Sanofi |
00024065601 |
SARCLISA (isatuximab-irfc) |
2020-03-09 |
3250.0000 |
Marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by Healthcare Providers most likely to manage patients with relapsed and refractory multiple myeloma, materials to be used by sales representatives to share information on SARCLISA with prescribers, and materials to educate patients about relapsed and refractory multiple myeloma and SARCLISA. Direct to Consumer (DTC) outreach for SARCLISA 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. |
None |
30000 |
None |
None |
None |
None |
None |
None |
In the United States, it is estimated that there are 131,392 people living with multiple myeloma (MM). In 2019, according to the American Cancer Society, MM was the third most common hematologic malignancy with 32,110 new cases. The national Surveillance Epidemiology and End Results (SEER), reported an annual age-standardized rate of 6.9 per 100,000 person for MM. MM remains an incurable disease with many patients relapsing multiple times throughout the course of the disease. It is estimated that 48%-66% of all treated patients are relapsed refractory multiple myeloma patients. Patients with relapsed refractory multiple myeloma who have received two prior therapies including lenalidomide and a proteasome inhibitor may be prescribed SARCLISA. Based upon the US prevalence of MM and the information above, sanofi-aventis US LLC reasonably estimates that the number of patients in the United States with a condition for which the new prescription drug may be prescribed is approximately 30,000.
Regarding the request for acquisition data (items 10-13) there is No Data to Report - Not Acquired. |
None |
Seattle Genetics, Inc. |
51144000212 |
TUKYSA (tucatinib) 150 mg x 120 |
2020-04-17 |
18500.0000 |
With regard to marketing plans, efforts to ensure that healthcare providers with appropriate patients are aware of TUKYSA™ 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.
Pursuant to discussions with OSHPD, cancer.net lists that an estimated 276,480 women in the United States will be diagnosed with invasive breast cancer. Additional, it lists that About 6% of women have metastatic cancer when they are first diagnosed with breast cancer. The issue with these two sources of data is that they do not reflect the actual pool of patients that are eligible to use TUKYSA. TUKYSA is indicated for use with HER2+ Metastatic Breast Cancer patients. The first statistic lists ALL breast cancer patients, and the second only relates to patients who are diagnosed as metastatic upon FIRST diagnosis with their doctor. Over time, more of the breast cancer population will develop mestases. As such, both of these numbers, even combined, do not represent the TUKYSA patient population.
Additionally, Seattle Genetics notes this product is indicated for metastatic HER2+ breast cancer after receiving one or more prior anti-HER2-based regimens in the metastatic setting, and we are able to provide the following additional publicly available information on breast cancer more generally. Specifically, in 2019, it is estimated that there will be 268,600 people diagnosed with breast cancer. However, this data does not include patients who progress to metastatic stage or recur. According to SEER statistics from 2009-2015, 6% of breast cancers were metastatic (distant). Please note that this data is out of date. According to a retrospective analysis of 159,334 breast cancer patients diagnosed between 2010 to 2013, 26% of metastatic breast cancers are HER2+. There is no public information Seattle Genetics is aware of regarding the number of HER2+ metastatic breast cancer patients receive anti-HER2-based regimens. |
None |
Seattle Genetics, Inc. |
51144000260 |
TUKYSA (tucatinib) 150 mg x 60 |
2020-04-17 |
9250.0000 |
With regard to marketing plans, efforts to ensure that healthcare providers with appropriate patients are aware of TUKYSA™ 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.
Pursuant to discussions with OSHPD, cancer.net lists that an estimated 276,480 women in the United States will be diagnosed with invasive breast cancer. Additional, it lists that About 6% of women have metastatic cancer when they are first diagnosed with breast cancer. The issue with these two sources of data is that they do not reflect the actual pool of patients that are eligible to use TUKYSA. TUKYSA is indicated for use with HER2+ Metastatic Breast Cancer patients. The first statistic lists ALL breast cancer patients, and the second only relates to patients who are diagnosed as metastatic upon FIRST diagnosis with their doctor. Over time, more of the breast cancer population will develop mestases. As such, both of these numbers, even combined, do not represent the TUKYSA patient population.
Additionally, Seattle Genetics notes this product is indicated for metastatic HER2+ breast cancer after receiving one or more prior anti-HER2-based regimens in the metastatic setting, and we are able to provide the following additional publicly available information on breast cancer more generally. Specifically, in 2019, it is estimated that there will be 268,600 people diagnosed with breast cancer. However, this data does not include patients who progress to metastatic stage or recur. According to SEER statistics from 2009-2015, 6% of breast cancers were metastatic (distant). Please note that this data is out of date. According to a retrospective analysis of 159,334 breast cancer patients diagnosed between 2010 to 2013, 26% of metastatic breast cancers are HER2+. There is no public information Seattle Genetics is aware of regarding the number of HER2+ metastatic breast cancer patients receive anti-HER2-based regimens. |
None |
Seattle Genetics, Inc. |
51144000160 |
TUKYSA (tucatinib) 50 mg x 60 |
2020-04-17 |
4600.0000 |
With regard to marketing plans, efforts to ensure that healthcare providers with appropriate patients are aware of TUKYSA™ 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.
Pursuant to discussions with OSHPD, cancer.net lists that an estimated 276,480 women in the United States will be diagnosed with invasive breast cancer. Additional, it lists that About 6% of women have metastatic cancer when they are first diagnosed with breast cancer. The issue with these two sources of data is that they do not reflect the actual pool of patients that are eligible to use TUKYSA. TUKYSA is indicated for use with HER2+ Metastatic Breast Cancer patients. The first statistic lists ALL breast cancer patients, and the second only relates to patients who are diagnosed as metastatic upon FIRST diagnosis with their doctor. Over time, more of the breast cancer population will develop mestases. As such, both of these numbers, even combined, do not represent the TUKYSA patient population.
Additionally, Seattle Genetics notes this product is indicated for metastatic HER2+ breast cancer after receiving one or more prior anti-HER2-based regimens in the metastatic setting, and we are able to provide the following additional publicly available information on breast cancer more generally. Specifically, in 2019, it is estimated that there will be 268,600 people diagnosed with breast cancer. However, this data does not include patients who progress to metastatic stage or recur. According to SEER statistics from 2009-2015, 6% of breast cancers were metastatic (distant). Please note that this data is out of date. According to a retrospective analysis of 159,334 breast cancer patients diagnosed between 2010 to 2013, 26% of metastatic breast cancers are HER2+. There is no public information Seattle Genetics is aware of regarding the number of HER2+ metastatic breast cancer patients receive anti-HER2-based regimens. |
None |
Shionogi Inc. |
59630026610 |
FETROJA, for injection, 1 gram of cefiderocol, 2 grams of FETROJA for injection every 8 hours, 10 single-dose vials per pack |
2020-02-24 |
1833.3300 |
None |
1 |
142000 |
None |
1 |
None |
None |
None |
None |
Pursuant to Cal. Health & Safety Code § 127681(c), the information provided in this report is limited to that which is otherwise in the public domain or publicly available.
The marketing/pricing plan for Fetroja® is not in the public domain or publicly available.
The estimated volume of patients who might be prescribed Fetroja® is not in the public domain or publicly available.
Fetroja® was developed by Shionogi & Co., Ltd. and its affiliates; therefore, there is no acquisition price to report. |
None |
SK Life Science, Inc. |
71699010030 |
XCOPRI® Cenobamate Tablets 100mg |
2020-05-07 |
985.0000 |
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 |
SK Life Science, Inc. |
71699020128 |
XCOPRI® Cenobamate Tablets 12.5mg(14)+25mg(14) |
2020-05-07 |
90.0000 |
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 |
SK Life Science, Inc. |
71699015030 |
XCOPRI® Cenobamate Tablets 150mg |
2020-05-07 |
985.0000 |
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 |
SK Life Science, Inc. |
71699020328 |
XCOPRI® Cenobamate Tablets 150mg(14)+200mg(14) |
2020-05-07 |
985.0000 |
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 |
SK Life Science, Inc. |
71699020030 |
XCOPRI® Cenobamate Tablets 200mg |
2020-05-07 |
985.0000 |
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 |
SK Life Science, Inc. |
71699010356 |
XCOPRI® Cenobamate Tablets 200mg(28)+150mg(28) |
2020-05-07 |
1970.0000 |
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 |
SK Life Science, Inc. |
71699010256 |
XCOPRI® Cenobamate Tablets 200mg(28)+50mg(28) |
2020-05-07 |
985.0000 |
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 |
SK Life Science, Inc. |
71699005030 |
XCOPRI® Cenobamate Tablets 50mg |
2020-05-07 |
985.0000 |
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 |
SK Life Science, Inc. |
71699020228 |
XCOPRI® Cenobamate Tablets 50mg(14)+100mg(14) |
2020-05-07 |
985.0000 |
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 |
SpecGx |
00406222401 |
Levorphanol Tartrate Tablets 2mg |
2020-01-10 |
4450.0000 |
This is a generic product, not marketed directly to consumers or healthcare professionals. WAC price is based upon an analysis of existing generic and brand WAC prices. The details of this analysis are considered proprietary information. |
None |
19600000 |
None |
None |
None |
None |
None |
None |
While the Centers for Disease Control and Prevention estimates that 19.6M individuals across the United States suffer from high-impact chronic pain, this product is appropriate for an extremely limited subset of patients with that condition. Physician guidance and the drug product labeling serve to identify the appropriate patient subset, which may result in approximately 1,000 prescriptions for this product per month across the United States.
This is a new product developed/manufactured by SpecGx and not acquired. |
None |
Strides Pharma, Inc. |
42543096104 |
Cinacalcet Tablets 30mg, 30 (Singapore) |
2020-06-01 |
685.7000 |
Cinacalcet Tablets 30mg, 60mg, and 90mg are marketed in the generic multisource space, and therefore marketing of these product are not based on any aspects of the products themselves, but their prices 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 |
100000 |
None |
None |
None |
None |
None |
None |
The reason for leaving the acquisition-related fields blank was because Strides developed the drugs. The source for the estimated patients is National Organization for Rare Disorders. |
None |
Strides Pharma, Inc. |
42543096204 |
Cinacalcet Tablets 60mg, 30 (Singapore) |
2020-06-01 |
1371.3900 |
Cinacalcet Tablets 30mg, 60mg, and 90mg are marketed in the generic multisource space, and therefore marketing of these product are not based on any aspects of the products themselves, but their prices 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 |
100000 |
None |
None |
None |
None |
None |
None |
The reason for leaving the acquisition-related fields blank was because Strides developed the drugs. The source for the estimated patients is National Organization for Rare Disorders. |
None |
Strides Pharma, Inc. |
42543096304 |
Cinacalcet Tablets 90mg, 30 (Singapore) |
2020-06-01 |
2057.0900 |
Cinacalcet Tablets 30mg, 60mg, and 90mg are marketed in the generic multisource space, and therefore marketing of these product are not based on any aspects of the products themselves, but their prices 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 |
100000 |
None |
None |
None |
None |
None |
None |
The reason for leaving the acquisition-related fields blank was because Strides developed the drugs. The source for the estimated patients is National Organization for Rare Disorders. |
None |
Strides Pharma, Inc. |
64380090190 |
Triamcinolone Acetonide Ointment .05% 430G, 1 |
2020-06-08 |
779.3000 |
Triamcinolone Acetonide .05% 430G 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 |
39600000 |
None |
None |
None |
None |
None |
None |
The reason for leaving the acquisition-related fields blank was because Strides developed the drugs.The source for the estimated number of patients is the National Psoriasis Foundation and the National Eczema Association. |
https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=442 |
SUN PHARMACEUTICALS |
10631000331 |
Absorica LD™ (isotretinoin) capsules 16mg |
2020-01-27 |
1063.1700 |
• 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 |
1. This product was developed by Sun Pharmaceutical Industries, Ltd.("Sun") 2.The reason for leaving the acquisition-related fields blank was because Sun developed the drugs |
None |
SUN PHARMACEUTICALS |
10631000531 |
Absorica LD™ (isotretinoin) capsules 24mg |
2020-01-27 |
1143.9100 |
• 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 |
1. This product was developed by Sun Pharmaceutical Industries, Ltd.("Sun") 2.The reason for leaving the acquisition-related fields blank was because Sun developed the drugs |
None |
SUN PHARMACEUTICALS |
10631000731 |
Absorica LD™ (isotretinoin) capsules 32mg |
2020-01-27 |
1143.9100 |
• 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 |
1. This product was developed by Sun Pharmaceutical Industries, Ltd.("Sun") 2.The reason for leaving the acquisition-related fields blank was because Sun developed the drugs |
None |
SUN PHARMACEUTICALS |
10631000231 |
Absorica LD™ (isotretinoin) capsules 8mg |
2020-01-27 |
1063.1700 |
• 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 |
1. This product was developed by Sun Pharmaceutical Industries, Ltd.("Sun") 2.The reason for leaving the acquisition-related fields blank was because Sun developed the drugs |
None |
SUN PHARMACEUTICALS |
63304072105 |
DILTIAZEM ER HCL 300MG 500 Capsules |
2020-03-05 |
795.1700 |
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 also offers the convenience and economy of bulk packaging. |
None |
10000000 |
None |
None |
None |
None |
None |
None |
1. This product was developed by Sun Pharmaceutical Industries, Ltd.("Sun") 2.The reason for leaving the acquisition-related fields blank was because Sun developed the drugs 3. This product (ANDA approval) is being marketed in the generic, multisource space |
None |
SUN PHARMACEUTICALS |
47335017149 |
Tobramycin Inhalation Solution 300mg/ 5ml |
2020-04-21 |
1880.0500 |
This product is priced to reflect a discount off of the Reference Drug listed by the FDA. Cost-based, quality-adjusted, or value-based pricings were not used to establish Wholesale Acquisition Cost for this product. This product is being marketed in the generic, multisource space. Sun representatives, who are responsible for generic sales, do not promote to health care providers. |
None |
6000 |
None |
None |
None |
None |
None |
None |
1) This product (ANDA approval) is being marketed in the generic, multisource space; 2) The reason for leaving the acquisition-related fields blank was because Sun developed the drugs |
None |
SUN PHARMACEUTICALS |
63304058360 |
Fosamprenavir Oral Tablet 700mg |
2020-06-05 |
999.8900 |
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 |
1200000 |
None |
None |
None |
None |
None |
None |
None |
None |
SUN PHARMACEUTICALS |
10631009510 |
HALOG SOLUTION USP 0.1% 5ML 120ML |
2020-07-27 |
770.0600 |
This product is priced to reflect the clinical value of the drug and is priced on par with two other Halog formulations on the market - Halog Ointment and Halog Cream. The prevalence of corticosteroid-responsive dermatoses is unknown. However psoriasis and atopic dermatitis which fall within the category of corticosteroid-responsive dermatoses together represent a good proxy for the number of patients. in the United States, approximately 4.6% of
the population is affected with psoriasis1 and nearly 18 million people have AD2. |
None |
18000000 |
None |
None |
2015-03-25 |
None |
1 |
Product was acquired by Sun Pharmaceuticals Ind. (SPIL) as part of the Ranbaxy acquisition estimated total acquisition of over $4 billion on 25th March 2015. There was no acquisition price directly associated with the Halog Solution product as the product was not launched at the time of company acquisition. |
None |
None |
Sunovion Pharmaceuticals Inc. |
63402001030 |
KYNMOBI 10 MG (Apomorphine Sublingual Film) |
2020-06-09 |
787.5000 |
"KYNMOBI™ (apomorphine hydrochloride) Sublingual Film was approved by the FDA in May 2020. It is the first and only sublingual film for the acute, intermittent treatment of OFF episodes in patients with Parkinson's disease (PD). The WAC for a trade box of 30 films is slightly higher than the Medicare Part D Specialty Tier Threshold. KYNMOBI is available in 5 strengths (10mg, 15mg, 20mg, 25mg and 30mg). To market KYNMOBI™ (apomorphine hydrochloride) Sublingual Film, Sunovion designed activities to increase awareness and understanding with healthcare providers about this new product and its clinical efficacy, safety, and tolerability. Marketing activities will include education and training provided by our existing sales force and by contracted speakers to health care providers (HCPs) in peer-to-peer forums. There will be a Direct-to-Patient advertising campaign to educate patients about KYNMOBI and the treatment of OFF episodes. Sunovion will offer copayment assistance to commercially insured patients through a copay card program. Sunovion has also signed a national agreement with Walgreen’s retail pharmacies to provide easy access to a $0 titration kit and other support services.
Pricing:
Sunovion is focused on the innovative application of science and medicine to help people living with serious psychiatric, neurological and respiratory conditions. Our philosophy around the pricing of our medications is grounded in three key pillars: providing value; facilitating broad and sustainable access; and supporting patients.
Sunovion’s scientific advancements and breakthrough medical innovations help drive improvement in individual patient care and outcomes and the overall healthcare system. Our treatment options provide significant clinical value for patients. We are committed to working with health care providers, policy makers, and public and private payers, to ensure patients have broad and sustainable access to our innovative therapies. We offer rebates, discounts and co-pay cards. We also maintain a prescription assistance program to help patients who require financial assistance. Eligible patients are able to access Sunovion’s life-changing therapies at no cost.
The price of Kynmobi was guided by our key pillars. We believe that Kynmobi’s strong safety and efficacy profile, as demonstrated in clinical trials, and unique route of administration exemplify scientific innovation and deliver significant benefits to patients living with Parkinson’s disease. We sought to balance the need to sustain current business operations and fuel future innovation with the interests of ensuring broad and open access for patients. We considered feedback from patients, physicians and payers, unmet medical needs, patient affordability, and the medication’s likely coverage and formulary placement. We also evaluated competitor products within the Parkinson’s disease space and strove to deliver the benefits of Kynmobi to patients, physicians and payers at a lower list price than its branded competitors.
Except as otherwise described, we did not use any cost-based pricing, quality-adjusted pricing, value-based pricing, or other specific pricing models or strategies in setting the price for Kynmobi." |
None |
558000 |
None |
None |
2016-10-21 |
635000000.0000 |
None |
None |
patient estimate based on internal calculation using public data. |
None |
Sunovion Pharmaceuticals Inc. |
63402001530 |
KYNMOBI 15 MG (Apomorphine Sublingual Film) |
2020-06-09 |
787.5000 |
"KYNMOBI™ (apomorphine hydrochloride) Sublingual Film was approved by the FDA in May 2020. It is the first and only sublingual film for the acute, intermittent treatment of OFF episodes in patients with Parkinson's disease (PD). The WAC for a trade box of 30 films is slightly higher than the Medicare Part D Specialty Tier Threshold. KYNMOBI is available in 5 strengths (10mg, 15mg, 20mg, 25mg and 30mg). To market KYNMOBI™ (apomorphine hydrochloride) Sublingual Film, Sunovion designed activities to increase awareness and understanding with healthcare providers about this new product and its clinical efficacy, safety, and tolerability. Marketing activities will include education and training provided by our existing sales force and by contracted speakers to health care providers (HCPs) in peer-to-peer forums. There will be a Direct-to-Patient advertising campaign to educate patients about KYNMOBI and the treatment of OFF episodes. Sunovion will offer copayment assistance to commercially insured patients through a copay card program. Sunovion has also signed a national agreement with Walgreen’s retail pharmacies to provide easy access to a $0 titration kit and other support services.
Pricing:
Sunovion is focused on the innovative application of science and medicine to help people living with serious psychiatric, neurological and respiratory conditions. Our philosophy around the pricing of our medications is grounded in three key pillars: providing value; facilitating broad and sustainable access; and supporting patients.
Sunovion’s scientific advancements and breakthrough medical innovations help drive improvement in individual patient care and outcomes and the overall healthcare system. Our treatment options provide significant clinical value for patients. We are committed to working with health care providers, policy makers, and public and private payers, to ensure patients have broad and sustainable access to our innovative therapies. We offer rebates, discounts and co-pay cards. We also maintain a prescription assistance program to help patients who require financial assistance. Eligible patients are able to access Sunovion’s life-changing therapies at no cost.
The price of Kynmobi was guided by our key pillars. We believe that Kynmobi’s strong safety and efficacy profile, as demonstrated in clinical trials, and unique route of administration exemplify scientific innovation and deliver significant benefits to patients living with Parkinson’s disease. We sought to balance the need to sustain current business operations and fuel future innovation with the interests of ensuring broad and open access for patients. We considered feedback from patients, physicians and payers, unmet medical needs, patient affordability, and the medication’s likely coverage and formulary placement. We also evaluated competitor products within the Parkinson’s disease space and strove to deliver the benefits of Kynmobi to patients, physicians and payers at a lower list price than its branded competitors.
Except as otherwise described, we did not use any cost-based pricing, quality-adjusted pricing, value-based pricing, or other specific pricing models or strategies in setting the price for Kynmobi." |
None |
558000 |
None |
None |
2016-10-21 |
635000000.0000 |
None |
None |
patient estimate based on internal calculation using public data. |
None |
Sunovion Pharmaceuticals Inc. |
63402002030 |
KYNMOBI 20 MG (Apomorphine Sublingual Film) |
2020-06-09 |
787.5000 |
"KYNMOBI™ (apomorphine hydrochloride) Sublingual Film was approved by the FDA in May 2020. It is the first and only sublingual film for the acute, intermittent treatment of OFF episodes in patients with Parkinson's disease (PD). The WAC for a trade box of 30 films is slightly higher than the Medicare Part D Specialty Tier Threshold. KYNMOBI is available in 5 strengths (10mg, 15mg, 20mg, 25mg and 30mg). To market KYNMOBI™ (apomorphine hydrochloride) Sublingual Film, Sunovion designed activities to increase awareness and understanding with healthcare providers about this new product and its clinical efficacy, safety, and tolerability. Marketing activities will include education and training provided by our existing sales force and by contracted speakers to health care providers (HCPs) in peer-to-peer forums. There will be a Direct-to-Patient advertising campaign to educate patients about KYNMOBI and the treatment of OFF episodes. Sunovion will offer copayment assistance to commercially insured patients through a copay card program. Sunovion has also signed a national agreement with Walgreen’s retail pharmacies to provide easy access to a $0 titration kit and other support services.
Pricing:
Sunovion is focused on the innovative application of science and medicine to help people living with serious psychiatric, neurological and respiratory conditions. Our philosophy around the pricing of our medications is grounded in three key pillars: providing value; facilitating broad and sustainable access; and supporting patients.
Sunovion’s scientific advancements and breakthrough medical innovations help drive improvement in individual patient care and outcomes and the overall healthcare system. Our treatment options provide significant clinical value for patients. We are committed to working with health care providers, policy makers, and public and private payers, to ensure patients have broad and sustainable access to our innovative therapies. We offer rebates, discounts and co-pay cards. We also maintain a prescription assistance program to help patients who require financial assistance. Eligible patients are able to access Sunovion’s life-changing therapies at no cost.
The price of Kynmobi was guided by our key pillars. We believe that Kynmobi’s strong safety and efficacy profile, as demonstrated in clinical trials, and unique route of administration exemplify scientific innovation and deliver significant benefits to patients living with Parkinson’s disease. We sought to balance the need to sustain current business operations and fuel future innovation with the interests of ensuring broad and open access for patients. We considered feedback from patients, physicians and payers, unmet medical needs, patient affordability, and the medication’s likely coverage and formulary placement. We also evaluated competitor products within the Parkinson’s disease space and strove to deliver the benefits of Kynmobi to patients, physicians and payers at a lower list price than its branded competitors.
Except as otherwise described, we did not use any cost-based pricing, quality-adjusted pricing, value-based pricing, or other specific pricing models or strategies in setting the price for Kynmobi." |
None |
558000 |
None |
None |
2016-10-21 |
635000000.0000 |
None |
None |
patient estimate based on internal calculation using public data. |
None |
Sunovion Pharmaceuticals Inc. |
63402002530 |
KYNMOBI 25 MG (Apomorphine Sublingual Film) |
2020-06-09 |
787.5000 |
"KYNMOBI™ (apomorphine hydrochloride) Sublingual Film was approved by the FDA in May 2020. It is the first and only sublingual film for the acute, intermittent treatment of OFF episodes in patients with Parkinson's disease (PD). The WAC for a trade box of 30 films is slightly higher than the Medicare Part D Specialty Tier Threshold. KYNMOBI is available in 5 strengths (10mg, 15mg, 20mg, 25mg and 30mg). To market KYNMOBI™ (apomorphine hydrochloride) Sublingual Film, Sunovion designed activities to increase awareness and understanding with healthcare providers about this new product and its clinical efficacy, safety, and tolerability. Marketing activities will include education and training provided by our existing sales force and by contracted speakers to health care providers (HCPs) in peer-to-peer forums. There will be a Direct-to-Patient advertising campaign to educate patients about KYNMOBI and the treatment of OFF episodes. Sunovion will offer copayment assistance to commercially insured patients through a copay card program. Sunovion has also signed a national agreement with Walgreen’s retail pharmacies to provide easy access to a $0 titration kit and other support services.
Pricing:
Sunovion is focused on the innovative application of science and medicine to help people living with serious psychiatric, neurological and respiratory conditions. Our philosophy around the pricing of our medications is grounded in three key pillars: providing value; facilitating broad and sustainable access; and supporting patients.
Sunovion’s scientific advancements and breakthrough medical innovations help drive improvement in individual patient care and outcomes and the overall healthcare system. Our treatment options provide significant clinical value for patients. We are committed to working with health care providers, policy makers, and public and private payers, to ensure patients have broad and sustainable access to our innovative therapies. We offer rebates, discounts and co-pay cards. We also maintain a prescription assistance program to help patients who require financial assistance. Eligible patients are able to access Sunovion’s life-changing therapies at no cost.
The price of Kynmobi was guided by our key pillars. We believe that Kynmobi’s strong safety and efficacy profile, as demonstrated in clinical trials, and unique route of administration exemplify scientific innovation and deliver significant benefits to patients living with Parkinson’s disease. We sought to balance the need to sustain current business operations and fuel future innovation with the interests of ensuring broad and open access for patients. We considered feedback from patients, physicians and payers, unmet medical needs, patient affordability, and the medication’s likely coverage and formulary placement. We also evaluated competitor products within the Parkinson’s disease space and strove to deliver the benefits of Kynmobi to patients, physicians and payers at a lower list price than its branded competitors.
Except as otherwise described, we did not use any cost-based pricing, quality-adjusted pricing, value-based pricing, or other specific pricing models or strategies in setting the price for Kynmobi." |
None |
558000 |
None |
None |
2016-10-21 |
635000000.0000 |
None |
None |
patient estimate based on internal calculation using public data. |
None |
Sunovion Pharmaceuticals Inc. |
63402003030 |
KYNMOBI 30 MG (Apomorphine Sublingual Film) |
2020-06-09 |
787.5000 |
"KYNMOBI™ (apomorphine hydrochloride) Sublingual Film was approved by the FDA in May 2020. It is the first and only sublingual film for the acute, intermittent treatment of OFF episodes in patients with Parkinson's disease (PD). The WAC for a trade box of 30 films is slightly higher than the Medicare Part D Specialty Tier Threshold. KYNMOBI is available in 5 strengths (10mg, 15mg, 20mg, 25mg and 30mg). To market KYNMOBI™ (apomorphine hydrochloride) Sublingual Film, Sunovion designed activities to increase awareness and understanding with healthcare providers about this new product and its clinical efficacy, safety, and tolerability. Marketing activities will include education and training provided by our existing sales force and by contracted speakers to health care providers (HCPs) in peer-to-peer forums. There will be a Direct-to-Patient advertising campaign to educate patients about KYNMOBI and the treatment of OFF episodes. Sunovion will offer copayment assistance to commercially insured patients through a copay card program. Sunovion has also signed a national agreement with Walgreen’s retail pharmacies to provide easy access to a $0 titration kit and other support services.
Pricing:
Sunovion is focused on the innovative application of science and medicine to help people living with serious psychiatric, neurological and respiratory conditions. Our philosophy around the pricing of our medications is grounded in three key pillars: providing value; facilitating broad and sustainable access; and supporting patients.
Sunovion’s scientific advancements and breakthrough medical innovations help drive improvement in individual patient care and outcomes and the overall healthcare system. Our treatment options provide significant clinical value for patients. We are committed to working with health care providers, policy makers, and public and private payers, to ensure patients have broad and sustainable access to our innovative therapies. We offer rebates, discounts and co-pay cards. We also maintain a prescription assistance program to help patients who require financial assistance. Eligible patients are able to access Sunovion’s life-changing therapies at no cost.
The price of Kynmobi was guided by our key pillars. We believe that Kynmobi’s strong safety and efficacy profile, as demonstrated in clinical trials, and unique route of administration exemplify scientific innovation and deliver significant benefits to patients living with Parkinson’s disease. We sought to balance the need to sustain current business operations and fuel future innovation with the interests of ensuring broad and open access for patients. We considered feedback from patients, physicians and payers, unmet medical needs, patient affordability, and the medication’s likely coverage and formulary placement. We also evaluated competitor products within the Parkinson’s disease space and strove to deliver the benefits of Kynmobi to patients, physicians and payers at a lower list price than its branded competitors.
Except as otherwise described, we did not use any cost-based pricing, quality-adjusted pricing, value-based pricing, or other specific pricing models or strategies in setting the price for Kynmobi." |
None |
558000 |
None |
None |
2016-10-21 |
635000000.0000 |
None |
None |
patient estimate based on internal calculation using public data. |
None |
Sunrise Pharmaceutical Inc. |
11534019701 |
chlordiazePOXIDE-Clidinium Oral Capsule 5-2.5 MG 100 ct |
2020-08-03 |
1395.0000 |
o Our plan is to offer this product for sale to wholesale, and retail customers |
None |
5000000 |
None |
None |
None |
None |
None |
None |
None |
None |