| SUN PHARMACEUTICALS |
47335093640 |
Leuprolide Acetate Injection 1Mg/0.2Ml, 2.8Ml |
2019-03-01 |
705.6700 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
ESTIMATED_PATIENTS: unknown to Sun; MARKETING_PRICING_NONPUBLIC:This information is proprietary to Sun and as such, is non-public. |
None |
| SUN PHARMACEUTICALS |
47335023683 |
Ambrisentan 5 mg Tabs 30ct |
2019-04-25 |
7500.0000 |
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 |
Estimated average of patients per month is unknown to Sun Pharma. This product (ANDA approval) is being marketed in the generic, multisource space. |
None |
| SUN PHARMACEUTICALS |
47335023783 |
Ambrisentan 10 mg Tabs 30ct |
2019-04-25 |
7500.0000 |
This product is priced to reflect a discount off of the Reference Drug listed by the FDA. Sun representatives, who are responsible for teneric sales, do not promote to health care providers. |
None |
0 |
None |
None |
None |
None |
None |
None |
Estimated average of patients per month is unknown to Sun Pharma. This product (ANDA approval) is being marketed in the generic, multisource space. |
None |
| SUN PHARMACEUTICALS |
47335003886 |
Bosentan Tablets 62.5mg 60ct |
2019-06-14 |
6281.0700 |
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 |
Estimated average of patients per month is unknown to Sun Pharma. This product (ANDA approval) is being marketed in the generic, multisource space. |
None |
| SUN PHARMACEUTICALS |
47335003986 |
Bosentan Tablets 125mg 60ct |
2019-06-14 |
6281.0700 |
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 |
Estimated average of patients per month is unknown to Sun Pharma. This product (ANDA approval) is being marketed in the generic, multisource space. |
None |
| SUN PHARMACEUTICALS |
63304073410 |
Esomeprazole 20mg DR Cap 1000ct |
2019-05-15 |
826.7100 |
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 |
Estimated average of patients per month is unknown to Sun Pharma. This product (ANDA approval) is being marketed in the generic, multisource space. |
None |
| SUN PHARMACEUTICALS |
63304073510 |
Esomeprazole 40mg DR Cap 1000ct |
2019-05-07 |
826.7100 |
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 |
Estimated average of patients per month is unknown to Sun Pharma. This product (ANDA approval) is being marketed in the generic, multisource space. |
None |
| SUN PHARMACEUTICALS |
47335037983 |
Cinacalcet HCL Oral Tablet 30MG |
2019-08-27 |
685.7000 |
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 |
Estimated average of patients per month is unknown to Sun Pharma; Sun received FDA approval for the drug’s ANDA application (Application number A207008) |
None |
| SUN PHARMACEUTICALS |
47335038083 |
Cinacalcet HCL Oral Tablet 60MG |
2019-08-27 |
1371.3900 |
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. |
None |
0 |
None |
None |
None |
None |
None |
None |
Estimated average of patients per month is unknown to Sun Pharma; Sun received FDA approval for the drug’s ANDA application (Application number A207008) |
None |
| SUN PHARMACEUTICALS |
47335060083 |
Cinacalcet HCL Oral Tablet 90MG |
2019-08-27 |
2057.0900 |
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 |
Estimated average of patients per month is unknown to Sun Pharma; Sun received FDA approval for the drug’s ANDA application (Application number A207008) |
None |
| SUN PHARMACEUTICALS |
63304009530 |
Erlotinib Tab 25mg/30ct |
2019-11-11 |
2481.0000 |
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 |
None |
None |
None |
None |
None |
None |
None |
Estimated average of patients per month is unknown to Sun; the reason for leaving the acquisition-related fields blank was because Sun Pharmaceuticals developed the drugs. |
None |
| SUN PHARMACEUTICALS |
63304009630 |
Erlotinib Tab 100mg/30ct |
2019-11-11 |
6445.8200 |
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 |
None |
None |
None |
None |
None |
None |
None |
Estimated average of patients per month is unknown to Sun; the reason for leaving the acquisition-related fields blank was because Sun Pharmaceuticals developed the drugs |
None |
| SUN PHARMACEUTICALS |
63304013530 |
Erlotinib Tab 150mg/30ct |
2019-11-11 |
7302.0100 |
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 |
None |
None |
None |
None |
None |
None |
None |
Estimated average of patients per month is unknown to Sun; the reason for leaving the acquisition-related fields blank was because Sun Pharmaceuticals developed the drugs |
None |
| SUN PHARMACEUTICALS |
62756009045 |
MEDROXYPROGESTERONE 150 mg/ml 1 ml Vial 25pk |
2019-10-02 |
2036.3800 |
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 |
None |
None |
None |
None |
None |
None |
None |
1. Estimated average of patients per month is unknown to Sun 2. A limited amount of this NDC11 was only sold to a single Wholesaler on 10/2/2019 prior to the official commercial launch date of 11/20/19. ON 11/20/19 both the trade and the compendia were notified of the launch as of that date 3. The reason for leaving the acquisition-related fields blank was because Sun Pharmaceuticals developed the drugs |
None |
| SUN PHARMACEUTICALS |
62756057083 |
Deferasirox OS Tab 500mg 30ct |
2019-12-17 |
760.0800 |
This product is being marketed in the generic, multi source 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 |
Estimated average of patients per month is unknown to Sun Pharma. This drug was not acquired. |
https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=333 |
| Sanofi |
05846802271 |
Cablivi (caplacizumab-yhdp) |
2019-04-02 |
7300.0000 |
Marketing initiatives include print and digital media, engagement at scientific meetings attended by HCPs most likely to manage patients with acquired thrombotic thrombocytopenic purpura (aTTP), materials to be used by sales representatives to share information on caplacizumab with prescribers, and materials to educate patients about aTTP. 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 disclose 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. |
None |
1800 |
None |
1 |
None |
None |
None |
None |
Ablynx, a Sanofi Company, was acquired by Sanofi in 2018. |
None |
| Sandoz Inc. |
00781342080 |
TREPROSTINIL INJECTION 20MG/20ML (1MG/ML) 1LIVI |
2019-03-25 |
1145.9900 |
Sandoz Inc. currently only sells treprostinil in the U.S. Sandoz Inc.'s commercialization partner has sales resources in the field detailing this product to healthcare providers. The WAC is priced lower than the brand WAC. |
None |
52000 |
None |
None |
None |
None |
None |
None |
Estimated number of patients is approximately 52,000, based on patients that have been diagnosed with Pulmonary Arterial Hypertension (PAH) in the United States. Source: (DataMonitor) 2016 Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product |
https://oshpd.ca.gov/ml/v1/resources/document?rs:path=/Data-And-Reports/Documents/Topics/Cost-Transparency/Rx/Q2-New-Drug-Public-Release-Supporting-Documents/California-SB17-New-Drug-Report-Submission-ID-90776.pdf |
| Sandoz Inc. |
00781342580 |
TREPROSTINIL INJECTION 50MG/20ML (2.5MG/ML) 1LIVI |
2019-03-25 |
2864.9700 |
Sandoz Inc. currently only sells treprostinil in the U.S. Sandoz Inc.'s commercialization partner has sales resources in the field detailing this product to healthcare providers. The WAC is priced lower than the brand WAC. |
None |
52000 |
None |
None |
None |
None |
None |
None |
Estimated number of patients is approximately 52,000, based on patients that have been diagnosed with Pulmonary Arterial Hypertension (PAH) in the United States. Source: (DataMonitor) 2016 Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product |
https://oshpd.ca.gov/ml/v1/resources/document?rs:path=/Data-And-Reports/Documents/Topics/Cost-Transparency/Rx/Q2-New-Drug-Public-Release-Supporting-Documents/California-SB17-New-Drug-Report-Submission-ID-90776.pdf |
| Sandoz Inc. |
00781342780 |
TREPROSTINIL INJECTION 100MG/20ML (5MG/ML) 1LIVI |
2019-03-25 |
5729.9400 |
Sandoz Inc. currently only sells treprostinil in the U.S. Sandoz Inc.'s commercialization partner has sales resources in the field detailing this product to healthcare providers. The WAC is priced lower than the brand WAC. |
None |
52000 |
None |
None |
None |
None |
None |
None |
Estimated number of patients is approximately 52,000, based on patients that have been diagnosed with Pulmonary Arterial Hypertension (PAH) in the United States. Source: (DataMonitor) 2016 Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product |
https://oshpd.ca.gov/ml/v1/resources/document?rs:path=/Data-And-Reports/Documents/Topics/Cost-Transparency/Rx/Q2-New-Drug-Public-Release-Supporting-Documents/California-SB17-New-Drug-Report-Submission-ID-90776.pdf |
| Sandoz Inc. |
00781343080 |
TREPROSTINIL INJECTION 200MG/20ML (10MG/ML) 1LIVI |
2019-03-25 |
11459.8800 |
Sandoz Inc. currently only sells treprostinil in the U.S. Sandoz Inc.'s commercialization partner has sales resources in the field detailing this product to healthcare providers. The WAC is priced lower than the brand WAC. |
None |
52000 |
None |
None |
None |
None |
None |
None |
Estimated number of patients is approximately 52,000, based on patients that have been diagnosed with Pulmonary Arterial Hypertension (PAH) in the United States. Source: (DataMonitor) 2016 Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product |
https://oshpd.ca.gov/ml/v1/resources/document?rs:path=/Data-And-Reports/Documents/Topics/Cost-Transparency/Rx/Q2-New-Drug-Public-Release-Supporting-Documents/California-SB17-New-Drug-Report-Submission-ID-90776.pdf |
| Sandoz Inc. |
00781307912 |
FULVESTRANT 250MG/5ML 2LISY |
2019-05-29 |
1745.1500 |
This launch is specific to the U.S. Sandoz Inc. is currently contracting within the oncology space. The WAC is priced lower than the WAC of the reference product. |
None |
187628 |
None |
None |
None |
None |
None |
None |
Sandoz’s Fulvestrant Injection is a hormonal therapy medicine used to treat breast cancer in women with: Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer, who have gone through menopause and have not been previously treated with endocrine therapy, HR-positive advanced breast cancer, who have gone through menopause and whose disease has progressed after endocrine therapy, HR-positive, HER2-negative advanced breast cancer or breast cancer that has spread to other parts of the body (metastatic), in combination with palbociclib or abemaciclib in women whose disease has progressed after endocrine therapy. According to Kantar Health, there is an estimated 187,628 patients with this condition in the United States. Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product. |
https://oshpd.ca.gov/ml/v1/resources/document?rs:path=/Data-And-Reports/Documents/Topics/Cost-Transparency/Rx/Q2-New-Drug-Public-Release-Supporting-Documents/California-SB17-New-Drug-Report-Submission-ID-103955.pdf |
| Sandoz Inc. |
61314086601 |
ZIEXTENZO 6MG/0.6ML 1LISY |
2019-11-12 |
3925.5300 |
This launch is specific to the U.S., however, Sandoz biosimilar pegfilgrastim has been approved and marketed in Europe as Ziextenzo (pegfilgrastim) since 2018. Sandoz Inc. is currently contracting within the oncology space. The WAC is priced lower than the WAC of the reference product. |
None |
108419 |
None |
None |
None |
None |
None |
None |
>650,000 patients with cancer receive chemotherapy annually in the United States. Treatment of cancer with chemotherapy may lead to bone marrow suppression, which can mask the early signs and symptoms of an infection as well as diminish the patient’s capacity to fight infections. Neutropenia and subsequent infectious complications are some of the most serious treatment-related toxicities of chemotherapy for cancer and result in preventable morbidity and mortality. Previous estimates indicate that >60,000 persons with cancer are hospitalized with neutropenia and >4,000 persons die of febrile neutropenia each year in the United States. To decrease the incidence of infection to Patients with cancer receiving myelosuppressive chemotherapy . For 2012, sources identified 91,560 cancer-related neutropenia hospitalizations among adults and 16,859 cancer-related neutropenia hospitalizations among children in the NIS and KID data. (Source: CDC,https://www.cdc.gov/cancer/dcpc/research/articles/neutropenia.htm) . 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 |
| Servier Pharmaceuticals LLC |
72694051501 |
Asparlas 750 U/mL 5 mL vials |
2019-11-29 |
24000.0000 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
The “Estimated Number of Patients” field was left blank because the estimated number of patients is not known to Servier. While the estimated volume of patients who may be prescribed Asparlas is not known to Servier, Asparlas is approved specifically for the treatment of acute lymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 years. In the U.S., the National Cancer Institute estimates that approximately 5,930 people (of all ages) will be diagnosed with acute lymphoblastic leukemia in 2019. Regarding the estimated number of patients in the US that may be prescribed Asparlas for acute lymphoblastic leukemia, Servier 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). The “Acquisition Date” and “Acquisition Price” fields were left blank because the product was approved under a new drug application for Servier and Servier is the first manufacturer to market the product. Also, please note that the Introduced to Market Date" should read 11/13/2019. |
None |
| Sarepta Therapeutics Inc |
60923046502 |
VYONDYS 53 Golodirsen 100MG/2ML Injection vial in carton |
2019-12-12 |
1600.0000 |
None |
1 |
None |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": VYONDYS 53 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 53 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 53 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 |
| Sigmapharm Laboratories, LLC |
42794005108 |
Ambrisentan 5 mg tab 30ct |
2019-04-29 |
5980.0000 |
Sigmapharm’s pricing and marketing plan for its products is not in the public domain or otherwise publicly available. Therefore, Sigmapharm is limiting the information reported pursuant to § 96076(c). |
None |
None |
None |
None |
None |
None |
None |
None |
Field 7: Ambrisentan is an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): (i) To improve exercise ability and delay clinical worsening; and (ii) In combination with tadalafil to reduce the risks of disease progression and hospitalization for worsening PAH, and to improve exercise ability. Sigmapharm Laboratories, LLC (Sigmapharm), lacks sufficient information to determine the total number of patients who may be prescribed its Ambrisentan Tablets products given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; and (ii) the current existence of 6 other approved AB-rated generics as well as the RLD. Fields 10-13: Sigmapharm developed its Ambrisentan Tablets products in-house. The fields are therefore inapplicable. |
None |
| Sigmapharm Laboratories, LLC |
42794005208 |
Ambrisentan 10 mg tab 30ct |
2019-04-29 |
5980.0000 |
Sigmapharm’s pricing and marketing plan for its products is not in the public domain or otherwise publicly available. Therefore, Sigmapharm is limiting the information reported pursuant to § 96076(c). |
None |
None |
None |
None |
None |
None |
None |
None |
Field 7: Ambrisentan is an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): (i) To improve exercise ability and delay clinical worsening; and (ii) In combination with tadalafil to reduce the risks of disease progression and hospitalization for worsening PAH, and to improve exercise ability. Sigmapharm Laboratories, LLC (Sigmapharm), lacks sufficient information to determine the total number of patients who may be prescribed its Ambrisentan Tablets products given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; and (ii) the current existence of 6 other approved AB-rated generics as well as the RLD. Fields 10-13: Sigmapharm developed its Ambrisentan Tablets products in-house. The fields are therefore inapplicable. |
None |
| Seattle Genetics, Inc. |
51144002001 |
PADCEV (enfortumab vedotin-ejfv) 20 mg |
2019-12-18 |
2110.0000 |
With regard to marketing plans, efforts to ensure that healthcare providers with appropriate patients are aware of PADCEV™ 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, Seattle Genetics 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 |
None |
1 |
1 |
None |
None |
None |
None |
Seattle Genetics 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), Seattle Genetics has left that field blank. Seattle Genetics notes this product is indicated for metastatic urothelial carcinoma, a type of bladder cancer, and we are able to provide the following publicly available information on bladder cancer more generally. Specifically, in 2018, more than 82,000 people were diagnosed with bladder cancer in the U.S. However, this data does not include patients who progress to metastatic stage or recur. According to SEER statistics from 2009-2015, 5% of urinary bladder cancers were metastatic (distant), and 7% were locally advanced (regional). Please note that this data is out of date. According to a retrospective analysis of 1,703 metastatic bladder cancer patients from 2004 to 2011, 42% of patients received a first-line treatment, and 35% of that population received a second-line treatment. This data likely underestimates the percentage of treated patients, as the data was gathered prior to the introduction of checkpoint inhibitors. Because this drug was not acquired, the fields "acquisition date," "acquisition price" and "acquisition price comment" have been left blank. Seattle Genetics co-developed PADCEV™ with Astellas. |
None |
| Seattle Genetics, Inc. |
51144003001 |
PADCEV (enfortumab vedotin-ejfv) 30 mg |
2019-12-18 |
3165.0000 |
With regard to marketing plans, efforts to ensure that healthcare providers with appropriate patients are aware of PADCEV™ 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, Seattle Genetics 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 |
None |
1 |
1 |
None |
None |
None |
None |
Seattle Genetics 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), Seattle Genetics has left that field blank. Seattle Genetics notes this product is indicated for metastatic urothelial carcinoma, a type of bladder cancer, and we are able to provide the following publicly available information on bladder cancer more generally. Specifically, in 2018, more than 82,000 people were diagnosed with bladder cancer in the U.S. However, this data does not include patients who progress to metastatic stage or recur. According to SEER statistics from 2009-2015, 5% of urinary bladder cancers were metastatic (distant), and 7% were locally advanced (regional). Please note that this data is out of date. According to a retrospective analysis of 1,703 metastatic bladder cancer patients from 2004 to 2011, 42% of patients received a first-line treatment, and 35% of that population received a second-line treatment. This data likely underestimates the percentage of treated patients, as the data was gathered prior to the introduction of checkpoint inhibitors. Because this drug was not acquired, the fields "acquisition date," "acquisition price" and "acquisition price comment" have been left blank. Seattle Genetics co-developed PADCEV™ with Astellas. |
None |
| Sage Therapeutics, Inc. |
72152054720 |
ZULRESSO (brexanolone) injection CIV |
2019-06-20 |
7450.0000 |
None |
1 |
None |
1 |
1 |
None |
None |
None |
None |
Comment regarding fields 5, 7, and 12: Sage Therapeutics has not released information on the marketing/pricing plan for ZULRESSO, or the estimated number of patients in the public domain and does not believe this information is publicly available. The acquisition date and acquisition price are not applicable. Sage Therapeutics developed ZULRESSO. |
None |
| Sentynl Therapeutics, Inc. |
42358010310 |
Levorphanol Tartrate Tablets 3mg |
2019-01-21 |
6675.0000 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
The product is a new 3 mg strength of levorphanol tartrate tablets developed by Sentynl Therapeutics, Inc. between 2015 and 2018 and not acquired from a third party. The WAC reflects various factors, including, but not limited to, the cost of the Active Pharmaceutical Ingredient and the expenses associated with developing, manufacturing and offering the product for sale in the United States. The product is currently indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Thus, it is impossible to accurately estimate the number of patients in the United States with a condition for which this new prescription drug may be prescribed. |
None |