| Padagis US LLC |
00574016712 |
Diclofenac Sodium Topical Solution 2% w/w 3.8 FL. OZ (112 grams) |
2022-11-22 |
1616.8200 |
Product is be priced to deliver value to the market as compared to the Brand referenced drug. |
None |
32500000 |
None |
None |
None |
None |
None |
None |
Diclofenac 2% Topical Solution is indicated for treatment of the pain of osteoarthritis of the knee. According to the CDC, osteoarthritis affects 32.5 million US Adults.
As a generic manufacturer, Padagis does not have information available to accurately determinate the number of patients that could potentially have a condition for which the drug may be prescribed. Padagis neither collects nor uses estimated patient information and does not believe there is publicly available data that accurately represents the number of patients for all indications.
Based on IQVIA NPA data available to Padagis, Padagis estimates that approximately 268,000 prescriptions were filled for the product in the past 12 months, but number of prescriptions filled should not be misinterpreted as an accurate estimate of the number of patients with a condition for which the new drug may be prescribed, as dosage and therapy may vary across individual patients. |
None |
| Par Pharmaceutical |
49884004233 |
Glycopyrrolate Oral Solution 1 mg/5 mL (0.2 mg/mL) |
2022-01-04 |
399.6000 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions.
(1) Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Moreover, Par notes that because this product will compete in an established space, Par did not consider, nor did it identify, the estimated patient population in determining market need for the product.
Accordingly, Par is unable to provide an estimate of the average number of patients who may be treated by this product beyond publicly available data.
Par notes that this product is indicated to reduce chronic severe drooling in patients aged 3 to 16 years with neurologic conditions associated with problem drooling (e.g., cerebral palsy).
The forum on Child and Family Statistics estimates as of 2022 there are approximately 74.3 million children in the United States ( https://www.childstats.gov/americaschildren/tables/pop1.asp).
The Centers for Disease Control state that 1 in 345 children have been identified with Cerebral Palsy. (https://www.cdc.gov/ncbddd/cp/features/cerebral-palsy-11-things.html ).
The National Institutes of Health reported in 2016 between 10% and 58% of children with Cerebral Palsy have excess drooling, with estimates that 10% of children with excessive drooling have embarrassing drooling (
https://pubmed.ncbi.nlm.nih.gov/27281791/ , https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2827743/ ).
Par has not independently verified this information.
Further, Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to accurately provide an estimate of the average number of patients that will be prescribed this product each month.
Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s product because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states:
“Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at:
https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market.
Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank.
2. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank.
3. Par did not acquire this product. As a result, Par has left the acquisition related data fields blank. |
None |
| Par Pharmaceutical |
49884028302 |
Everolimus Tablets 1mg 60s |
2022-01-25 |
1780.4500 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
1. Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Moreover, Par notes that because this product will compete in an established space, Par did not consider, nor did it identify, the estimated patient population in determining market need for the product.
Accordingly, Par is unable to provide an estimate of the average number of patients who may be treated by this product beyond publicly available data.
Par notes this product indicated for the prophylaxis of organ rejection in adult patients who have had kidney or liver transplants.
The Centers for Disease Control and Prevention (“CDC”) states that 20,167 patients had a kidney transplant in the United States in 2017. ( https://nccd.cdc.gov/ckd/detail.aspx?Qnum=Q234 )
The National Institutes of Health (“NIH”) states that about 7,100 liver transplants were performed in the United States in 2015. ( https://www.niddk.nih.gov/health-information/liver-disease/liver-transplant/definition-facts )
Par has not independently verified this information.
Further, Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to accurately provide an estimate of the average number of patients that will be prescribed this product each month.
Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s product because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states:
“Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at:
https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market.
Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank.
2. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank.
3. Par did not acquire this product. As a result, Par has left the acquisition related data fields blank. |
None |
| Par Pharmaceutical |
42023023710 |
Vasostrict (Vasopressin Inj., USP) 10 units/100mL (0.2 units/mL) |
2022-02-03 |
2123.7700 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
1) The information contained in this report is subject to the following limitations and assumptions.
Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. However, Par notes that this product is indicated to increase blood pressure in adults with vasodilatory shock (e.g., post-cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines.
Par has not been able to identify an estimate of the average number of patients in the U.S. who may experience vasodilatory shock. Additionally Vasostrict is indicated as a secondary treatment for vasodilatory shock for patients who remain hypotensive despite fluids and catecholamines. Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to accurately provide an estimate of the average number of patients that will be prescribed this product each month.
Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s product because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states:
“Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at:
https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market.
Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank.
2. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank.
3. Par did not acquire this product. As a result, Par has left the acquisition related data fields blank. |
None |
| Par Pharmaceutical |
42023021910 |
Vasostrict (Vasopressin Inj., USP) 40 units/100mL (0.4 units/mL) |
2022-02-03 |
4247.5400 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
1) The information contained in this report is subject to the following limitations and assumptions.
Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. However, Par notes that this product is indicated to increase blood pressure in adults with vasodilatory shock (e.g., post-cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines.
Par has not been able to identify an estimate of the average number of patients in the U.S. who may experience vasodilatory shock. Additionally Vasostrict is indicated as a secondary treatment for vasodilatory shock for patients who remain hypotensive despite fluids and catecholamines. Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to accurately provide an estimate of the average number of patients that will be prescribed this product each month.
Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s product because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states:
“Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at:
https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market.
Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank.
2. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank.
3. Par did not acquire this product. As a result, Par has left the acquisition related data fields blank. |
None |
| Par Pharmaceutical |
49884076854 |
Tolvaptan Tablets 15mg 10s |
2022-03-10 |
3302.0400 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions.
(1) Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Moreover, Par notes that because this product will compete in an established space, Par did not consider, nor did it identify, the estimated patient population in determining market need for the product.
Accordingly, Par is unable to provide an estimate of the average number of patients who may be treated by this product beyond publicly available data.
Par notes this product indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia.
The National Center for Biotechnology Information (“NCBI”) states that hyponatremia has a 20 to 35% prevalence in hospitalized patients. ( https://www.ncbi.nlm.nih.gov/books/NBK470386/#_article-23274_s4_ )
Par has not independently verified this information.
Further, Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to accurately provide an estimate of the average number of patients that will be prescribed this product each month.
Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s product because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states:
“Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at:
https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market.
Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank.
2. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank.
3. Par did not acquire this product. As a result, Par has left the acquisition related data fields blank. |
None |
| Par Pharmaceutical |
49884077054 |
Tolvaptan Tablets 30mg 10s |
2022-03-10 |
3496.5000 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions.
(1) Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Moreover, Par notes that because this product will compete in an established space, Par did not consider, nor did it identify, the estimated patient population in determining market need for the product.
Accordingly, Par is unable to provide an estimate of the average number of patients who may be treated by this product beyond publicly available data.
Par notes this product indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia.
The National Center for Biotechnology Information (“NCBI”) states that hyponatremia has a 20 to 35% prevalence in hospitalized patients. ( https://www.ncbi.nlm.nih.gov/books/NBK470386/#_article-23274_s4_ )
Par has not independently verified this information.
Further, Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to accurately provide an estimate of the average number of patients that will be prescribed this product each month.
Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s product because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states:
“Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at:
https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market.
Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank.
2. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank.
3. Par did not acquire this product. As a result, Par has left the acquisition related data fields blank. |
None |
| Par Pharmaceutical |
49884012891 |
Everolimus Tablets 10mg 28s |
2022-11-29 |
1272.1700 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions.
1. Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Moreover, Par notes that because this product will compete in an established space, Par did not consider, nor did it identify, the estimated patient population in determining market need for the product.
Par notes this product indicated for the treatment of numerous diseases including Hormone Receptor-Positive, HER2-Negative Breast Cancer, Neuroendocrine Tumors (NET), Renal Cell Carcinoma (RCC), Tuberous Sclerosis Complex (TSC)-Associated Renal Angiomyolipoma, and Tuberous Sclerosis Complex (TSC)-Associated Subependymal Giant Cell Astrocytoma (SEGA).
Because of the product’s widespread indications, and because
Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to accurately provide an estimate of the average number of patients that will be prescribed this product each month.
Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s product because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states:
“Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at:
https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market.
Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank.
2. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank.
3. Par did not acquire this product. As a result, Par has left the acquisition related data fields blank. |
None |
| Par Pharmaceutical |
49884016002 |
Everolimus Tablets 0.75mg 60s |
2022-12-13 |
1335.3400 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions.
(1) Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Moreover, Par notes that because this product will compete in an established space, Par did not consider, nor did it identify, the estimated patient population in determining market need for the product.
Accordingly, Par is unable to provide an estimate of the average number of patients who may be treated by this product beyond publicly available data.
Par notes this product indicated for the prophylaxis of organ rejection in adult patients who have had kidney or liver transplants.
The Centers for Disease Control and Prevention (“CDC”) states that 20,167 patients had a kidney transplant in the United States in 2017. ( https://nccd.cdc.gov/ckd/detail.aspx?Qnum=Q234 )
The National Institutes of Health (“NIH”) states that about 7,100 liver transplants were performed in the United States in 2015. ( https://www.niddk.nih.gov/health-information/liver-disease/liver-transplant/definition-facts )
Par has not independently verified this information.
Further, Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to accurately provide an estimate of the average number of patients that will be prescribed this product each month.
Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s product because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states:
“Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at:
https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market.
Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank.
2. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank.
3. Par did not acquire this product. As a result, Par has left the acquisition related data fields blank. |
None |
| Pfizer |
00409082901 |
AZTREONAM 1gm SFDPO 1x10 VL US |
2022-01-24 |
330.0000 |
None |
1 |
21528 |
None |
None |
None |
None |
None |
None |
Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pfizer estimates that in total, approximately 21,528 patients across the United States, could potentially receive aztreonam. Comment regarding Fields 10-13: Aztreonam was not acquired; therefore, Columns 10 – 13 are intentionally left blank. |
None |
| Pfizer |
00409083001 |
AZTREONAM 2gm SFDPO 1x10 VL US |
2022-01-24 |
650.0000 |
None |
1 |
21528 |
None |
None |
None |
None |
None |
None |
Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pfizer estimates that in total, approximately 21,528 patients across the United States, could potentially receive aztreonam. Comment regarding Fields 10-13: Aztreonam was not acquired; therefore, Columns 10 – 13 are intentionally left blank. |
None |
| Pfizer |
00069150130 |
TALZENNA (Talazoparib) 0.5MG CAP 1X30 40CC BTL US |
2022-01-31 |
16231.7600 |
None |
1 |
3500 |
None |
1 |
2016-09-28 |
14300000000.0000 |
None |
On September 28, 2016, Pfizer Inc. acquired Medivation for approximately $14.3 billion in cash ($13.9 billion, net of cash acquired). |
Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pfizer estimates that in total, approximately 3500 patients in the U.S. could potentially receive a TALZENNA prescription. (Total pool of gBRCA-mutated metastatic breast cancer patients tested and eligible for treatment with a PARP inhibitor) |
None |
| Pfizer |
00069175130 |
TALZENNA (Talazoparib) 0.75MG CAP 1X30 40CC BTL US |
2022-01-31 |
16231.7600 |
None |
1 |
3500 |
None |
1 |
2016-09-28 |
14300000000.0000 |
None |
On September 28, 2016, Pfizer Inc. acquired Medivation for approximately $14.3 billion in cash ($13.9 billion, net of cash acquired). |
Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pfizer estimates that in total, approximately 3500 patients in the U.S. could potentially receive a TALZENNA prescription. (Total pool of gBRCA-mutated metastatic breast cancer patients tested and eligible for treatment with a PARP inhibitor) |
None |
| Pfizer |
00069033530 |
CIBINQO 100mg TAB 1x30 BTL US |
2022-02-08 |
4914.0000 |
None |
1 |
1200000 |
1 |
1 |
None |
None |
None |
None |
Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pfizer estimates that there are approximately 1.2M patients in the United States that could potentially receive CIBINQO® for the treatment of moderate-to-severe atopic dermatitis. Comment regarding Fields 10-13: CIBINQO® was not acquired; therefore, Columns 10 – 13 are intentionally left blank. |
None |
| Pfizer |
00069043530 |
CIBINQO 200mg TAB 1x30 BTL US |
2022-02-08 |
4914.0000 |
None |
1 |
1200000 |
1 |
1 |
None |
None |
None |
None |
Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pfizer estimates that there are approximately 1.2M patients in the United States that could potentially receive CIBINQO® for the treatment of moderate-to-severe atopic dermatitis. Comment regarding Fields 10-13: CIBINQO® was not acquired; therefore, Columns 10 – 13 are intentionally left blank. |
None |
| Pfizer |
00069023530 |
CIBINQO 50mg TAB 1x30 BTL US |
2022-02-08 |
4914.0000 |
None |
1 |
1200000 |
1 |
1 |
None |
None |
None |
None |
Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pfizer estimates that there are approximately 1.2M patients in the United States that could potentially receive CIBINQO® for the treatment of moderate-to-severe atopic dermatitis. Comment regarding Fields 10-13: CIBINQO® was not acquired; therefore, Columns 10 – 13 are intentionally left blank. |
None |
| Pfizer |
00409170401 |
BORTEZOMIB 1mg SFDPO 1x1 VL US |
2022-05-16 |
81.1700 |
None |
1 |
481000 |
None |
None |
None |
None |
None |
None |
Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pfizer estimates that in total, approximately 481,000 patients across the United States, could potentially receive bortezomib. Comment regarding Fields 10-13: Bortezomib was not acquired; therefore, Columns 10 – 13 are intentionally left blank. |
None |
| Pfizer |
00409170301 |
BORTEZOMIB 2.5mg SFDPO 1x1 VL US |
2022-05-16 |
192.0100 |
None |
1 |
481000 |
None |
None |
None |
None |
None |
None |
Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pfizer estimates that in total, approximately 481,000 patients across the United States, could potentially receive bortezomib. Comment regarding Fields 10-13: Bortezomib was not acquired; therefore, Columns 10 – 13 are intentionally left blank. |
None |
| Pfizer |
00409106001 |
PEMETREXED 100mg SPO 1x1 VL |
2022-06-21 |
110.0000 |
None |
1 |
130000 |
None |
None |
None |
None |
None |
None |
Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pemetrexed is a secondary treatment for locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer. Pfizer estimates that in total, approximately 130,000 patients across the United States, could potentially receive pemetrexed. Comment regarding Fields 10-13: Pemetrexed was not acquired; therefore, Columns 10 – 13 are intentionally left blank. |
None |
| Pfizer |
00409106101 |
PEMETREXED 500mg SPO 1x1 VL |
2022-06-21 |
497.8400 |
None |
1 |
130000 |
None |
None |
None |
None |
None |
None |
Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pemetrexed is a secondary treatment for locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer. Pfizer estimates that in total, approximately 130,000 patients across the United States, could potentially receive pemetrexed. Comment regarding Fields 10-13: Pemetrexed was not acquired; therefore, Columns 10 – 13 are intentionally left blank. |
None |
| Pfizer |
00409104501 |
PEMETREXED 100mg/4ml SLIQ 1x1 FTGVIAL US |
2022-06-27 |
110.0000 |
None |
1 |
130000 |
None |
None |
None |
None |
None |
None |
Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pemetrexed is a secondary treatment for locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer. Pfizer estimates that in total, approximately 130,000 patients across the United States, could potentially receive pemetrexed. Comment regarding Fields 10-13: Pemetrexed was not acquired; therefore, Columns 10 – 13 are intentionally left blank. |
None |
| Pfizer |
00409353201 |
PEMETREXED 1gm/40ml SLIQ 1x1 FTGVIAL US |
2022-06-27 |
900.0000 |
None |
1 |
130000 |
None |
None |
None |
None |
None |
None |
Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pemetrexed is a secondary treatment for locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer. Pfizer estimates that in total, approximately 130,000 patients across the United States, could potentially receive pemetrexed. Comment regarding Fields 10-13: Pemetrexed was not acquired; therefore, Columns 10 – 13 are intentionally left blank. |
None |
| Pfizer |
00409218801 |
PEMETREXED 500mg/20ml SLIQ 1x1 FTGVIAL US |
2022-06-27 |
497.8400 |
None |
1 |
130000 |
None |
None |
None |
None |
None |
None |
Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pemetrexed is a secondary treatment for locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer. Pfizer estimates that in total, approximately 130,000 patients across the United States, could potentially receive pemetrexed. Comment regarding Fields 10-13: Pemetrexed was not acquired; therefore, Columns 10 – 13 are intentionally left blank. |
None |
| Pfizer |
00409170001 |
BORTEZOMIB 3.5mg SFDPO 1x1 VL US |
2022-07-27 |
250.0000 |
None |
1 |
481000 |
None |
None |
None |
None |
None |
None |
Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pfizer estimates that in total, approximately 481,000 patients across the United States, could potentially receive bortezomib. Comment regarding Fields 10-13: Bortezomib was not acquired; therefore, Columns 10 – 13 are intentionally left blank. |
None |
| Pfizer |
00069025310 |
FRAGMIN 2500IU SSOL 10x4ml GVL US |
2022-10-17 |
279.6000 |
None |
1 |
3 |
None |
None |
None |
None |
None |
None |
Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pfizer is the sole market manufacture for Fragmin®. Since a pediatric dosing has never been available before, we cannot confirm usage. The pediatric formulation launch was developed at the request from the FDA for pediatric dosing. Therefore, Pfizer estimates the number of patients to range from 0-3 annually. Comment regarding Fields 10-13: Fragmin was not acquired; therefore, Columns 10 – 13 are intentionally left blank. |
None |
| Pharmaceutical Associates, Inc |
00121097400 |
SUCRALFATE ORAL SUSPENSION - 1g/10mL - 10mL - 100/cs |
2022-09-15 |
899.7000 |
PAI will utilize its sales team to market this product to customers across the country. PAI will offer market competitive pricing to retail chains, independent pharmacies, hospitals, long-term care facilities and government agencies in order to provide value for our customers |
None |
15000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Pharmacyclics an AbbVie Company |
57962000712 |
Imbruvica® (ibrutinib) Oral Suspension 70mg/mL |
2022-09-12 |
9614.6300 |
None |
1 |
20 |
None |
None |
None |
None |
None |
None |
Pharmacyclcis is providing information for pediatrics only as there is very limited market intelligence available as to whether the suspension will be utilized by adults with trouble swallowing pills, or only pediatric patients as studied in the clinical setting. The pediatric market only of 15-20 patients annually. |
None |
| Piramal Critical Care |
66794023942 |
Zinc Sulfate injection 25mg/5mL 1 box of 25 vials |
2022-06-27 |
950.0000 |
Piramal considers multiple factors when setting a list price for a medicine, including: benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. Market and business considerations, including: Ongoing research-investment costs, Medical- and patient-service costs (which may or may not include patient assistance programs and capital-investment costs associated with manufacturing, storage and supply)
Piramal'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 Zinc Sulfate. |
None |
303036 |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Piramal is limiting its response to that which is otherwise in the public domain or publicly available. As a manufacturer, Piramal does not estimate the number of patients that may be prescribed our products. We manufacture volume based on an estimated market share and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. This product was not acquired; however, Piramal distributes on a non-exclusive basis. Piramal does not believe this information is publicly available and has not released this information in the public domain. |
None |
| Piramal Critical Care |
66794024042 |
Zinc Sulfate injection 30mg/10mL 1 box of 25 vials |
2022-06-27 |
1100.0000 |
Piramal considers multiple factors when setting a list price for a medicine, including: benefits the medicine brings to patients, healthcare systems and society - in terms of clinical outcomes and quality of life, longevity of life, and savings generated for other parts of the healthcare system such as reduced hospitalization and treatment costs. Market and business considerations, including: Ongoing research-investment costs, Medical- and patient-service costs (which may or may not include patient assistance programs and capital-investment costs associated with manufacturing, storage and supply)
Piramal'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 Zinc Sulfate. |
None |
8800 |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Piramal is limiting its response to that which is otherwise in the public domain or publicly available. As a manufacturer, Piramal does not estimate the number of patients that may be prescribed our products. We manufacture volume based on an estimated market share and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. This product was not acquired; however, Piramal distributes on a non-exclusive basis. Piramal does not believe this information is publicly available and has not released this information in the public domain. |
None |
| Primus Pharmaceuticals Inc |
68040071338 |
IMPOYZ® External Cream; Clobetasol propionate 0.025%; Cream; 100g |
2022-01-24 |
1235.0000 |
None |
1 |
25000 |
None |
None |
2021-03-01 |
None |
1 |
The manufacturer believes that this information should be protected as trade secret. The acquisition cost information is not patented. Since the manufacturer is a private company, the acquisition cost is not publicly available and is only known to certain individuals within its organization or consultants subject to confidentiality obligations. The information is also subject to confidentiality agreements with the selling entity. If this information were disclosed, it could negatively impact the manufacturer's negotiation power in future acquisitions and allow competitors to gain insight into the manufacturer's costs and margins for the product. This information is not necessary for consumers (HCPs or patients) to make a decision whether to use the manufacturer's product, as that decision would be made on publicly available information like clinical data, price for the product and its competition and insurance coverage. |
None |
None |
| Provention Bio, Inc. |
73650031610 |
TZIELD (teplizumab injection 2mg/2ml) 10 Vial Carton |
2022-12-02 |
138500.0000 |
Provention conducted extensive market research and analysis on appropriate pricing, taking into account a variety of factors, including, without limitation, the unmet need, the competitive landscape, and the potential value that treatment could provide |
None |
1000 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Provention Bio, Inc. |
73650031614 |
TZIELD (teplizumab injection 2mg/2ml) 14 Vial Carton |
2022-12-02 |
193900.0000 |
Provention conducted extensive market research and analysis on appropriate pricing, taking into account a variety of factors, including, without limitation, the unmet need, the competitive landscape, and the potential value that treatment could provide. |
None |
1000 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Provention Bio, Inc. |
73650031601 |
TZIELD (teplizumab injection 2mg/2ml) Single Vial |
2022-12-02 |
13850.0000 |
Provention conducted extensive market research and analysis on appropriate pricing, taking into account a variety of factors, including, without limitation, the unmet need, the competitive landscape, and the potential value that treatment could provide |
None |
1000 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| PureTek Corporation |
59088052454 |
Dotremin (30ct), Folate (as folic acid) 1700mcg DFE (1000mcg folic acid) + Vitamin D3 (cholecalciferol) 250mcg (1000IU) |
2022-01-17 |
1704.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
250000 |
None |
None |
None |
None |
None |
None |
Dispensed by prescription only |
None |
| PureTek Corporation |
59088052554 |
Multitam Multivitamin (30ct) |
2022-01-17 |
1800.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
275000 |
None |
None |
None |
None |
None |
None |
Dispensed by prescription only |
None |
| PureTek Corporation |
59088078500 |
Diclotrex II, Diclofenac Sodium Topical Solution 1.5% w/w 5floz (150ml), Camphotrex 3oz (85g) |
2022-03-02 |
3275.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
300000 |
None |
None |
None |
None |
None |
None |
Dispensed by prescription only |
None |
| PureTek Corporation |
59088078400 |
Lexitral Pharmapak II, Diclofenac SodiumTopical Solution 1.5%w/w 5floz (150mL), Penetral Cream Capsaicin 8fl. oz. |
2022-03-02 |
3748.9300 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
185000 |
None |
None |
None |
None |
None |
None |
Dispensed by prescription only |
None |
| PureTek Corporation |
59088042907 |
Lydexa 4.12% Cream, Lidocaine HCI 4.12%, (3oz) |
2022-03-02 |
1398.4000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
275000 |
None |
None |
None |
None |
None |
None |
Dispensed by prescription only |
None |
| PureTek Corporation |
59088078300 |
Xrylix II, Diclofenac Sodium Topical Solution 1.5% w/w 5floz (150ml),Xrylix sheets (30ct) |
2022-03-02 |
3969.5700 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
225000 |
None |
None |
None |
None |
None |
None |
Dispensed by prescription only |
None |
| PureTek Corporation |
59088048916 |
Urea 41% Cream, Urea 41%, (8oz) |
2022-06-01 |
3162.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
300000 |
None |
None |
None |
None |
None |
None |
Dispensed by prescription only |
None |
| PureTek Corporation |
59088069554 |
Davimet Multivitamin, Vitamin A 83%, Vitamin C 67%, Vitamin D3 50%, Vitamin E 67%, Thiamin 88%, Riboflavin 92%, Niacin 84%, Vitamin B6 62%, Folate 417%, Vitamin B12 18%, Chewable tablets, grape flavor, (30ct) |
2022-09-19 |
1800.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
250000 |
None |
None |
None |
None |
None |
None |
Dispensed by prescription only |
None |
| PureTek Corporation |
59088048307 |
Lidotran Cream, Lidocaine 3.88%, cream, (3oz) |
2022-09-19 |
1123.8100 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
325000 |
None |
None |
None |
None |
None |
None |
Dispensed by prescription only |
None |
| PureTek Corporation |
59088063000 |
Naprotin, Naproxen tablets, USP, 500mg, (100 ct)_Penetral Cream (Capsaicin 0.025%, 8fl oz/ 237ml) |
2022-09-27 |
3510.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
175000 |
None |
None |
None |
None |
None |
None |
Dispensed by prescription only |
None |