| 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 |