more predictable • ABSORICA LD also delivers twice the level of absorption of ABSORICA in a fasted state, with a comparable safety profile. ABSORICA LD is not substitutable with any other currently available isotretinoin. |
None |
10000000 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
57664002197 |
Isotretinoin Capsules 20mg 3 x 10 Packs |
2021-04-29 |
850.5400 |
• ABSORICA LD is the only isotretinoin formulation to feature Sun Pharma’s micronization technology, which utilizes micronized particles to optimize absorption at a 20% lower dose. ABSORICA LD can be taken with or without food removing uncertainty surrounding timing of dosing and making absorption more predictable • ABSORICA LD also delivers twice the level of absorption of ABSORICA in a fasted state, with a comparable safety profile. ABSORICA LD is not substitutable with any other currently available isotretinoin. |
None |
10000000 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
57664002297 |
Isotretinoin Capsules 25mg 3 x 10 Packs |
2021-04-29 |
915.1300 |
• ABSORICA LD is the only isotretinoin formulation to feature Sun Pharma’s micronization technology, which utilizes micronized particles to optimize absorption at a 20% lower dose. ABSORICA LD can be taken with or without food removing uncertainty surrounding timing of dosing and making absorption more predictable • ABSORICA LD also delivers twice the level of absorption of ABSORICA in a fasted state, with a comparable safety profile. ABSORICA LD is not substitutable with any other currently available isotretinoin. |
None |
10000000 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
57664002397 |
Isotretinoin Capsules 30mg 3 x 10 Packs |
2021-04-29 |
915.1300 |
• ABSORICA LD is the only isotretinoin formulation to feature Sun Pharma’s micronization technology, which utilizes micronized particles to optimize absorption at a 20% lower dose. ABSORICA LD can be taken with or without food removing uncertainty surrounding timing of dosing and making absorption more predictable • ABSORICA LD also delivers twice the level of absorption of ABSORICA in a fasted state, with a comparable safety profile. ABSORICA LD is not substitutable with any other currently available isotretinoin. |
None |
10000000 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
57664002497 |
Isotretinoin Capsules 35mg 3 x 10 Packs |
2021-04-29 |
915.1300 |
• ABSORICA LD is the only isotretinoin formulation to feature Sun Pharma’s micronization technology, which utilizes micronized particles to optimize absorption at a 20% lower dose. ABSORICA LD can be taken with or without food removing uncertainty surrounding timing of dosing and making absorption more predictable • ABSORICA LD also delivers twice the level of absorption of ABSORICA in a fasted state, with a comparable safety profile. ABSORICA LD is not substitutable with any other currently available isotretinoin. |
None |
10000000 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
63304009127 |
Sunitinib Malate Capsules 12.5mg 28ct |
2021-08-16 |
5092.7900 |
This product is being marketed in the generic, multisource space. This product is priced to reflect a discount off of the Reference Drug listed by the FDA. Sun representatives, who are responsible for generic sales, do not promote to health care providers. This product (ANDA approval) is being marketed in the generic, multisource space. This product is priced to reflect a discount off of the Reference Drug listed by the FDA. |
None |
4999 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
63304009227 |
Sunitinib Malate Capsules 25mg 28ct |
2021-08-16 |
10185.5900 |
This product is being marketed in the generic, multisource space. This product is priced to reflect a discount off of the Reference Drug listed by the FDA. Sun representatives, who are responsible for generic sales, do not promote to health care providers. This product (ANDA approval) is being marketed in the generic, multisource space. This product is priced to reflect a discount off of the Reference Drug listed by the FDA. |
None |
4999 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
63304009327 |
Sunitinib Malate Capsules 37.5mg 28ct |
2021-08-16 |
15278.3900 |
This product is being marketed in the generic, multisource space. This product is priced to reflect a discount off of the Reference Drug listed by the FDA. Sun representatives, who are responsible for generic sales, do not promote to health care providers. This product (ANDA approval) is being marketed in the generic, multisource space. This product is priced to reflect a discount off of the Reference Drug listed by the FDA. |
None |
4999 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
63304009427 |
Sunitinib Malate Capsules 50mg 28ct |
2021-08-16 |
17731.6700 |
This product is being marketed in the generic, multisource space. This product is priced to reflect a discount off of the Reference Drug listed by the FDA. Sun representatives, who are responsible for generic sales, do not promote to health care providers. This product (ANDA approval) is being marketed in the generic, multisource space. This product is priced to reflect a discount off of the Reference Drug listed by the FDA. |
None |
4999 |
None |
None |
None |
None |
None |
None |
None |
None |