| AbbVie |
00074709530 |
QULIPTA (atogepant) is 10mg tablet taken orally once daily with or without food |
2021-10-06 |
991.0000 |
QULIPTA is marketed for treatment of episodic migraine in adults. The Wholesale Acquisition Cost (WAC) of QULIPTA is $991.00 per a month supply for 10 mg (30 count), 30 mg (30 count), and 60 mg (30 count). To date AbbVie has not filed for regulatory approval of QULIPTA in jurisdictions outside the United States. |
None |
14200000 |
None |
1 |
None |
None |
None |
None |
Response on estimated volume of patients who may be prescribed the drug:
QULIPTA is marketed for treatment of episodic migraine in adults. Based upon published analysis, episodic migraine affects approximately 14.2 million adults in the United States that are diagnosed and insured. See American Migraine Prevalence and Preventions studies (Lipton et al., 2007 & Buse et al., 2012), Chronic Migraine Epidemiology and Outcomes (CaMEO) study (Adams et al., 2015), Adelphi Migraine US DSP (Ford et al., 2017 & Mutebi, 2016), Diamond et al., 2007, US Census Bureau, 2017, and Current population survey (CPS), 2019. QULIPTA may be prescribed for that fraction of those patients for whom a physician and patient in consultation may consider this treatment appropriate. |
None |
| AbbVie |
00074709630 |
QULIPTA (atogepant) is 30mg tablet taken orally once daily with or without food |
2021-10-06 |
991.0000 |
QULIPTA is marketed for treatment of episodic migraine in adults. The Wholesale Acquisition Cost (WAC) of QULIPTA is $991.00 per a month supply for 10 mg (30 count), 30 mg (30 count), and 60 mg (30 count). To date AbbVie has not filed for regulatory approval of QULIPTA in jurisdictions outside the United States. |
None |
14200000 |
None |
1 |
None |
None |
None |
None |
Response on estimated volume of patients who may be prescribed the drug (see Cal. Health & Saf. Code § 96076(b)(2):
QULIPTA is marketed for treatment of episodic migraine in adults. Based upon published analysis, episodic migraine affects approximately 14.2 million adults in the United States that are diagnosed and insured. See American Migraine Prevalence and Preventions studies (Lipton et al., 2007 & Buse et al., 2012), Chronic Migraine Epidemiology and Outcomes (CaMEO) study (Adams et al., 2015), Adelphi Migraine US DSP (Ford et al., 2017 & Mutebi, 2016), Diamond et al., 2007, US Census Bureau, 2017, and Current population survey (CPS), 2019. QULIPTA may be prescribed for that fraction of those patients for whom a physician and patient in consultation may consider this treatment appropriate. |
None |
| AbbVie |
00074709430 |
QULIPTA (atogepant) is 60mg tablet taken orally once daily with or without food |
2021-10-06 |
991.0000 |
QULIPTA is marketed for treatment of episodic migraine in adults. The Wholesale Acquisition Cost (WAC) of QULIPTA is $991.00 per a month supply for 10 mg (30 count), 30 mg (30 count), and 60 mg (30 count). To date AbbVie has not filed for regulatory approval of QULIPTA in jurisdictions outside the United States. |
None |
14200000 |
None |
1 |
None |
None |
None |
None |
Response on estimated volume of patients who may be prescribed the drug:
QULIPTA is marketed for treatment of episodic migraine in adults. Based upon published analysis, episodic migraine affects approximately 14.2 million adults in the United States that are diagnosed and insured. See American Migraine Prevalence and Preventions studies (Lipton et al., 2007 & Buse et al., 2012), Chronic Migraine Epidemiology and Outcomes (CaMEO) study (Adams et al., 2015), Adelphi Migraine US DSP (Ford et al., 2017 & Mutebi, 2016), Diamond et al., 2007, US Census Bureau, 2017, and Current population survey (CPS), 2019. QULIPTA may be prescribed for that fraction of those patients for whom a physician and patient in consultation may consider this treatment appropriate. |
None |
| Accord Healthcare, Inc. |
16729043630 |
Fulvestrant 50 mg/ml (PFS) |
2021-01-12 |
850.0000 |
None |
1 |
0 |
None |
None |
None |
None |
None |
None |
Accord did not acquire the NDC for Fulvestrant, the generic product was developed in house.
Note that Accord is required to and does follow the innovator with respect to its prescribing information, including dosage. Accord does not interact with healthcare providers or advise on usage, other than to direct any questions to Accord’s prescribing information.
Accord does not have internal methods or procedures to estimate a reasonable number of patients with a disease state and therefore, cannot answer this question with any level of accuracy that is needed in order to comply with the requirement. |
None |
| Accord Healthcare, Inc. |
16729041759 |
Dimethyl Fumarate DR 240mg |
2021-01-20 |
1050.0000 |
None |
1 |
0 |
None |
None |
None |
None |
None |
None |
Accord did not acquire the NDC for Dimethyl Fumarate, the generic product was developed in house.
Note that Accord is required to and does follow the innovator with respect to its prescribing information, including dosage. Accord does not interact with healthcare providers or advise on usage, other than to direct any questions to Accord’s prescribing information.
Accord does not have internal methods or procedures to estimate a reasonable number of patients with a disease state and therefore, cannot answer this question with any level of accuracy that is needed in order to comply with the requirement. |
None |
| Accord Healthcare, Inc. |
16729043043 |
Argatroban in 0.9% Sodium Chloride |
2021-10-07 |
1980.0000 |
None |
1 |
0 |
None |
None |
None |
None |
None |
None |
Accord did not acquire the NDC for Argatroban, the generic product was developed in house.
Note that Accord is required to and does follow the innovator with respect to its prescribing information, including dosage. Accord does not interact with healthcare providers or advise on usage, other than to direct any questions to Accord’s prescribing information.
Accord does not have internal methods or procedures to estimate a reasonable number of patients with a disease state and therefore, cannot answer this question with any level of accuracy that is needed in order to comply with the requirement. |
None |
| Actelion Pharmaceuticals US, Inc |
66215071801 |
UPTRAVI® (selexipag) IV, Strength: 1800mcg, Form: 1 Single Vial |
2021-08-12 |
19200.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we plan to market UPTRAVI® IV in the US and promote to appropriate healthcare professionals who treat PAH patients who are hospitalized and are temporarily unable to take their UPTRAVI® Tablets. The pricing plan has WAC set for 1800mcg vial at $19,200.00 for a 30 day supply. The list price of UPTRAVI® IV is not reflective of discounts and rebates which may be available through Medicaid, Medicare, and commercial insurance. UPTRAVI® IV will also be discounted as required under the 340B program, Federal Supply Schedule, and other government programs. International approvals are pending. |
None |
None |
None |
None |
None |
None |
None |
None |
The estimated number of patients in the United States with a condition for which UPTRAVI® IV may be prescribed is not in the public domain or publicly available. |
None |
| ADC Therapeutics |
79952011001 |
ZYNLONTA™ (loncastuximab tesirine-lpyl) 10mg per Vial |
2021-05-01 |
23500.0000 |
None |
1 |
1300 |
None |
None |
None |
None |
None |
None |
None |
None |
| Albireo Pharma, Inc. |
74528012001 |
Bylvay/Odevixibat 1200mcg 30 capsules |
2021-07-20 |
39600.0000 |
Albireo plans to engage in a range of marketing and sales activities to maximize patient benefit through BylvayTM awareness and education.
Marketing communications and sales activities in the U.S. include: market research, detailing, peer-to-peer speaker programs and symposia, congress sponsorships/exhibits/theaters, email and printed letter communications, websites, webinars, medical journal and website banner ads, social media announcements, and patient and physician announcement and educational materials.
Currently, Albireo does not plan to engage in free drug sampling, television or radio advertising, or direct-to-consumer promotional incentives.
The company’s pricing plans for the product are not in the public domain or otherwise publicly available. |
None |
150 |
None |
1 |
None |
None |
None |
None |
BYLVAYTM (Odevixibat) is FDA-approved for the treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC). There are no available registries or other sources of information that provide a definitive figure on the number of patients living with Progressive Familial Intrahepatic Cholestasis. Based on analysis of literature estimates of disease incidence and survival rates, we believe that there are approximately 3,500 patients in the United States living with some form of Progressive Familial Intrahepatic Cholestasis of which we expect approximately 600 will be eligible for treatment with Bylvay. We do not know how many of these potential patients might be prescribed Bylvay. |
None |
| Albireo Pharma, Inc. |
74528002001 |
Bylvay/Odevixibat 200mcg 30 capsules |
2021-07-20 |
6600.0000 |
Albireo plans to engage in a range of marketing and sales activities to maximize patient benefit through BylvayTM awareness and education.
Marketing communications and sales activities in the U.S. include: market research, detailing, peer-to-peer speaker programs and symposia, congress sponsorships/exhibits/theaters, email and printed letter communications, websites, webinars, medical journal and website banner ads, social media announcements, and patient and physician announcement and educational materials.
Currently, Albireo does not plan to engage in free drug sampling, television or radio advertising, or direct-to-consumer promotional incentives.
The company’s pricing plans for the product are not in the public domain or otherwise publicly available. |
None |
150 |
None |
1 |
None |
None |
None |
None |
BYLVAYTM (Odevixibat) is FDA-approved for the treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC). There are no available registries or other sources of information that provide a definitive figure on the number of patients living with Progressive Familial Intrahepatic Cholestasis. Based on analysis of literature estimates of disease incidence and survival rates, we believe that there are approximately 3,500 patients in the United States living with some form of Progressive Familial Intrahepatic Cholestasis of which we expect approximately 600 will be eligible for treatment with Bylvay. We do not know how many of these potential patients might be prescribed Bylvay. |
None |
| Albireo Pharma, Inc. |
74528004001 |
Bylvay/Odevixibat 400mcg 30 capsules |
2021-07-20 |
13200.0000 |
Albireo plans to engage in a range of marketing and sales activities to maximize patient benefit through BylvayTM awareness and education.
Marketing communications and sales activities in the U.S. include: market research, detailing, peer-to-peer speaker programs and symposia, congress sponsorships/exhibits/theaters, email and printed letter communications, websites, webinars, medical journal and website banner ads, social media announcements, and patient and physician announcement and educational materials.
Currently, Albireo does not plan to engage in free drug sampling, television or radio advertising, or direct-to-consumer promotional incentives.
The company’s pricing plans for the product are not in the public domain or otherwise publicly available. |
None |
150 |
None |
1 |
None |
None |
None |
None |
BYLVAYTM (Odevixibat) is FDA-approved for the treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC). There are no available registries or other sources of information that provide a definitive figure on the number of patients living with Progressive Familial Intrahepatic Cholestasis. Based on analysis of literature estimates of disease incidence and survival rates, we believe that there are approximately 3,500 patients in the United States living with some form of Progressive Familial Intrahepatic Cholestasis of which we expect approximately 600 will be eligible for treatment with Bylvay. We do not know how many of these potential patients might be prescribed Bylvay. |
None |
| Albireo Pharma, Inc. |
74528006001 |
Bylvay/Odevixibat 600mcg 30 capsules |
2021-07-20 |
19800.0000 |
Albireo plans to engage in a range of marketing and sales activities to maximize patient benefit through BylvayTM awareness and education.
Marketing communications and sales activities in the U.S. include: market research, detailing, peer-to-peer speaker programs and symposia, congress sponsorships/exhibits/theaters, email and printed letter communications, websites, webinars, medical journal and website banner ads, social media announcements, and patient and physician announcement and educational materials.
Currently, Albireo does not plan to engage in free drug sampling, television or radio advertising, or direct-to-consumer promotional incentives.
The company’s pricing plans for the product are not in the public domain or otherwise publicly available. |
None |
150 |
None |
1 |
None |
None |
None |
None |
BYLVAYTM (Odevixibat) is FDA-approved for the treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC). There are no available registries or other sources of information that provide a definitive figure on the number of patients living with Progressive Familial Intrahepatic Cholestasis. Based on analysis of literature estimates of disease incidence and survival rates, we believe that there are approximately 3,500 patients in the United States living with some form of Progressive Familial Intrahepatic Cholestasis of which we expect approximately 600 will be eligible for treatment with Bylvay. We do not know how many of these potential patients might be prescribed Bylvay. |
None |
| Alkermes, Inc |
65757065242 |
olanzapine and samidorphan tablets 10 mg/10 mg, 30 capsule count |
2021-10-18 |
1390.0000 |
"The marketing plan for LYBALVI® (olanzapine and samidorphan) at the time of commercial launch is current as of the time of reporting. Marketing plans are subject to change based on market conditions, product life cycle, regulatory considerations, and other factors.
Consumer Education: Alkermes is engaging in activities to educate relevant consumers, including potential patients and caregivers, about LYBALVI. A LYBALVI product website contains information directed to a consumer audience. The LYBALVI website offers educational information about LYBALVI as a potential treatment option for adult patients with schizophrenia or bipolar I disorder, including efficacy and safety information contained in the LYBALVI FDA-approved Prescribing Information and Medication Guide. Patient educational information is available for healthcare professionals to share with appropriate patients and includes an educational brochure, patient wallet card, patient journal and doctor discussion guide. There are no direct-to-consumer media advertisements on television, web-based, consumer magazines, radio, or billboards. The LYBALVI Co-pay Savings Program is available for commercially insured eligible patients who meet the program terms and conditions. Information about the LYBALVI Co-pay Savings Program is provided to healthcare professionals by sales representatives and via the healthcare professionals website, as well as to consumers via the consumer facing LYBALVI product website. There are no additional direct-to-consumer free trial offers, rebates, coupons, or other utilization incentives available to patients.
Healthcare Professional Education: Alkermes has sales representatives that engage in professional detailing activities with healthcare professionals to provide LYBALVI product education related to the approved indications for LYBALVI. Approved LYBALVI promotional materials are used during the detailing activities. LYBALVI product samples are available for healthcare professionals where appropriate. Commercial personnel also have virtual and in-person meetings with potential LYBALVI customers including hospital, healthcare systems, and payers to discuss LYBALVI. Alkermes sponsors promotional product theater programs for healthcare professionals, hosts promotional booths at conferences attended by healthcare professionals, and develops peer-to-peer speaker programs. There are web-based and print advertisements that are distributed to healthcare professionals through mobile applications, websites, social media, professional publications, and conference materials. There are no sponsorships for continuing education for health professionals or gifts provided to healthcare professionals.
Regarding pricing, there is nothing publicly available other than the Wholesale Acquisition Cost." |
None |
6500000 |
None |
None |
None |
None |
None |
None |
The estimated number of patients is based on the total US population who may have either schizophrenia or bipolar 1 disorder. This drug was not acquired. |
None |
| Alkermes, Inc |
65757065244 |
olanzapine and samidorphan tablets 10 mg/10 mg, 90 capsule count |
2021-10-18 |
4170.0000 |
"The marketing plan for LYBALVI® (olanzapine and samidorphan) at the time of commercial launch is current as of the time of reporting. Marketing plans are subject to change based on market conditions, product life cycle, regulatory considerations, and other factors.
Consumer Education: Alkermes is engaging in activities to educate relevant consumers, including potential patients and caregivers, about LYBALVI. A LYBALVI product website contains information directed to a consumer audience. The LYBALVI website offers educational information about LYBALVI as a potential treatment option for adult patients with schizophrenia or bipolar I disorder, including efficacy and safety information contained in the LYBALVI FDA-approved Prescribing Information and Medication Guide. Patient educational information is available for healthcare professionals to share with appropriate patients and includes an educational brochure, patient wallet card, patient journal and doctor discussion guide. There are no direct-to-consumer media advertisements on television, web-based, consumer magazines, radio, or billboards. The LYBALVI Co-pay Savings Program is available for commercially insured eligible patients who meet the program terms and conditions. Information about the LYBALVI Co-pay Savings Program is provided to healthcare professionals by sales representatives and via the healthcare professionals website, as well as to consumers via the consumer facing LYBALVI product website. There are no additional direct-to-consumer free trial offers, rebates, coupons, or other utilization incentives available to patients.
Healthcare Professional Education: Alkermes has sales representatives that engage in professional detailing activities with healthcare professionals to provide LYBALVI product education related to the approved indications for LYBALVI. Approved LYBALVI promotional materials are used during the detailing activities. LYBALVI product samples are available for healthcare professionals where appropriate. Commercial personnel also have virtual and in-person meetings with potential LYBALVI customers including hospital, healthcare systems, and payers to discuss LYBALVI. Alkermes sponsors promotional product theater programs for healthcare professionals, hosts promotional booths at conferences attended by healthcare professionals, and develops peer-to-peer speaker programs. There are web-based and print advertisements that are distributed to healthcare professionals through mobile applications, websites, social media, professional publications, and conference materials. There are no sponsorships for continuing education for health professionals or gifts provided to healthcare professionals.
Regarding pricing, there is nothing publicly available other than the Wholesale Acquisition Cost." |
None |
6500000 |
None |
None |
None |
None |
None |
None |
The estimated number of patients is based on the total US population who may have either schizophrenia or bipolar 1 disorder. This drug was not acquired. |
None |
| Alkermes, Inc |
65757065342 |
olanzapine and samidorphan tablets 15 mg/10 mg, 30 capsule count |
2021-10-18 |
1390.0000 |
"The marketing plan for LYBALVI® (olanzapine and samidorphan) at the time of commercial launch is current as of the time of reporting. Marketing plans are subject to change based on market conditions, product life cycle, regulatory considerations, and other factors.
Consumer Education: Alkermes is engaging in activities to educate relevant consumers, including potential patients and caregivers, about LYBALVI. A LYBALVI product website contains information directed to a consumer audience. The LYBALVI website offers educational information about LYBALVI as a potential treatment option for adult patients with schizophrenia or bipolar I disorder, including efficacy and safety information contained in the LYBALVI FDA-approved Prescribing Information and Medication Guide. Patient educational information is available for healthcare professionals to share with appropriate patients and includes an educational brochure, patient wallet card, patient journal and doctor discussion guide. There are no direct-to-consumer media advertisements on television, web-based, consumer magazines, radio, or billboards. The LYBALVI Co-pay Savings Program is available for commercially insured eligible patients who meet the program terms and conditions. Information about the LYBALVI Co-pay Savings Program is provided to healthcare professionals by sales representatives and via the healthcare professionals website, as well as to consumers via the consumer facing LYBALVI product website. There are no additional direct-to-consumer free trial offers, rebates, coupons, or other utilization incentives available to patients.
Healthcare Professional Education: Alkermes has sales representatives that engage in professional detailing activities with healthcare professionals to provide LYBALVI product education related to the approved indications for LYBALVI. Approved LYBALVI promotional materials are used during the detailing activities. LYBALVI product samples are available for healthcare professionals where appropriate. Commercial personnel also have virtual and in-person meetings with potential LYBALVI customers including hospital, healthcare systems, and payers to discuss LYBALVI. Alkermes sponsors promotional product theater programs for healthcare professionals, hosts promotional booths at conferences attended by healthcare professionals, and develops peer-to-peer speaker programs. There are web-based and print advertisements that are distributed to healthcare professionals through mobile applications, websites, social media, professional publications, and conference materials. There are no sponsorships for continuing education for health professionals or gifts provided to healthcare professionals.
Regarding pricing, there is nothing publicly available other than the Wholesale Acquisition Cost." |
None |
6500000 |
None |
None |
None |
None |
None |
None |
The estimated number of patients is based on the total US population who may have either schizophrenia or bipolar 1 disorder. This drug was not acquired. |
None |
| Alkermes, Inc |
65757065344 |
olanzapine and samidorphan tablets 15 mg/10 mg, 90 capsule count |
2021-10-18 |
4170.0000 |
"The marketing plan for LYBALVI® (olanzapine and samidorphan) at the time of commercial launch is current as of the time of reporting. Marketing plans are subject to change based on market conditions, product life cycle, regulatory considerations, and other factors.
Consumer Education: Alkermes is engaging in activities to educate relevant consumers, including potential patients and caregivers, about LYBALVI. A LYBALVI product website contains information directed to a consumer audience. The LYBALVI website offers educational information about LYBALVI as a potential treatment option for adult patients with schizophrenia or bipolar I disorder, including efficacy and safety information contained in the LYBALVI FDA-approved Prescribing Information and Medication Guide. Patient educational information is available for healthcare professionals to share with appropriate patients and includes an educational brochure, patient wallet card, patient journal and doctor discussion guide. There are no direct-to-consumer media advertisements on television, web-based, consumer magazines, radio, or billboards. The LYBALVI Co-pay Savings Program is available for commercially insured eligible patients who meet the program terms and conditions. Information about the LYBALVI Co-pay Savings Program is provided to healthcare professionals by sales representatives and via the healthcare professionals website, as well as to consumers via the consumer facing LYBALVI product website. There are no additional direct-to-consumer free trial offers, rebates, coupons, or other utilization incentives available to patients.
Healthcare Professional Education: Alkermes has sales representatives that engage in professional detailing activities with healthcare professionals to provide LYBALVI product education related to the approved indications for LYBALVI. Approved LYBALVI promotional materials are used during the detailing activities. LYBALVI product samples are available for healthcare professionals where appropriate. Commercial personnel also have virtual and in-person meetings with potential LYBALVI customers including hospital, healthcare systems, and payers to discuss LYBALVI. Alkermes sponsors promotional product theater programs for healthcare professionals, hosts promotional booths at conferences attended by healthcare professionals, and develops peer-to-peer speaker programs. There are web-based and print advertisements that are distributed to healthcare professionals through mobile applications, websites, social media, professional publications, and conference materials. There are no sponsorships for continuing education for health professionals or gifts provided to healthcare professionals.
Regarding pricing, there is nothing publicly available other than the Wholesale Acquisition Cost." |
None |
6500000 |
None |
None |
None |
None |
None |
None |
The estimated number of patients is based on the total US population who may have either schizophrenia or bipolar 1 disorder. This drug was not acquired. |
None |
| Alkermes, Inc |
65757065442 |
olanzapine and samidorphan tablets 20 mg/10 mg, 30 capsule count |
2021-10-18 |
1390.0000 |
"The marketing plan for LYBALVI® (olanzapine and samidorphan) at the time of commercial launch is current as of the time of reporting. Marketing plans are subject to change based on market conditions, product life cycle, regulatory considerations, and other factors.
Consumer Education: Alkermes is engaging in activities to educate relevant consumers, including potential patients and caregivers, about LYBALVI. A LYBALVI product website contains information directed to a consumer audience. The LYBALVI website offers educational information about LYBALVI as a potential treatment option for adult patients with schizophrenia or bipolar I disorder, including efficacy and safety information contained in the LYBALVI FDA-approved Prescribing Information and Medication Guide. Patient educational information is available for healthcare professionals to share with appropriate patients and includes an educational brochure, patient wallet card, patient journal and doctor discussion guide. There are no direct-to-consumer media advertisements on television, web-based, consumer magazines, radio, or billboards. The LYBALVI Co-pay Savings Program is available for commercially insured eligible patients who meet the program terms and conditions. Information about the LYBALVI Co-pay Savings Program is provided to healthcare professionals by sales representatives and via the healthcare professionals website, as well as to consumers via the consumer facing LYBALVI product website. There are no additional direct-to-consumer free trial offers, rebates, coupons, or other utilization incentives available to patients.
Healthcare Professional Education: Alkermes has sales representatives that engage in professional detailing activities with healthcare professionals to provide LYBALVI product education related to the approved indications for LYBALVI. Approved LYBALVI promotional materials are used during the detailing activities. LYBALVI product samples are available for healthcare professionals where appropriate. Commercial personnel also have virtual and in-person meetings with potential LYBALVI customers including hospital, healthcare systems, and payers to discuss LYBALVI. Alkermes sponsors promotional product theater programs for healthcare professionals, hosts promotional booths at conferences attended by healthcare professionals, and develops peer-to-peer speaker programs. There are web-based and print advertisements that are distributed to healthcare professionals through mobile applications, websites, social media, professional publications, and conference materials. There are no sponsorships for continuing education for health professionals or gifts provided to healthcare professionals.
Regarding pricing, there is nothing publicly available other than the Wholesale Acquisition Cost." |
None |
6500000 |
None |
None |
None |
None |
None |
None |
The estimated number of patients is based on the total US population who may have either schizophrenia or bipolar 1 disorder. This drug was not acquired. |
None |
| Alkermes, Inc |
65757065444 |
olanzapine and samidorphan tablets 20 mg/10 mg, 90 capsule count |
2021-10-18 |
4170.0000 |
"The marketing plan for LYBALVI® (olanzapine and samidorphan) at the time of commercial launch is current as of the time of reporting. Marketing plans are subject to change based on market conditions, product life cycle, regulatory considerations, and other factors.
Consumer Education: Alkermes is engaging in activities to educate relevant consumers, including potential patients and caregivers, about LYBALVI. A LYBALVI product website contains information directed to a consumer audience. The LYBALVI website offers educational information about LYBALVI as a potential treatment option for adult patients with schizophrenia or bipolar I disorder, including efficacy and safety information contained in the LYBALVI FDA-approved Prescribing Information and Medication Guide. Patient educational information is available for healthcare professionals to share with appropriate patients and includes an educational brochure, patient wallet card, patient journal and doctor discussion guide. There are no direct-to-consumer media advertisements on television, web-based, consumer magazines, radio, or billboards. The LYBALVI Co-pay Savings Program is available for commercially insured eligible patients who meet the program terms and conditions. Information about the LYBALVI Co-pay Savings Program is provided to healthcare professionals by sales representatives and via the healthcare professionals website, as well as to consumers via the consumer facing LYBALVI product website. There are no additional direct-to-consumer free trial offers, rebates, coupons, or other utilization incentives available to patients.
Healthcare Professional Education: Alkermes has sales representatives that engage in professional detailing activities with healthcare professionals to provide LYBALVI product education related to the approved indications for LYBALVI. Approved LYBALVI promotional materials are used during the detailing activities. LYBALVI product samples are available for healthcare professionals where appropriate. Commercial personnel also have virtual and in-person meetings with potential LYBALVI customers including hospital, healthcare systems, and payers to discuss LYBALVI. Alkermes sponsors promotional product theater programs for healthcare professionals, hosts promotional booths at conferences attended by healthcare professionals, and develops peer-to-peer speaker programs. There are web-based and print advertisements that are distributed to healthcare professionals through mobile applications, websites, social media, professional publications, and conference materials. There are no sponsorships for continuing education for health professionals or gifts provided to healthcare professionals.
Regarding pricing, there is nothing publicly available other than the Wholesale Acquisition Cost." |
None |
6500000 |
None |
None |
None |
None |
None |
None |
The estimated number of patients is based on the total US population who may have either schizophrenia or bipolar 1 disorder. This drug was not acquired. |
None |
| Alkermes, Inc |
65757065142 |
olanzapine and samidorphan tablets 5 mg/10 mg, 30 capsule count |
2021-10-18 |
1390.0000 |
"The marketing plan for LYBALVI® (olanzapine and samidorphan) at the time of commercial launch is current as of the time of reporting. Marketing plans are subject to change based on market conditions, product life cycle, regulatory considerations, and other factors.
Consumer Education: Alkermes is engaging in activities to educate relevant consumers, including potential patients and caregivers, about LYBALVI. A LYBALVI product website contains information directed to a consumer audience. The LYBALVI website offers educational information about LYBALVI as a potential treatment option for adult patients with schizophrenia or bipolar I disorder, including efficacy and safety information contained in the LYBALVI FDA-approved Prescribing Information and Medication Guide. Patient educational information is available for healthcare professionals to share with appropriate patients and includes an educational brochure, patient wallet card, patient journal and doctor discussion guide. There are no direct-to-consumer media advertisements on television, web-based, consumer magazines, radio, or billboards. The LYBALVI Co-pay Savings Program is available for commercially insured eligible patients who meet the program terms and conditions. Information about the LYBALVI Co-pay Savings Program is provided to healthcare professionals by sales representatives and via the healthcare professionals website, as well as to consumers via the consumer facing LYBALVI product website. There are no additional direct-to-consumer free trial offers, rebates, coupons, or other utilization incentives available to patients.
Healthcare Professional Education: Alkermes has sales representatives that engage in professional detailing activities with healthcare professionals to provide LYBALVI product education related to the approved indications for LYBALVI. Approved LYBALVI promotional materials are used during the detailing activities. LYBALVI product samples are available for healthcare professionals where appropriate. Commercial personnel also have virtual and in-person meetings with potential LYBALVI customers including hospital, healthcare systems, and payers to discuss LYBALVI. Alkermes sponsors promotional product theater programs for healthcare professionals, hosts promotional booths at conferences attended by healthcare professionals, and develops peer-to-peer speaker programs. There are web-based and print advertisements that are distributed to healthcare professionals through mobile applications, websites, social media, professional publications, and conference materials. There are no sponsorships for continuing education for health professionals or gifts provided to healthcare professionals.
Regarding pricing, there is nothing publicly available other than the Wholesale Acquisition Cost." |
None |
6500000 |
None |
None |
None |
None |
None |
None |
The estimated number of patients is based on the total US population who may have either schizophrenia or bipolar 1 disorder. This drug was not acquired. |
None |
| Alkermes, Inc |
65757065144 |
olanzapine and samidorphan tablets 5 mg/10 mg, 90 capsule count |
2021-10-18 |
4170.0000 |
"The marketing plan for LYBALVI® (olanzapine and samidorphan) at the time of commercial launch is current as of the time of reporting. Marketing plans are subject to change based on market conditions, product life cycle, regulatory considerations, and other factors.
Consumer Education: Alkermes is engaging in activities to educate relevant consumers, including potential patients and caregivers, about LYBALVI. A LYBALVI product website contains information directed to a consumer audience. The LYBALVI website offers educational information about LYBALVI as a potential treatment option for adult patients with schizophrenia or bipolar I disorder, including efficacy and safety information contained in the LYBALVI FDA-approved Prescribing Information and Medication Guide. Patient educational information is available for healthcare professionals to share with appropriate patients and includes an educational brochure, patient wallet card, patient journal and doctor discussion guide. There are no direct-to-consumer media advertisements on television, web-based, consumer magazines, radio, or billboards. The LYBALVI Co-pay Savings Program is available for commercially insured eligible patients who meet the program terms and conditions. Information about the LYBALVI Co-pay Savings Program is provided to healthcare professionals by sales representatives and via the healthcare professionals website, as well as to consumers via the consumer facing LYBALVI product website. There are no additional direct-to-consumer free trial offers, rebates, coupons, or other utilization incentives available to patients.
Healthcare Professional Education: Alkermes has sales representatives that engage in professional detailing activities with healthcare professionals to provide LYBALVI product education related to the approved indications for LYBALVI. Approved LYBALVI promotional materials are used during the detailing activities. LYBALVI product samples are available for healthcare professionals where appropriate. Commercial personnel also have virtual and in-person meetings with potential LYBALVI customers including hospital, healthcare systems, and payers to discuss LYBALVI. Alkermes sponsors promotional product theater programs for healthcare professionals, hosts promotional booths at conferences attended by healthcare professionals, and develops peer-to-peer speaker programs. There are web-based and print advertisements that are distributed to healthcare professionals through mobile applications, websites, social media, professional publications, and conference materials. There are no sponsorships for continuing education for health professionals or gifts provided to healthcare professionals.
Regarding pricing, there is nothing publicly available other than the Wholesale Acquisition Cost." |
None |
6500000 |
None |
None |
None |
None |
None |
None |
The estimated number of patients is based on the total US population who may have either schizophrenia or bipolar 1 disorder. This drug was not acquired. |
None |
| Almirall LLC |
16110039105 |
Klisyri 1% Ointment Packet |
2021-02-08 |
990.0000 |
Marketing: Klisyri is FDA approved treatment for Actinic keratosis on the face or scalp which affects a number of patients in the US annually. Almirall's approach will focus on educating healthcare providers on how to identify and diagnose potential patients to provide relief from symptoms as early as possible - the education will provide information about treatment with Almirall products.
Pricing: Based on meaningful market research, which looks at comparative products within the same clinical indication, therapeutic class and patient population, a cross functional team evaluates how the product differentiates from its competition in the market and, based
on the entirety of the data available, assesses a product baseline fair market value.
Following interactions with payers, internal methodology is used to forecast a realistic cost of rebates and other instruments designed to facilitate patient access.
Product price at launch reflects the sum of the data analysis in the light of all the principles outlined above, coupled with the Company’s assessment of its fair market value when compared with similar products already on the market. Full analysis of the clinical data, conducted to assess product differentiation from existing treatments available in that approved indication, represents an element of consideration in that regard. |
None |
40000000 |
None |
None |
None |
None |
None |
None |
The American Academy of Dermatology has estimated that approximately 40 million Americans may be affected by AK. J. Am. Acad. Dermatol. 2018; 78:710. |
None |
| ALVOGEN |
47781092501 |
Pyrimethamine Tabs, 25mgs x 100 count |
2021-12-01 |
29250.0000 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| ALVOGEN |
47781092530 |
Pyrimethamine Tabs, 25mgs x 30 count |
2021-12-01 |
8775.0000 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| American Health Packaging |
68084095001 |
Fluphenazine HCl Tablet 10mg 100UD |
2021-02-16 |
1342.8600 |
See Attached |
None |
2600000 |
None |
None |
2021-01-26 |
385.0000 |
None |
As a repackager, AHP does not engage in a licensing agreement with the ANDA holder rather we purchase commercially available batches of drug product and repackage into unit-dose presentations under an AHP NDC. There is no licensing acquisition cost as each batch of product is purchased independently and repackaged in whole-batch quantities per FDA regulations and guidance. Price indicated is for initial receipt of product for launch of the repackaged NDC. |
1.ESTIMATED # PATIENTS: Patient Information - CANNOT BE DETERMINED: Fluphenazine, is a typical antipsychotic prescribed for treatment of schizophrenia, mania, bipolar disorder and dementia (reference: https://www.webmd.com/search/search_results/default.aspx?query=Fluphenazine+HCl+) and the estimated patient population for schizophrenia is 2.6 million (reference: https://www.treatmentadvocacycenter.org/evidence-and-research/learn-more-about/25-schizophrenia-fact-sheet#:~:text=Schizophrenia%20is%20a%20chronic%20and%20severe%20neurological%20brain%20disorder%20estimated,untreated%20in%20any%20given%20year).
2. Course of Therapy: Course of Therapy has been reviewed to determine submission. |
https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=543 |
| American Health Packaging |
68084084601 |
Fluphenazine HCl Tablet 5mg 100UD |
2021-02-16 |
1071.4300 |
See Attached |
None |
2600000 |
None |
None |
2021-01-26 |
305.0000 |
None |
As a repackager, AHP does not engage in a licensing agreement with the ANDA holder rather we purchase commercially available batches of drug product and repackage into unit-dose presentations under an AHP NDC. There is no licensing acquisition cost as each batch of product is purchased independently and repackaged in whole-batch quantities per FDA regulations and guidance. Price indicated is for initial receipt of product for launch of the repackaged NDC. |
1.ESTIMATED # PATIENTS: Patient Information - CANNOT BE DETERMINED: Fluphenazine, is a typical antipsychotic prescribed for treatment of schizophrenia, mania, bipolar disorder and dementia (reference: https://www.webmd.com/search/search_results/default.aspx?query=Fluphenazine+HCl+) and the estimated patient population for schizophrenia is 2.6 million (reference: https://www.treatmentadvocacycenter.org/evidence-and-research/learn-more-about/25-schizophrenia-fact-sheet#:~:text=Schizophrenia%20is%20a%20chronic%20and%20severe%20neurological%20brain%20disorder%20estimated,untreated%20in%20any%20given%20year).
2. Course of Therapy: Course of Therapy has been reviewed to determine submission. |
https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=542 |
| American Health Packaging |
68001044432 |
Cyclophosphamide Inj 1mg/100ml vial |
2021-03-12 |
1318.5000 |
See Attached |
None |
90000 |
None |
None |
2021-01-22 |
473.0000 |
None |
As a repackager, AHP does not engage in a licensing agreement with the ANDA holder rather we purchase commercially available batches of drug product and repackage into unit-dose presentations under an AHP NDC. There is no licensing acquisition cost as each batch of product is purchased independently and repackaged in whole-batch quantities per FDA regulations and guidance. Price indicated is for initial receipt of product for launch of the repackaged NDC. |
1.ESTIMATED # PATIENTS: Patient Information - CANNOT BE DETERMINED: Cyclophosphamide is used to treat various types of cancer including Hodgkins and Non-Hodgkins lymphoma. It is a chemotherapy drug that works by slowing or stopping cell growth (reference: http://chemocare.com/chemotherapy/drug-info/cyclophosphamide.aspx). The estimated patient population for Hodgkins/Non-Hodgkins is approximately 90,000 (reference www.cancer.net).
2. Course of Therapy: Course of Therapy has been reviewed to determine submission. |
https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=545 |
| American Health Packaging |
68001047008 |
Metoprolol Succinate ER Tablet 100mg 1000 Bottle |
2021-04-30 |
732.0400 |
See Attached |
None |
10800000 |
None |
None |
2021-04-26 |
178.0000 |
None |
As a repackager, AHP does not engage in a licensing agreement with the ANDA holder rather we purchase commercially available batches of drug product and repackage into unit-dose presentations under an AHP NDC. There is no licensing acquisition cost as each batch of product is purchased independently and repackaged in whole-batch quantities per FDA regulations and guidance. Price indicated is for initial receipt of product for launch of the repackaged NDC. |
1.ESTIMATED # PATIENTS: Metoprolol Succinate is used to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. (reference: https://www.webmd.com/drugs/2/search?type=drugs&query=Metoprolol%20Succinate%20ER) and the patient population is estimated at 108 million (reference: https://www.cdc.gov/bloodpressure/facts.htm#:~:text=Nearly%20half%20of%20adults%20in,are%20taking%20medication%20for%20hypertension.&text=Only%20about%201%20in%204,have%20their%20condition%20under%20control).
2. Course of Therapy: Course of Therapy has been reviewed to determine submission. |
https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=544 |
| American Health Packaging |
68001049905 |
Venlafaxine ER Tablet 225mg |
2021-04-30 |
774.6800 |
Create collateral of new item; initiative ABC stream serve; Email collateral to AHP customer base; utilize AHP & ABC inside sales team to create awareness of new item; place collateral in industry publications for visibility to the pharmacy practice |
None |
50000000 |
None |
None |
2021-10-01 |
25.0000 |
None |
As a repackager, AHP does not engage in a licensing agreement with the ANDA holder rather we purchase commercially available batches of drug product and repackage into unit-dose presentations under an AHP NDC. There is no licensing acquisition cost as each batch of product is purchased independently and repackaged in whole-batch quantities per FDA regulations and guidance. Price indicated is for initial receipt of product for launch of the repackaged NDC. |
1.ESTIMATED # PATIENTS: Patient Information - CANNOT BE DETERMINED: Venlafaxine is used for treatment of depression, anxiety, panic attacks, and social anxiety disorder (social phobia). (reference:the CDC estimates that in 2019, 8.1% of adults aged 18 and over had symptoms of anxiety disorder, 6.5% had symptoms of depressive disorder, and 10.8% had symptoms of anxiety disorder or depressive disorder). https://www.cdc.gov/nchs/covid19/pulse/mental-health.htm
2. Course Of Therapy: Course of Therapy has been reviewed to determine submission. |
None |
| American Health Packaging |
60687059921 |
Flucytosine Capsule 250mg |
2021-05-01 |
2455.8600 |
Create collateral of new item; initiative AB stream serve; Email collateral to AHP customer base; utilize AHP & AB inside sales team to create awareness of new item; place collateral in industry publications for visibility to the pharmacy practice |
None |
9000000 |
None |
None |
2021-10-01 |
679.0000 |
None |
As a repackager, AHP does not engage in a licensing agreement with the ANDA holder rather we purchase commercially available batches of drug product and repackage into unit-dose presentations under an AHP NDC. There is no licensing acquisition cost as each batch of product is purchased independently and repackaged in whole-batch quantities per FDA regulations and guidance. Price indicated is for initial receipt of product for launch of the repackaged NDC. |
1.ESTIMATED # PATIENTS: Patient Information - CANNOT BE DETERMINED: Flucytosine is used for treatment of serious fungal infections, the CDC indicates that there were over 75,000 hospitalizations and nearly 9 million outpatient visits for fungal diseases in 2017. https://www.cdc.gov/fungal/cdc-and-fungal/burden.html
2. Course Of Therapy: Course of Therapy has been reviewed to determine submission. |
https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=559 |
| American Health Packaging |
60687061021 |
Flucytosine Capsule 500mg |
2021-05-02 |
4700.1000 |
Create collateral of new item; initiative ABC stream serve; Email collateral to AHP customer base; utilize AHP & ABC inside sales team to create awareness of new item; place collateral in industry publications for visibility to the pharmacy practice |
None |
9000000 |
None |
None |
2021-10-01 |
749.0000 |
None |
As a repackager, AHP does not engage in a licensing agreement with the ANDA holder rather we purchase commercially available batches of drug product and repackage into unit-dose presentations under an AHP NDC. There is no licensing acquisition cost as each batch of product is purchased independently and repackaged in whole-batch quantities per FDA regulations and guidance. Price indicated is for initial receipt of product for launch of the repackaged NDC. |
1.ESTIMATED # PATIENTS: Patient Information - CANNOT BE DETERMINED: Flucytosine is used for treatment of serious fungal infections, the CDC indicates that there were over 75,000 hospitalizations and nearly 9 million outpatient visits for fungal diseases in 2017. https://www.cdc.gov/fungal/cdc-and-fungal/burden.html
2. Course Of Therapy: Course of Therapy has been reviewed to determine submission. |
https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=560 |
| American Health Packaging |
68001049236 |
Doxorubicin HCl Liposome Injection 20mg/10ml |
2021-05-31 |
969.0000 |
Create collateral of new item; initiative ABC stream serve; Email collateral to AHP customer base; utilize AHP & ABC inside sales team to create awareness of new item; place collateral in industry publications for visibility to the pharmacy practice |
None |
147000 |
None |
None |
2021-10-01 |
349.0000 |
None |
As a repackager, AHP does not engage in a licensing agreement with the ANDA holder rather we purchase commercially available batches of drug product and repackage into unit-dose presentations under an AHP NDC. There is no licensing acquisition cost as each batch of product is purchased independently and repackaged in whole-batch quantities per FDA regulations and guidance. Price indicated is for initial receipt of product for launch of the repackaged NDC. |
1.ESTIMATED #PATIENTS: Patient Information - CANNOT BE DETERMINED: Doxorubicin HCl Liposome is used for treatment of anthracycline type of chemotherapy that is used to treat several different types of cancer. Doxorubicin works by slowing or stopping the growth of cancer cells.(reference: https://www.webmd.com/drugs/2/drug-7750/doxorubicin-intravenous/details)(https://clinicaltrials.gov/ct2/show/NCT04650984).
2. Course Of Therapy: Course of Therapy has been reviewed to determine submission. |
None |
| American Health Packaging |
68001049326 |
Doxorubicin HCl Liposome Injection 50mg/25ml |
2021-05-31 |
2422.5500 |
Create collateral of new item; initiative ABC stream serve; Email collateral to AHP customer base; utilize AHP & ABC inside sales team to create awareness of new item; place collateral in industry publications for visibility to the pharmacy practice |
None |
147000 |
None |
None |
2021-10-01 |
873.0000 |
None |
As a repackager, AHP does not engage in a licensing agreement with the ANDA holder rather we purchase commercially available batches of drug product and repackage into unit-dose presentations under an AHP NDC. There is no licensing acquisition cost as each batch of product is purchased independently and repackaged in whole-batch quantities per FDA regulations and guidance. Price indicated is for initial receipt of product for launch of the repackaged NDC. |
1.ESTIMATED #PATIENTS: Patient Information - CANNOT BE DETERMINED: Doxorubicin HCl Liposome is used for treatment of anthracycline type of chemotherapy that is used to treat several different types of cancer. Doxorubicin works by slowing or stopping the growth of cancer cells.(reference: https://www.webmd.com/drugs/2/drug-7750/doxorubicin-intravenous/details)(https://clinicaltrials.gov/ct2/show/NCT04650984).
2. Course Of Therapy: Course of Therapy has been reviewed to determine submission. |
https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=561 |
| Amgen |
55513022401 |
RIABNI 10mg/mL Vial (10-pkg size) |
2021-01-04 |
716.8000 |
There will be no direct-to-consumer marketing for RIABNI such as TV ads or magazine ads. The only platforms directed to patients is patient education brochure and RIABNI.com website entitled “For Patients”. This content is designed to educate patients about the diseases aligned with the RIABNI indications and potential treatment with RIABNI, including important safety information.
Promotional activities to physicians will include professional detailing by Amgen sales representatives. Amgen is utilizing its existing oncology sales force to educate health care professionals about RIABNI, including the requirements for establishing biosimilarity to the reference product, Rituxan, and important safety information. Professional detailing entails resources such as a core visual aid and promotional leave-behind literature. There is no free drug or sample program.
RIABNI’s Wholesale Acquisition Cost (WAC, sometimes referred to as list price) will be lower than its reference product, Rituxan. The WAC of RIABNI in the U.S. is 23.7% lower than the reference product, Rituxan. RIABNI is being made available at a WAC of $716.80 per 100 mg and $3,584.00 per 500 mg single-dose vial. |
None |
None |
None |
None |
None |
None |
None |
None |
Per CA Health & Safety Code §127681(c) Amgen respectfully declines to submit the Estimated Number of Patients, as it is not otherwise in the public domain or publicly available. |
None |
| Amgen |
55513032601 |
RIABNI 10mg/mL Vial (50 pkg size) |
2021-01-04 |
3584.0000 |
There will be no direct-to-consumer marketing for RIABNI such as TV ads or magazine ads. The only platforms directed to patients is patient education brochure and RIABNI.com website entitled “For Patients”. This content is designed to educate patients about the diseases aligned with the RIABNI indications and potential treatment with RIABNI, including important safety information.
Promotional activities to physicians will include professional detailing by Amgen sales representatives. Amgen is utilizing its existing oncology sales force to educate health care professionals about RIABNI, including the requirements for establishing biosimilarity to the reference product, Rituxan, and important safety information. Professional detailing entails resources such as a core visual aid and promotional leave-behind literature. There is no free drug or sample program.
RIABNI’s Wholesale Acquisition Cost (WAC, sometimes referred to as list price) will be lower than its reference product, Rituxan. The WAC of RIABNI in the U.S. is 23.7% lower than the reference product, Rituxan. RIABNI is being made available at a WAC of $716.80 per 100 mg and $3,584.00 per 500 mg single-dose vial. |
None |
None |
None |
None |
None |
None |
None |
None |
Per CA Health & Safety Code §127681(c) Amgen respectfully declines to submit the Estimated Number of Patients, as it is not otherwise in the public domain or publicly available. |
None |
| Amgen |
55513048824 |
Lumakras (30-day supply, 1 bottle of 240 120mg tablets) |
2021-06-03 |
17900.0000 |
Pursuant to CA Health and Safety Code 127681, Amgen provides the following information:
There is no direct-to-consumer marketing for Lumakras via TV or magazine ads. Promotional activities for patients are (1) patient website www.Lumakras.com, search and banner advertising (2) patient educational brochure and (3) pill caddy. The purpose of the website, drivers to website and brochure is to educate patients on testing for KRAS G12C and Lumakras aligned to the Lumakras USPI, including Important Safety Information. The pill caddy is available via Specialty Pharmacies and the Amgen Nurse Navigator program should a patient be prescribed Lumakras.
Promotional activities to HCPs include sales representative detailing, speaker programs, congresses and non-personal promotion such as HCP website, www.Lumakrashcp.com, search, banner advertising, and other digital educational programming in line with the Lumakras USPI. The purpose of these tools is for education on testing for KRAS G12C and Lumakras. There are no direct-to-consumer promotional incentives such as free trial offers. There is no sample program.
Amgen understands that the cost of prescription drugs is a concern for many people, and we are committed to the responsible pricing of our medicines.
Our approach to pricing across the globe is underpinned by two simple core principles:
I. Pricing our products according to the value they deliver
II. Employs flexible pricing approaches to ensure patient access
LUMAKRAS is available at a WAC of $17,900 per 30-day supply. This price is in line with other targeted therapies in oncology. |
None |
None |
1 |
1 |
None |
None |
None |
None |
Per CA Health & Safety Code §127681(c) Amgen respectfully declines to submit the Estimated Number of Patients, as it is not otherwise in the public domain or publicly available. |
None |
| Amivas (US), LLC |
73607000111 |
Artesunate for Injection - 2 pack |
2021-03-30 |
9960.0000 |
Launch Plan Objectives:
Demonstrate early sales traction with stockpiling and pre-positioning sales within 1-3 months of NDA approval. Reinforce early sales traction through annual Infectious Disease conference attendance/booths in both Europe and US markets.
Launch Strategy:
Website and social media presence that directs inquiries to the infectious disease community and distributors. Targeting hospitals with calls in historic malaria case regions/countries. Achieve through analysis of historical malaria rates but also ID physician hospital locations available through ID societies. Attend several ID conferences held during the year. Marketing has already been initiated as official organizations/literature have adopted Artesunate for Injection as first line therapy. This has been augmented by Amivas/USAMMDA cooperating in supplying Artesunate for Injection to the U.S. CDC for compassionate use under their treatment IND and this has been recognized by the American Society of Tropical Medicine and Hygiene (ASTMH).
Pricing Plan:
The cost per 110 mg vial of IV Artesunate provided by the manufacturer, Amivas (US), LLC is set at $4,980. Based on the studies conducted in the US, the average number of vials used per dose (2.4 mg/kg) resulting in an estimated cost per dose of roughly $35,403. Amivas conducted a base case cost-effectiveness analysis that had shown an indicative cost per life year saved of $62,232 and is calculated for treatment with Artesunate for Injection compared to using IV Quinine. Following annual 3% discounting of Life Years only as costs are all incurred in the first year, the Incremental cost-effectiveness ratio (ICER) = $110,469 per life year saved (discounted). Overall, the pricing and availability of a formulation of Artesunate for Injection in the US will provide substantive value in access for what is considered the international standard of care for an otherwise fatal disease. |
None |
300 |
1 |
1 |
2017-02-13 |
10000.0000 |
None |
none |
None |
None |
| Amivas (US), LLC |
73607000110 |
Artesunate for Injection - 4 pack |
2021-03-30 |
19920.0000 |
Launch Plan Objectives:
Demonstrate early sales traction with stockpiling and pre-positioning sales within 1-3 months of NDA approval. Reinforce early sales traction through annual Infectious Disease conference attendance/booths in both Europe and US markets.
Launch Strategy:
Website and social media presence that directs inquiries to the infectious disease community and distributors. Targeting hospitals with calls in historic malaria case regions/countries. Achieve through analysis of historical malaria rates but also ID physician hospital locations available through ID societies. Attend several ID conferences held during the year. Marketing has already been initiated as official organizations/literature have adopted Artesunate for Injection as first line therapy. This has been augmented by Amivas/USAMMDA cooperating in supplying Artesunate for Injection to the U.S. CDC for compassionate use under their treatment IND and this has been recognized by the American Society of Tropical Medicine and Hygiene (ASTMH).
Pricing Plan:
The cost per 110 mg vial of IV Artesunate provided by the manufacturer, Amivas (US), LLC is set at $4,980. Based on the studies conducted in the US, the average number of vials used per dose (2.4 mg/kg) resulting in an estimated cost per dose of roughly $35,403. Amivas conducted a base case cost-effectiveness analysis that had shown an indicative cost per life year saved of $62,232 and is calculated for treatment with Artesunate for Injection compared to using IV Quinine. Following annual 3% discounting of Life Years only as costs are all incurred in the first year, the Incremental cost-effectiveness ratio (ICER) = $110,469 per life year saved (discounted). Overall, the pricing and availability of a formulation of Artesunate for Injection in the US will provide substantive value in access for what is considered the international standard of care for an otherwise fatal disease. |
None |
300 |
1 |
1 |
2017-02-13 |
10000.0000 |
None |
none |
None |
None |
| Amneal Pharmaceuticals |
69238175406 |
Abiraterone Acetate Oral Tablet 500mg 60 |
2021-01-04 |
7446.7200 |
This is a generic product that is not marketed. |
None |
191930 |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Amneal is limiting its response to that which is otherwise in the public domain or publicly available. The estimated average number of patients per month is unknown to Amneal. Amneal did not acquire this product. |
None |
| Amneal Pharmaceuticals |
69238209203 |
Emtricitabine - Tenofovir Disoproxil Fumarate Oral Tablet 100-150MG 30 |
2021-01-18 |
1411.7400 |
This is a generic product that is not marketed. |
None |
36400 |
None |
None |
None |
None |
None |
None |
This drug was not acquired |
None |
| Amneal Pharmaceuticals |
69238209303 |
Emtricitabine - Tenofovir Disoproxil Fumarate Oral Tablet 133-200MG 30 |
2021-01-18 |
1411.7400 |
This is a generic product that is not marketed. |
None |
36400 |
None |
None |
None |
None |
None |
None |
This drug was not acquired |
None |
| Amneal Pharmaceuticals |
69238209403 |
Emtricitabine - Tenofovir Disoproxil Fumarate Oral Tablet 167-250MG 30 |
2021-01-18 |
1411.7400 |
This is a generic product that is not marketed. |
None |
36400 |
None |
None |
None |
None |
None |
None |
This drug was not acquired |
None |
| Amneal Pharmaceuticals |
69238162103 |
Metyrosine Oral Capsule 250mg 30 |
2021-01-20 |
7500.0000 |
This is a generic product that is not marketed |
None |
41 |
None |
None |
None |
None |
None |
None |
This drug was developed in-house and was not acquired. |
None |
| Amneal Pharmaceuticals |
69238170303 |
Deferasirox Oral Granules 180mg 30 |
2021-02-19 |
2049.9800 |
This is a generic product that is not marketed. |
None |
41 |
None |
None |
None |
None |
None |
None |
This drug was developed in-house and was not acquired. |
None |
| Amneal Pharmaceuticals |
69238170403 |
Deferasirox Oral Granules 360mg 30 |
2021-02-19 |
4099.8700 |
This is a generic product that is not marketed. |
None |
41 |
None |
None |
None |
None |
None |
None |
None |
None |
| Amneal Pharmaceuticals |
60219172107 |
Etravirine 100 MG |
2021-06-14 |
1287.2900 |
This is a generic product that is not marketed. |
None |
100 |
None |
None |
None |
None |
None |
None |
This drug was developed in-house and was not acquired. |
None |
| Amneal Pharmaceuticals |
60219172206 |
Etravirine 200 MG |
2021-06-14 |
1287.2900 |
This is a generic product that is not marketed. |
None |
100 |
None |
None |
None |
None |
None |
None |
This drug was developed in-house and was not acquired. |
None |
| Amneal Pharmaceuticals |
00115214216 |
Colestipol Hydrochloride |
2021-09-13 |
123.7800 |
This is a generic product that is not marketed |
None |
41 |
None |
None |
None |
None |
None |
None |
This is an existing product with an updated NDC |
None |
| Amneal Pharmaceuticals |
70121148307 |
arsenic Trioxide Injection 10mg/10ML (1 mg/1mL) |
2021-09-16 |
4266.1100 |
This is a generic product that is not marketed |
None |
41 |
None |
None |
None |
None |
None |
None |
None |
None |
| Amneal Pharmaceuticals |
70121165801 |
arsenic Trioxide Injection 12mg/6ML (2 mg/1mL) |
2021-09-16 |
5119.3300 |
This is a generic product that is not marketed |
None |
41 |
None |
None |
None |
None |
None |
None |
None |
None |
| Amneal Pharmaceuticals |
60219203601 |
Azathioprine 75mg |
2021-11-22 |
1408.4900 |
This is a generic product that is not marketed. |
None |
1000000 |
None |
None |
None |
None |
None |
None |
This drug was developed in-house and was not acquired. |
None |
| ANIP |
62559027705 |
Nebivolol Tablets 10mg 500ct |
2021-10-01 |
1408.3300 |
ANI did some market research with customers to understand how many generic manufacturers would be coming to market on day 1. We realized that we would be most likely be the only TAA compliant product that would qualify to sell to the government. We were approached by a few companies that specialize in selling to the government to be our distribution and marketing partner and chose to go with Golden State. Through their expertise in selling new generic launches, they gave us guidance on an opening price point discounted off the branded prices. At this time, ANI is only focused on selling Nebivolol in the United States. |
None |
12000 |
None |
None |
None |
None |
None |
None |
None |
None |
| ANIP |
62559027583 |
Nebivolol Tablets 2.5mg 2300ct |
2021-10-01 |
6478.3300 |
ANI did some market research with customers to understand how many generic manufacturers would be coming to market on day 1. We realized that we would be most likely be the only TAA compliant product that would qualify to sell to the government. We were approached by a few companies that specialize in selling to the government to be our distribution and marketing partner and chose to go with Golden State. Through their expertise in selling new generic launches, they gave us guidance on an opening price point discounted off the branded prices. At this time, ANI is only focused on selling Nebivolol in the United States. |
None |
12000 |
None |
None |
None |
None |
None |
None |
None |
None |
| ANIP |
62559027805 |
Nebivolol Tablets 20mg 500ct |
2021-10-01 |
1408.3300 |
ANI did some market research with customers to understand how many generic manufacturers would be coming to market on day 1. We realized that we would be most likely be the only TAA compliant product that would qualify to sell to the government. We were approached by a few companies that specialize in selling to the government to be our distribution and marketing partner and chose to go with Golden State. Through their expertise in selling new generic launches, they gave us guidance on an opening price point discounted off the branded prices. At this time, ANI is only focused on selling Nebivolol in the United States. |
None |
12000 |
None |
None |
None |
None |
None |
None |
None |
None |
| ANIP |
62559027671 |
Nebivolol Tablets 5mg 1100ct |
2021-10-01 |
3098.3300 |
ANI did some market research with customers to understand how many generic manufacturers would be coming to market on day 1. We realized that we would be most likely be the only TAA compliant product that would qualify to sell to the government. We were approached by a few companies that specialize in selling to the government to be our distribution and marketing partner and chose to go with Golden State. Through their expertise in selling new generic launches, they gave us guidance on an opening price point discounted off the branded prices. At this time, ANI is only focused on selling Nebivolol in the United States. |
None |
12000 |
None |
None |
None |
None |
None |
None |
None |
None |
| ANIP |
62559086015 |
Cortrophin Gel 400 USP units/5mL |
2021-12-01 |
31851.0000 |
The Purified Cortrophin Gel marketing plan includes a small field-based sales force. Their efforts will focus on helping clinicians understand how to identify the appropriate chronic autoimmune disorder patients who could potentially benefit from treatment with Cortrophin Gel. Cortrophin Gel is generally reserved for use after first-line treatment or for acute treatment. Based on market research conducted by ANI, it’s estimated that there will be approximately 325 patients treated with Purified Cortrophin Gel in 2022. At this time, ANI is only focused on selling Purified Cortrophin Gel in the U.S.
ANI will be launching Cortrophin Gel in the US Market in the first quarter of 2022. Cortrophin Gel is the first branded prescription alternative to Acthar Gel in the US Market. ANI has decided to launch Cortrophin Gel at a discount of twenty percent from Acthar Gel in order to bring a more affordable Corticotropin therapy to patients who need this therapy. |
None |
325 |
None |
None |
None |
None |
None |
None |
None |
None |
| Apellis Pharmaceuticals |
73606001001 |
Empaveli 1080mg/20ml (54 mg/ml) in a single dose vial |
2021-05-18 |
4403.8400 |
Marketing: EMPAVELITM is a FDA approved treatment for Paroxysmal Nocturnal Hemoglobinuria (PNH). PNH often presents with persistently low hemoglobin, thrombosis and debilitating symptoms. Apellis’s approach will focus on educating healthcare providers and staff on how to diagnose PNH and provide information about treatment. Educational materials will be provided across the patient journey, to both HCPs and to families, and highlight access and affordability support to ensure rapid access to EMPAVELI.
Pricing: EMPAVELITM has been developed for the treatment of patients with Paroxysmal Nocturnal Hemoglobinuria (PNH). EMPAVELI provides an option to deliver a safe, effective treatment that reduces the risk of persistently low hemoglobin and other debilitating symptoms in patients. EMPAVELI is priced responsibly compared to similar agents. Pricing accounts for development costs, complexity of manufacturing, distribution, and storage. Apellis demonstrates a strong commitment to patients and their ability to get access to care with support programs that leaves no patient behind. |
None |
6000 |
None |
1 |
None |
None |
None |
None |
Regarding the request for Acquisition Data (items 10-13), there is no data to report; not an Acquired Drug. |
None |
| Apotex Corp |
60505612006 |
Micafungin PINJ 100mg |
2021-02-12 |
1870.0000 |
None |
1 |
2083 |
None |
None |
None |
None |
None |
None |
None |
None |
| Apotex Corp |
60505611905 |
Micafungin PINJ 50mg |
2021-02-12 |
935.0000 |
None |
1 |
2083 |
None |
None |
None |
None |
None |
None |
None |
None |
| Apotex Corp |
60505621401 |
Icatibant Acetate Inj |
2021-04-15 |
2795.7900 |
None |
1 |
6628 |
None |
None |
None |
None |
None |
None |
Apotex’s trade secret information is very valuable to its competitors. Disclosure of Apotex Trade Secrets would permit Apotex’s competitors to understand Apotex’s potential pricing for Icatibant Acetate Inj and limitations on discounting, etc., such as by learning pricing methodology for Icatibant Acetate Inj. Such information would provide Apotex’s competitors an unfair advantage in competing for customers. The generic drug market is highly competitive in many therapeutic classes, making Apotex Trade Secrets very valuable to both Apotex and its competitors.
Because of the measures put in place by Apotex to protect the information, Apotex submits that it would be extremely difficult for anyone, including a competitor, to obtain a copy of Apotex Trade Secrets unless release as public information by the state of Oregon Department of Consumer and Business Services. Apotex is not aware of any Apotex Trade Secrets presently in any of its competitor’s hands. Competitors in the industry with one another should not share such trade secret information because it is competition sensitive. Indeed, competitors that share trade secret information, including pricing and production costs, with one another could be pursued by regulatory authorities for violating laws prohibiting collusive bidding and anti-competitive conduct. Apotex Trade Secrets cannot be properly or legally acquired by its competitors.
In conclusion, because Apotex Trade Secrets meet the definition of “trade secret” under the Federal Defend Trade Secrets Act of 2016, codified at 18 U.S.C. 1836, and the Price Transparency reporting for Icatibant Acetate Inj was marked to reflect such. |
None |
| Apotex Corp |
60505476406 |
ABIRATERONE FCT 500MG 60 BTL |
2021-07-14 |
4964.4800 |
None |
1 |
20833 |
None |
None |
None |
None |
None |
None |
Apotex’s trade secret information is very valuable to its competitors. Disclosure of Apotex Trade Secrets would permit Apotex’s competitors to understand Apotex’s potential pricing for Abiraterone and limitations on discounting, etc., such as by learning pricing methodology for Abiraterone. Such information would provide Apotex’s competitors an unfair advantage in competing for customers. The generic drug market is highly competitive in many therapeutic classes, making Apotex Trade Secrets very valuable to both Apotex and its competitors. |
None |
| Arbor Pharmaceuticals, LLC |
24338041024 |
Chlorpromazine Hydrocloride Oral Concentrate 100mg/mL 240mL Bottle |
2021-08-09 |
2160.0000 |
Chlorpromazine Hydrochloride Oral Concentrate is the only FDA approved oral concentrate of chlorpromazine which serves an unmet need for patients who need chlorpromazine but can’t or won’t swallow chlorpromazine tablets. It is priced on a comparative dose to dose cost similar to the existing brand tablet forms. |
None |
2200000 |
None |
None |
None |
None |
None |
None |
None |
None |
| argenx US Inc. |
07347530415 |
VYVGART™ (efgartigimod alfa-fcab) 400 mg per 20 mL (20mg/mL) single use vial |
2021-12-27 |
5950.0000 |
None |
1 |
1 |
None |
None |
None |
None |
None |
None |
The "estimated patients" quantity does not exist. We do not have information available that provides a reasonable basis to determine the estimated number of patients per month. Consistent with Cal. Health & Safety Code 127681(c), argenx is limiting its response to that which is otherwise in the public domain or publicly available. argenx’s estimated number of patients is argenx confidential and proprietary information and is not in the public domain or publicly available. |
None |
| Ascend Laboratories, LLC |
67877067362 |
Rufinamide Oral Suspension 40mg 460ML |
2021-03-03 |
1202.3800 |
None |
1 |
1 |
None |
None |
None |
None |
None |
None |
Please note that an entry of "1" in the Estimated Average patients per month is essentially a place holder as the system does not allow a blank entry. The number of estimated patients is unknown to Ascend, and therefore cannot provide this information. |
None |
| Ascend Laboratories, LLC |
67877074801 |
SIROLIMUS 2MG TABLETS |
2021-03-23 |
997.8200 |
None |
1 |
1 |
None |
None |
None |
None |
None |
None |
Please note that an entry of "1" in the Estimated Average patients per month is essentially a place holder as the system does not allow a blank entry. The number of estimated patients is unknown to Ascend, and therefore cannot provide this information. |
None |
| Ascend Laboratories, LLC |
67877073101 |
Chlordiazepoxide HCL 5/2.5mg 100 Caps |
2021-04-01 |
840.0000 |
None |
1 |
40000000 |
None |
None |
None |
None |
None |
None |
Please note that an entry of "1" in the Estimated Average patients per month is essentially a place holder as the system does not allow a blank entry. The number of estimated patients is unknown to Ascend, and therefore cannot provide this information.
Chlordiazepoxide is an FDA approved medication for adults with mild to moderate to severe anxiety, preoperative anxiety and alcohol withdrawal |
None |
| Ascend Laboratories, LLC |
67877063633 |
Tolvaptan 30mg 1X10 Tabs |
2021-05-10 |
4805.2500 |
None |
1 |
12000000 |
None |
None |
None |
None |
None |
None |
Autosomal dominant polycystic kidney disease (ADPKD) is the most common hereditary kidney disease affecting over 12 million people worldwide. It's estimated that between 1 in every 400 to 2,500 people has the disease. It can affect women and men, across all ethnic groups. |
None |
| Ascend Laboratories, LLC |
67877072131 |
EVEROLIMUS 1MG TABLET 60 tabs |
2021-11-30 |
2047.5000 |
Ascend does not have patented marketing information. Any marketing related to this product is only known to Ascend's commercial team. Marketing information has potential value and allowing this information to remain non-public and confidential, allows Ascend to obtain a business advantage over its competitors who do not know Ascend's marketing information. Making this public would not serve the public interest and therefore is not required.
Ascend does not have patented pricing methodology information. Any pricing methodology information related to this product is only known to Ascend's commercial team. Pricing methodology information has potential value and allowing this information to remain non-public and confidential, allows Ascend to obtain a business advantage over its competitors who do not know Ascend's pricing methodology information. Making this public would not serve the public interest and therefore is not required. |
None |
1 |
None |
None |
None |
None |
None |
None |
The estimated number of patients is unknown to Ascend Laboratories. This is a generic product with more than one manufacturer. |
None |
| Ascend Laboratories, LLC |
67877072031 |
EVEROLIMUS 0.75MG TABLET 60 Tabs |
2021-12-01 |
750.0000 |
Ascend does not have patented marketing information. Any marketing related to this product is only known to Ascend's commercial team. Marketing information has potential value and allowing this information to remain non-public and confidential, allows Ascend to obtain a business advantage over its competitors who do not know Ascend's marketing information. Making this public would not serve the public interest and therefore is not required.
Ascend does not have patented pricing methodology information. Any pricing methodology information related to this product is only known to Ascend's commercial team. Pricing methodology information has potential value and allowing this information to remain non-public and confidential, allows Ascend to obtain a business advantage over its competitors who do not know Ascend's pricing methodology information. Making this public would not serve the public interest and therefore is not required. |
None |
0 |
None |
None |
None |
None |
None |
None |
The estimated total of patients is unknown as of this time. |
None |
| Ascendis Pharma, Inc. |
73362000601 |
SKYTROFA is a lyophilized powder available in single-dose, dual-chamber, prefilled cartridges containing lonapegsomatropin-tcgd and diluent, water for Injection. 20.8 mg/package. |
2021-10-13 |
4544.8000 |
None |
1 |
40000 |
None |
None |
None |
None |
None |
None |
WAC per mg is $218.50. WAC is an undiscounted price that does not reflect chargebacks, discounts, rebates or other price reductions received by customers. The amount the patient pays will largely depend on his/her prescription drug insurance plan or eligibility for support programs.
Regarding the Estimated Patients, it is estimated that about 40K of children in the United States have pediatric growth hormone deficiency condition. Ascendis deems information regarding its forecasted market share, including the estimated number of patients for each NDC to be proprietary and confidential. |
None |
| Ascendis Pharma, Inc. |
73362000701 |
SKYTROFA is a lyophilized powder available in single-dose, dual-chamber, prefilled cartridges containing lonapegsomatropin-tcgd and diluent, water for Injection. 25.2 mg/package |
2021-10-13 |
5506.2000 |
None |
1 |
40000 |
None |
None |
None |
None |
None |
None |
WAC per mg is $218.50. WAC is an undiscounted price that does not reflect chargebacks, discounts, rebates or other price reductions received by customers. The amount the patient pays will largely depend on his/her prescription drug insurance plan or eligibility for support programs.
Regarding the Estimated Patients, it is estimated that about 40K of children in the United States have pediatric growth hormone deficiency condition. Ascendis deems information regarding its forecasted market share, including the estimated number of patients for each NDC to be proprietary and confidential. |
None |
| Ascendis Pharma, Inc. |
73362000401 |
SKYTROFA is a lyophilized powder available in single-dose, dual-chamber, prefilled cartridges containing lonapegsomatropin-tcgd and diluent, water for Injection. 14.4 mg/package. |
2021-10-13 |
3146.4000 |
None |
1 |
40000 |
None |
None |
None |
None |
None |
None |
WAC per mg is $218.50. WAC is an undiscounted price that does not reflect chargebacks, discounts, rebates or other price reductions received by customers. The amount the patient pays will largely depend on his/her prescription drug insurance plan or eligibility for support programs.
Regarding the Estimated Patients, it is estimated that about 40K of children in the United States have pediatric growth hormone deficiency condition. Ascendis deems information regarding its forecasted market share, including the estimated number of patients for each NDC to be proprietary and confidential. |
None |
| Ascendis Pharma, Inc. |
73362000501 |
SKYTROFA is a lyophilized powder available in single-dose, dual-chamber, prefilled cartridges containing lonapegsomatropin-tcgd and diluent, water for Injection. 17.2 mg/package. |
2021-10-13 |
3758.2000 |
None |
1 |
40000 |
None |
None |
None |
None |
None |
None |
WAC per mg is $218.50. WAC is an undiscounted price that does not reflect chargebacks, discounts, rebates or other price reductions received by customers. The amount the patient pays will largely depend on his/her prescription drug insurance plan or eligibility for support programs.
Regarding the Estimated Patients, it is estimated that about 40K of children in the United States have pediatric growth hormone deficiency condition. Ascendis deems information regarding its forecasted market share, including the estimated number of patients for each NDC to be proprietary and confidential. |
None |
| Ascendis Pharma, Inc. |
73362000801 |
SKYTROFA is a lyophilized powder available in single-dose, dual-chamber, prefilled cartridges containing lonapegsomatropin-tcgd and diluent, water for Injection. 30.4 mg/package. |
2021-10-13 |
6642.4000 |
None |
1 |
40000 |
None |
None |
None |
None |
None |
None |
WAC per mg is $218.50. WAC is an undiscounted price that does not reflect chargebacks, discounts, rebates or other price reductions received by customers. The amount the patient pays will largely depend on his/her prescription drug insurance plan or eligibility for support programs.
Regarding the Estimated Patients, it is estimated that about 40K of children in the United States have pediatric growth hormone deficiency condition. Ascendis deems information regarding its forecasted market share, including the estimated number of patients for each NDC to be proprietary and confidential. |
None |
| Ascendis Pharma, Inc. |
73362000901 |
SKYTROFA is a lyophilized powder available in single-dose, dual-chamber, prefilled cartridges containing lonapegsomatropin-tcgd and diluent, water for Injection. 36.4 mg/package. |
2021-10-13 |
7953.4000 |
None |
1 |
40000 |
None |
None |
None |
None |
None |
None |
WAC per mg is $218.50. WAC is an undiscounted price that does not reflect chargebacks, discounts, rebates or other price reductions received by customers. The amount the patient pays will largely depend on his/her prescription drug insurance plan or eligibility for support programs.
Regarding the Estimated Patients, it is estimated that about 40K of children in the United States have pediatric growth hormone deficiency condition. Ascendis deems information regarding its forecasted market share, including the estimated number of patients for each NDC to be proprietary and confidential. |
None |
| Ascendis Pharma, Inc. |
73362001001 |
SKYTROFA is a lyophilized powder available in single-dose, dual-chamber, prefilled cartridges containing lonapegsomatropin-tcgd and diluent, water for Injection. 44 mg/package. |
2021-10-13 |
9614.0000 |
None |
1 |
40000 |
None |
None |
None |
None |
None |
None |
WAC per mg is $218.50. WAC is an undiscounted price that does not reflect chargebacks, discounts, rebates or other price reductions received by customers. The amount the patient pays will largely depend on his/her prescription drug insurance plan or eligibility for support programs.
Regarding the Estimated Patients, it is estimated that about 40K of children in the United States have pediatric growth hormone deficiency condition. Ascendis deems information regarding its forecasted market share, including the estimated number of patients for each NDC to be proprietary and confidential. |
None |
| Ascendis Pharma, Inc. |
73362001101 |
SKYTROFA is a lyophilized powder available in single-dose, dual-chamber, prefilled cartridges containing lonapegsomatropin-tcgd and diluent, water for Injection. 53.2/package. |
2021-10-13 |
11624.2000 |
None |
1 |
40000 |
None |
None |
None |
None |
None |
None |
WAC per mg is $218.50. WAC is an undiscounted price that does not reflect chargebacks, discounts, rebates or other price reductions received by customers. The amount the patient pays will largely depend on his/her prescription drug insurance plan or eligibility for support programs.
Regarding the Estimated Patients, it is estimated that about 40K of children in the United States have pediatric growth hormone deficiency condition. Ascendis deems information regarding its forecasted market share, including the estimated number of patients for each NDC to be proprietary and confidential. |
None |
| Ascendis Pharma, Inc. |
73362000301 |
SKYTROFA? is a lyophilized powder available in single-dose, dual-chamber, prefilled cartridges containing lonapegsomatropin-tcgd and diluent, water for Injection. 12 mg/package. |
2021-10-13 |
2622.0000 |
None |
1 |
40000 |
None |
None |
None |
None |
None |
None |
WAC per mg is $218.50. WAC is an undiscounted price that does not reflect chargebacks, discounts, rebates or other price reductions received by customers. The amount the patient pays will largely depend on his/her prescription drug insurance plan or eligibility for support programs.
Regarding the Estimated Patients, it is estimated that about 40K of children in the United States have pediatric growth hormone deficiency condition. Ascendis deems information regarding its forecasted market share, including the estimated number of patients for each NDC to be proprietary and confidential. |
None |
| Astellas Pharma US, Inc. |
00469062599 |
Xtandi® (enzalutamide) 40 mg Tablets |
2021-03-01 |
12275.7000 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
Astellas has not released the information requested in column 7 (estimated volume of patients that may be prescribed the drug) in the public domain. Further, Astellas does not currently believe this information is in the public domain or publicly available. As a result, Astellas is limiting its response to this reporting requirement pursuant to Cal. Health & Safety Code Section 127681(c). Xtandi Tablets was not acquired; therefore, columns 10 – 13 are intentionally left blank. |
None |
| Astellas Pharma US, Inc. |
00469072560 |
Xtandi® (enzalutamide) 80 mg Tablets |
2021-03-01 |
12275.7000 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
Astellas has not released the information requested in column 7 (estimated volume of patients that may be prescribed the drug) in the public domain. Further, Astellas does not currently believe this information is in the public domain or publicly available. As a result, Astellas is limiting its response to this reporting requirement pursuant to Cal. Health & Safety Code Section 127681(c). Xtandi Tablets was not acquired; therefore, columns 10 – 13 are intentionally left blank. |
None |
| AstraZeneca |
00310061028 |
Name- Koselugo (selumetinib) Dosage- 25mg/m2 Form- Capsules: 10mg 28 count bottle |
2021-05-20 |
2117.0800 |
AstraZeneca will engage 2 sales representatives to cover the state of California. Patient brochures as well as therapy management guides, may be left behind in offices for informational purposes. AstraZeneca provides online resources via KOSELUGO™ US healthcare professionals and patient websites. Patients may register for the KOSELUGO™ support program via the website which will enroll them in a digital relationship marketing program to receive materials such as welcome letters, patient brochures, etc. The KOSELUGO™ patient savings program for eligible commercially insured patients will be available for patients in California and can be found via AstraZeneca’s Product website. The KOSELUGO™ is currently only marketed in the United States. When setting the price of medicines AstraZeneca aims to reflect its value to patients, to payers, and to society in general as well as the cost of research and development (R&D). AstraZeneca’s pricing decisions are based on many factors that reflect our commitment to patients and the US Healthcare System as well as our obligation to shareholders. We are mindful of healthcare costs and are working to explore innovative opportunities and solutions working with others in the US Healthcare system to deliver innovative medicines while considering cost and value. Importantly, the WAC or list price is rarely the price paid by an individual patient as it does not account for a series of factors, including individual insurance plan design, provider access, assistance programs or savings offers. |
None |
1556 |
1 |
1 |
2003-12-18 |
None |
1 |
KOSELUGO™ is an orally available, inhibitor of mitogen-activated protein kinases 1 and 2 (MEK1/2) and is indicated for the treatment of pediatric patients 2 years and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). |
None |
None |
| AstraZeneca |
00310062528 |
Name- Koselugo (selumetinib) Dosage- 25mg/m2 Form- Capsules: 25mg 28 count bottle |
2021-05-20 |
5292.5600 |
AstraZeneca will engage 2 sales representatives to cover the state of California. Patient brochures as well as therapy management guides, may be left behind in offices for informational purposes. AstraZeneca provides online resources via KOSELUGO™ US healthcare professionals and patient websites. Patients may register for the KOSELUGO™ support program via the website which will enroll them in a digital relationship marketing program to receive materials such as welcome letters, patient brochures, etc. The KOSELUGO™ patient savings program for eligible commercially insured patients will be available for patients in California and can be found via AstraZeneca’s Product website. The KOSELUGO™ is currently only marketed in the United States. When setting the price of medicines AstraZeneca aims to reflect its value to patients, to payers, and to society in general as well as the cost of research and development (R&D). AstraZeneca’s pricing decisions are based on many factors that reflect our commitment to patients and the US Healthcare System as well as our obligation to shareholders. We are mindful of healthcare costs and are working to explore innovative opportunities and solutions working with others in the US Healthcare system to deliver innovative medicines while considering cost and value. Importantly, the WAC or list price is rarely the price paid by an individual patient as it does not account for a series of factors, including individual insurance plan design, provider access, assistance programs or savings offers. |
None |
1556 |
1 |
1 |
2003-12-18 |
None |
1 |
KOSELUGO™ is an orally available, inhibitor of mitogen-activated protein kinases 1 and 2 (MEK1/2) and is indicated for the treatment of pediatric patients 2 years and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). |
None |
None |
| AstraZeneca |
00310304000 |
SAPHNELO (anifrolumab-fnia): LIQUID 300mg/2mL 300mg VIAL |
2021-08-02 |
4600.5400 |
AstraZeneca will engage 2 sales representative to cover the state of California. Patient brochures as well as therapy management guides, may be left behind in offices for informational purposes.
AstraZeneca provides online resources via SAPHNELO™ US healthcare professionals and patient websites. Patients may register for the SAPHNELO™ support program via the website which will enroll them in a digital relationship marketing program to receive materials such as welcome letters, patient brochures, etc. The SAPHNELO™ patient savings program for eligible commercially insured patients will be available for patients in New Hampshire and can be found via AstraZeneca’s Product website.
The SAPHNELO™ is currently only marketed in the United States. When setting the price of medicines AstraZeneca aims to reflect its value to patients, to payers, and to society in general as well as the cost of research and development (R&D). AstraZeneca’s pricing decisions are based on many factors that reflect our commitment to patients and the US Healthcare System as well as our obligation to shareholders. We are mindful of healthcare costs and are working to explore innovative opportunities and solutions working with others in the US Healthcare system to deliver innovative medicines while considering cost and value.
Importantly, the WAC or list price is rarely the price paid by an individual patient as it does not account for a series of factors, including individual insurance plan design, provider access, assistance programs or savings offers. |
None |
300000 |
None |
None |
None |
None |
None |
None |
SAPHNELO (anifrolumab-fnia) is indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy. |
None |
| Aurinia Pharma U.S., Inc. |
75626000101 |
LUPKYNIS (voclosporin) |
2021-01-22 |
3950.0000 |
Specific marketing and pricing plans are not available in the public domain or publicly available. To market LUPKYNIS, Aurinia engages in activities with healthcare providers and appropriate patients to increase awareness and understanding of lupus nephritis and this drug product which is the first oral treatment specifically approved for adult patients with active lupus nephritis. When determining the price of LUPKYNIS, we considered the value that this innovative product offers to patients and the US healthcare system as a whole in the context of the lupus nephritis disease burden. Our objectives when setting the price for LUPKYNIS were to ensure that: Patients and clinicians have access to this new valuable treatment option; the healthcare system benefits from reduced economic disease burden from Lupus Nephritis; the value of LUPKYNIS relative to other treatment options is reflected; Aurinia can continue to invest in patient support and future innovation. |
None |
100000 |
None |
1 |
None |
None |
None |
None |
It is estimated that between 200-300K patients have systemic lupus erythematosus (SLE) in the US. Approximately 40-50% of those patients will develop lupus nephritis over their lifetime. There are no available population estimates that quantify the number of lupus nephritis patients with active disease. We expect that a subset of these lupus nephritis patients with active disease may be prescribed LUPKYNIS.
The product was not acquired |
None |
| Aurobindo Pharma USA, Inc. |
59651037790 |
Droxidopa Capsules USP 300 mg 90/Bottle |
2021-02-18 |
688.0500 |
None |
1 |
5000 |
None |
None |
None |
None |
None |
None |
None |
https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=563 |
| AuroMedics Pharma LLC |
55150029710 |
Dexmedetomidine HCl Injection, Single Dose Bag 400mcg/100mL - 10s |
2021-02-10 |
800.0000 |
we plan to market the drug to hospital customers |
None |
100000 |
None |
None |
2020-12-07 |
None |
1 |
acquisition price is proprietary |
this is a generic drug, with several other manufacturers in the market. number of patients is an estimate |
None |
| AuroMedics Pharma LLC |
55150027101 |
Cyclophosphamide Injection, SDV 1g/5mL - 1s |
2021-10-12 |
730.0000 |
We plan to market the drug to oncology physicians, clinics and hospitals |
None |
65000 |
None |
None |
None |
None |
None |
None |
This is a 505b2 drug, with other manufacturers and drug presentations in the market. Number of patients is an estimate. |
None |
| AuroMedics Pharma LLC |
55150031625 |
Isoproterenol Hydrochloride Injection USP, 0.2mg/1mL Ampules - 25s |
2021-12-31 |
11250.0000 |
We plan to market the drug to hospital customers |
None |
5000 |
None |
None |
None |
None |
None |
None |
This is a generic drug, with other manufacturers and drug presentations in the market. Number of patients is an estimate |
None |
| AuroMedics Pharma LLC |
55150031710 |
Isoproterenol Hydrochloride Injection USP, 1mg/5mL Ampules - 10s |
2021-12-31 |
5450.0000 |
We plan to market the drug to hospital customers |
None |
5000 |
None |
None |
None |
None |
None |
None |
This is a generic drug, with other manufacturers and drug presentations in the market. Number of patients is an estimate. |
None |
| AVEO Pharmaceuticals, Inc. |
45629008901 |
Fotivada Oral Capsule .89mg/cap |
2021-03-24 |
24150.0000 |
Marketing: Fotivada is a treatment for relapsed or refractory advanced renal cell carcinoma (RCC) in adult patients. Aveo's marketing approach will focus on educating health care providers on how to diagnose and treat patients efficiently to relieve symptoms for patients. Educational materials will be provided across the patient journey, to both HCPs and to families, and highlight access and affordability support for Fotivada to ensure rapid access to therapy.
Pricing: Fotivada has been developed for the treatment of relapsed or refractory advanced renal cell carcinoma (RCC). Fotivada provides an option to deliver a safe, effective treatment that reduces the symptoms in patients. Fotivada is priced responsibly compared to similar oncology agents with significant clinical benefit and disease modification. Pricing accounts for development costs, complexity of manufacturing, distribution, and storage. Aveo demonstrates a strong commitment to patients and their ability to get access to care with support programs that leaves no patient behind. |
None |
48000 |
None |
None |
None |
None |
None |
None |
None |
None |
| AVEO Pharmaceuticals, Inc. |
45629013401 |
Fotivada Oral Capsule 1.34mg/cap |
2021-03-24 |
24150.0000 |
Marketing: Fotivada is a treatment for relapsed or refractory advanced renal cell carcinoma (RCC) in adult patients. Aveo's marketing approach will focus on educating health care providers on how to diagnose and treat patients efficiently to relieve symptoms for patients. Educational materials will be provided across the patient journey, to both HCPs and to families, and highlight access and affordability support for Fotivada to ensure rapid access to therapy.
Pricing: Fotivada has been developed for the treatment of relapsed or refractory advanced renal cell carcinoma (RCC). Fotivada provides an option to deliver a safe, effective treatment that reduces the symptoms in patients. Fotivada is priced responsibly compared to similar oncology agents with significant clinical benefit and disease modification. Pricing accounts for development costs, complexity of manufacturing, distribution, and storage. Aveo demonstrates a strong commitment to patients and their ability to get access to care with support programs that leaves no patient behind. |
None |
48000 |
None |
None |
None |
None |
None |
None |
None |
None |
| AvKare |
42291020516 |
PHENobarbital-Belladonna Alk Oral Elixir 16.2 MG/5ML |
2021-03-16 |
1297.8300 |
None |
1 |
3400000 |
None |
None |
None |
None |
None |
None |
This drug was not acquired |
None |
| AvKare |
42291043930 |
Emtricitabine-Tenofovir DF Oral Tablet 200-300 MG |
2021-04-12 |
861.3600 |
None |
1 |
1200000 |
None |
None |
None |
None |
None |
None |
Drug was not acquired |
None |
| AvKare |
50268033112 |
Flucytosine Oral Capsule 250 MG |
2021-05-10 |
1631.7700 |
None |
1 |
220000 |
None |
None |
None |
None |
None |
None |
None |
None |
| AvKare |
50268033212 |
Flucytosine Oral Capsule 500 MG |
2021-05-10 |
3082.9400 |
None |
1 |
220000 |
None |
None |
None |
None |
None |
None |
None |
None |
| AvKare |
42291007360 |
Abiraterone Acetate 500mg Tablet 60ct |
2021-07-12 |
6339.5800 |
None |
1 |
248530 |
None |
None |
None |
None |
None |
None |
Drug was not acquired |
None |
| B. Braun Medical Inc. |
00264440054 |
1 g of Magnesium Sulfate in 100 mL 5% Dextrose Injection |
2021-09-09 |
153.1200 |
WAC pricing is based on B. Braun's assessment of costs to develop and produce the drug as well as an assessment of market pricing for similar products. At the time of entering the commercial market, the marketing plan for this drug was still in development and not available at the time of this notification. Marketing of this drug is expected to begin in October 2021. |
None |
400000 |
None |
None |
None |
None |
None |
None |
There was a question regarding the Course of Therapy and we were unable to calculate to cost until we resolved the question causing the delay in reporting.
The Prices noted herein are B. Braun's distributor in-to-stock prices for its authorized distributors, as published by third party database companies, such as Red Book, First Databank, Medi-Span and Gold Standard. B. Braun's in-to-stock prices may not represent actual transaction prices, and do not include prompt pay or other discounts, rebates, chargebacks, or other reductions in price. By providing a distributor in-to-stock price, B. Braun does not make any representation or suggestion concerning the amount for which any healthcare provider should be or should seek to be reimbursed or the likelihood of coverage or reimbursement for any referenced product. These prices should not be considered a reflection of the actual selling prices for products purchased from B. Braun or B. Braun's view of the actual prices at which B. Braun's products may be resold by wholesalers or other customers. |
None |
| B. Braun Medical Inc. |
00264420452 |
2 g of Magnesium Sulfate in 50 mL Water for Injection |
2021-10-04 |
301.9200 |
WAC pricing is based on B. Braun's assessment of costs to develop and produce the drug as well as an assessment of market pricing for similar products. Marketing for this drug will begin in early November through online display ads and email marketing. |
None |
400000 |
None |
None |
None |
None |
None |
None |
"
The Prices noted herein are B. Braun's distributor in-to-stock prices for its authorized distributors, as published by third party database companies, such as Red Book, First Databank, Medi-Span and Gold Standard. B. Braun's in-to-stock prices may not represent actual transaction prices, and do not include prompt pay or other discounts, rebates, chargebacks, or other reductions in price. By providing a distributor in-to-stock price, B. Braun does not make any representation or suggestion concerning the amount for which any healthcare provider should be or should seek to be reimbursed or the likelihood of coverage or reimbursement for any referenced product. These prices should not be considered a reflection of the actual selling prices for products purchased from B. Braun or B. Braun's view of the actual prices at which B. Braun's products may be resold by wholesalers or other customers. " |
None |
| Bausch + Lomb, Inc. |
71565004001 |
XIPERE (triamcinolone acetonide injectable suspension) 40mg/mL |
2021-11-29 |
1650.0000 |
None |
1 |
60000 |
None |
None |
None |
None |
None |
None |
The product was not acquired. There are an estimated 60,000 patients that suffer from uveitic macular edema. We do not know how many patients will be prescribed XIPERE™. |
None |
| Baxter Healthcare Corporation |
10019098201 |
Cyclo 25MG USP 100 TABLETS |
2021-05-03 |
294.6000 |
Oral Cyclophosphamide is a generic medication that has been on market for several years. Baxter intends to provide the product at competitive price based off the current market landscape today. |
None |
5410 |
None |
None |
None |
None |
None |
None |
Estimated Number of Patients:
This drug is used to treat various forms of cancer. It is difficult to estimate the number of patients based on calculations we estimate per month divided by the 2020 units sold per IQVIA.
General Comment: Cyclophosphamide Tablet is prescribed based on diagnosis and weight of the patient. While there are instances in which the monthly supply of the drug could exceed the Medicare Specialty tier of $670.00 threshold based on the above stated factors triggering State Transparency Reporting per your State’s legislation. However, Baxter Healthcare Corporation does not believe the threshold will be exceeded often. |
None |
| Baxter Healthcare Corporation |
10019098401 |
Cyclo 50MG USP 100 TABLETS |
2021-05-03 |
420.9900 |
Oral Cyclophosphamide is a generic medication that has been on market for several years. Baxter intends to provide the product at competitive price based off the current market landscape today. |
None |
37139 |
None |
None |
None |
None |
None |
None |
Estimated Number of Patients:
This drug is used to treat various forms of cancer. It is difficult to estimate the number of patients based on calculations we estimate per month divided by the 2020 units sold per IQVIA.
General Comment: Cyclophosphamide Tablet is prescribed based on diagnosis and weight of the patient. While there are instances in which the monthly supply of the drug could exceed the Medicare Specialty tier of $670.00 threshold based on the above stated factors triggering State Transparency Reporting per your State’s legislation. However, Baxter Healthcare Corporation does not believe the threshold will be exceeded often. |
None |
| Biocon Limited |
70377001322 |
Everolimus Tablets 10mg 28ct |
2021-10-01 |
3141.0000 |
Launch of a generic pharmaceutical. Pricing and supply offers made to large GPOs with purchasing decision authority for retail, wholesale, and specialty outlets. GPOs include Red Oak Sourcing, Walgreens Boots Alliance Development, ClarusONE Sourcing Services, and Econdisc. Biocon will offer an eVoucherRx program to lower patient co-pays at the point of sale. |
None |
13000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Biocon Limited |
70377001022 |
Everolimus Tablets 2.5mg 28ct |
2021-10-01 |
3141.0000 |
Launch of a generic pharmaceutical. Pricing and supply offers made to large GPOs with purchasing decision authority for retail, wholesale, and specialty outlets. GPOs include Red Oak Sourcing, Walgreens Boots Alliance Development, ClarusONE Sourcing Services, and Econdisc. Biocon will offer an eVoucherRx program to lower patient co-pays at the point of sale. |
None |
13000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Biocon Limited |
70377001122 |
Everolimus Tablets 5mg 28ct |
2021-10-01 |
3141.0000 |
Launch of a generic pharmaceutical. Pricing and supply offers made to large GPOs with purchasing decision authority for retail, wholesale, and specialty outlets. GPOs include Red Oak Sourcing, Walgreens Boots Alliance Development, ClarusONE Sourcing Services, and Econdisc. Biocon will offer an eVoucherRx program to lower patient co-pays at the point of sale. |
None |
13000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Biocon Limited |
70377001222 |
Everolimus Tablets 7.5mg 28ct |
2021-10-01 |
3141.0000 |
Launch of a generic pharmaceutical. Pricing and supply offers made to large GPOs with purchasing decision authority for retail, wholesale, and specialty outlets. GPOs include Red Oak Sourcing, Walgreens Boots Alliance Development, ClarusONE Sourcing Services, and Econdisc. Biocon will offer an eVoucherRx program to lower patient co-pays at the point of sale. |
None |
13000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Biogen |
64406001701 |
PLEGRIDY (peginterferon beta-1a) injection for intramuscular use is available in a carton (NDC: 64406-0017-01) containing two-125 mcg/0.5 mL single-dose prefilled syringes of PLEGRIDY |
2021-03-01 |
7205.5400 |
Plegridy Intramuscular will be marketed to Healthcare Professionals, Patients, Payers, and other appropriate audiences for use in patients with Relapsing forms of Multiple Sclerosis. Biogen has a set of Pricing Principles that inform pricing decisions for its products. Those principles are: 1. Value to Patients 2. Present and Future Benefit to Society 3. Fullfilling our commitment to Innovation 4. Evolution toward Value Based Care and 5. Affordability & Sustainability. Further information can found at: https://www.biogen.com/content/dam/corporate/en_us/pdfs/BIOGEN_PricingPrinciplesInfographic_4-26-19.pdf |
None |
504000 |
None |
None |
None |
None |
None |
None |
PLEGRIDY (peginterferon beta-1a) is indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. The estimated number of patients is based on 2021 prevalence estimates resulting from analyses of several data sources and publications. |
None |
| Biogen |
64406010101 |
Aduhelm 170 mg/1.7 mL (100 mg/mL) single-dose vial |
2021-06-15 |
952.0000 |
ADUHELM will be marketed to Healthcare Professionals, Patients, Payers, and other appropriate audiences.
[Biogen has] engaged extensively with health economists, public health experts, and payers about ADUHELM – and we have examined other recent biologic drug innovations. Consistent with our pricing principles, we have established a price for ADUHELM that reflects the overall value this treatment brings to patients, caregivers and society – and one that will enable continuous innovation. We have determined the launch price of ADUHELM based on our belief in the impact of treatment as well as the size of the appropriate patient population based on the entry criteria of our clinical trials. Biogen has established the price of ADUHELM based on the overall value this treatment is expected to bring to patients, caregivers, and society, while reflecting key principles such as innovation, access and sustainability. The wholesale acquisition cost (WAC) of ADUHELM, which is an infusion once every four weeks, is $4,312 per infusion for a patient of 74 kg–the average weight of a U.S. patient with mild cognitive impairment (MCI) or mild dementia. The yearly cost at the maintenance dose (10 mg/kg) would be $56,000. The cost during the first year of treatment will be lower due to the titration period. WAC is a list price and not the net price or the price paid by patients with insurance.
Biogen has a set of Pricing Principles that inform pricing decisions for its products. Those principles are: 1. Value to Patients, 2. Present and Future Benefit to Society, 3. Fulfilling our commitment to Innovation, 4. Evolution toward Value Based Care, and 5. Affordability & Sustainability.
Further information can be found at:
https://www.biogen.com/content/dam/corporate/en_us/pdfs/BIOGEN_PricingPrinciplesInfographic_4-26-19.pdf |
None |
2000000 |
None |
1 |
None |
None |
None |
None |
With regards to the "ESTIMATED_PATIENTS", based on the entry criteria of the clinical trials conducted with ADUHELM, we estimate the appropriate patient population for ADUHELM to be approximately 1-2 million. These are patients who have been clinically diagnosed with mild cognitive impairment or mild dementia suspected to be due to Alzheimer’s disease who would have confirmed amyloid beta pathology, if tested.It is important to note that we do not expect all of these patients will be treated with ADUHELM, for a variety of reasons, including appropriate patient selection criteria, a complex diagnostic and care pathway and limited capacity of specialists, who we believe will be the primary prescribers of ADUHELM. As a result of these factors, we anticipate that patient uptake will be gradual over a number of years. |
None |
| Biogen |
64406010202 |
Aduhelm 300 mg/3 mL (100 mg/mL) single-dose vial |
2021-06-15 |
1680.0000 |
ADUHELM will be marketed to Healthcare Professionals, Patients, Payers, and other appropriate audiences.
[Biogen has] engaged extensively with health economists, public health experts, and payers about ADUHELM – and we have examined other recent biologic drug innovations. Consistent with our pricing principles, we have established a price for ADUHELM that reflects the overall value this treatment brings to patients, caregivers and society – and one that will enable continuous innovation. We have determined the launch price of ADUHELM based on our belief in the impact of treatment as well as the size of the appropriate patient population based on the entry criteria of our clinical trials. Biogen has established the price of ADUHELM based on the overall value this treatment is expected to bring to patients, caregivers, and society, while reflecting key principles such as innovation, access and sustainability. The wholesale acquisition cost (WAC) of ADUHELM, which is an infusion once every four weeks, is $4,312 per infusion for a patient of 74 kg–the average weight of a U.S. patient with mild cognitive impairment (MCI) or mild dementia. The yearly cost at the maintenance dose (10 mg/kg) would be $56,000. The cost during the first year of treatment will be lower due to the titration period. WAC is a list price and not the net price or the price paid by patients with insurance.
Biogen has a set of Pricing Principles that inform pricing decisions for its products. Those principles are: 1. Value to Patients, 2. Present and Future Benefit to Society, 3. Fulfilling our commitment to Innovation, 4. Evolution toward Value Based Care, and 5. Affordability & Sustainability.
Further information can be found at:
https://www.biogen.com/content/dam/corporate/en_us/pdfs/BIOGEN_PricingPrinciplesInfographic_4-26-19.pdf |
None |
2000000 |
None |
1 |
None |
None |
None |
None |
With regards to the "ESTIMATED_PATIENTS", based on the entry criteria of the clinical trials conducted with ADUHELM, we estimate the appropriate patient population for ADUHELM to be approximately 1-2 million. These are patients who have been clinically diagnosed with mild cognitive impairment or mild dementia suspected to be due to Alzheimer’s disease who would have confirmed amyloid beta pathology, if tested.It is important to note that we do not expect all of these patients will be treated with ADUHELM, for a variety of reasons, including appropriate patient selection criteria, a complex diagnostic and care pathway and limited capacity of specialists, who we believe will be the primary prescribers of ADUHELM. As a result of these factors, we anticipate that patient uptake will be gradual over a number of years. |
None |
| Bristol Myers Squibb |
73153090001 |
Breyanzi packed in a carton containing up to 4 vials, depending upon the concentration of the cryopreserved drug product CAR-positive viable T cells |
2021-02-08 |
410300.0000 |
We consider multiple factors when setting a list price for a medicine, including:
• The benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs.
• Market and business considerations, including:
• Ongoing research-investment costs; BMS invests more than 35% of its annual revenues in R&D, among the highest of any large company in any industry in the world;
• Medical- and patient-service costs; this includes funding growing patient assistance programs; Inflationary and capital-investment costs associated with manufacturing, storage and supply
To market Breyanzi, Bristol-Myers Squibb has, to date, engaged in the following activities: • Direct-To-Consumer Marketing: Developing digital, web-based and print advertisements that are distributed through mobile applications and websites.
• Healthcare Professional Marketing Practices: Developing web-based and print advertisements that are distributed to healthcare professionals through mobile applications, websites, and magazines; developing a peer-to-peer speaker program; hosting promotional booths at conferences attended by healthcare professionals |
None |
130 |
1 |
1 |
2019-11-20 |
74000000000.0000 |
None |
BMS obtained rights for BREYANZI as part of Celgene acquisition. This acquisition did not consist of costs for individual assets |
Based on 2020 Q1-Q2 earnings reports, CAR T commercially infused patients have been estimated to be around 140 patients per month (roughly 800 patients in the first 2 QTRs). BMS is unable to provide an estimate of the number of patients who will be prescribed BREYANZI each month |
None |
| Bristol Myers Squibb |
59572051502 |
ABECMA® 250 mL infusion bag and metal cassette |
2021-03-26 |
419500.0000 |
We consider multiple factors when setting a list price for a medicine, including: (i) The benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. (ii) Market and business considerations, including: Ongoing research-investment costs; BMS invests more than 35% of its annual revenues in R&D, among the highest of any large company in any industry in the world; and Medical- and patient-service costs; this includes funding growing patient assistance programs; Inflationary and capital-investment costs associated with manufacturing, storage and supply |
None |
1680 |
1 |
1 |
2019-11-20 |
74000000000.0000 |
None |
BMS obtained rights for ABECMA as part of Celgene acquisition. This acquisition did not consist of costs for individual assets |
Comment regarding Field 7: Based on 2020 Q1-Q2 earnings reports, CAR T commercially infused patients have been estimated to be around 140 patients per month (roughly 800 patients in the first 2 QTRs). BMS is unable to provide exact number of patients who will be prescribed ABECMA each month |
None |
| Bristol Myers Squibb |
59572051501 |
ABECMA® 50 mL infusion bag and metal cassette |
2021-03-26 |
419500.0000 |
We consider multiple factors when setting a list price for a medicine, including: (i) The benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. (ii) Market and business considerations, including: Ongoing research-investment costs; BMS invests more than 35% of its annual revenues in R&D, among the highest of any large company in any industry in the world; and Medical- and patient-service costs; this includes funding growing patient assistance programs; Inflationary and capital-investment costs associated with manufacturing, storage and supply |
None |
1680 |
1 |
1 |
2019-11-20 |
74000000000.0000 |
None |
BMS obtained rights for ABECMA as part of Celgene acquisition. This acquisition did not consist of costs for individual assets |
Comment regarding Field 7: Based on 2020 Q1-Q2 earnings reports, CAR T commercially infused patients have been estimated to be around 140 patients per month (roughly 800 patients in the first 2 QTRs). BMS is unable to provide exact number of patients who will be prescribed ABECMA each month |
None |
| Bristol Myers Squibb |
59572051503 |
ABECMA® 500 mL infusion bag and metal cassette |
2021-03-26 |
419500.0000 |
We consider multiple factors when setting a list price for a medicine, including: (i) The benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. (ii) Market and business considerations, including: Ongoing research-investment costs; BMS invests more than 35% of its annual revenues in R&D, among the highest of any large company in any industry in the world; and Medical- and patient-service costs; this includes funding growing patient assistance programs; Inflationary and capital-investment costs associated with manufacturing, storage and supply |
None |
1680 |
1 |
1 |
2019-11-20 |
74000000000.0000 |
None |
BMS obtained rights for ABECMA as part of Celgene acquisition. This acquisition did not consist of costs for individual assets |
Comment regarding Field 7: Based on 2020 Q1-Q2 earnings reports, CAR T commercially infused patients have been estimated to be around 140 patients per month (roughly 800 patients in the first 2 QTRs). BMS is unable to provide exact number of patients who will be prescribed ABECMA each month |
None |
| ChemoCentryx, Inc. |
73556016801 |
TAVNEOS (avacopan) 10 mg capsules, 1 x 180 |
2021-10-18 |
14450.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we plan to market in the US and promote to appropriate healthcare professionals who treat adults diagnosed with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA)), in line with the TAVNEOS?? Prescribing Information. Promotional activities to HCPs include sales representative detailing with appropriate supporting materials, journal ads, speaker programs, congress participation and non-personal promotion such as an HCP website, www.tavneos.com, search, banner advertising, and other digital educational programming. There is no sample program and no free trial offers for consumers.
Direct-to-consumer activities may include a patient website (with accompanying digital promotion), patient brochures, and additional resources such as a peer program or welcome kit. The purpose of the website, drivers to website, and brochure is to educate patients on the availability of new treatment options aligned to the TAVNEOS Prescribing Information and Medication Guide, including Important Safety Information. There is no direct-to-consumer marketing for TAVNEOS via TV.
ChemoCentryx considers multiple factors when setting a list price for a medicine, such as the following: 1. Value of the drug to patients; 2. The clinical and economic value of the drug; 3. Overall research and development costs; 4. Commitment to R&D and Innovation; 5. Cost of comprehensive patient support programs to ensure patient access. |
None |
1000 |
None |
None |
None |
None |
None |
None |
None |
None |
| ChemoCentryx, Inc. |
73556016802 |
TAVNEOS (avacopan) 10 mg capsules, 1 x 30 |
2021-10-18 |
2408.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we plan to market in the US and promote to appropriate healthcare professionals who treat adults diagnosed with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA)), in line with the TAVNEOS?? Prescribing Information. Promotional activities to HCPs include sales representative detailing with appropriate supporting materials, journal ads, speaker programs, congress participation and non-personal promotion such as an HCP website, www.tavneos.com, search, banner advertising, and other digital educational programming. There is no sample program and no free trial offers for consumers.
Direct-to-consumer activities may include a patient website (with accompanying digital promotion), patient brochures, and additional resources such as a peer program or welcome kit. The purpose of the website, drivers to website, and brochure is to educate patients on the availability of new treatment options aligned to the TAVNEOS Prescribing Information and Medication Guide, including Important Safety Information. There is no direct-to-consumer marketing for TAVNEOS via TV.
ChemoCentryx considers multiple factors when setting a list price for a medicine, such as the following: 1. Value of the drug to patients; 2. The clinical and economic value of the drug; 3. Overall research and development costs; 4. Commitment to R&D and Innovation; 5. Cost of comprehensive patient support programs to ensure patient access. |
None |
1000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Chiesi USA |
10122021256 |
Bronchitol 4-Week Carton (56ct carton) |
2021-03-03 |
3482.0000 |
Marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by Healthcare Providers (HCPs) most likely to manage patients with cystic fibrosis, materials to be used by sales representatives to share information on Bronchitol with HCPs who treat patients with cystic fibrosis or prescribe Bronchitol to such patients, and materials to educate patients about cystic fibrosis and Bronchitol. Sustainability has always been important for Chiesi, but today it is part of our strategic plan. This means that we are committed to improving the quality of life of patients, to protect the planet and its inhabitants, to put ourselves at the service of the community, to encourage the growth of our people, and to guarantee the maximum transparency of our work. |
None |
622 |
None |
None |
None |
None |
None |
None |
Acquired while in development; Approved while owned by Chiesi USA. |
None |
| Chiesi USA |
10122021214 |
Bronchitol 7-Day Carton (14ct carton) |
2021-03-03 |
870.5000 |
Marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by Healthcare Providers (HCPs) most likely to manage patients with cystic fibrosis, materials to be used by sales representatives to share information on Bronchitol with HCPs who treat patients with cystic fibrosis or prescribe Bronchitol to such patients, and materials to educate patients about cystic fibrosis and Bronchitol. Sustainability has always been important for Chiesi, but today it is part of our strategic plan. This means that we are committed to improving the quality of life of patients, to protect the planet and its inhabitants, to put ourselves at the service of the community, to encourage the growth of our people, and to guarantee the maximum transparency of our work. |
None |
622 |
None |
None |
None |
None |
None |
None |
Acquired while in development; Approved while owned by Chiesi USA. |
None |
| Chiesi USA |
10122010305 |
FERRIPROX 1000mg (TID) FILM COATED TABLETS |
2021-09-25 |
7215.7300 |
Marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by Healthcare Providers (HCPs) most likely to manage patients with thalassemia, sickle cell disease, and other anemias. Sustainability has always been important for Chiesi, but today it is part of our strategic plan. This means that we are committed to improving the quality of life of patients, to protect the planet and its inhabitants, to put ourselves at the service of the community, to encourage the growth of our people, and to guarantee the maximum transparency of our work. |
None |
650 |
None |
None |
None |
None |
None |
None |
New NDC reflecting manufacturer's labeler code. |
None |
| Chiesi USA |
10122010010 |
FERRIPROX 500mg FILM COATED TABLETS |
2021-11-01 |
7215.7300 |
Marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by Healthcare Providers (HCPs) most likely to manage patients with thalassemia, sickle cell disease, and other anemias. Sustainability has always been important for Chiesi, but today it is part of our strategic plan. This means that we are committed to improving the quality of life of patients, to protect the planet and its inhabitants, to put ourselves at the service of the community, to encourage the growth of our people, and to guarantee the maximum transparency of our work. |
None |
730 |
None |
None |
None |
None |
None |
None |
New NDC reflecting manufacturer's labeler code. |
None |
| Cintex Services LLC |
24470092360 |
Chlorzoxazone Tablets USP 250 mg |
2021-09-23 |
1194.0000 |
None |
1 |
12000 |
None |
None |
None |
None |
None |
None |
ANDA 215158 for this product was approved on 07/29/21. The approval owner was Senores Pharma. Cintex subsequently obtained marketing rights from Senores for this product, which will be sold under the Cintex label, NDC number 24470-0923-60. The begin marketing date/entry to marker for this NDC is 09/23/21. |
None |
| Civica, Inc |
72572003510 |
Bivalirudin Trifluoroacetate IV 250 mg 10 pack |
2021-01-01 |
1094.7000 |
None |
1 |
427081 |
None |
None |
2020-12-21 |
None |
1 |
Civica is selling under a product supply agreement under the manufacturer. There was no licensing fee, or acquisition price, only a fee per unit purchased from the manufacturer |
None |
None |
| Dash Pharmaceuticals, LLC |
69339013012 |
Zileuton ER Tablets |
2021-01-04 |
3222.0400 |
This product will only be marketed in the US. DASH plans to sell this product to major wholesale distributors at a price that is competitive with the other AB Rated Zileuton generic products currently in the marketplace. |
None |
6829 |
None |
None |
2021-01-04 |
None |
1 |
DASH is selling under a licensing agreement from the manufacturer. There was no licensing fee, just a profit split in the marketing arrangement. |
None |
None |
| Dash Pharmaceuticals, LLC |
69339014819 |
Sucralfate Oral Suspension |
2021-02-25 |
899.7000 |
Product will be priced competitively with other equivalent generics currently in the marketplace. |
None |
134 |
None |
None |
None |
None |
None |
None |
None |
None |
| Dr. Reddy's Laboratories, Inc. |
43598065101 |
Vigabatrin Tablets USP 500mg US 100s |
2021-02-01 |
10511.8900 |
None |
1 |
400000 |
None |
1 |
None |
None |
None |
None |
Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. However, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its Vigabatrin Tablet 500MG product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) Vigabatrin tablets dosing regimen depends on the indication, age group, weight, and dosage form (tablets or powder for oral solution). Because of the risk of vision loss, Vigabatrin should be withdrawn from patients with refractory complex partial seizures who fail to show substantial clinical benefit within 3 months of initiation and within 2 to 4 weeks of initiation for patients with infantile spasms, or sooner if treatment failure becomes obvious.(iii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iv) the existence of numerous other prescriptions drugs to treat these same conditions. In any event, roughly 400,000 people living in the United States are likely to have refractory epilepsy. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598047730 |
Sapropterin Dihydrochloride Sachets, 100 mg, 30 ct |
2021-04-06 |
870.4800 |
None |
1 |
19000 |
None |
None |
None |
None |
None |
None |
1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Notwithstanding, according to the National Organization for Rare Disorders, the reported incidence of Phenylketonuria (PKU) from newborn screening programs ranges from one in 13,500 to 19,000 newborns in the United States However, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its Sapropterin dihydrochloride sachets 100mg product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. 2) Dr. Reddy’s did not acquire the product. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598045202 |
Albendazole Tabs USP 200mg US 2s |
2021-04-28 |
80.0000 |
None |
1 |
1300 |
None |
None |
None |
None |
None |
None |
1) Though the WAC is only $80 per package, the drug exceeds the threshold based on monthly usage. 2) Dr. Reddy’s did not acquire the product |
None |
| Dr. Reddy's Laboratories, Inc. |
43598090158 |
Ertapenem for Injection 1g per vial,10s |
2021-05-10 |
1000.0000 |
None |
1 |
250000 |
None |
None |
None |
None |
None |
None |
1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. However, we listed the number of cases of pyelonephritis in the US, which is one of the conditions this product treats, for reference. 2) Dr. Reddy’s did not acquire the product; Dr. Reddy’s is, however, licensing the product for commercialization from Gland Pharma Ltd. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598062857 |
Carmustine for Injection, USP 100mg/vial |
2021-10-14 |
750.0000 |
None |
1 |
700000 |
None |
None |
None |
None |
None |
None |
1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with other generics available. The patient size provided is the number of Americans with brain tumor, which this chemotherapy drug is used to treat. 2) Dr. Reddy’s did not acquire the product as this product is a DRL-owned ANDA. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598047611 |
Daptomycin for Injection, 350mg/vial |
2021-10-14 |
40.0000 |
None |
1 |
165000 |
None |
None |
None |
None |
None |
None |
1. Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with other generics available. The estimate provided is based on the incidence rate of staphylococcus aureus bacteremia in the US, which this drug is used to treat. 2. Dr. Reddy’s did not acquire the product as this product is a DRL-owned ANDA.3. Although the WAC per package is only $40, the monthly course of therapy exceeds the threshold of $670. |
None |
| Eiger BioPharmaceuticals, Inc. |
73079005030 |
Zokinvy Oral Capsule 50 MG 30 pack |
2021-01-25 |
21510.0000 |
ZOKINVY is the first and only FDA approved treatment for Progeria (Hutchinson-Gilford Progeria Syndrome, or HGPS) and Processing Deficient Progeroid Laminopathies, very rare genetic diseases causing children to age rapidly resulting in a median survival rate of 14.5 years for patients that are not treated with ZOKINVY. As a general matter, Eiger's activities supporting the launch are designed to educate providers about the approved indication, efficacy and safety data contained within the FDA approved label.
If requested, educational materials will be provided to patients and families to support drug access and affordability for ZOKINVY to ensure rapid access to this critical therapy. Eiger is committed in ensuring availability of its products to those patients in need. Eiger considered its price determination with comparisons to similar ultra-orphan agents with significant clinical benefit and disease modification as well as development costs, complexity of manufacturing, distribution, access, education, and storage. |
None |
15 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Eiger BioPharmaceuticals, Inc. |
73079007530 |
Zokinvy Oral Capsule 75 MG 30 pack |
2021-01-25 |
32265.0000 |
ZOKINVY is the first and only FDA approved treatment for Progeria (Hutchinson-Gilford Progeria Syndrome, or HGPS) and Processing Deficient Progeroid Laminopathies, very rare genetic diseases causing children to age rapidly resulting in a median survival rate of 14.5 years for patients that are not treated with ZOKINVY. As a general matter, Eiger's activities supporting the launch are designed to educate providers about the approved indication, efficacy and safety data contained within the FDA approved label.
If requested, educational materials will be provided to patients and families to support drug access and affordability for ZOKINVY to ensure rapid access to this critical therapy. Eiger is committed in ensuring availability of its products to those patients in need. Eiger considered its price determination with comparisons to similar ultra-orphan agents with significant clinical benefit and disease modification as well as development costs, complexity of manufacturing, distribution, access, education, and storage. |
None |
15 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Eli Lilly and Company |
00002121001 |
TAUVID™ injection for intravenous use 10 mCi 1 syringe |
2021-01-11 |
3500.0000 |
None |
1 |
910000 |
None |
1 |
None |
None |
None |
None |
TAUVID™, a radioactive diagnostic agent, was approved by the FDA in May 2020 for positron emission tomography (PET) imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs) in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD).
Based on Alzheimer's Disease Facts and Figures, [https://www.alz.org/media/Documents/alzheimers-facts-and-figures.pdf], the incidence of Alzheimer's in the United States is 910,000 per year (an average of 75,833/month). Patients with Alzheimer's may or may not be prescribed TAUVID for use in diagnostic imaging.
In 2013, Lilly announced that it had acquired two investigational positron emission tomography (PET) tracers from Siemens Molecular Imaging, Inc. One of the acquired tracers was flortaucipir F 18. Pursuant to California SB 17, Lilly is limiting its response to what is in the public domain or otherwise publicly available. Lilly does not believe the acquisition date or cost is in the public domain. [https://investor.lilly.com/news-releases/news-release-details/lilly-acquires-novel-tau-tangle-diagnostic-program-bolster]
All information is provided by Eli Lilly and Company ("Lilly") to the best of our knowledge at the time of submission. Lilly provides this report consistent with its understanding and interpretation of California Health and Safety Code Chapter 9 §127675-127686 and its related provisions. In providing this report, Lilly does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California Health and Safety Code Chapter 9 §127675-127686 as it may relate to Lilly or any of its affiliates now or in the future. Lilly, on behalf of itself and affiliates, expressly reserves all such rights. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Lilly believes is otherwise in the public domain or publicly available. |
https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=464 |
| Epic Pharma |
42806056201 |
Chlordiazepoxide Hcl Cap 10mg 100ct |
2021-06-17 |
1686.0000 |
None |
1 |
1940 |
None |
None |
None |
None |
None |
None |
None |
None |
| Epic Pharma |
42806056301 |
Chlordiazepoxide Hcl Cap 25mg 100ct |
2021-06-17 |
1786.0000 |
None |
1 |
2825 |
None |
None |
None |
None |
None |
None |
None |
None |
| Estreno Pharma |
72763020110 |
Tavaborole Topical Solution, 5% |
2021-02-11 |
1284.2000 |
Generic launch- priced with competitive market. |
None |
45000000 |
None |
None |
None |
None |
None |
None |
ANDA approved 2/3/2021
ANDA approval was in the name of Flatwing Pharmaceuticals, the ANDA was just transferred to IdentiRx of which Estreno Pharmaceuticals is the distributor for IdentiRx. Estreno controls the WAC. |
None |
| Eton Pharmaceuticals, Inc. |
71863011460 |
Carglumic acid tablet for oral suspension 200mg |
2021-12-20 |
10921.8000 |
"To market CARGLUMIC ACID, Eton designed activities to increase awareness and understanding with healthcare providers about CARGLUMIC ACID. Marketing activities will include education and training provided by our sales force and by contracted speakers to health care providers. Consumer-directed communications to educate patients on the disease state and CARGLUMIC ACID are planned. At Eton, we are driven by rigorous science and committed to ensuring patients have access to our innovative medicines. We responsibly price our drugs by balancing the value of the outcomes and innovation they bring to patients and the health care system within market and societal expectations.
The product is launching at a price 18% lower than the branded product to provide broader access to the drug at a lower cost for patients. Eton's pricing plan is set for CARGLUMIC ACID prices at approximately cost plus a margin to cover Eton's overhead and research and development expenses. " |
None |
10 |
None |
None |
2021-10-28 |
3250000.0000 |
None |
None |
None |
None |
| Exelan Pharmaceuticals, Inc. |
76282067830 |
Efavirenz-Emtricitab-Tenofovir Oral Tablet 600-200-300 MG |
2021-04-27 |
1599.9000 |
None |
1 |
1200000 |
None |
None |
None |
None |
None |
None |
Product not acquired |
None |
| Exelan Pharmaceuticals, Inc. |
76282067730 |
EMTRICITABINE AND TENOFOVIR DF TAB 200mg/300mg |
2021-05-07 |
852.5300 |
None |
1 |
1200000 |
None |
None |
None |
None |
None |
None |
Product not acquired |
None |
| Fresenius Kabi USA LLC |
65219019030 |
VORICONAZOLE (voriconazole) 200mg Each |
2021-02-02 |
60.0000 |
None |
1 |
2000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Fresenius Kabi USA LLC |
63323087550 |
FOSCARNET 6000 mg per 250 mL |
2021-02-11 |
472.7700 |
None |
1 |
1000 |
None |
None |
None |
None |
None |
None |
FOSCARNET is not an acquired product. |
None |
| Fresenius Kabi USA LLC |
65219020005 |
TEMSIROLIMUS (temsirolimus) 25mg/ml |
2021-05-03 |
1180.0000 |
None |
1 |
2186 |
None |
None |
None |
None |
None |
None |
None |
None |
| G1 Therapeutics, Inc. |
73462010101 |
COSELA (trilaciclib) for injection, 300mg |
2021-03-01 |
1417.0000 |
None |
1 |
21000 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Genentech USA |
50242007855 |
Susvimo, 10mg/0.1ml Vial with Initial Fill Needle |
2021-11-29 |
8000.0000 |
Marketing activities that support the launch of a new medicine are designed to raise awareness and understanding with healthcare providers and - in some cases - patients about the approved indication(s), efficacy and safety data contained within the medicine's FDA approved label.
We take decisions related to the prices of our medicines very seriously. When determining pricing, we consider a number of factors including: how well the medicine works and how it compares to other available treatments; the financial resources required to continue discovering new medicines for people with serious diseases; and how to ensure that the price doesn’t prevent our medicines getting to people who need them. |
None |
288 |
None |
None |
None |
None |
None |
None |
Estimated number of patients per year.
Susvimo Fill Needle was not acquired from a 3rd party. |
None |
| Genentech USA |
50242007812 |
Susvimo, 10mg/0.1ml Vial, Refill Needle |
2021-11-29 |
8000.0000 |
Marketing activities that support the launch of a new medicine are designed to raise awareness and understanding with healthcare providers and - in some cases - patients about the approved indication(s), efficacy and safety data contained within the medicine's FDA approved label.
We take decisions related to the prices of our medicines very seriously. When determining pricing, we consider a number of factors including: how well the medicine works and how it compares to other available treatments; the financial resources required to continue discovering new medicines for people with serious diseases; and how to ensure that the price doesn’t prevent our medicines getting to people who need them. |
None |
84 |
None |
None |
None |
None |
None |
None |
Estimated number of patients for Susvimo refill needle is per year.
Susvimo was not acquired from a 3rd party. |
None |
| Gilead Sciences, Inc. |
61958220501 |
EPCLUSA® (sofosbuvir 150mg/velpatasvir 37.5mg) oral pellets, 28 packets |
2021-10-18 |
24920.0000 |
None |
1 |
None |
None |
1 |
None |
None |
None |
None |
The information provided in this report is subject to general limitations and assumptions Gilead has shared with HCAI (previously known as OSHPD). The limitations and assumptions address gaps in guidance related to the definition and interpretation of various data elements within New Drug Reports. Additionally, consistent with the relevant statutes and regulations, the information provided in this report is limited to that which Gilead believes is in the public domain or otherwise publicly available.
EPCLUSA oral pellets were granted orphan drug status by the FDA since it is estimated that, for the product, less than 200,000 patients in the U.S. are affected by a condition that it may be used to treat. However, Gilead is not aware of publicly available information related to the estimated number of patients that may be treated with EPCLUSA oral pellets. Consistent with Section 127681(c) of the California Health and Safety Code, Gilead is unable to provide an estimated number of patients in its report.
Gilead has not provided a response to the drug acquisition related data fields for this drug product because Gilead developed this drug product. |
None |
| Gilead Sciences, Inc. |
61958220401 |
EPCLUSA® (sofosbuvir 200mg/velpatasvir 50mg) oral pellets, 28 packets |
2021-10-18 |
24920.0000 |
None |
1 |
None |
None |
1 |
None |
None |
None |
None |
The information provided in this report is subject to general limitations and assumptions Gilead has shared with HCAI (previously known as OSHPD). The limitations and assumptions address gaps in guidance related to the definition and interpretation of various data elements within New Drug Reports. Additionally, consistent with the relevant statutes and regulations, the information provided in this report is limited to that which Gilead believes is in the public domain or otherwise publicly available.
EPCLUSA oral pellets were granted orphan drug status by the FDA since it is estimated that, for the product, less than 200,000 patients in the U.S. are affected by a condition that it may be used to treat. However, Gilead is not aware of publicly available information related to the estimated number of patients that may be treated with EPCLUSA oral pellets. Consistent with Section 127681(c) of the California Health and Safety Code, Gilead is unable to provide an estimated number of patients in its report.
Gilead has not provided a response to the drug acquisition related data fields for this drug product because Gilead developed this drug product. |
None |
| GlaxoSmithKline |
00173089803 |
JEMPERLI INJ 500MG/10ML |
2021-04-23 |
10369.3800 |
None |
1 |
2663 |
1 |
1 |
None |
None |
None |
None |
Endometrial cancer is a main type of uterine cancer that forms in the inner lining of the uterus, known as the endometrium. Endometrial cancer can be classified as mismatch repair-deficient/microsatellite instability-high (dMMR/MSI-H) or mismatch repair-proficient/microsatellite stable. There are limited treatment options for women whose disease progresses on or after first-line therapy.? Nearly 60,000 new cases of endometrial cancer are expected in the US in 2021, making endometrial cancer the most common gynaecologic malignancy in the US. Approximately 25% of women with endometrial cancer will be diagnosed with advanced disease or will experience a recurrence. Of these, approximately 25% will be mismatch repair deficient with 71% or approximately 2,663 patients having progressed on prior platinum-based chemotherapy and therefore eligible for JEMPERLI. Diagnosed patients may or may not be prescribed JEMPERLI (NDC: 00173089803) depending on their known resistance to the medicines and other patient specific factors such as allergic reactions or other medical conditions that may preclude a patient's ability to be effectively treated with JEMPERLI (NDC: 00173089803).
GSK has not released JEMPERLI's (NDC: 00173089803) marketing or pricing plan information in the public domain and is limiting its response to that which is publicly available pursuant to California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c). |
None |
| Glenmark Pharmaceuticals Inc., USA |
68462037130 |
Topiramate Extended-Release Capsules USP, 200 mg |
2021-02-05 |
730.3800 |
None |
1 |
152914 |
None |
None |
None |
None |
None |
None |
Marketing/Pricing Plan not in the public domain or publically available. Estimated patients not known. However, IQVIA MAT data for the 12 months ending December 2020 is 152,914 total prescriptions. Acquisition fields left blank as drug was developed by Glenmark. |
None |
| Glenmark Pharmaceuticals Inc., USA |
68462071308 |
RUFINAMIDE TABS 200MG 120 |
2021-06-01 |
901.1400 |
None |
1 |
82125 |
None |
None |
None |
None |
None |
None |
Marketing/Pricing Plan not in the public domain or publically available. Estimated patients not known. However, IQVIA MAT data for the 12 months ending April 2021 is 82,125 total prescriptions. Acquisition fields left blank as drug was developed by Glenmark. |
None |
| Glenmark Pharmaceuticals Inc., USA |
68462071408 |
RUFINAMIDE TABS 400MG 120 |
2021-06-01 |
1802.2700 |
None |
1 |
82125 |
None |
None |
None |
None |
None |
None |
Marketing/Pricing Plan not in the public domain or publically available. Estimated patients not known. However, IQVIA MAT data for the 12 months ending April 2021 is 82,125 total prescriptions. Acquisition fields left blank as drug was developed by Glenmark. |
None |
| Glenmark Pharmaceuticals Inc., USA |
68462068401 |
Sirolimus Tablets 2 mg |
2021-06-03 |
2777.5400 |
None |
1 |
209827 |
None |
None |
None |
None |
None |
None |
Marketing/Pricing Plan not in the public domain or publically available. Estimated patients not known. However, IQVIA MAT data for the 12 months ending April 2021 is 209,827 prescriptions. Acquisition fields left blank as drug was developed by Glenmark. |
None |
| Glenmark Pharmaceuticals Inc., USA |
68462083365 |
Arformoterol Tartrate Inhalation Solution 15 mcg/2ml 60X2ml |
2021-06-23 |
1026.5400 |
None |
1 |
279013 |
None |
None |
None |
None |
None |
None |
Marketing/Pricing Plan not in the public domain or publically available. Estimated patients not known. However, IQVIA MAT data for the 12 months ending May 2021 is 279,013 total prescriptions. Acquisition fields left blank as drug was developed by Glenmark. |
None |
| Granules Pharmaceuticals Inc. |
70010049709 |
Metformin Hydrochloride Extended-Release Tablets, USP 1000MG |
2021-02-12 |
2625.0000 |
None |
1 |
1000 |
None |
None |
None |
None |
None |
None |
The dates mentioned here are accurate and the dates appear on NDC lookup and Medspan are tentative marketing dates given during Initial ANDA SPL submission. |
None |
| Granules Pharmaceuticals Inc. |
70010049601 |
Metformin Hydrochloride Extended-Release Tablets, USP 500MG |
2021-02-12 |
1615.0000 |
None |
1 |
1000 |
None |
None |
None |
None |
None |
None |
The dates mentioned here are accurate and the dates appear on NDC lookup and Medspan are tentative marketing dates given during Initial ANDA SPL submission. |
None |
| Heritage Pharmacueticals Inc. D/B/A Avet Pharmacueticals Inc |
23155054025 |
Doxercalciferol Capsules 2.5 mg 50 ct |
2021-02-24 |
695.0000 |
None |
1 |
250 |
None |
None |
None |
None |
None |
None |
None |
None |
| Heritage Pharmacueticals Inc. D/B/A Avet Pharmacueticals Inc |
23155074841 |
Pentamidine Isethionate for Injection 300mg 10 pack |
2021-05-25 |
977.0000 |
None |
1 |
3500 |
None |
None |
None |
None |
None |
None |
None |
None |
| Heritage Pharmacueticals Inc. D/B/A Avet Pharmacueticals Inc |
23155079041 |
Carmustine for Injection 100 mg i Vial Private Label |
2021-07-06 |
1226.0000 |
None |
1 |
700 |
None |
None |
2012-11-28 |
None |
1 |
None |
None |
None |
| Hikma Pharmaceuticals USA Inc |
00054048013 |
Everolimus Tablets 2.5mg, Bottle of 30 |
2021-02-10 |
12012.9800 |
None |
1 |
76080 |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product. Hikma is replacing previously launched NDC #00054-0480-14 (blister pack of 28 tablets) with a new package configuration of 30 tablets per bottle.
Hikma has not evaluated the volume of patients in the USA. Everolimus is a kinase inhibitor indicated for the treatment of (1) advanced renal cell carcinoma; and (2) renal angiomyolipoma and tuberous sclerosis complex. According to the American Cancer Society, in 2021 approximately76,080 people will be diagnosed with advanced renal cell carcinoma. |
None |
| Hikma Pharmaceuticals USA Inc |
00054363063 |
Naproxen Oral Suspension, USP, 125mg per 5mL, 500mL Bottle |
2021-02-22 |
896.4400 |
This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only. |
None |
29000000 |
None |
None |
2015-07-28 |
2650000000.0000 |
None |
The ANDA for Naproxen OS was acquired along with all of the assets of Roxane Laboratories, Inc. in a transaction which closed February 29, 2016. Total acquisition price was 2,650,000,000.00 including the Naproxen ANDA. |
Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available.
Hikma has not evaluated the volume of patients in the USA. Naproxen oral suspension is a non-steroidal anti-inflammatory drug indicated for the relief of the signs and symptoms of: rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, polyarticular juvenile idiopathic arthritis, tendonitis, bursitis, acute gout; and the management of: pain and primary dysmenorrhea. According to sciencedaily.com, about 29 million Americans use over-the-counter nonsteroidal anti-inflammatory drugs (NSAIDs) to treat pain. |
None |
| Hikma Pharmaceuticals USA Inc |
00054057625 |
Deferiprone Tablets, 500mg, 1 bottle of 100 |
2021-05-29 |
6148.0800 |
This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only. |
None |
1000 |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product. Hikma has not evaluated the volume of patients in the USA. Deferiprone is indicated for the treatment of patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate. According to the Boston Children's Hospital, in the United States, there are only about 1,000 people with thalassemia major |
None |
| Hikma Pharmaceuticals USA Inc |
00054042623 |
Rufinamide Tablets, 400mg, 1 bottle of 120 |
2021-05-30 |
737.0400 |
This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only. |
None |
86060 |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product. Hikma has not evaluated the volume of patients in the USA. Rufinamide is indicated as adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome ("LGS") in pediatric patients 1 year of age and older and in adults. The incidence of LGS is estimated at approximately 26 per 100,000 people. Therefore, there are approximately 86,060 patients in the United States. |
None |
| Hikma Pharmaceuticals USA Inc |
00054048113 |
Everolimus Tablets, 5mg, bottle of 30 |
2021-06-07 |
12565.3700 |
This is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only. |
None |
76080 |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product. Hikma is replacing previously launched NDC #00054-0481-14 (blister pack of 28 tablets) with a new package configuration of 30 tablets per bottle.
Hikma has not evaluated the volume of patients in the USA. Everolimus is a kinase inhibitor indicated for the treatment of (1) advanced renal cell carcinoma; and (2) renal angiomyolipoma and tuberous sclerosis complex. According to the American Cancer Society, in 2021 approximately 76,080 people will be diagnosed with advanced renal cell carcinoma. |
None |
| Hikma Pharmaceuticals USA Inc |
00143929910 |
Ganciclovir for Injection, 500mg, 20mL |
2021-06-14 |
684.0000 |
This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only. |
None |
10000000 |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product. Hikma has not evaluated the volume of patients in the USA. Ganciclovir is indicated for the treament of CMV retinitis in immunocompromised adult patients; or prevention of CMV disease in adult transplant recipients. According to the Medline Plus, approximately 50% and 80% of adults in the US have had a CMV infection by age 40. |
None |
| Hikma Pharmaceuticals USA Inc |
00143939810 |
Ertapenem for Injection, 1GM, vial size 20mL, 10 vial package |
2021-08-16 |
900.0000 |
This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only. |
None |
13100 |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product.
Hikma has not evaluated the volume of patients in the USA. Ertapenem Injection is a penem antibacterial indicated for the treatment of moderate to severe infections caused by susceptible bacteria. According to the CDC.gov, in 2017 CRE ("carbapenem-resistant Enterobacterales") caused an estimated 13,100 infections in the United States. |
None |
| Hikma Pharmaceuticals USA Inc |
00054049713 |
Everolimus Tablets, 7.5mg, bottle of 30 |
2021-08-23 |
12565.3700 |
This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only. |
None |
76080 |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product. Hikma is replacing previously launched NDC #00054-0497-14 (blister pack of 28 tablets) with a new package configuration of 30 tablets per bottle.
Hikma has not evaluated the volume of patients in the USA. Everolimus is a kinase inhibitor indicated for the treatment of (1) advanced renal cell carcinoma; and (2) renal angiomyolipoma and tuberous sclerosis complex. According to the American Cancer Society, in 2021 approximately 76,080 people will be diagnosed with advanced renal cell carcinoma. |
None |
| Hikma Pharmaceuticals USA Inc |
00054060421 |
Everolimus Tablets, 1mg, Bottle of 60 |
2021-11-19 |
1902.8500 |
This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only. |
None |
106859 |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product.
Hikma has not evaluated the volume of patients in the USA. Everolimus is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients: kidney and liver transplant. According to organdonor.gov, there are approximately 106,859 people on the national transplant waiting list. |
None |
| Hikma Pharmaceuticals USA Inc |
00054048213 |
Everolimus Tablets, 10mg, Bottle of 30 |
2021-11-23 |
6714.6200 |
This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only. |
None |
70080 |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product.
Hikma has not evaluated the volume of patients in the USA. Everolimus is a kinase inhibitor indicated for the treatment of (1) advanced renal cell carcinoma; and (2) renal angiomyolipoma and tuberous sclerosis complex. According to the American Cancer Society, in 2021 approximately 76,080 people will be diagnosed with advanced renal cell carcinoma. |
None |
| Impel NeuroPharma, Inc. |
77530072504 |
TRUDHESA™, DHE Nasal Spray, 1.45mg, 4 single-dose units |
2021-09-17 |
850.0000 |
None |
1 |
67000 |
None |
None |
None |
None |
None |
None |
1= Proprietary, non public information |
None |
| Incyte Corporation |
50881000705 |
Opzelura (ruxolitinib) cream 1.5% 60gm tube |
2021-10-04 |
1950.0000 |
"To market OPZELURA, Incyte designed activities to increase awareness and understanding with healthcare providers about OPZELURA. Marketing activities will include education and training provided by our sales force and by contracted speakers to health care providers. Consumer-directed communications to educate patients on the disease state and OPZELURA are planned. At Incyte, we are driven by rigorous science and committed to ensuring patients have access to our innovative medicines. We responsibly price our drugs by balancing the value of the outcomes and innovation they bring to patients and the health care system within market and societal expectations.
OPZELURA is indicated for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Use of OPZELURA in combination with therapeutic biologics, other JAK inhibitors or potent immunosuppressants such as azathioprine or cyclosporine is not recommended." |
None |
5500000 |
None |
1 |
None |
None |
None |
None |
Comment regarding Field 7: Provide source of population data (e.g. IQVIA) or explanation "Incyte's estimated volume of patients who may be prescribed OPZELURA is not available in the public domain. Estimated population is derived from the following publically available information . . ." Comment regarding Fields 8 and 9: Acquisition fields left blank as drug was developed by Incyte. General Comment: In the event 2017 California Senate Bill 17 (“SB-17”) and the laws it implements, including Cal. Health & Safety Code § 127677, are found unconstitutional or otherwise unlawful, Incyte reserves all of its legal rights. In issuing this report in an attempt to comply with Cal. Health & Safety Code § 127677, Incyte does not waive any legal claims or legal rights related to SB-17. Please note that portions of this report and its contents may be exempted from disclosure under the California Public Records Act, Cal. Gov. Code § 6250 et seq. (“PRA”) as the material contains and constitutes Incyte’s proprietary commercial information and otherwise would not be in the public interest to disclose. We ask that you please contact the Incyte legal department at 1801 Augustine Cut-Off, Wilmington, DE 19803 if you receive any PRA requests so that we may take appropriate steps to work with you to protect such information. |
None |
| Ingenus Pharmaceuticals, LLC |
50742052110 |
Cyclophosphamide 200mg 10ml Injection |
2021-12-17 |
1465.0000 |
Ingenus prices their products based on the current market conditions along with a number of variables. All of these product specific variables are entered into a pricing model and pricing is determined. Some examples ( not all ) are cost of goods, profit share, freight costs, product volume, customer specific volumes, the COT/channels the specific product is sold in, rebates, chargebacks, contractual obligations. These factors vary product by product and aren’t all applicable in every case. |
None |
30000 |
None |
None |
None |
None |
None |
None |
As a manufacturer, Ingenus does not estimate the number of patients that may be prescribed our products. We manufacturer volume based on an estimated market share and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. Acquisition is not applicable. |
None |
| Janssen Biotech, Inc. |
57894050101 |
RYBREVANT™ (amivantamab-vmjw), Strength: 350mg/7mL, Form: 1 Single Vial |
2021-05-24 |
2986.4300 |
While specific marketing and pricing plans are not available in the public domain, generally we plan to market in the US and promote to appropriate healthcare professionals who treat individuals diagnosed with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon 20 insertion. The pricing plan has WAC set for 350 mg / 7 mL vial at $2,986.43. The list price of RYBREVANT™ is not reflective of discounts and rebates which may be available through Medicaid, Medicare, and commercial insurance. RYBREVANT™ will also be discounted as required under the 340B program, Federal Supply Schedule, and other government programs. International approvals are pending. |
None |
None |
1 |
1 |
None |
None |
None |
None |
The estimated number of patients in the United States with a condition for which RYBREVANT™ may be prescribed is not in the public domain or publicly available. |
None |
| Janssen Pharmaceuticals, Inc. |
50458070714 |
PONVORY™ (ponesimod) Starter Pack Strength:10MG Form:Tablet |
2021-03-24 |
3772.3000 |
While specific marketing and pricing plans are not available in the public domain, generally we plan to market in the US and promote to appropriate healthcare professionals who treat individuals diagnosed with Relapsing forms of Multiple Sclerosis (RMS). The pricing plan has WAC set for the Multiple Strength, Titration Pack 14 set at $3,772.30. The list price of PONVORY is not reflective of discounts and rebates which may be available through Medicaid, Medicare, and commercial insurance. PONVORY will also be discounted as required under the 340B program, Federal Supply Schedule, and other government programs. International approvals are pending. |
None |
None |
None |
None |
None |
None |
None |
None |
Janssen's estimated volume of patients who may be prescribed PONVORY is not available in the public domain. This was not an acquisition. |
None |
| Janssen Pharmaceuticals, Inc. |
50458072030 |
PONVORY™ (ponesimod) Strength:20MG Form:Tablet |
2021-03-24 |
8083.5000 |
While specific marketing and pricing plans are not available in the public domain, generally we plan to market in the US and promote to appropriate healthcare professionals who treat individuals diagnosed with Relapsing forms of Multiple Sclerosis (RMS). The pricing plan has WAC set for a 30 day supply of the 20 mg maintenance dose at $8,083.50. The list price of PONVORY is not reflective of discounts and rebates which may be available through Medicaid, Medicare, and commercial insurance. PONVORY will also be discounted as required under the 340B program, Federal Supply Schedule, and other government programs. International approvals are pending. |
None |
None |
None |
None |
None |
None |
None |
None |
Janssen's estimated volume of patients who may be prescribed PONVORY is not available in the public domain. This was not an acquisition. |
None |
| Janssen Pharmaceuticals, Inc. |
50458057501 |
XARELTO® for Oral Suspension Strength: 1 mg/mL, Form: Suspension, Reconstituted, Oral |
2021-12-28 |
492.5000 |
While specific marketing and pricing plans are not available in the public domain, generally we plan to market XARELTO® for Oral Suspension in the US through non-personal channels to appropriate healthcare professionals who treat pediatric patients that fall within approved indications. The pricing plan has WAC set for 155mg at $492.50 for a 30-day maintenance dose. . The list price of XARELTO® for Oral Suspension is not reflective of discounts and rebates which may be available through Medicaid, Medicare, and commercial insurance. XARELTO® for Oral Suspension will also be discounted as required under the 340B program, Federal Supply Schedule, and other government programs. |
None |
1560 |
None |
None |
None |
None |
None |
None |
The 1,560 estimated number of patients reflects the CDC.gov estimate of the annual incidence of Venous Thromboembolism (VTE) in children of up to 2.1 per 100,000, applied to the US child population of 74.3 million (from childstats.gov.) |
None |
| Jazz Pharmaceuticals, Inc. |
68727090003 |
Rylaze, one carton containing 3 single dose vials, each single dose vial contains 10 mg/0.5 mL solution of asparaginase erwinia chrysanthemi (recombinant)-rywn |
2021-07-15 |
13170.0000 |
None |
1 |
6000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Kadmon Pharmaceuticals, LLC |
79802020030 |
REZUROCK™ (belumosudil) tablets |
2021-08-15 |
15500.0000 |
Kadmon announced the product’s approval and also made available, through healthcare professionals, patient savings and support programs, which includes co-pay savings for eligible commercial patients. Marketing initiatives include print and digital media, engagement at scientific meetings and speaker events attended by HCPs most likely to manage patients with chronic graft-versus-host disease (cGVHD), materials to be used by sales representatives to share information on REZUROCKTM with prescribers, and materials to educate patients about cGVHD. Pricing methodology is based on cost (including development and manufacturing costs) and the market (including the current number of branded and generic competitors and the number of competitors expected to enter the market). Kadmon established its WAC price at $15,500 for a 30-count bottle of REZUROCKTM (belumosudil) tablets based on, amongst other factors, its unique clinical value and the pricing of other branded products for the same disease. At the same time, Kadmon set its WAC at a level it hopes will enable it, among other things, to i) recoup the significant costs it incurred in evaluating the economic and intellectual property landscape surrounding a prospective product, sponsoring the clinical trials, sourcing the active pharmaceutical ingredient (API), sourcing excipients, conducting R&D to achieve the acceptable formulation of the product, conducting biostudies, conducting stability studies, developing analytical methods, paying facility fees, submitting the NDA and responding to FDA inquiries; ii) cover its manufacturing costs; iii) cover distribution costs; iv) provide discounts and fund chargebacks as required by partners in the supply chain, including the cost for copay assistance and free drug programs for patients; and v) earn a reasonable return on investment for its shareholders. |
None |
5000 |
1 |
1 |
None |
None |
None |
None |
The monthly prevalence of cGVHD patients is believed to be approximately 5,000 patients. The expectation is for our product to be prescribed to a portion of these patients. Reference: Source Healthcare Analytics - PrescriberSource APLD 2019 |
None |
| KMM Pharmaceuticals, LLC |
52187054548 |
Iodoquinol 1% - Hydrocortisone Acetate 2% - Aloe Polysaccharides 1% Gel48gm |
2021-02-18 |
2000.0000 |
None |
1 |
480 |
None |
None |
None |
None |
None |
None |
This is an unapproved DESI/Grandfathered drug not considered a "New Prescription Drug" under Chapter 9.5, Art. 1, 96060 (f) |
None |
| Lannett Company, Inc. |
00527323737 |
LEVORPHANOL TARTRATE 3 mg Tablet 100 ct |
2021-01-21 |
6675.0000 |
Levorphanol Tartrate is a FDA approved treatment which Lannett’s approach will focus on educating healthcare professional staff on how to diagnose within the critical time window, and provide information about treatment with Levorphanol Tartrate. Educational materials will be provided across the patient journey, to both HCPs and to families, and highlight access and affordability support to ensure rapid access to therapy.
Levorphanol Tartrate has been developed for the treatment of patients and provides treatment options to delivers a safe, effective treatment. Levorphanol Tartrate is priced responsibly compared to similar agents with significant clinical benefit. Pricing accounts for development costs, complexity of manufacturing, distribution, and storage of product. Lannett demonstrates a strong commitment to patients and their ability to get access to care with support programs that leaves no patient behind. |
None |
96327 |
None |
None |
None |
None |
None |
None |
Lannett does not actively track estimated patients therefore the answer submitted is an estimate formulated by determining the estimated patient volumes for each indication and applying a market share factor to arrive at a final estimate for the product. |
None |
| Lannett Company, Inc. |
00527296443 |
CHLORPROMAZINE HCL 100 mg Tablet 1000 ct |
2021-02-02 |
5295.8600 |
Chlorpromazine is a FDA approved treatment which Lannett’s approach will focus on educating healthcare professional staff on how to diagnose within the critical time window, and provide information about treatment with Chlorpromazine. Educational materials will be provided across the patient journey, to both HCPs and to families, and highlight access and affordability support to ensure rapid access to therapy.
Chlorpromazine has been developed for the treatment of patients and provides treatment options to delivers a safe, effective treatment. Chlorpromazine is priced responsibly compared to similar agents with significant clinical benefit. Pricing accounts for development costs, complexity of manufacturing, distribution, and storage of product. Lannett demonstrates a strong commitment to patients and their ability to get access to care with support programs that leaves no patient behind. |
None |
59486 |
None |
None |
None |
None |
None |
None |
Lannett does not actively track estimated patients therefore the answer submitted is an estimate formulated by determining the estimated patient volumes for each indication and applying a market share factor to arrive at a final estimate for the product. |
None |
| Lannett Company, Inc. |
00527296543 |
CHLORPROMAZINE HCL 200 mg Tablet 1000 ct |
2021-02-02 |
7553.1500 |
Chlorpromazine is a FDA approved treatment which Lannett’s approach will focus on educating healthcare professional staff on how to diagnose within the critical time window, and provide information about treatment with Chlorpromazine. Educational materials will be provided across the patient journey, to both HCPs and to families, and highlight access and affordability support to ensure rapid access to therapy.
Chlorpromazine has been developed for the treatment of patients and provides treatment options to delivers a safe, effective treatment. Chlorpromazine is priced responsibly compared to similar agents with significant clinical benefit. Pricing accounts for development costs, complexity of manufacturing, distribution, and storage of product. Lannett demonstrates a strong commitment to patients and their ability to get access to care with support programs that leaves no patient behind. |
None |
59486 |
None |
None |
None |
None |
None |
None |
Lannett does not actively track estimated patients therefore the answer submitted is an estimate formulated by determining the estimated patient volumes for each indication and applying a market share factor to arrive at a final estimate for the product. |
None |
| Lannett Company, Inc. |
00527296243 |
CHLORPROMAZINE HCL 25 mg Tablet 1000 ct |
2021-02-02 |
2669.5500 |
Chlorpromazine is a FDA approved treatment which Lannett’s approach will focus on educating healthcare professional staff on how to diagnose within the critical time window, and provide information about treatment with Chlorpromazine. Educational materials will be provided across the patient journey, to both HCPs and to families, and highlight access and affordability support to ensure rapid access to therapy.
Chlorpromazine has been developed for the treatment of patients and provides treatment options to delivers a safe, effective treatment. Chlorpromazine is priced responsibly compared to similar agents with significant clinical benefit. Pricing accounts for development costs, complexity of manufacturing, distribution, and storage of product. Lannett demonstrates a strong commitment to patients and their ability to get access to care with support programs that leaves no patient behind. |
None |
59486 |
None |
None |
None |
None |
None |
None |
Lannett does not actively track estimated patients therefore the answer submitted is an estimate formulated by determining the estimated patient volumes for each indication and applying a market share factor to arrive at a final estimate for the product. |
None |
| Lannett Company, Inc. |
00527296343 |
CHLORPROMAZINE HCL 50 mg Tablet 1000 ct |
2021-02-02 |
3765.0500 |
Chlorpromazine is a FDA approved treatment which Lannett’s approach will focus on educating healthcare professional staff on how to diagnose within the critical time window, and provide information about treatment with Chlorpromazine. Educational materials will be provided across the patient journey, to both HCPs and to families, and highlight access and affordability support to ensure rapid access to therapy.
Chlorpromazine has been developed for the treatment of patients and provides treatment options to delivers a safe, effective treatment. Chlorpromazine is priced responsibly compared to similar agents with significant clinical benefit. Pricing accounts for development costs, complexity of manufacturing, distribution, and storage of product. Lannett demonstrates a strong commitment to patients and their ability to get access to care with support programs that leaves no patient behind. |
None |
59486 |
None |
None |
None |
None |
None |
None |
Lannett does not actively track estimated patients therefore the answer submitted is an estimate formulated by determining the estimated patient volumes for each indication and applying a market share factor to arrive at a final estimate for the product. |
None |
| LEADING PHARMA, LLC |
69315023203 |
Aminocaproic Acid Tabs 1000mg |
2021-03-16 |
713.4600 |
Generic product no pricing or marketing plan |
None |
33000 |
None |
None |
2016-04-16 |
None |
1 |
None |
This is an AB rated generic product that was developed by Carnegie Pharmaceuticals. Acquisition date was 4/16/2016 and price is not applicable. Additionally, as Leading Pharma sells generic products to wholesalers and retail pharmacies, we do not estimate the number of patients that may be prescribed our products neither by state or nationally, nor do we have access to any information which would indicate the number of patients in the United States with the condition(s) for which our products may be prescribed. We determine manufacturing volumes based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Leading Pharma subscribes to. Leading Pharma feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. |
None |
| Lupin Pharmaceuticals |
70748025807 |
Posaconazole DR Tablets 100mg x 60 |
2021-02-16 |
3289.4400 |
This is a partner product that we do not manufacture, but just help market and distribute. Price was determined by original owner, AET. |
None |
10000 |
None |
None |
None |
None |
None |
None |
This is a marketing agreement with the original manufacturer. We did not acquire the product, we just assist in marketing and distribution with a royalty sharing agreement in place. |
None |
| Lupin Pharmaceuticals |
70748015301 |
PENICILLAMINE TAB 250mg x 100 |
2021-03-01 |
4652.9200 |
Product has generic competition so pricing was determined to be competitive with current market contenders. |
None |
500 |
None |
None |
None |
None |
None |
None |
This product was internally developed by Lupin R&D. No acquisition to report. |
None |
| Lupin Pharmaceuticals |
43386040512 |
Nitazoxanide Tablets 500mg x 12 |
2021-03-03 |
1561.1000 |
WAC pricing was established at approximately a 14% discount to the Brand product. Contract pricing was negotiated at a customer specific level across our customer base. |
None |
3000 |
None |
None |
None |
None |
None |
None |
We did not acquire this drug. It is an AG of our own product in house. |
None |
| Lupin Pharmaceuticals |
43386040503 |
Nitazoxanide Tablets 500mg x 30 |
2021-03-05 |
3625.8100 |
WAC pricing was established at approximately a 14% discount to the Brand product. Contract pricing was negotiated at a customer specific level across our customer base. |
None |
3000 |
None |
None |
None |
None |
None |
None |
We did not acquire this drug. It is an AG of our own product in house. |
None |
| Macrogenics, Inc. |
74527002202 |
MARGENZA™ (margetuximab-cmkb) 25mg/mL per Vial {1 Vial per Pack} |
2021-03-04 |
2077.0000 |
None |
1 |
7000 |
None |
None |
None |
None |
None |
None |
Confidential Trade Secret Information of MacroGenics, not for public disclosure: We estimate that there are approximately 7,000 patients in the U.S. with metastatic HER2 positive breast cancer that are in the third or later line of therapy for their metastatic disease.
Confidential Trade Secret Information of MacroGenics, not for public disclosure: The marketing plans for the launch of MARGENZA include a product website, creation of various physical and electronic marketing brochures, and web advertising for the product. In addition, commercial personnel will have virtual and in-person meetings with potential MARGENZA customers including healthcare professionals, hospital and healthcare systems, and payors to discuss the product. The pricing plan for the launch of MARGENZA includes listing the WAC price for the product in major pricing compendia. MacroGenics will also provide appropriate product discounts off of the WAC price to contracted customers, and to contracted GPO members. MARGENZA is only approved at this time in the United States, and it is not at this time anticipated MARGENZA will be approved outside the United States in 2021, and therefore it is not anticipated there will be sales of MARGENZA in 2021 outside of the United States.t. |
None |
| Macrogenics, Inc. |
74527002203 |
MARGENZA™ (margetuximab-cmkb) 25mg/mL per Vial {4 Vials per Pack} |
2021-03-10 |
8308.0000 |
None |
1 |
7000 |
None |
None |
None |
None |
None |
None |
Confidential Trade Secret Information of MacroGenics, not for public disclosure: The marketing plans for the launch of MARGENZA include a product website, creation of various physical and electronic marketing brochures, and web advertising for the product. In addition, commercial personnel will have virtual and in-person meetings with potential MARGENZA customers including healthcare professionals, hospital and healthcare systems, and payors to discuss the product. The pricing plan for the launch of MARGENZA includes listing the WAC price for the product in major pricing compendia. MacroGenics will also provide appropriate product discounts off of the WAC price to contracted customers, and to contracted GPO members. MARGENZA is only approved at this time in the United States, and it is not at this time anticipated MARGENZA will be approved outside the United States in 2021, and therefore it is not anticipated there will be sales of MARGENZA in 2021 outside of the United States.t.
Confidential Trade Secret Information of MacroGenics, not for public disclosure: We estimate that there are approximately 7,000 patients in the U.S. with metastatic HER2 positive breast cancer that are in the third or later line of therapy for their metastatic disease. |
None |
| Mayne Pharma Inc |
51862069010 |
Tavaborole Topical Solution 5% 10mL (Mayne Label) |
2021-02-15 |
1284.2200 |
NDC change from previous listed Encube ND (21922002012). |
None |
53356 |
None |
None |
2020-12-08 |
204000.0000 |
None |
None |
Estimated number of patients is based off IMS MAT TRx script data.
NDC change from 21922002012. No WAC change. |
None |
| Mayne Pharma Inc |
51862051260 |
Calcipotriene Foam 0.005% |
2021-04-29 |
765.1000 |
None |
1 |
3693 |
None |
None |
None |
None |
None |
None |
The estimated number of patients is purely an estimate based on the Sorilux brand (51862037660) IMS TRx data. Mayne Pharma has no visibility into the prescribing habits of HCPs sufficient to provide a reliable number. Please refer to https://www.cdc.gov/ for additional information. |
None |
| Mayne Pharma Inc |
68308057530 |
ISOtretinoin Oral Capsule 40 MG 30 count |
2021-09-03 |
1036.6000 |
None |
1 |
173179 |
None |
None |
None |
None |
None |
None |
Estimated number of patients based on IMS weekly Rx data. |
None |
| Mayne Pharma Inc |
68308057030 |
ISOtretinoin Oral Capsule 10 MG 30 count |
2021-09-24 |
963.4400 |
None |
1 |
7975 |
None |
None |
None |
None |
None |
None |
Estimated number of patients based on IMS weekly Rx data. |
None |
| Mayne Pharma Inc |
68308057130 |
ISOtretinoin Oral Capsule 20 MG 30 count |
2021-09-24 |
963.4400 |
None |
1 |
43797 |
None |
None |
None |
None |
None |
None |
Estimated number of patients based on IMS weekly Rx data. |
None |
| Mayne Pharma Inc |
68308057330 |
ISOtretinoin Oral Capsule 30 MG 30 count |
2021-09-24 |
1036.6000 |
None |
1 |
220707 |
None |
None |
None |
None |
None |
None |
Estimated number of patients based on IMS weekly Rx data. |
None |
| Meitheal Pharmaceuticals, Inc. |
71288012820 |
Clofarabine Injection 20mg 20 mL (1mg/mL) SDV |
2021-03-24 |
800.0000 |
Meitheal markets generic clofarabine as a therapeutic equivalent to the innovator (brand) drug. As such, Meitheal relies on the safety and efficacy findings of the FDA with respect to the innovator drug. Meitheal markets to group purchasing organizations (GPOs), Integrated Delivery Networks (IDNs), and hospital/alternate site (own use) customers based solely on price and availability and therefore does not engage in direct-to-consumer, direct-to-physician, or prescriber marketing. Meitheal does not market based on any aspects of the drug itself, nor does Meitheal aim to treat a certain number of patients. Rather, Meitheal evaluates the size of the total market for a particular drug and strives to achieve a certain market share for that product. |
None |
3000 |
None |
None |
None |
None |
None |
None |
Because its clofarabine product is a generic product and there are a number of alternative options available, Meitheal Pharmaceuticals does not track the number of patients that are prescribed clofarabine. As such, given clofarabine's primary use for the treatment of acute lymphoblastic leukemia (ALL) in pediatric patients under the age of 21, Meitheal's best estimate regarding a patient population can be derived from the Centers for Disease Control and Prevention's ("CDC") tracking of ALL diagnoses within the United States. According to the CDC's most recent data (in 2017), the number of new cases of ALL in pediatric patients is 3,000 or more. (https://www.cdc.gov/mmwr/volumes/66/wr/mm6636a3.htm). |
None |
| Meitheal Pharmaceuticals, Inc. |
71288012902 |
Dactinomycin for Injection, USP 500mcg (0.5mg) 2mL SDV |
2021-04-20 |
1400.0000 |
Meitheal markets generic dactinomycin as a therapeutic equivalent to the innovator (brand) drug. As such, Meitheal relies on the safety and efficacy findings of the FDA with respect to the innovator drug. Meitheal markets to group purchasing organizations (GPOs), Integrated Delivery Networks (IDNs), and hospital/alternate site (own use) customers based solely on price and availability and therefore does not engage in direct-to-consumer, direct-to-physician, or prescriber marketing. Meitheal does not market based on any aspects of the drug itself, nor does Meitheal aim to treat a certain number of patients. Rather, Meitheal evaluates the size of the total market for a particular drug and strives to achieve a certain market share for that product. |
None |
200000 |
None |
None |
None |
None |
None |
None |
Because its dactinomycin product is a generic product and there are a number of alternative options available, Meitheal Pharmaceuticals does not track the number of patients that are prescribed dactinomycin. In addition, there are several indications where the use of dactinomycin is approved to treat a number of conditions. Meitheal reasonably estimates, based on information publicly available on cancer.org via the American Cancer Society, that there is potential for approximately 200,000 prescriptions of dactinomycin annually for treatment for a number of diseases. |
None |
| Meitheal Pharmaceuticals, Inc. |
71288080506 |
Isosulfan Blue Injection 1% 50mg 5mL (10mg/mL) SD Vial |
2021-11-03 |
800.0000 |
Meitheal markets generic isosulfan blue 1% as a therapeutic equivalent to the innovator (brand) drug. As such, Meitheal relies on the safety and efficacy findings of the FDA with respect to the innovator drug. Meitheal primarily markets to group purchasing organizations (GPOs), Integrated Delivery Networks (IDNs), and hospital/alternate site (own use) customers based solely on price and availability and therefore does not engage in direct-to-consumer, direct-to-physician, or prescriber marketing. Meitheal does not market based on any aspects of the drug itself, nor does Meitheal aim to treat a certain number of patients. Rather, Meitheal evaluates the size of the total market for a particular drug and strives to achieve a certain market share for that product. The target users for isosulfan blue are large cancer centers, teaching hospitals and cancer clinics. |
None |
80000 |
None |
None |
None |
None |
None |
None |
IIsosulfan blue injection 1% is a diagnostic product and is not a therapeutic used to treat a specific condition. It is used as an aid (or adjunct)in a procedure called lymphography (medical imaging procedure) to test how well the lymphatic system is working in certain parts of the body. It is used to find: lymphedema, chyluria, chylous ascites, chylothorax, and cancer of the lymph nodes. Isosulfan blue is a dye made in the laboratory that helps identify the sentinel lymph node (the first lymph node that cancer spreads to from a primary tumor). Based on IMS (IQVIA) prescription data, Meitheal estimates that there are 80,000 units sold in the US each year. Meitheal also estimates that there are 80,000 patients prescribed this product annually. |
https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=562 |
| Melinta Therapeutics, LLC |
70842022501 |
KIMYRSA is supplied as sterile, lyophilized powder containing 1,200 mg of oritavancin (as oritavancin diphosphate) in a single-dose clear glass vial, which must be reconstituted and further diluted prior to intravenous administration. One vial is packaged |
2021-07-07 |
4884.0000 |
None |
1 |
705600 |
None |
None |
None |
None |
None |
None |
This drug was not acquired. In regard to the estimated number of patients, KIMYRSA™ (oritavancin) for Injection is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused or suspected to be caused by susceptible isolates of the following gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible [MSSA] and methicillin-resistant [MRSA] isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus), and Enterococcus faecalis (vancomycin-susceptible isolates only). Available literature on disease incidence generally focuses on skin and skin structure infections (SSTIs), which are acute or chronic infections of the skin and underlying tissue without a minimum lesion size requirement. SSTIs covers a broader array of skin infections and includes, for example, ABSSSIs, necrotizing fasciitis, and infections caused by gram-negative and anaerobic pathogens. The estimated annual incidence of patients who receive intravenous antibiotics for SSTI is 705,600 (8.4M annual patient visits for purulent SSTI, with 8.4% receiving an intravenous antibiotic). (Reference: Fritz SA, Shapiro DJ, Hersh AL. National Trends in Incidence of Purulent Skin and Soft Tissue Infections in Patients Presenting to Ambulatory and Emergency Department Settings, 2000-2015. Clin Infect Dis. 2020 Jun 10;70(12):2715-2718. doi: 10.1093/cid/ciz977. PMID: 31605485.) |
None |
| Merck & Co., Inc. |
00006533101 |
belzutifan, tablet, 90, 40 mg |
2021-08-30 |
26400.0000 |
Marketing Description: Promotional activities for WELIREG will primarily include detailing of the product by Merck sales representatives to health care professionals including physicians, pharmacists, payers, and other healthcare providers. WELIREG will also be marketed in the US with print distribution and digital resources to health care professionals and patients.
Pricing Plan Description: Merck considers several factors in determining the price of our medications. These factors are listed below and are largely based on the value of the product, as well as the competitive landscape, and market for the medication.
•Value provided to patients: To what extent does a new medicine or vaccine establish a new standard of care that has the potential to significantly extend and improve patient lives?
•Value provided to healthcare systems: To what extent does a new medicine or vaccine reduce the costs associated with hospitalization and other costly complications of disease if not appropriately (or optimally) treated?
•Unmet need: Does a new medicine or vaccine address a critical unmet medical need for large numbers of people,
where few or no treatments exist?
•Access and Affordability: How can we assure that various customers-including national, regional or local institutional payers, physicians, employers and patients-can afford to pay for our products?
•R&D sustainability: Given the long-term risk and cost of capital, are we appropriately compensating our investors to ensure that we can continue the risky and capital-intensive biopharmaceutical research and development that will bring forward medically-important breakthroughs?
•Competition: What are the costs of other treatments and interventions currently on the market relative to the value provided by Merck's products? |
None |
6000 |
1 |
1 |
2019-07-11 |
1200000000.0000 |
None |
•This drug was acquired in development stage from clinical-stage biopharmaceutical company.
•Merck made an upfront payment of $1.2 billion for the asset acquisition of Peloton.
•Research and development expenses recorded at acquisition were $993 million. |
Marketing/Pricing Plan (Non Public):
Consistent with SB 17, Merck has limited its response to information publicly available or otherwise in the public domain.
Estimated Patients:
WELIREG is indicated for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery. Von Hippel-Lindau (VHL) disease is a rare hereditary tumor syndrome affecting an estimated 1/36,000 live births globally [NORD. Accessed January 28, 2021. https://rarediseases.org/rare-diseases/von-hippel-lindau-disease/ ]. It is estimated that 2020 US prevalence of VHL disease is 10,000 patients. At any given time, renal cell carcinoma (RCC) may affect up to 30% of VHL patients in the US [Chittiboina P, Lonser RR. Handb Clin Neurol. 2015;132:139–156.]. For patients with tumors that reach greater than 3cm in size, a partial nephrectomy may be performed to reduce the risk of metastasis while maintaining kidney function[Varshney N et al. J Kidney Cancer VHL. 2017;4:20–29.]. Additionally, it is estimated Central nervous system (CNS) hemangioblastomas affecting 60% to 80% of all patients [Varshney N, Kebede AA, Owusu-Dapaah H, et al. A review of von Hippel-Lindau syndrome. J Kidney Cancer VHL. 2017;4(3):20–29.] Finally, pancreatic neuroendocrine tumors (pNET) affect approximately 15% of VHL patients [Michael Charlesworth, Caroline S Verbeke, Gavin A Falk, et al. Pancreatic lesions in von Hippel-Lindau disease? A systematic review and meta-synthesis of the literature. J Gastrointest Surg. 2012 Jul;16(7):1422-8. doi: 10.1007/s11605-012-1847-0. Epub 2012 Feb 28.] However, we do not expect all of these patients would be eligible for therapy and not all of these patients will receive WELIREG. |
https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=553 |
| Micro Labs USA, Inc. |
72485011310 |
Isoproterenol HCl Injection, USP 1 mg/5 mL (0.2 mg/mL) 10 Ampules Pack |
2021-09-09 |
8495.0000 |
Marketing partner - Armas intends to engage with purchasing organizations and bring savings to convert customers to Armas product |
None |
8810 |
None |
None |
None |
None |
None |
None |
Estimated Number of Patients is based on the past 12 month`s IMS data. Column 10 to 13 intentionally left blank as its not applicable. |
None |
| Mirum Pharmaceuticals |
79378011001 |
Product Name – Maralixibat oral solution Dosage Strength – 9.5mg/mL Package Size – 30mL Bottle Dosage Form – Oral |
2021-09-29 |
46500.0000 |
None |
1 |
2500 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Mitsubishi Tanabe Pharma America, Inc. |
70510220102 |
Exservan (riluzole) oral film |
2021-05-12 |
3143.0000 |
None |
1 |
400 |
None |
None |
2021-01-21 |
None |
1 |
None |
None |
None |
| Mylan Institutional Inc |
67457038681 |
Mycophenolate Mofetil 500mg LYO 4PK |
2021-01-26 |
290.0000 |
None |
1 |
35381 |
None |
None |
None |
None |
None |
None |
Please note that, although not all courses of treatment of the Product trigger the threshold established by the Centers for Medicare and Medicaid Services for specialty drugs in the Medicare Part D program (the “threshold”), this notice is being submitted because the Product triggers the threshold only when taking into account the maximum recommended dose as listed in the Product Prescribing Information.
Mycophenolate mofetil for injection is indicated for prophylaxis of organ rejection in recipients of allogeneic kidney, heart or liver transplants, and should be used in combination with other immunosuppressants. Based on the literature, in 2020, 22,817 had kidney transplants, 3,658 had heart transplants, and 8,906 had liver transplants (https://unos.org/data/transplant-trends/). Therefore, an estimated (using available data) 35,381 patients in the United States could potentially use this product during the current year.
The product was not a result of an acquisition. |
None |
| Mylan Pharmaceuticals Inc |
00378233078 |
Rufinamide Tablets USP, 200 mg |
2021-06-01 |
1367.0600 |
None |
1 |
48000 |
None |
None |
None |
None |
None |
None |
Rufinamide tablets are indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults (see US Prescribing Information). Based on the literature, approximately 48,000 children and adults in the United States suffer from LGS. (https://www.lgsfoundation.org/epidemiology). Therefore, an estimated (using available data) 48,000 patients in the United States could potentially use this product during the current year. |
None |
| Mylan Pharmaceuticals Inc |
00378233178 |
Rufinamide Tablets USP, 400 mg |
2021-06-01 |
2734.1100 |
None |
1 |
48000 |
None |
None |
None |
None |
None |
None |
Rufinamide tablets are indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults (see US Prescribing Information). Based on the literature, approximately 48,000 children and adults in the United States suffer from LGS. (https://www.lgsfoundation.org/epidemiology). Therefore, an estimated (using available data) 48,000 patients in the United States could potentially use this product during the current year. |
None |
| Mylan Pharmaceuticals Inc |
00378163193 |
Formoterol Fumarate 20mcg/2mL, Nebulizer Solution, 30 ct. |
2021-06-22 |
481.2600 |
None |
1 |
16400000 |
None |
None |
None |
None |
None |
None |
Formoterol Fumarate 20mcg/2mL, Nebulizer Solution is indicated for the long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Based on the literature, in 2018, 16.4 million people reported a diagnosis of any type of COPD (chronic bronchitis, emphysema, or COPD). (https://www.cdc.gov/copd/index.html). Therefore, an estimated (using available data) 16.4 million patients in the United States could potentially use this product during the current year.
Mylan reserves the right to reassess reporting requirements under the definition of a "new prescription drug" in any future submissions. This authorized generic Product is marketed under an NDA that was previously approved in 2007 and did not receive an initial approval under an original NDA. |
None |
| Mylan Pharmaceuticals Inc |
00378163191 |
Formoterol Fumarate 20mcg/2mL, Nebulizer Solution, 60 ct. |
2021-06-22 |
962.4700 |
None |
1 |
16400000 |
None |
None |
None |
None |
None |
None |
Formoterol Fumarate 20mcg/2mL, Nebulizer Solution is indicated for the long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Based on the literature, in 2018, 16.4 million people reported a diagnosis of any type of COPD (chronic bronchitis, emphysema, or COPD). (https://www.cdc.gov/copd/index.html). Therefore, an estimated (using available data) 16.4 million patients in the United States could potentially use this product during the current year.
Mylan reserves the right to reassess reporting requirements under the definition of a "new prescription drug" in any future submissions. This authorized generic Product is marketed under an NDA that was previously approved in 2007 and did not receive an initial approval under an original NDA. |
None |
| Mylan Pharmaceuticals Inc |
00378000585 |
Everolimus Dispersible Tablets, 2mg |
2021-10-01 |
12894.9800 |
None |
1 |
50000 |
None |
1 |
None |
None |
None |
None |
Everolimus Tabs is indicated for oral suspension for adult and pediatric patients with Tuberous Sclerosis Complex. Based on the literature, approximately 50,000 patients in the United States have Tuberous Sclerosis Complex (https://www.tscalliance.org/about-tsc/what-is-tsc/). Therefore, an estimated (using available data) 50,000 patients in the United States could potentially use this product during the current year. |
None |
| Mylan Pharmaceuticals Inc |
00378000685 |
Everolimus Dispersible Tablets, 3mg |
2021-10-01 |
13024.1400 |
None |
1 |
50000 |
None |
1 |
None |
None |
None |
None |
Everolimus Tabs is indicated for oral suspension for adult and pediatric patients with Tuberous Sclerosis Complex. Based on the literature, approximately 50,000 patients in the United States have Tuberous Sclerosis Complex (https://www.tscalliance.org/about-tsc/what-is-tsc/). Therefore, an estimated (using available data) 50,000 patients in the United States could potentially use this product during the current year. |
None |
| Mylan Pharmaceuticals Inc |
00378000785 |
Everolimus Dispersible Tablets, 5mg |
2021-10-01 |
13555.5200 |
None |
1 |
50000 |
None |
1 |
None |
None |
None |
None |
Everolimus Tabs is indicated for oral suspension for adult and pediatric patients with Tuberous Sclerosis Complex. Based on the literature, approximately 50,000 patients in the United States have Tuberous Sclerosis Complex (https://www.tscalliance.org/about-tsc/what-is-tsc/). Therefore, an estimated (using available data) 50,000 patients in the United States could potentially use this product during the current year. |
None |
| Mylan Pharmaceuticals Inc |
00378438591 |
Naproxen and Esomeprazole Magnesium DR Tablets 375mg/20mg |
2021-11-22 |
1613.4300 |
None |
1 |
3354920 |
None |
1 |
None |
None |
None |
None |
Naproxen component of Naproxen and Esomeprazole is indicated for relief of signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in adults, and juvenile idiopathic arthritis (JIA) in adolescent patients. The esomeprazole magnesium component is indicated to decrease the risk of developing naproxen-associated gastric ulcers. Based on the literature, the occurrence of rheumatoid arthritis and ankylosing spondylitis in the general population has a frequency between 0.3% and 1.5% (https://www.ncbi.nlm.nih.gov/books/NBK532288/). With the available United States population data of 333,880,005, that is an average of 3,004,920 patients (https://www.worldometers.info/world-population/us-population/). In the United States, about 350,000 new cases of peptic ulcers are diagnosed each year (https://pubmed.ncbi.nlm.nih.gov/6378441/). Therefore, an estimated (using available data) 3,354,920 patients in the United States could potentially use this product during the current year. |
None |
| Mylan Pharmaceuticals Inc |
00378438691 |
Naproxen and Esomeprazole Magnesium DR Tablets 500mg/20mg |
2021-11-22 |
1613.4300 |
None |
1 |
3354920 |
None |
1 |
None |
None |
None |
None |
Naproxen component of Naproxen and Esomeprazole is indicated for relief of signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in adults, and juvenile idiopathic arthritis (JIA) in adolescent patients. The esomeprazole magnesium component is indicated to decrease the risk of developing naproxen-associated gastric ulcers. Based on the literature, the occurrence of rheumatoid arthritis and ankylosing spondylitis in the general population has a frequency between 0.3% and 1.5% (https://www.ncbi.nlm.nih.gov/books/NBK532288/). With the available United States population data of 333,880,005, that is an average of 3,004,920 patients (https://www.worldometers.info/world-population/us-population/). In the United States, about 350,000 new cases of peptic ulcers are diagnosed each year (https://pubmed.ncbi.nlm.nih.gov/6378441/). Therefore, an estimated (using available data) 3,354,920 patients in the United States could potentially use this product during the current year. |
None |
| Mylan Specialty LP |
49502025080 |
Semglee® (insulin glargine-yfgn) 1000IU/10mL 1PK Vial |
2021-11-15 |
269.3800 |
None |
1 |
34200000 |
None |
None |
None |
None |
None |
None |
*Please note that, although not all courses of treatment of the Products trigger the threshold established by the Centers for Medicare and Medicaid Services for specialty drugs in the Medicare Part D program (the “threshold”), this notice is being submitted because the Products may trigger the threshold depending on the units a patient may use in a 30-day period.
Semglee is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. Based on the literature and assuming all type 1 and type 2 patients will be insulin dependent, approximately 34.2 million people of all ages had diagnosed diabetes in the United State (https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf). However, not all type 2 diabetes patients are in need of insulin. All 1.6 million patients with type 1 diabetes will need insulin (https://www.diabetes.org/resources/statistics/statistics-about-diabetes). Therefore, an estimated (using available data) 34.2 million patients in the United States could potentially use this product during the current year. |
None |
| Mylan Specialty LP |
49502025175 |
Semglee® (insulin glargine-yfgn) 300IU/3ML 5PK Pen |
2021-11-15 |
404.0400 |
None |
1 |
34200000 |
None |
None |
None |
None |
None |
None |
*Please note that, although not all courses of treatment of the Products trigger the threshold established by the Centers for Medicare and Medicaid Services for specialty drugs in the Medicare Part D program (the “threshold”), this notice is being submitted because the Products may trigger the threshold depending on the units a patient may use in a 30-day period.
Semglee is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. Based on the literature and assuming all type 1 and type 2 patients will be insulin dependent, approximately 34.2 million people of all ages had diagnosed diabetes in the United State (https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf). However, not all type 2 diabetes patients are in need of insulin. All 1.6 million patients with type 1 diabetes will need insulin (https://www.diabetes.org/resources/statistics/statistics-about-diabetes). Therefore, an estimated (using available data) 34.2 million patients in the United States could potentially use this product during the current year. |
None |
| Myovant Sciences Inc. |
72974041501 |
MYFEMBREE (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) 28 tablets |
2021-06-17 |
974.5400 |
None |
1 |
5000000 |
None |
None |
None |
None |
None |
None |
MYFEMBREE is a combination of relugolix, a gonadotropin-releasing hormone (GnRH) receptor antagonist, estradiol, an estrogen, and norethindrone acetate, a progestin, indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. |
None |
| Nabriva Therapeutics US, Inc. |
72000011010 |
Xenleta 600 mg tablets blister pack 10 |
2021-11-10 |
1375.0000 |
Nabriva pricing decisions regarding the WAC price of a medication are determined after consideration of many factors, including clinical and economic value of the particular therapy, therapeutic category, market dynamics, competitor pricing, discounts provided to customers in both the commercial and government channels, patient support to ensure patient access to life-saving and life-changing medications, overall research and development costs. |
None |
28 |
None |
None |
None |
None |
None |
None |
None |
None |
| Neurocrine Biosciences, Inc. |
70370106001 |
INGREZZA 60 MG CAPSULES |
2021-06-01 |
7043.0000 |
We determine the price of our medicines based on their value and impact to patients, families, care partners, providers, insurers and society. In so doing, we adhere to the highest ethical and compliance standards and are guided by the following principles:
• Improving the lives and well-being of patients
• Maximizing access and reducing out-of-pocket costs for eligible patients
• Striving to reduce obstacles for patients to fill a prescription or undergo treatment
• Fueling the discovery and development of life-changing medicines |
None |
500000 |
1 |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Neurocrine Biosciences, Inc. is limiting its response to that which is otherwise in the public domain or publicly available. Marketing Plans are not in the public domain or publicly available. This drug was developed in-house and was not acquired. Tardive Dyskinesia affects an estimated 500,000 people in the U.S. |
None |
| Nostrum Laboratories, Inc. |
29033021401 |
Carisoprodol 100ct 350mg Tablets in 1 Bottle |
2021-01-25 |
808.8500 |
None |
1 |
5000 |
None |
None |
None |
None |
None |
None |
This product is drug listed but has not yet been sold/entered the market. Nostrum Labs expects to begin selling this product/launch the product in the next two months. |
None |
| Novartis |
00078109120 |
SCEMBLIX 20 mg, 60 tablets |
2021-10-29 |
17900.0000 |
The marketing for SCEMBLIX includes education and promotion to physicians, direct to consumer promotions, other types of marketing (e.g., online platforms and education). Novartis considered many factors in determining the price of SCEMBLIX. SCEMBLIX is the first FDA-approved CML treatment that works by binding to the ABL myristoyl pocket, and represents an important development for patients who experience resistance and/or intolerance to currently available TKI therapies1-3. We priced in parity to other branded treatments in this therapeutic area and are focused on access to SCEMBLIX i for this patient population. |
None |
61700 |
1 |
1 |
None |
None |
None |
None |
Novartis estimates there are 61700 patients with Chronic Myeloid Leukemia in the United States. Novartis 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, Novartis does not waive any rights that it 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 Novartis or any of its affiliates now or in the future. Novartis, on behalf of itself and affiliates, expressly reserves all such rights. 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 Novartis is notified of the request and afforded the opportunity to submit objections to disclosure. |
None |
| Novartis |
00078109820 |
SCEMBLIX 40 mg, 60 tablets |
2021-10-29 |
17900.0000 |
The marketing for SCEMBLIX includes education and promotion to physicians, direct to consumer promotions, other types of marketing (e.g., online platforms and education). Novartis considered many factors in determining the price of SCEMBLIX. SCEMBLIX is the first FDA-approved CML treatment that works by binding to the ABL myristoyl pocket, and represents an important development for patients who experience resistance and/or intolerance to currently available TKI therapies1-3. We priced in parity to other branded treatments in this therapeutic area and are focused on access to SCEMBLIX i for this patient population. |
None |
61700 |
1 |
1 |
None |
None |
None |
None |
Novartis estimates there are 61700 patients with Chronic Myeloid Leukemia in the United States. Novartis 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, Novartis does not waive any rights that it 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 Novartis or any of its affiliates now or in the future. Novartis, on behalf of itself and affiliates, expressly reserves all such rights. 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 Novartis is notified of the request and afforded the opportunity to submit objections to disclosure. |
None |
| Novartis |
00078100060 |
LEQVIO (Inclisiran 284mg subcutaneous injection) |
2021-12-22 |
3250.0000 |
Novartis considered many factors in determining the price of LEQVIO. LEQVIO is a first-in-class siRNA and is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of low-density lipoprotein cholesterol (LDL-C). We priced in parity to other branded treatments in this therapeutic area and are focused on access to LEQVIO for this patient population. |
None |
30000000 |
None |
None |
None |
None |
None |
None |
Novartis estimates there are 30,000,000 diagnosed prevalent patients with ASCVD in the United States.
In January 2020, Novartis acquired The Medicines Company for $9.7 billion which included the global rights to develop, manufacture, and commercialize inclisiran under a license and collaboration agreement with Alnylam Pharmaceuticals. During the acquisition and integration of the company, The Medicines Company submitted the New Drug Application for inclisiran in December 2019.
Novartis 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, Novartis does not waive any rights that it 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 Novartis or any of its affiliates now or in the future. Novartis, on behalf of itself and affiliates, expressly reserves all such rights. 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 Novartis is notified of the request and afforded the opportunity to submit objections to disclosure. |
None |
| Novo |
00169452514 |
Wegovy™ 0.25 mg/0.5 mL in 1 pre-filled pen; 4 pens in 1 carton |
2021-06-15 |
1349.0200 |
None |
1 |
2600000 |
None |
1 |
None |
None |
None |
None |
Wegovy™ is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kg/m2 or greater (obesity) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia). The Prescribing Information for Wegovy™, is available at: https://www.novo-pi.com/wegovy.pdf.
Regarding the reported patient estimate, per IQVIA’s Longitudinal Access and Adjudication Database, citing 2020 year data, there are currently 2.6 million patients on pharmacotherapy medication for anti-obesity in the US. For the estimated patients requirement, Novo Nordisk utilizes this number of estimated patients on pharmacotherapy, however, we note that the total number of patients diagnosed with obesity is roughly 30 million, the majority of those patients will not go onto an anti-obesity pharmacotherapy treatment. Please note, this is not an estimate of prescriptions that might be written for Wegovy™ or each available dose of Wegovy™. Wegovy™ will represent a portion of the broader market for anti-obesity therapies.
Wegovy™ was developed by Novo Nordisk. |
None |
| Novo |
00169450514 |
Wegovy™ 0.5 mg/0.5 mL in 1 pre-filled pen; 4 pens in 1 carton |
2021-06-15 |
1349.0200 |
None |
1 |
2600000 |
None |
1 |
None |
None |
None |
None |
Wegovy™ is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kg/m2 or greater (obesity) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia). The Prescribing Information for Wegovy™, is available at: https://www.novo-pi.com/wegovy.pdf.
Regarding the reported patient estimate, per IQVIA’s Longitudinal Access and Adjudication Database, citing 2020 year data, there are currently 2.6 million patients on pharmacotherapy medication for anti-obesity in the US. For the estimated patients requirement, Novo Nordisk utilizes this number of estimated patients on pharmacotherapy, however, we note that the total number of patients diagnosed with obesity is roughly 30 million, the majority of those patients will not go onto an anti-obesity pharmacotherapy treatment. Please note, this is not an estimate of prescriptions that might be written for Wegovy™ or each available dose of Wegovy™. Wegovy™ will represent a portion of the broader market for anti-obesity therapies.
Wegovy™ was developed by Novo Nordisk. |
None |
| Novo |
00169450114 |
Wegovy™ 1 mg/ 0.5 mL in 1 pre-filled pen; 4 pens in 1 carton |
2021-06-15 |
1349.0200 |
None |
1 |
2600000 |
None |
1 |
None |
None |
None |
None |
Wegovy™ is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kg/m2 or greater (obesity) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia). The Prescribing Information for Wegovy™, is available at: https://www.novo-pi.com/wegovy.pdf.
Regarding the reported patient estimate, per IQVIA’s Longitudinal Access and Adjudication Database, citing 2020 year data, there are currently 2.6 million patients on pharmacotherapy medication for anti-obesity in the US. For the estimated patients requirement, Novo Nordisk utilizes this number of estimated patients on pharmacotherapy, however, we note that the total number of patients diagnosed with obesity is roughly 30 million, the majority of those patients will not go onto an anti-obesity pharmacotherapy treatment. Please note, this is not an estimate of prescriptions that might be written for Wegovy™ or each available dose of Wegovy™. Wegovy™ will represent a portion of the broader market for anti-obesity therapies.
Wegovy™ was developed by Novo Nordisk. |
None |
| Novo |
00169451714 |
Wegovy™ 1.7 mg/0.75 mL in 1 pre-filled pen; 4 pens in 1 carton |
2021-06-15 |
1349.0200 |
None |
1 |
2600000 |
None |
1 |
None |
None |
None |
None |
Wegovy™ is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kg/m2 or greater (obesity) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia). The Prescribing Information for Wegovy™, is available at: https://www.novo-pi.com/wegovy.pdf.
Regarding the reported patient estimate, per IQVIA’s Longitudinal Access and Adjudication Database, citing 2020 year data, there are currently 2.6 million patients on pharmacotherapy medication for anti-obesity in the US. For the estimated patients requirement, Novo Nordisk utilizes this number of estimated patients on pharmacotherapy, however, we note that the total number of patients diagnosed with obesity is roughly 30 million, the majority of those patients will not go onto an anti-obesity pharmacotherapy treatment. Please note, this is not an estimate of prescriptions that might be written for Wegovy™ or each available dose of Wegovy™. Wegovy™ will represent a portion of the broader market for anti-obesity therapies.
Wegovy™ was developed by Novo Nordisk. |
None |
| Novo |
00169452414 |
Wegovy™ 2.4 mg/0.75 mL in 1 pre-filled pen; 4 pens in 1 carton |
2021-06-15 |
1349.0200 |
None |
1 |
2600000 |
None |
1 |
None |
None |
None |
None |
Wegovy™ is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kg/m2 or greater (obesity) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia). The Prescribing Information for Wegovy™, is available at: https://www.novo-pi.com/wegovy.pdf.
Regarding the reported patient estimate, per IQVIA’s Longitudinal Access and Adjudication Database, citing 2020 year data, there are currently 2.6 million patients on pharmacotherapy medication for anti-obesity in the US. For the estimated patients requirement, Novo Nordisk utilizes this number of estimated patients on pharmacotherapy, however, we note that the total number of patients diagnosed with obesity is roughly 30 million, the majority of those patients will not go onto an anti-obesity pharmacotherapy treatment. Please note, this is not an estimate of prescriptions that might be written for Wegovy™ or each available dose of Wegovy™. Wegovy™ will represent a portion of the broader market for anti-obesity therapies.
Wegovy™ was developed by Novo Nordisk. |
None |
| Oncopeptides, Inc. |
73657002001 |
Pepaxto (melphalan flufenamide) for intravenous use |
2021-03-01 |
9500.0000 |
None |
1 |
500 |
None |
1 |
None |
None |
None |
None |
Estimated number of patients represent number who might potentially receive this drug in the US |
None |
| Organon |
78206017202 |
SINGULAIR 10 mg tablet 90 count |
2021-07-19 |
684.9000 |
Marketing: Organon does not currently actively market this product and does not plan to create any marketing efforts in the future; there are no Organon professional representatives detailing this product, nor is Organon sponsoring any medical education or awareness programs involving this product.
Pricing: Organon is inheriting the pricing for Singulair from Merck, Organon is not adjusting WAC prices at time of launch. |
None |
14288 |
None |
None |
2021-07-19 |
None |
1 |
Organon is the resulting organization from the divesture of Merck's women's health division, biosimilars, and select legacy products for clarity these products being sold under the Organon label are not new to market products as they existed previously under Merck but are being sold now under the Organon label. |
Total 2018 patients for Moktelukast (generic Singulair) was 7,017,347 - assuming an average yearly patient population growth rate of .6% (annual average in US) and a market share rate of 1% and patients receiving one dosage do not also recieve another dosage strength in the same year the total patient volume in 2021 is 14,288. |
None |
| Organon |
78206017402 |
VYTORIN 10; 10 mg/1; mg/1 Tablet 90 count |
2021-07-19 |
1025.1000 |
Marketing: Organon does not currently actively market this product and does not plan to create any marketing efforts in the future; there are no Organon professional representatives detailing this product, nor is Organon sponsoring any medical education or awareness programs involving this product.
Pricing: Organon is inheriting the pricing for Vytorin from Merck, Organon is not adjusting WAC prices at time of launch. |
None |
60937 |
None |
None |
2021-07-19 |
None |
1 |
Organon is the resulting organization from the divesture of Merck's women's health division, biosimilars, and select legacy products for clarity these products being sold under the Organon label are not new to market products as they existed previously under Merck but are being sold now under the Organon label. |
Total 2021 patients for Ezetimibe (generic Vytorin) was 65,000,000 - assuming a market share rate of .75% and patients receiving one dosage do not also recieve another dosage strength in the same year the total patient volume in 2021 is 60,937. |
None |
| Organon |
78206017502 |
VYTORIN 10; 20 mg/1; mg/1 Tablet 90 count |
2021-07-19 |
1025.1000 |
Marketing: Organon does not currently actively market this product and does not plan to create any marketing efforts in the future; there are no Organon professional representatives detailing this product, nor is Organon sponsoring any medical education or awareness programs involving this product.
Pricing: Organon is inheriting the pricing for Vytorin from Merck, Organon is not adjusting WAC prices at time of launch. |
None |
60937 |
None |
None |
2021-07-19 |
None |
1 |
Organon is the resulting organization from the divesture of Merck's women's health division, biosimilars, and select legacy products for clarity these products being sold under the Organon label are not new to market products as they existed previously under Merck but are being sold now under the Organon label. |
Total 2021 patients for Ezetimibe (generic Vytorin) was 65,000,000 - assuming a market share rate of .75% and patients receiving one dosage do not also recieve another dosage strength in the same year the total patient volume in 2021 is 60,937. |
None |
| Organon |
78206017602 |
VYTORIN 10; 40 mg/1; mg/1 Tablet 90 count |
2021-07-19 |
1025.1000 |
Marketing: Organon does not currently actively market this product and does not plan to create any marketing efforts in the future; there are no Organon professional representatives detailing this product, nor is Organon sponsoring any medical education or awareness programs involving this product.
Pricing: Organon is inheriting the pricing for Vytorin from Merck, Organon is not adjusting WAC prices at time of launch. |
None |
60937 |
None |
None |
2021-07-19 |
None |
1 |
Organon is the resulting organization from the divesture of Merck's women's health division, biosimilars, and select legacy products for clarity these products being sold under the Organon label are not new to market products as they existed previously under Merck but are being sold now under the Organon label. |
Total 2021 patients for Ezetimibe (generic Vytorin) was 65,000,000 - assuming a market share rate of .75% and patients receiving one dosage do not also recieve another dosage strength in the same year the total patient volume in 2021 is 60,937. |
None |
| Organon |
78206017702 |
VYTORIN 10; 80 mg/1; mg/1 Tablet 90 count |
2021-07-19 |
1025.1000 |
Marketing: Organon does not currently actively market this product and does not plan to create any marketing efforts in the future; there are no Organon professional representatives detailing this product, nor is Organon sponsoring any medical education or awareness programs involving this product.
Pricing: Organon is inheriting the pricing for Vytorin from Merck, Organon is not adjusting WAC prices at time of launch. |
None |
60937 |
None |
None |
2021-07-19 |
None |
1 |
Organon is the resulting organization from the divesture of Merck's women's health division, biosimilars, and select legacy products for clarity these products being sold under the Organon label are not new to market products as they existed previously under Merck but are being sold now under the Organon label. |
Total 2021 patients for Ezetimibe (generic Vytorin) was 65,000,000 - assuming a market share rate of .75% and patients receiving one dosage do not also recieve another dosage strength in the same year the total patient volume in 2021 is 60,937. |
None |
| Organon |
78206018102 |
ZOCOR 20 mg/1 Tablet 90 count |
2021-07-19 |
725.4000 |
Marketing: Organon does not currently actively market this product and does not plan to create any marketing efforts in the future; there are no Organon professional representatives detailing this product, nor is Organon sponsoring any medical education or awareness programs involving this product.
Pricing: Organon is inheriting the pricing for Zocor from Merck, Organon is not adjusting WAC prices at time of launch. |
None |
17660 |
None |
None |
2021-07-19 |
None |
1 |
Organon is the resulting organization from the divesture of Merck's women's health division, for clarity these products being sold under the Organon label are not new to market products as they existed previously under Merck but are being sold now under the Organon label. |
Total 2018 patients for Simvastatin (generic Zocor) was 10,407,988 - assuming an average yearly patient population growth rate of .6% (annual average in US) and a market share rate of 1% and patients receiving one dosage do not also recieve another dosage strength in the same year the total patient volume in 2021 is 17,660. |
None |
| Organon |
78206018202 |
ZOCOR 40 mg/1 Tablet 90 count |
2021-07-19 |
725.4000 |
Marketing: Organon does not currently actively market this product and does not plan to create any marketing efforts in the future; there are no Organon professional representatives detailing this product, nor is Organon sponsoring any medical education or awareness programs involving this product.
Pricing: Organon is inheriting the pricing for Zocor from Merck, Organon is not adjusting WAC prices at time of launch. |
None |
17660 |
None |
None |
2021-07-19 |
None |
1 |
Organon is the resulting organization from the divesture of Merck's women's health division, for clarity these products being sold under the Organon label are not new to market products as they existed previously under Merck but are being sold now under the Organon label. |
Total 2018 patients for Simvastatin (generic Zocor) was 10,407,988 - assuming an average yearly patient population growth rate of .6% (annual average in US) and a market share rate of 1% and patients receiving one dosage do not also recieve another dosage strength in the same year the total patient volume in 2021 is 17,660. |
None |
| Organon |
78206017902 |
ZOCOR 80 mg/1 Tablet 90 count |
2021-07-19 |
725.4000 |
Marketing: Organon does not currently actively market this product and does not plan to create any marketing efforts in the future; there are no Organon professional representatives detailing this product, nor is Organon sponsoring any medical education or awareness programs involving this product.
Pricing: Organon is inheriting the pricing for Zocor from Merck, Organon is not adjusting WAC prices at time of launch. |
None |
17660 |
None |
None |
2021-07-19 |
None |
1 |
Organon is the resulting organization from the divesture of Merck's women's health division, for clarity these products being sold under the Organon label are not new to market products as they existed previously under Merck but are being sold now under the Organon label. |
Total 2018 patients for Simvastatin (generic Zocor) was 10,407,988 - assuming an average yearly patient population growth rate of .6% (annual average in US) and a market share rate of 1% and patients receiving one dosage do not also recieve another dosage strength in the same year the total patient volume in 2021 is 17,660. |
None |
| Organon |
78206011901 |
Clarinex 5 mg Tablet 100 ct |
2021-08-16 |
730.0000 |
Marketing: Organon does not currently actively market this product and does not plan to create any marketing efforts in the future; there are no Organon professional representatives detailing this product, nor is Organon sponsoring any medical education or awareness programs involving this product.
Pricing: Organon is inheriting the pricing for Clarinex from Merck, Organon is not adjusting WAC prices at time of launch. |
None |
162500 |
None |
None |
2021-08-16 |
None |
1 |
Organon is the resulting organization from the divesture of Merck's women's health division, biosimilars, and select legacy products for clarity these products being sold under the Organon label are not new to market products as they existed previously under Merck but are being sold now under the Organon label. |
Total 2021 patients for Desloratadine (generic Clarinex) was 32,500,000 - assuming a market share rate of 1% and patients receiving one dosage do not also receive another dosage strength in the same year the total patient volume in 2021 is 162,500. |
None |
| Organon |
78206014501 |
Nexplanon 68 mg Implant 1 ct |
2021-08-16 |
1030.6400 |
Marketing: Organon does not currently actively market this product and does not plan to create any marketing efforts in the future; there are no Organon professional representatives detailing this product, nor is Organon sponsoring any medical education or awareness programs involving this product.
Pricing: Organon is inheriting the pricing for Nexplanon from Merck, Organon is not adjusting WAC prices at time of launch. |
None |
904000 |
None |
None |
2021-08-16 |
None |
1 |
Organon is the resulting organization from the divesture of Merck's women's health division, biosimilars, and select legacy products for clarity these products being sold under the Organon label are not new to market products as they existed previously under Merck but are being sold now under the Organon label. |
To account for the impact of COVID the estimated number of patients in 2019 and 2020 have been averaged resulting in an estimated 904,000 patients annually in the US. |
None |
| Organon |
78206014701 |
Ontruzant 150 mg 1 vial injection |
2021-10-01 |
1324.6600 |
"Marketing: Organon does not currently actively market this product and does not plan to create any marketing efforts in the future; there are no Organon professional representatives detailing this product, nor is Organon sponsoring any medical education or awareness programs involving this product.
Pricing: Organon is inheriting the pricing from Merck, Organon is not adjusting WAC prices at time of launch." |
None |
639 |
None |
None |
2021-10-01 |
None |
1 |
Organon is the resulting organization from the divesture of Merck's women's health division, for clarity these products being sold under the Organon label are not new to market products as they existed previously under Merck but are being sold now under the Organon label. |
None |
None |
| Organon |
78206014801 |
Ontruzant 420 mg 1 vial injection |
2021-10-01 |
3709.0400 |
"Marketing: Organon does not currently actively market this product and does not plan to create any marketing efforts in the future; there are no Organon professional representatives detailing this product, nor is Organon sponsoring any medical education or awareness programs involving this product.
Pricing: Organon is inheriting the pricing from Merck, Organon is not adjusting WAC prices at time of launch." |
None |
639 |
None |
None |
2021-10-01 |
None |
1 |
Organon is the resulting organization from the divesture of Merck's women's health division, for clarity these products being sold under the Organon label are not new to market products as they existed previously under Merck but are being sold now under the Organon label. |
None |
None |
| Organon |
78206016201 |
Renflexis 100 mg solution 1 vial |
2021-10-01 |
753.3900 |
"Marketing: Organon does not currently actively market this product and does not plan to create any marketing efforts in the future; there are no Organon professional representatives detailing this product, nor is Organon sponsoring any medical education or awareness programs involving this product.
Pricing: Organon is inheriting the pricing from Merck, Organon is not adjusting WAC prices at time of launch." |
None |
24299 |
None |
None |
2021-10-01 |
None |
1 |
Organon is the resulting organization from the divesture of Merck's women's health division, for clarity these products being sold under the Organon label are not new to market products as they existed previously under Merck but are being sold now under the Organon label. |
None |
None |
| Origin Biosciences Inc. |
73129000101 |
Nulibry (fosdenopterin hydrobromide) for injection 9.5mg/vial |
2021-02-26 |
1369.8600 |
Nulibry is the first and only FDA approved treatment for MoCD Type A, a rare and rapidly progressing, fatal, inborn error of metabolism that often presents with intractable seizures shortly after birth. Origin’s approach will focus on educating pediatric neurologists, neonatologists, geneticists, and all NICU/PICU staff on how to diagnose MoCD Type A within the critical time window, and provide information about treatment with Nulibry. Educational materials will be provided across the patient journey, to both HCPs and to families, and highlight access and affordability support for Nulibry to ensure rapid access to life saving therapy |
None |
20 |
1 |
1 |
None |
None |
None |
None |
The product was not acquired and as such no information is to be disclosed |
None |
| Padagis US LLC |
00574093125 |
Doxorubicin Hydrochloride Liposome Injection 50 mg/25 mL (2mg/mL) 25mL |
2021-10-25 |
1515.6000 |
Product is be priced to deliver value to the market as compared to the Brand referenced drug. |
None |
39976 |
None |
None |
None |
None |
None |
None |
As a generic manufacturer, Padagis does not have information available to accurately determinate the number of patients that could potentially have a condition for which the drug may be prescribed. Padagis neither collects nor uses estimated patient information and does not believe there is publicly available data that accurately represents the number of patients for all indications.
Based on NSP data available to Padagis, Padagis estimates that approximately 39,976 Total Units were sold for this drug in the past 12 months, but number of units sold should not be misinterpreted as an accurate estimate of the number of patients with a condition for which the new drug may be prescribed, as dosage and therapy may vary across individual patients. |
None |
| Par Pharmaceutical |
00254205301 |
Chlorzoxazone Tablets 375mg 100s |
2021-06-10 |
370.0000 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions.
(1) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank.
(2) Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Par notes that this product is indicated adjunct to other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The World Health Organization (“WHO”) indicates approximately 1,710,000,000 people have musculoskeletal conditions world-wide (see https://www.who.int/news-room/fact-sheets/detail/musculoskeletal-conditions#:~:text=%20Musculoskeletal%20conditions%20include%20conditions%20that%20affect%3A%20,body%20areas%20or%20systems%2C%20such%20as...%20More%20 ).
However, WHO does not specify the number of patients diagnosed each month or year with musculoskeletal conditions. Further, Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level.
Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s Chlorzoxazone Tablets because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states: “Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at: https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market.
Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank.
(3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank. |
None |
| Par Pharmaceutical |
49884015576 |
Varenicline Tablets .5mg 56s |
2021-09-16 |
364.5200 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions.
(1) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank.
(2) Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Par notes that this product is indicated as an aid to smoking cessation treatment. The Centers for Disease Control and Prevention (“CDC”) indicates that in 2015 22.7 million adult smokers in the United States wanted to quit smoking. https://www.cdc.gov/tobacco/data_statistics/fact_sheets/cessation/smoking-cessation-fast-facts/index.html
However, CDC does not specify the number of smokers intending to quit each month or year. Further, Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level.
Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s Varenicline Tablets because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states: “Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at: https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market.
Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank.
(3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank. |
None |
| Par Pharmaceutical |
49884055601 |
Isosorbide Dinitrate Tablets, USP 40mg 100s |
2021-12-13 |
1335.3700 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions.
(1) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank.
(2) Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Moreover, Par notes that because this product is a generic, Par did not consider, nor did it identify, the estimated patient population in determining market need for the product.
Accordingly, Par is unable to provide an estimate of the average number of patients who may be treated by this product beyond publicly available data.
Par notes that this product is indicated for the prevention of angina pectoris due to coronary artery disease. The Centers for Disease Control and Prevention (“CDC”) estimates that 18.2 million adults in the United States have coronary artery disease and the Mayo Clinic notes that angina is a common symptom of coronary artery disease. ( https://www.cdc.gov/heartdisease/facts.htm, https://www.mayoclinic.org/diseases-conditions/angina/symptoms-causes/syc-20369373 )
The CDC did not indicate how many cases of coronary artery disease occur each month.
Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s Isosorbide because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states:
“Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at:
https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market.
Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank.
(3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank. |
None |
| Pfizer |
00069102902 |
XELJANZ 1MG/ML ORSOL 1X240ML PBTL US |
2021-02-08 |
3944.3900 |
None |
1 |
3000 |
None |
None |
None |
None |
None |
None |
Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pfizer estimates that in total, approximately 3,000 patients across the United States, could potentially receive the Oral Solution formulation. Comment regarding Fields 10-13: Xeljanz Oral Solution was not acquired; therefore, Columns 10 – 13 are intentionally left blank. |
None |
| Pfizer |
00409012001 |
Daptomycin for Injection 350mg per Vial (1’s) |
2021-10-04 |
50.0000 |
None |
1 |
393466 |
None |
None |
None |
None |
None |
None |
Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Approximately 393,466 patients are estimated to receive Daptomycin annually. Comment regarding Fields 10-13: Daptomycin was not acquired; therefore, Columns 10 – 13 are intentionally left blank. |
None |
| Pfizer |
00409012201 |
Daptomycin for Injection 500mg per Vial (1’s) |
2021-10-04 |
79.0000 |
None |
1 |
393466 |
None |
None |
None |
None |
None |
None |
Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Approximately 393,466 patients are estimated to receive Daptomycin annually. Comment regarding Fields 10-13: Daptomycin was not acquired; therefore, Columns 10 – 13 are intentionally left blank. |
None |
| PharmaEssentia USA Corporation |
73536050001 |
BESREMi (Ropeginterferon alfa-2b-njft) 500 mcg/ml single use vial |
2021-12-03 |
6988.0000 |
None |
1 |
161110 |
None |
1 |
None |
None |
None |
None |
None |
None |
| Piramal Critical Care |
66794023444 |
Dexmedetomidine Hydrochloride Injection, USP 200 mcg/50mL (4 mcg/mL) |
2021-08-15 |
720.0000 |
Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Piramal Critical Care’s Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is priced responsibly and in line with current market conditions. |
None |
750315 |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Piramal is limiting its response to that which is otherwise in the public domain or publicly available. The Estimated Patient amount is based on the number of eaches sold in the last 12 month period from July 2020 through June 2021. This number does not account for multiple vials dosed to a single patient as this information is not readily available. This product was not acquired; however, Piramal's marketing rights were in-licensed. Piramal does not believe this information is publicly available and has not released this information in the public domain. |
None |
| Piramal Critical Care |
66794023541 |
Dexmedetomidine Hydrochloride Injection, USP 400 mcg/100mL (4 mcg/mL) |
2021-08-15 |
720.0000 |
Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Piramal Critical Care’s Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is priced responsibly and in line with current market conditions. |
None |
3237152 |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Piramal is limiting its response to that which is otherwise in the public domain or publicly available. The Estimated Patient amount is based on the number of eaches sold in the last 12 month period from July 2020 through June 2021. This number does not account for multiple vials dosed to a single patient as this information is not readily available. This product was not acquired; however, Piramal's marketing rights were in-licensed. Piramal does not believe this information is publicly available and has not released this information in the public domain. |
None |
| Primus Pharmaceuticals Inc |
68040071428 |
Sernivo® Spray; Betamethasone dipropionate 0.05% |
2021-08-02 |
997.5000 |
None |
1 |
45000 |
None |
None |
2021-03-11 |
None |
1 |
None |
None |
https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=554, https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=555 |
| Progenics Pharmaceuticals, Inc. |
71258002200 |
PYLARIFY® (piflufolastat F 18) Injection |
2021-05-26 |
4600.0000 |
Product will be marketed in the US and the pricing model will be consistant with our WAC Pricing through December 31, 2021 |
None |
250000 |
None |
1 |
None |
None |
None |
None |
Brand New Product to Market, we do not have estimate of usage yet. |
None |
| Puma Biotechnology, Inc. |
70437024033 |
Nerlynx (neratinib) 40mg 133 count bottle |
2021-06-21 |
12940.0000 |
None |
1 |
3350 |
None |
None |
None |
None |
None |
None |
None |
None |
| PureTek Corporation |
59088077200 |
Sumansetron, sumatriptan tablets USP 50mg (9ct) + Ondansetron tablets USP 4mg (30ct) |
2021-01-01 |
3352.8000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
0 |
None |
None |
None |
None |
None |
None |
None |
None |
| PureTek Corporation |
59088017554 |
Probitrol, capsules, 31 billion, 30ct |
2021-01-04 |
1744.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
0 |
None |
None |
None |
None |
None |
None |
None |
None |
| PureTek Corporation |
59088017457 |
Promerol, capsules, 31 billion, 30ct |
2021-01-04 |
3136.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
0 |
None |
None |
None |
None |
None |
None |
None |
None |
| PureTek Corporation |
59088017354 |
Vitranol Fe, caplets, multivitamin + iron, 30ct |
2021-01-04 |
1800.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
0 |
None |
None |
None |
None |
None |
None |
None |
None |
| PureTek Corporation |
59088017754 |
Venexa Fe, multivitamin + iron (30CT) |
2021-01-29 |
1930.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
150000 |
None |
None |
None |
None |
None |
None |
None |
None |
| PureTek Corporation |
59088017654 |
Venexa, caplets, multivitamin, 30ct |
2021-01-29 |
1544.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
0 |
None |
None |
None |
None |
None |
None |
None |
None |
| PureTek Corporation |
59088017854 |
Pretrate, prenatal/postnatal multivitamin, (30ct) caplets |
2021-02-01 |
1460.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
2000000 |
None |
None |
None |
None |
None |
None |
0 |
None |
| PureTek Corporation |
59088017954 |
Lacterol (30ct), probiotic (30ct) |
2021-02-10 |
1962.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
100000 |
None |
None |
None |
None |
None |
None |
Dispensed by prescription |
None |
| PureTek Corporation |
59088018158 |
Foltin-Z, multivitamin (60ct) |
2021-02-11 |
1740.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
150000 |
None |
None |
None |
None |
None |
None |
None |
None |
| PureTek Corporation |
59088018258 |
Ribotin- E, multivitamin (60ct) caplets |
2021-02-11 |
1740.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
150000 |
None |
None |
None |
None |
None |
None |
None |
None |
| PureTek Corporation |
59088018058 |
Zintrexyl-C, multivitamin (60ct) |
2021-02-11 |
1740.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
150000 |
None |
None |
None |
None |
None |
None |
None |
None |
| PureTek Corporation |
59088018354 |
Probitran, probiotic (30ct) |
2021-05-03 |
1962.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
100000 |
None |
None |
None |
None |
None |
None |
dispensed by prescription |
None |
| PureTek Corporation |
59088018454 |
Purefoltin, Folic acid 1mg + Vitamin D3 5,000 IU (30ct) |
2021-05-03 |
2200.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
300000 |
None |
None |
None |
None |
None |
None |
None |
None |
| PureTek Corporation |
59088018654 |
Ventrixyl, multivitamin (30ct) |
2021-06-04 |
1800.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
150000 |
None |
None |
None |
None |
None |
None |
None |
None |
| PureTek Corporation |
59088046607 |
Lidogel, Lidocaine HCI 2.8% Gel, (100g) |
2021-07-21 |
1516.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
250000 |
None |
None |
None |
None |
None |
None |
0 |
None |
| PureTek Corporation |
59088018754 |
Ventrixyl Fe, Multivitamin (30ct) tablets |
2021-08-11 |
1800.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
150000 |
None |
None |
None |
None |
None |
None |
None |
None |
| PureTek Corporation |
59088019454 |
Probinate, probiotic, (30ct) capsules |
2021-08-20 |
1480.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
100000 |
None |
None |
None |
None |
None |
None |
None |
None |
| PureTek Corporation |
59088019354 |
Vitramyn, multivitamin (30ct) caplets |
2021-08-20 |
1800.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
150000 |
None |
None |
None |
None |
None |
None |
None |
None |
| PureTek Corporation |
59088018554 |
Folditam, Folic Acid 1mg + Vit D3 10,000IU, tablets (30ct) |
2021-09-02 |
1704.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
2000000 |
None |
None |
None |
None |
None |
None |
None |
None |
| PureTek Corporation |
59088043207 |
Radiaura Skin Recovery Cream, Lidocaine HCI 3%_ Hydrocotisone Acetate 0.5%, cream (85g) |
2021-09-02 |
1123.8100 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
500000 |
None |
None |
None |
None |
None |
None |
None |
None |
| PureTek Corporation |
59088048058 |
Foliflex Multivitamin, 30ct caplets |
2021-10-14 |
1392.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
350000 |
None |
None |
None |
None |
None |
None |
Dispensed by prescription only |
None |
| PureTek Corporation |
59088047507 |
Lidorex. Lidocaie HCI 2.8% Gel, 3.5oz (100g) |
2021-10-14 |
1516.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
275000 |
None |
None |
None |
None |
None |
None |
Dispensed by prescription only |
None |
| PureTek Corporation |
59088020054 |
Foltamin, Folic Acid 1mg + Vitamin D3 5000IU, tablets (30ct) |
2021-11-29 |
1760.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
300000 |
None |
None |
None |
None |
None |
None |
Dispensed by prescription only |
None |
| PureTek Corporation |
59088071500 |
Lidotor, Lidocaine 2.5%/Prilocaine 2.5% cream USP 30gm + Occlusive Dressing (5ct) |
2021-11-29 |
1820.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
150000 |
None |
None |
None |
None |
None |
None |
Dispensed by prescription only |
None |
| PureTek Corporation |
59088019954 |
Probisol, 2 Strain AcidoBifido 31 Billion, capsules (30ct) |
2021-11-29 |
1569.6000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
250000 |
None |
None |
None |
None |
None |
None |
Dispensed by prescription only |
None |
| QED Therapeutics, Inc. |
72730011101 |
Truseltiq 100mg capsules 1 blister pack |
2021-06-16 |
21500.0000 |
Truseltiq (infigratinib) is a new option for 2L+ FGFR2 fusion CCA who are in need of therapeutic options after frontline therapy. QED’s approach will focus on educating physicians about CCA, NGS testing, Truseltiq and important information about treatment with targeted therapies like FGFR inhibitors. Educational materials will be provided across the patient journey, to HCPs and to consumers, and provide information about access support for Truseltiq. |
None |
250 |
None |
None |
None |
None |
None |
None |
Maximum potential of 250 patients (Total annual patient population in intrahepatic cholangiocarcinoma of 3,000 per year/ 12 months)
Source: https://rarediseases.org/rare-diseases/cholangiocarcinoma/#:~:text=Affected%20Populations&text=The%20incidence%20of%20intrahepatic%20cholangiocarcinoma,States%20is%20increasing%20%5B7%5D |
None |
| QED Therapeutics, Inc. |
72730010101 |
Truseltiq 125mg capsules 1 blister pack |
2021-06-16 |
21500.0000 |
Truseltiq (infigratinib) is a new option for 2L+ FGFR2 fusion CCA who are in need of therapeutic options after frontline therapy. QED’s approach will focus on educating physicians about CCA, NGS testing, Truseltiq and important information about treatment with targeted therapies like FGFR inhibitors. Educational materials will be provided across the patient journey, to HCPs and to consumers, and provide information about access support for Truseltiq. |
None |
250 |
None |
None |
None |
None |
None |
None |
Maximum potential of 250 patients (Total annual patient population in intrahepatic cholangiocarcinoma of 3,000 per year/ 12 months)
Source: https://rarediseases.org/rare-diseases/cholangiocarcinoma/#:~:text=Affected%20Populations&text=The%20incidence%20of%20intrahepatic%20cholangiocarcinoma,States%20is%20increasing%20%5B7%5D |
None |
| QED Therapeutics, Inc. |
72730050601 |
Truseltiq 50mg capsules 1 blister pack |
2021-06-16 |
21500.0000 |
Truseltiq (infigratinib) is a new option for 2L+ FGFR2 fusion CCA who are in need of therapeutic options after frontline therapy. QED’s approach will focus on educating physicians about CCA, NGS testing, Truseltiq and important information about treatment with targeted therapies like FGFR inhibitors. Educational materials will be provided across the patient journey, to HCPs and to consumers, and provide information about access support for Truseltiq. |
None |
250 |
None |
None |
None |
None |
None |
None |
Maximum potential of 250 patients (Total annual patient population in intrahepatic cholangiocarcinoma of 3,000 per year/ 12 months)
Source: https://rarediseases.org/rare-diseases/cholangiocarcinoma/#:~:text=Affected%20Populations&text=The%20incidence%20of%20intrahepatic%20cholangiocarcinoma,States%20is%20increasing%20%5B7%5D |
None |
| QED Therapeutics, Inc. |
72730020201 |
Truseltiq 75mg capsules 1 carton pack (2 blister packs) |
2021-06-16 |
21500.0000 |
Truseltiq (infigratinib) is a new option for 2L+ FGFR2 fusion CCA who are in need of therapeutic options after frontline therapy. QED’s approach will focus on educating physicians about CCA, NGS testing, Truseltiq and important information about treatment with targeted therapies like FGFR inhibitors. Educational materials will be provided across the patient journey, to HCPs and to consumers, and provide information about access support for Truseltiq. |
None |
250 |
None |
None |
None |
None |
None |
None |
Maximum potential of 250 patients (Total annual patient population in intrahepatic cholangiocarcinoma of 3,000 per year/ 12 months)
Source: https://rarediseases.org/rare-diseases/cholangiocarcinoma/#:~:text=Affected%20Populations&text=The%20incidence%20of%20intrahepatic%20cholangiocarcinoma,States%20is%20increasing%20%5B7%5D |
None |
| Regeneron Pharmaceuticals, Inc. |
61755001001 |
EVKEEZA (evinacumab-dgnb) 1200 mg/8 mL (150mg/ mL) |
2021-02-16 |
37500.0000 |
Marketing
Planned marketing activities that will support the approval of EVKEEZA™ (evinacumab-dgnb) include raising awareness about homozygous familial hypercholesterolemia (HoFH) and EVKEEZA among healthcare professionals through physician-focused product and disease education websites, other digital media, print media, and use of sales representatives to promote the FDA-approved indication. Anticipated direct-to-consumer marketing activities include a consumer-focused product website and other digital media.
Pricing
Regeneron approaches pricing with fairness, affordability and access at the forefront. Our pricing philosophy is guided by several principles.
First, medicines should be priced fairly. We take a value-based pricing approach that reflects their benefit to patients, society and the healthcare system. We consider the long-term investment and risk inherent in science and technology innovation, which is required to bring novel medicines to patients.
Second, medicines are only useful if patients in need can access and afford them. We are committed to supporting patients’ access by providing financial assistance for eligible patients.
Third, our growth is driven by scientific innovation, not pricing. Any price changes Regeneron makes is designed to keep pace with the medicine’s value and our costs, and in careful consideration of commercial competitiveness.
Regeneron also seeks to work collaboratively with other stakeholders in the healthcare system and welcome their input on fair and cost-effective pricing. These principles taken together help to ensure advancing our goal of setting fair, value-based prices for our medicines and breaking down barriers to patient access. |
None |
1300 |
1 |
1 |
None |
None |
None |
None |
All information submitted by Regeneron Pharmaceuticals, Inc. to the California Office of Statewide Health Planning and Development under Cal. Code. Regs. Tit. 22, § 96076, including all information contained in this submission, is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act. Regeneron requests that the confidentiality of this submission and of all Regeneron’s related information herein be maintained to the maximum extent permitted by law. To the extent that any of this designated information is requested, whether under the California Public Records Act or otherwise, Regeneron requests that it be notified of the request and afforded an opportunity to submit objections to disclosure. |
None |
| Regeneron Pharmaceuticals, Inc. |
61755001301 |
EVKEEZA (evinacumab-dgnb) 345 mg/2.3 mL (150mg/mL) |
2021-02-16 |
10781.2500 |
Marketing
Planned marketing activities that will support the approval of EVKEEZA™ (evinacumab-dgnb) include raising awareness about homozygous familial hypercholesterolemia (HoFH) and EVKEEZA among healthcare professionals through physician-focused product and disease education websites, other digital media, print media, and use of sales representatives to promote the FDA-approved indication. Anticipated direct-to-consumer marketing activities include a consumer-focused product website and other digital media.
Pricing
Regeneron approaches pricing with fairness, affordability and access at the forefront. Our pricing philosophy is guided by several principles.
First, medicines should be priced fairly. We take a value-based pricing approach that reflects their benefit to patients, society and the healthcare system. We consider the long-term investment and risk inherent in science and technology innovation, which is required to bring novel medicines to patients.
Second, medicines are only useful if patients in need can access and afford them. We are committed to supporting patients’ access by providing financial assistance for eligible patients.
Third, our growth is driven by scientific innovation, not pricing. Any price changes Regeneron makes is designed to keep pace with the medicine’s value and our costs, and in careful consideration of commercial competitiveness.
Regeneron also seeks to work collaboratively with other stakeholders in the healthcare system and welcome their input on fair and cost-effective pricing. These principles taken together help to ensure advancing our goal of setting fair, value-based prices for our medicines and breaking down barriers to patient access. |
None |
1300 |
1 |
1 |
None |
None |
None |
None |
All information submitted by Regeneron Pharmaceuticals, Inc. to the California Office of Statewide Health Planning and Development under Cal. Code. Regs. Tit. 22, § 96076, including all information contained in this submission, is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act. Regeneron requests that the confidentiality of this submission and of all Regeneron’s related information herein be maintained to the maximum extent permitted by law. To the extent that any of this designated information is requested, whether under the California Public Records Act or otherwise, Regeneron requests that it be notified of the request and afforded an opportunity to submit objections to disclosure. |
None |
| Rhythm Pharmaceuticals Inc. |
72829001001 |
Imcivree Injection 10 mg/ml |
2021-03-05 |
3300.0000 |
Marketing: Imcivree is the first and only FDA approved treatment for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency. Rhythm's approach will focus on educating health care providors on how to diagnose and treat patients efficently to relieve symptoms for patients. Educational materials will be provided across the patient journey, to both HCPs and to families, and highlight access and affordability support for Imcivree to ensure rapid access to life saving therapy
Pricing: Imcivree (Setmelanotide injection) has been developed for the treatment of obesity due to POMC, PCSK1 or LEPR deficiency are ultra-rare diseases caused by variants in POMC, PCSK1 or LEPR genes that impair the melanocortin-4 (MC4) receptor pathway. Imcivree provides an option where there is none currently and delivers a safe, effective treatment that reduces the symptoms in patients. Imcivree is priced responsibly compared to similar orphan agents with significant clinical benefit and disease modification. Pricing accounts for development costs, complexity of manufacturing, distribution, and storage. Rhythm demonstrates a strong commitment to patients and their ability to get access to care with support programs that leaves no patient behind. |
None |
200 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| 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 |
| Takeda Pharmaceuticals America, Inc. |
63020004012 |
EXKIVITY™ (mobocertinib) capsules |
2021-09-20 |
25000.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we do plan to market Exkivity in the US through print and digital media materials created to be used by sales representatives to share information on Exkivity with prescribers and through the use of print and digital materials made available to educate patients about Exkivity. We will also promote Exkivity to appropriate healthcare professionals, who treat individuals diagnosed with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon 20 insertion, a rare condition, through engagement at scientific meetings and conferences. Takeda considers a number of factors when deciding the price at which to set its prescription drugs, including, but not limited to: (i) the value medicine brings to patients and society; (ii) access to medicines; and (iii) providing a thoughtful approach that allows us to continue to deliver innovative medicines. Patients with epidermal growth factor receptor (EGFR) Exon20 insertion+ non-small cell lung cancer (NSCLC) make up approximately 1-2% of patients with NSCLC. This disease carries a worse prognosis than other EGFR mutations and has been historically underserved. Exkivity is a first-in-class, oral tyrosine kinase inhibitor (TKI) specifically designed to selectively target epidermal growth factor receptor (EGFR) Exon20 insertion mutations. In establishing WAC, Takeda also evaluated the access landscape for EGFR Exon20 insertion+ NSCLC patients, including the current treatment landscape and associated costs, likelihood of payor coverage, and options for patients without coverage. In addition, Takeda considered its ability to continue to fund the discovery of future oncology innovations and the resources needed to bring new therapies to market. |
None |
4000 |
1 |
1 |
None |
None |
None |
None |
The estimated number of patients in any given state in the United States (U.S.) with a condition for which EXKIVITY may be prescribed each month is not known but EGFR exon 20 disease makes up 1% to 2% of all NSCLC cases, or about 2,000 to 4,000 patients per year in the U.S. |
None |
| TARO PHARMACEUTICALS |
51672417406 |
Imiquimod Cream |
2021-02-09 |
1040.9300 |
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 |
2408 |
None |
None |
None |
None |
None |
None |
None |
None |
| Teva Pharmaceuticals USA |
51759020222 |
AJOVY® (fremanezumab-vfrm) Injection Autoinjector Triple Pack |
2021-01-19 |
1900.0800 |
None |
1 |
19000000 |
None |
None |
None |
None |
None |
None |
Estimated average of approximately 80,000 prescriptions per year, based on historic sales data, although research suggests that as many as 19 million Americans suffer from migraines, which this product is indicated to prevent.
Acquisition fields left blank; Teva developed this product. |
None |
| Teva Pharmaceuticals USA |
00591243315 |
ISOTRETINOIN CAPSULE 10MG 30 |
2021-04-30 |
763.5700 |
None |
1 |
7000000 |
None |
1 |
None |
None |
None |
None |
Estimated average of approximately 96,000 prescriptions per year (across all dosage strengths), based on historic IQVIA data, although research suggests that approximately 7,000,000 patients, age 12 and older, suffer from severe recalcitrant nodular acne, and thus are candidates to take this product. Acquisition fields left blank; Teva developed this product. |
None |
| Teva Pharmaceuticals USA |
00591243415 |
ISOTRETINOIN CAPSULE 20MG 30 |
2021-04-30 |
763.5700 |
None |
1 |
7000000 |
None |
1 |
None |
None |
None |
None |
Estimated average of approximately 96,000 prescriptions per year (across all dosage strengths), based on historic IQVIA data, although research suggests that approximately 7,000,000 patients, age 12 and older, suffer from severe recalcitrant nodular acne, and thus are candidates to take this product. Acquisition fields left blank; Teva developed this product. |
None |
| Teva Pharmaceuticals USA |
00591245115 |
ISOTRETINOIN CAPSULE 25MG 30 |
2021-04-30 |
821.5600 |
None |
1 |
7000000 |
None |
1 |
None |
None |
None |
None |
Estimated average of approximately 96,000 prescriptions per year (across all dosage strengths), based on historic IQVIA data, although research suggests that approximately 7,000,000 patients, age 12 and older, suffer from severe recalcitrant nodular acne, and thus are candidates to take this product. Acquisition fields left blank; Teva developed this product. |
None |
| Teva Pharmaceuticals USA |
00591243515 |
ISOTRETINOIN CAPSULE 30MG 30 |
2021-04-30 |
821.5600 |
None |
1 |
7000000 |
None |
1 |
None |
None |
None |
None |
Estimated average of approximately 96,000 prescriptions per year (across all dosage strengths), based on historic IQVIA data, although research suggests that approximately 7,000,000 patients, age 12 and older, suffer from severe recalcitrant nodular acne, and thus are candidates to take this product. Acquisition fields left blank; Teva developed this product. |
None |
| Teva Pharmaceuticals USA |
00591250115 |
ISOTRETINOIN CAPSULE 35MG 30 |
2021-04-30 |
821.5600 |
None |
1 |
7000000 |
None |
1 |
None |
None |
None |
None |
Estimated average of approximately 96,000 prescriptions per year (across all dosage strengths), based on historic IQVIA data, although research suggests that approximately 7,000,000 patients, age 12 and older, suffer from severe recalcitrant nodular acne, and thus are candidates to take this product. Acquisition fields left blank; Teva developed this product. |
None |
| Teva Pharmaceuticals USA |
00591243615 |
ISOTRETINOIN CAPSULE 40MG 30 |
2021-04-30 |
821.5600 |
None |
1 |
7000000 |
None |
1 |
None |
None |
None |
None |
Estimated average of approximately 96,000 prescriptions per year (across all dosage strengths), based on historic IQVIA data, although research suggests that approximately 7,000,000 patients, age 12 and older, suffer from severe recalcitrant nodular acne, and thus are candidates to take this product. Acquisition fields left blank; Teva developed this product. |
None |
| Teva Pharmaceuticals USA |
00093557201 |
ERYTHROMYCIN TABLETS 500MG 100 |
2021-05-04 |
997.1000 |
None |
1 |
66000000 |
None |
1 |
None |
None |
None |
None |
Estimated average of approximately 140,000 prescriptions per year, based on historic IQVIA data, although research suggests that approximately 66,000,000 patients per year are prescribed outpatient pharmacy antibiotics, and thus are candidates to take this product. Acquisition fields left blank; Teva developed this product. |
None |
| Teva Pharmaceuticals USA |
00093790901 |
TIOPRONIN ORAL TABLETS 100MG 100CT |
2021-05-17 |
2437.2700 |
None |
1 |
13200 |
None |
1 |
None |
None |
None |
None |
Research suggests that approximately 13,200 patients in the US suffer from severe homozygous cystinuria, and thus are candidates to take this product. Acquisition fields left blank; Teva developed this product. |
None |
| Teva Pharmaceuticals USA |
00093406106 |
FORMOTEROL FUMARATE INH SOL 10MCG/ML 60 |
2021-06-22 |
963.7900 |
None |
1 |
26500000 |
None |
None |
None |
None |
None |
None |
Estimated average of approximately 195,300 prescriptions per year, based on historic IQVIA data, although research suggests that approximately 26,500,000 US adults suffer from chronic obstructive pulmonary disease, and thus are candidates to take this product. Acquisition fields left blank; Teva developed this product. |
None |
| Teva Pharmaceuticals USA |
00591283201 |
BEXAROTENE 75MG SGL CAPSULES 100 |
2021-11-11 |
2835.7000 |
None |
1 |
1100 |
None |
None |
None |
None |
None |
None |
Estimated average of 700 prescriptions per month, based on historic IQVIA data. Research similarly suggests that there are approximately 1,100 patients in the US who suffer from cutaneous T-cell lymphoma and are being treated with bexarotene.
Acquisition fields left blank; Teva developed this product. |
None |
| Teva Pharmaceuticals USA |
00093766256 |
ERLOTINIB HCL TABLETS EQ 25MG 30 |
2021-12-08 |
1673.6800 |
None |
1 |
32000 |
None |
None |
None |
None |
None |
None |
Estimated average of up to 119 prescriptions per month, based on historic IQVIA data, although research suggests that there are as many as 32,000 patients in the US whose conditions match the product’s approved indications and, thus, are candidates to take the product. Acquisition fields left blank; Teva developed this product. |
None |
| Teva Pharmaceuticals USA |
00480372001 |
PYRIMETHAMINE TABLETS 25MG 100 |
2021-12-15 |
25650.0000 |
None |
1 |
2000 |
None |
1 |
None |
None |
None |
None |
Estimated average of roughly 100 prescriptions per month, based on historic IQVIA data, although research suggests that as many as 2,000 Americans take the product annually. Acquisition fields left blank; Teva developed this product. |
None |
| Teva Pharmaceuticals USA |
00480372056 |
PYRIMETHAMINE TABLETS 25MG 30 |
2021-12-15 |
7695.0000 |
None |
1 |
2000 |
None |
1 |
None |
None |
None |
None |
Estimated average of roughly 100 prescriptions per month, based on historic IQVIA data, although research suggests that as many as 2,000 Americans take the product annually. Acquisition fields left blank; Teva developed this product. |
None |
| Teva Pharmaceuticals USA |
00093819928 |
SUNITINIB MALATE CAPSULES 12.5MG 28 |
2021-12-22 |
4889.0700 |
None |
1 |
2800 |
None |
1 |
None |
None |
None |
None |
Estimated average of up to 1,057 prescriptions per month (across all dosage strengths), based on historic IQVIA data, although research suggests that as many as 2,800 Americans take the product annually. Acquisition fields left blank; Teva developed this product. |
None |
| Teva Pharmaceuticals USA |
00093822428 |
SUNITINIB MALATE CAPSULES 25MG 28 |
2021-12-22 |
9778.1600 |
None |
1 |
2800 |
None |
1 |
None |
None |
None |
None |
Estimated average of up to 1,057 prescriptions per month (across all dosage strengths), based on historic IQVIA data, although research suggests that as many as 2,800 Americans take the product annually. Acquisition fields left blank; Teva developed this product. |
None |
| Teva Pharmaceuticals USA |
00093822928 |
SUNITINIB MALATE CAPSULES 37.5MG 28 |
2021-12-22 |
14667.2500 |
None |
1 |
2800 |
None |
1 |
None |
None |
None |
None |
Estimated average of up to 1,057 prescriptions per month (across all dosage strengths), based on historic IQVIA data, although research suggests that as many as 2,800 Americans take the product annually. Acquisition fields left blank; Teva developed this product. |
None |
| Teva Pharmaceuticals USA |
00093823128 |
SUNITINIB MALATE CAPSULES 50MG 28 |
2021-12-22 |
17022.4000 |
None |
1 |
2800 |
None |
1 |
None |
None |
None |
None |
Estimated average of up to 1,057 prescriptions per month (across all dosage strengths), based on historic IQVIA data, although research suggests that as many as 2,800 Americans take the product annually. Acquisition fields left blank; Teva developed this product. |
None |
| TG Therapeutics, Inc. |
73150020012 |
UKONIQ (umbralisib) 200 mg tablets, 120 count bottle |
2021-02-05 |
15900.0000 |
Marketing Plan:
UKONIQ™ was approved on 2/5/2021 as a kinase inhibitor indicated for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen and relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy. TG has designed marketing activities to raise awareness and understanding with healthcare providers and - in some cases - patients about the approved indications, efficacy and safety data contained within UKONIQ’s FDA approved label.
• UKONIQ will not have any DTC advertisements on any platforms at launch. We will, however, have a patient-facing website that provides information about UKONIQ, the diseases it is approved to treat, and the TG Patient Support Program.
• At launch TG will not offer coupons or free trials. However, at launch TG will offer copayment assistance to commercially insured patients through the TG Patient Support Program. Information about the TG Patient Support Program, including the commercial co-pay program, will be provided to healthcare providers (“HCPs”) by our sales representatives and via an HCP website, and to patients via a patient-facing website.
Pricing Plan:
TG Therapeutics was founded with one broad mission: to develop novel and valuable treatment options for patients with B-cell diseases. Our commitment to patients, however, goes beyond science. We believe that access is essential in ensuring advances are available to patients who are in need of treatment options. Ahead of our first commercial launch, we created a unique approach to our decision-making around access and pricing anchored on the clinical value of our products and guided by three core pillars: fiercely focused on patients, access and solutions. These guiding principles are inspired by our mission, shaped our pricing decision for UKONIQ and will continue to shine through in our commitment to patients. Further information about our commitment to patient access can be found here: https://www.tgtherapeutics.com/wp-content/uploads/2021/02/Our-Commitment-to-Patient-Access.pdf |
None |
10000 |
1 |
1 |
2012-08-16 |
None |
1 |
The price TG Therapeutics paid for acquisition of the rights to develop and commercialize UKONIQ™ is not shared publicly, and TG Therapeutics has taken reasonable measures to keep this information confidential. Access to the information is limited to certain individuals within the company’s management team and finance functions. The information is subject to non-disclosure requirements in employment agreements. Accordingly, TG Therapeutics is limiting its response to this item pursuant to California Health & Safety Code § 127681(c). |
Comment regarding number of Estimated Patients field: Each year there are approximately 18,000-20,000 patients in the US who are in need of a new treatment for their relapsed disease in both Marginal zone lymphoma (MZL) and Follicular lymphoma (FL). Although difficult to estimate precisely, we believe there are ~8,000-10,000 patients within our FDA labelled indications. |
None |
| Upsher-Smith Laboratories, LLC |
00245057501 |
Isotretinoin Capsules 40 mg |
2021-06-25 |
821.5600 |
Isotretinoin is a generic medication. Upsher-Smith Laboratories, LLC intends to provide the product at a competitive price based off the current market landscape today. |
None |
1800000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Upsher-Smith Laboratories, LLC |
00245057001 |
Isotretinoin Capsules 10 mg |
2021-09-22 |
763.5700 |
Isotretinoin is a generic medication. Upsher-Smith Laboratories, LLC intends to provide the product at a competitive price based off the current market landscape today. |
None |
1800000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Upsher-Smith Laboratories, LLC |
00245057101 |
Isotretinoin Capsules 20 mg |
2021-09-22 |
763.5700 |
Isotretinoin is a generic medication. Upsher-Smith Laboratories, LLC intends to provide the product at a competitive price based off the current market landscape today. |
None |
1800000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Vanda Pharmaceuticals Inc. |
43068030406 |
Hetlioz LQ 158 mL 4mg/ mL |
2021-03-08 |
21205.5900 |
None |
1 |
15000 |
None |
1 |
None |
None |
None |
None |
SMS is estimated to affect 1/15,000-25,000 births in the U.S. (https://www.orpha.net/consor/cgi-bin/OC_Exp.php?Lng=GB&Expert=819) |
None |
| Vanda Pharmaceuticals Inc. |
43068030402 |
Hetlioz LQ 48 mL 4mg/ mL |
2021-03-08 |
6442.2000 |
None |
1 |
15000 |
None |
1 |
None |
None |
None |
None |
SMS is estimated to affect 1/15,000-25,000 births in the U.S. (https://www.orpha.net/consor/cgi-bin/OC_Exp.php?Lng=GB&Expert=819) |
None |
| Vgyaan Pharmaceuticals LLC |
72664061128 |
LEUPROLIDE ACETATE, 1MG/0.2ML, 2.8ML Vial |
2021-12-01 |
712.8000 |
None |
1 |
100000 |
None |
1 |
None |
None |
None |
None |
None |
None |
| ViiV Healthcare |
49702025315 |
CABENUVA (cabotegravir 400 mg/2mL; rilpivirine 600 mg/2mL) |
2021-02-01 |
3960.0000 |
None |
1 |
609000 |
None |
1 |
None |
None |
None |
None |
Regarding Marketing/Pricing Plan Description, ViiV has not released CABENUVA's marketing or pricing plan information in the public domain and is limiting its response to that which is publicly available pursuant to California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c).
The 609,000 patient figure does not reflect the number of patients that are estimated to be treated with Cabenuva; rather, it represents the estimated number of virologically- suppressed adults (18+) in the US living with diagnosed HIV-1 infection, based on the CDC Selected National HIV Prevention and Care Outcomes, July 2019. To be eligible for Cabenuva according to the indication, in addition to being virologically suppressed, the patient must be on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to cabotegravir or rilpivirine, however since there are no known estimates for these parameters, the estimated number of patients provided does not reflect any assumptions regarding these clinical requirements, nor does it take into consideration a projection for the number of patients willing to switch to an injectable formulation. CABENUVA is indicated as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. CABENUVA consists of long-acting cabotegravir, an integrase strand transfer inhibitor (INSTI), and long-acting rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI), which allows for 2 separate once-monthly provider administered injections. This is the first FDA-approved long-acting complete regimen for HIV-infected adults administered by providers once a month.
CABENUVA was granted priority review by the Food And Drug Administration.
Note on Acquisition Fields: CABENUVA was developed by ViiV Healthcare, therefore the following fields related to drug acquisition have been left blank: ACQUISITION_DATE, ACQUISITION_PRICE, ACQUISITION_PRICE_NONPUBLIC, ACQUISITION_PRICE_COMMENT. |
None |
| ViiV Healthcare |
49702024015 |
CABENUVA (cabotegravir 600 mg/3mL; rilpivirine 900 mg/3mL) |
2021-02-01 |
5940.0000 |
None |
1 |
609000 |
None |
1 |
None |
None |
None |
None |
Regarding Marketing/Pricing Plan Description, ViiV has not released CABENUVA's marketing or pricing plan information in the public domain and is limiting its response to that which is publicly available pursuant to California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c).
The 609,000 patient figure does not reflect the number of patients that are estimated to be treated with Cabenuva; rather, it represents the estimated number of virologically- suppressed adults (18+) in the US living with diagnosed HIV-1 infection, based on the CDC Selected National HIV Prevention and Care Outcomes, July 2019. To be eligible for Cabenuva according to the indication, in addition to being virologically suppressed, the patient must be on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to cabotegravir or rilpivirine, however since there are no known estimates for these parameters, the estimated number of patients provided does not reflect any assumptions regarding these clinical requirements, nor does it take into consideration a projection for the number of patients willing to switch to an injectable formulation. CABENUVA is indicated as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. CABENUVA consists of long-acting cabotegravir, an integrase strand transfer inhibitor (INSTI), and long-acting rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI), which allows for 2 separate once-monthly provider administered injections. This is the first FDA-approved long-acting complete regimen for HIV-infected adults administered by providers once a month.
CABENUVA was granted priority review by the Food And Drug Administration.
Note on Acquisition Fields: CABENUVA was developed by ViiV Healthcare, therefore the following fields related to drug acquisition have been left blank: ACQUISITION_DATE, ACQUISITION_PRICE, ACQUISITION_PRICE_NONPUBLIC, ACQUISITION_PRICE_COMMENT. |
None |
| VistaPharm Inc |
66689011010 |
Lacosamide Oral Solution 20mL x 10 UDC |
2021-11-15 |
740.0000 |
None |
1 |
18000 |
None |
None |
None |
None |
None |
None |
This drug was not acquired from the approval owner. UCB is still the owner of the approval. |
None |
| Woodward Pharma Services LLC |
69784024010 |
Carboprost Tromethamine Intramuscular Solution 250 MCG/ML |
2021-06-01 |
3189.9000 |
None |
1 |
5000 |
None |
None |
None |
None |
None |
None |
Product was not acquired therefore product acquisition cost is not N/A |
None |
| Woodward Pharma Services LLC |
69784081001 |
Sodium Phenylacetate and Sodium Benzoate Injection 10%/10%, 50mL, 1 ct |
2021-06-18 |
5000.0000 |
None |
1 |
3000 |
None |
None |
None |
None |
None |
None |
Product was not acquired therefore product acquisition cost is not N/A |
None |
| Y-mAbs Therapeutics Inc. |
73042020101 |
Danyelza Injection, 40mg/10mg, single use vial |
2021-02-01 |
20368.0000 |
Y-mAbs' pricing decisions regarding the introductory WAC was determined after very thoughtful and careful consideration of a number of interdependent factors.
These factors include but are not limited to the following:
1. The clinical and economic value of the drug;
2. Market dynamics and competitive pricing and total cost of care within the drug's therapeutic category;
3. Discounts provided to customers for commercial and government channels;
4. Cost of comprehensive patient support programs to ensure patient access; and
5. Overall research and development costs & reinvestment into future R&D
Y-mAbs will use (digital and print) promotion that focuses on raising awareness of Danyelza as well as the deployment of a national sales force. |
None |
700 |
1 |
1 |
None |
None |
None |
None |
Y-mAbs has left the fields regarding acquisition blank because Danyelza was not acquired, but was developed by Y-mAbs. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
70710153406 |
Cisatracurium Besylate 200mg/20mL Solution for Injection |
2021-01-15 |
2670.0000 |
None |
1 |
1 |
None |
None |
None |
None |
None |
None |
This is an AP rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has put a “1” in the “Estimated Number of Patients” column for the following reasons:
• Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat.
• We do not estimate the number of patients that may be prescribed our products neither by state or nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients.
• Cisatracurium Besylate Injection has multiple indications as listed in the Indications and Usage section in our Prescribing Information (as of January 22, 2021). Zydus neither collects nor uses estimated patient information in our normal course of business. We do not believe there is any publicly available data that accurately represents the estimated number of patients for all indications and we do not want to misrepresent the information in any way. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
70710139009 |
Droxidopa 200mg Capsules (90 Count) |
2021-02-19 |
1226.0500 |
None |
1 |
1 |
None |
None |
None |
None |
None |
None |
This is an AB rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has put a “1” in the “Estimated Number of Patients” column for the following reasons: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state or nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. We do not believe there is any publicly available data that accurately represents the estimated number of patients for all indications and we do not want to misrepresent the information in any way. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
70710139109 |
Droxidopa 300mg Capsules (90 Count) |
2021-02-19 |
1839.0800 |
None |
1 |
1 |
None |
None |
None |
None |
None |
None |
This is an AB rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has put a “1” in the “Estimated Number of Patients” column for the following reasons: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state or nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. We do not believe there is any publicly available data that accurately represents the estimated number of patients for all indications and we do not want to misrepresent the information in any way. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
68382012001 |
Azathioprine 100mg Tablets (100) |
2021-10-14 |
738.7600 |
None |
1 |
1 |
None |
None |
None |
None |
None |
None |
This is an AB rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has put a “1” in the “Estimated Number of Patients” column for the following reasons: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state or nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. We do not believe there is any publicly available data that accurately represents the estimated number of patients for all indications and we do not want to misrepresent the information in any way. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
68382011901 |
Azathioprine 75mg Tablets (100) |
2021-10-14 |
1657.0500 |
None |
1 |
1 |
None |
None |
None |
None |
None |
None |
This is an AB rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has put a “1” in the “Estimated Number of Patients” column for the following reasons: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state or nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. We do not believe there is any publicly available data that accurately represents the estimated number of patients for all indications and we do not want to misrepresent the information in any way. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
70710149105 |
Fluphenazine HCl 10mg Tablets (500) |
2021-10-26 |
1826.8000 |
None |
1 |
1 |
None |
None |
None |
None |
None |
None |
This is an AB rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has put a “1” in the “Estimated Number of Patients” column for the following reasons: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state or nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. We do not believe there is any publicly available data that accurately represents the estimated number of patients for all indications and we do not want to misrepresent the information in any way. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
70710149005 |
Fluphenazine HCl 5mg Tablets (500) |
2021-10-26 |
1448.9000 |
None |
1 |
1 |
None |
None |
None |
None |
None |
None |
This is an AB rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has put a “1” in the “Estimated Number of Patients” column for the following reasons: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state or nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. We do not believe there is any publicly available data that accurately represents the estimated number of patients for all indications and we do not want to misrepresent the information in any way. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
70710172608 |
Nelarabine Inj 250mg/50mL (6X5mL) |
2021-11-19 |
3966.0000 |
None |
1 |
186400 |
None |
None |
None |
None |
None |
None |
This is an AP rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has put a “186400” in the “Estimated Number of Patients” column. Approximately 1,519,907 people in the United States are living with or in remission from leukemia, lymphoma, myeloma, myelodysplastic syndromes (MDS) or myeloproliferative neoplasms (MPNs) and it is estimated that 186,400 people in the US will be diagnosed with leukemia, lymphoma or myeloma in 2021. *Information is from the Leukemia and Lymphoma Society website (https://www.lls.org/facts-and-statistics/facts-and-statistics-overview as of 11/30/2021
Zydus does not estimate the number of patients that may be prescribed our products neither by state or nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. Zydus neither collects nor uses estimated patient information in our normal course of business. |
None |
| Zydus Pharmaceuticals (USA) Inc. |
70710101403 |
Phytonadione (Vitamin K) 5mg Tablet 30 Count |
2021-12-13 |
1125.3700 |
None |
1 |
334 |
None |
None |
None |
None |
None |
None |
This is an AB rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has put a “334” in the “Estimated Number of Patients” column for the following reasons: (1). Zydus’ role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state or nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4). Phytonadione is indicated for the treatment of adults with coagulation disorders (hypoprothrombinemia). As per the Medscape article dated June 16, 2021, both acquired and inherited hypoprothrombinemia are exceedingly rare in the United States. Hypoprothrombinemia due to vitamin K deficiency is rarely seen since vitamin K injections are routinely given in the neonatal period. Per the Pubmed.gov (https://pubmed.ncbi.nlm.nih.gov/19141155/) online article dated November 14, 2008, Prothrombin (factor II) deficiency is a rare autosomal recessive coagulation disorder that occurs in approximately 1 in 1-2 million people. Zydus took this information by the estimated number of people in the USA as of December 20, 2021 (per https://www.worldometers.info/world-population/us-population/) and came up with our estimated patients number. |
None |