| Padagis US LLC |
45802043601 |
Tazarotene Gel 0.05% 100g |
Generic |
FDA |
2023-06-05 |
1316.7100 |
Product is be priced to deliver value to the market as compared to the Brand referenced drug. |
None |
655 |
None |
1 |
None |
None |
None |
None |
"As a generic manufacturer, Padagis does not have information available to accurately determinate the number of patients that could potentially have a condition for which the drug may be prescribed. Padagis neither collects nor uses estimated patient information and does not believe there is publicly available data that accurately represents the number of patients for all indications.
Based on IQVIA data available to Padagis, Padagis estimates that approximately 655 prescriptions were filled for the gel 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 |
| Padagis US LLC |
45802044201 |
Tazarotene Gel 0.1% 100g |
Generic |
FDA |
2023-06-05 |
1399.0700 |
Product is be priced to deliver value to the market as compared to the Brand referenced drug. |
None |
1657 |
None |
1 |
None |
None |
None |
None |
"As a generic manufacturer, Padagis does not have information available to accurately determinate the number of patients that could potentially have a condition for which the drug may be prescribed. Padagis neither collects nor uses estimated patient information and does not believe there is publicly available data that accurately represents the number of patients for all indications.
Based on IQVIA data available to Padagis, Padagis estimates that approximately 1,657 prescriptions were filled for the gel 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 |
| Padagis US LLC |
00574113316 |
Spironolactone Oral Suspension 25 mg/5 mL 473 mL |
Generic |
FDA |
2023-10-31 |
1498.5000 |
Product is be priced to deliver value to the market as compared to the Brand referenced drug. |
None |
6125 |
None |
None |
None |
None |
None |
None |
"As a generic manufacturer, Padagis does not have information available to accurately determinate the number of patients that could potentially have a condition for which the drug may be prescribed. Padagis neither collects nor uses estimated patient information and does not believe there is publicly available data that accurately represents the number of patients for all indications.
Based on IQVIA data available to Padagis, Padagis estimates that approximately 6,125 Total Units were sold for this drug in the past 12 months, but number of units sold should not be misinterpreted as an accurate estimate of the number of patients with a condition for which the new drug may be prescribed, as dosage and therapy may vary across individual patients." |
None |
| Par Pharmaceutical |
10370036801 |
Topiramate ER Caps 200mg 100s |
Generic |
FDA |
2023-03-24 |
3472.9200 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
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. 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 Topiramate extended-release capsules are indicated:
1) As initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older.
2) As adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 6 years of age and older.
3) For the preventive treatment of migraine in patients 12 years of age and older.
The Centers for Disease Control and Prevention (“CDC”) estimates that 3.4 million people in the United States had active epilepsy in 2015. This CDC did not further break out how many children ages 6-17 had active epilepsy as compared to children ages 0-5. ( https://www.cdc.gov/epilepsy/about/fast-facts.htm#:~:text=Active%20Epilepsy&text=This%20is%20about%203.4%20million,million%20adults%20and%20470%2C000%20children.&text=According%20to%20the%20latest%20estimates,17%20years%20have%20active%20epilepsy.&text=Think%20of%20a%20school%20with,of%20them%20could%20have%20epilepsy )
The National Institutes of Health (“NIH”) estimates that migraines affect about 12% of the population. (https://www.ncbi.nlm.nih.gov/books/NBK560787/ )
Par has not independently verified this information.
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 |
10370036811 |
Topiramate ER Caps 200mg 30s |
Generic |
FDA |
2023-03-24 |
1041.8900 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
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. 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 Topiramate extended-release capsules are indicated:
1) As initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older.
2) As adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 6 years of age and older.
3) For the preventive treatment of migraine in patients 12 years of age and older.
The Centers for Disease Control and Prevention (“CDC”) estimates that 3.4 million people in the United States had active epilepsy in 2015. This CDC did not further break out how many children ages 6-17 had active epilepsy as compared to children ages 0-5. ( https://www.cdc.gov/epilepsy/about/fast-facts.htm#:~:text=Active%20Epilepsy&text=This%20is%20about%203.4%20million,million%20adults%20and%20470%2C000%20children.&text=According%20to%20the%20latest%20estimates,17%20years%20have%20active%20epilepsy.&text=Think%20of%20a%20school%20with,of%20them%20could%20have%20epilepsy )
The National Institutes of Health (“NIH”) estimates that migraines affect about 12% of the population. (https://www.ncbi.nlm.nih.gov/books/NBK560787/ )
Par has not independently verified this information.
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 |
49884015802 |
Everolimus Tablets 0.25mg 60s |
Generic |
FDA |
2023-03-27 |
445.1100 |
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 |
| Par Pharmaceutical |
49884015902 |
Everolimus Tablets 0.5mg 60s |
Generic |
FDA |
2023-03-27 |
890.2300 |
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 |
| Par Pharmaceutical |
10370036701 |
Topiramate Extended-Release Capsules 100mg 100s |
Generic |
FDA |
2023-05-24 |
2538.8200 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
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. 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 Topiramate extended-release capsules are indicated:
1) As initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older.
2) As adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 6 years of age and older.
3) For the preventive treatment of migraine in patients 12 years of age and older.
The Centers for Disease Control and Prevention (“CDC”) estimates that 3.4 million people in the United States had active epilepsy in 2015. This CDC did not further break out how many children ages 6-17 had active epilepsy as compared to children ages 0-5. ( https://www.cdc.gov/epilepsy/about/fast-facts.htm#:~:text=Active%20Epilepsy&text=This%20is%20about%203.4%20million,million%20adults%20and%20470%2C000%20children.&text=According%20to%20the%20latest%20estimates,17%20years%20have%20active%20epilepsy.&text=Think%20of%20a%20school%20with,of%20them%20could%20have%20epilepsy )
The National Institutes of Health (“NIH”) estimates that migraines affect about 12% of the population. (https://www.ncbi.nlm.nih.gov/books/NBK560787/ )
Par has not independently verified this information.
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 |
10370036711 |
Topiramate Extended-Release Capsules 100mg 30s |
Generic |
FDA |
2023-05-24 |
761.6400 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
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. 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 Topiramate extended-release capsules are indicated:
1) As initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older.
2) As adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 6 years of age and older.
3) For the preventive treatment of migraine in patients 12 years of age and older.
The Centers for Disease Control and Prevention (“CDC”) estimates that 3.4 million people in the United States had active epilepsy in 2015. This CDC did not further break out how many children ages 6-17 had active epilepsy as compared to children ages 0-5. ( https://www.cdc.gov/epilepsy/about/fast-facts.htm#:~:text=Active%20Epilepsy&text=This%20is%20about%203.4%20million,million%20adults%20and%20470%2C000%20children.&text=According%20to%20the%20latest%20estimates,17%20years%20have%20active%20epilepsy.&text=Think%20of%20a%20school%20with,of%20them%20could%20have%20epilepsy )
The National Institutes of Health (“NIH”) estimates that migraines affect about 12% of the population. (https://www.ncbi.nlm.nih.gov/books/NBK560787/ )
Par has not independently verified this information.
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 |
10370036501 |
Topiramate Extended-Release Capsules 25mg 100s |
Generic |
FDA |
2023-05-24 |
983.7100 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
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. 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 Topiramate extended-release capsules are indicated:
1) As initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older.
2) As adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 6 years of age and older.
3) For the preventive treatment of migraine in patients 12 years of age and older.
The Centers for Disease Control and Prevention (“CDC”) estimates that 3.4 million people in the United States had active epilepsy in 2015. This CDC did not further break out how many children ages 6-17 had active epilepsy as compared to children ages 0-5. ( https://www.cdc.gov/epilepsy/about/fast-facts.htm#:~:text=Active%20Epilepsy&text=This%20is%20about%203.4%20million,million%20adults%20and%20470%2C000%20children.&text=According%20to%20the%20latest%20estimates,17%20years%20have%20active%20epilepsy.&text=Think%20of%20a%20school%20with,of%20them%20could%20have%20epilepsy )
The National Institutes of Health (“NIH”) estimates that migraines affect about 12% of the population. (https://www.ncbi.nlm.nih.gov/books/NBK560787/ )
Par has not independently verified this information.
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 |
10370036511 |
Topiramate Extended-Release Capsules 25mg 30s |
Generic |
FDA |
2023-05-24 |
295.1100 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
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. 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 Topiramate extended-release capsules are indicated:
1) As initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older.
2) As adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 6 years of age and older.
3) For the preventive treatment of migraine in patients 12 years of age and older.
The Centers for Disease Control and Prevention (“CDC”) estimates that 3.4 million people in the United States had active epilepsy in 2015. This CDC did not further break out how many children ages 6-17 had active epilepsy as compared to children ages 0-5. ( https://www.cdc.gov/epilepsy/about/fast-facts.htm#:~:text=Active%20Epilepsy&text=This%20is%20about%203.4%20million,million%20adults%20and%20470%2C000%20children.&text=According%20to%20the%20latest%20estimates,17%20years%20have%20active%20epilepsy.&text=Think%20of%20a%20school%20with,of%20them%20could%20have%20epilepsy )
The National Institutes of Health (“NIH”) estimates that migraines affect about 12% of the population. (https://www.ncbi.nlm.nih.gov/books/NBK560787/ )
Par has not independently verified this information.
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 |
10370036601 |
Topiramate Extended-Release Capsules 50mg 100s |
Generic |
FDA |
2023-05-25 |
1281.3800 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
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. 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 Topiramate extended-release capsules are indicated:
1) As initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older.
2) As adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 6 years of age and older.
3) For the preventive treatment of migraine in patients 12 years of age and older.
The Centers for Disease Control and Prevention (“CDC”) estimates that 3.4 million people in the United States had active epilepsy in 2015. This CDC did not further break out how many children ages 6-17 had active epilepsy as compared to children ages 0-5. ( https://www.cdc.gov/epilepsy/about/fast-facts.htm#:~:text=Active%20Epilepsy&text=This%20is%20about%203.4%20million,million%20adults%20and%20470%2C000%20children.&text=According%20to%20the%20latest%20estimates,17%20years%20have%20active%20epilepsy.&text=Think%20of%20a%20school%20with,of%20them%20could%20have%20epilepsy )
The National Institutes of Health (“NIH”) estimates that migraines affect about 12% of the population. (https://www.ncbi.nlm.nih.gov/books/NBK560787/ )
Par has not independently verified this information.
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 |
10370036611 |
Topiramate Extended-Release Capsules 50mg 30s |
Generic |
FDA |
2023-05-25 |
384.4100 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
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. 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 Topiramate extended-release capsules are indicated:
1) As initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older.
2) As adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 6 years of age and older.
3) For the preventive treatment of migraine in patients 12 years of age and older.
The Centers for Disease Control and Prevention (“CDC”) estimates that 3.4 million people in the United States had active epilepsy in 2015. This CDC did not further break out how many children ages 6-17 had active epilepsy as compared to children ages 0-5. ( https://www.cdc.gov/epilepsy/about/fast-facts.htm#:~:text=Active%20Epilepsy&text=This%20is%20about%203.4%20million,million%20adults%20and%20470%2C000%20children.&text=According%20to%20the%20latest%20estimates,17%20years%20have%20active%20epilepsy.&text=Think%20of%20a%20school%20with,of%20them%20could%20have%20epilepsy )
The National Institutes of Health (“NIH”) estimates that migraines affect about 12% of the population. (https://www.ncbi.nlm.nih.gov/books/NBK560787/ )
Par has not independently verified this information.
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 |
00254301255 |
Alvimopan Caps 12mg 30s |
Generic |
FDA |
2023-06-27 |
4713.2900 |
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 Alvimopan capsules are indicated to accelerate the time to upper and lower gastrointestinal recovery following surgeries that include partial bowel resection with primary anastomosis.
The National Institutes of Health (“NIH”) estimates that in the United States, there are more than 300,000 operations for diseases of the colon each year. ( https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5380454/ )
Par has not independently verified this information.
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 |
42023019501 |
Posaconazole Inj 18mg/mL 1vial |
Generic |
FDA |
2023-06-28 |
530.4500 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
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. 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 Posaconazole Injection are indicated for:
1) the treatment of invasive aspergillosis in adults and pediatric patients 13 years of age and older.
2) the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised
The Centers for Disease Control and Prevention (“CDC”) estimates 15,000 aspergillosis-associated hospitalizations occurred in the United States in 2014. The CDC further notes “because aspergillosis is not a reportable infection in the United States, the exact number of cases is difficult to determine.” (https://www.cdc.gov/fungal/diseases/aspergillosis/statistics.html )
The CDC estimates that approximately 25,000 cases of candidemia occur nationwide each year. ( https://www.cdc.gov/fungal/diseases/candidiasis/invasive/statistics.html )
Par has not independently verified this information.
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 |
| Pfizer |
00069350002 |
ZAVZPRET 10mg Nasal Spray 1x6 GVL |
Brand |
FDA |
2023-05-25 |
1100.0000 |
None |
1 |
6500000 |
1 |
None |
2022-10-03 |
1285800000.0000 |
None |
Pfizer Inc. acquired Biohaven, the maker of Nurtec ODT/Vydura (rimegepant), on October 3, 2022, an innovative therapy approved for both acute treatment of migraine and prevention of episodic migraine in adults. The transaction includes the acquisition of Biohaven’s CGRP programs, including rimegepant, zavegepant and a portfolio of five pre-clinical CGRP assets. Under the terms of the agreement, we acquired all outstanding common shares of Biohaven not already owned by us for $148.50 per share, in cash, for payments of approximately $11.5 billion, plus repayment of third-party debt of $863 million and redemption of Biohaven’s redeemable preferred stock for $495 million. Effective immediately prior to the closing of the acquisition, Biohaven completed the spin-off of Biohaven Ltd. (NYSE: BHVN), distributing Biohaven Ltd.’s shares to Biohaven shareholders. Biohaven Ltd. is a new publicly traded company that retained Biohaven’s non-CGRP development stage pipeline compounds. Pfizer, a Biohaven shareholder, received a pro rata portion of Biohaven Ltd.’s shares in the distribution and owns approximately 1.5% of Biohaven Ltd. as of December 31, 2022. |
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 6.5M patients in the United States that could potentially receive ZAVZPRET™, an innovative therapy approved for the acute treatment of migraine. Comment regarding Fields 8-9: ZAVZPRET™ did not receive breakthrough status and did not receive priority review; therefore, Columns 8-9 are intentionally left blank. Comment regarding Field 11 - The acquisition price is $12,858,000,000. The system would not allow us to enter the full acquisition price. |
None |
| Pfizer |
00069103130 |
TALZENNA 0.1mg Capsule 1x30 Bottle |
Brand |
FDA |
2023-06-21 |
17514.0700 |
None |
1 |
12000 |
None |
1 |
2016-09-28 |
1430000000.0000 |
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 12,000 patients in the U.S. could potentially receive TALZENNA™ in HRR-gene mutated metastatic castration-resistant prostate cancer. Comment regarding Field 8 - TALZENNA™ did not receive breakthrough status; therefore, Column 8 is intentionally left blank. Comment regarding Field 11 - The acquisition price is $14,300,000,000. The system would not allow us to enter the full acquisition price. |
None |
| Pfizer |
00069123530 |
TALZENNA 0.35mg Capsule 1x30 Bottle |
Brand |
FDA |
2023-06-21 |
17514.0700 |
None |
1 |
12000 |
None |
1 |
2016-09-28 |
1430000000.0000 |
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 12,000 patients in the U.S. could potentially receive TALZENNA™ in HRR-gene mutated metastatic castration-resistant prostate cancer. Comment regarding Field 8 - TALZENNA™ did not receive breakthrough status; therefore, Column 8 is intentionally left blank. Comment regarding Field 11 - The acquisition price is $14,300,000,000. The system would not allow us to enter the full acquisition price. |
None |
| Pfizer |
00069033428 |
LITFULO 50MG CAP 1X28 BTL US |
Brand |
FDA |
2023-07-06 |
3769.2300 |
None |
1 |
500000 |
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 there are approximately 0.5M patients in the United States that could potentially receive LITFULO™ in 2023 for the treatment of alopecia areata, an autoimmune disease. Comment regarding Fields 8-9: LITFULO™ did not receive breakthrough status and did not receive priority review; therefore, Columns 8-9 are intentionally left blank. Comment regarding Fields 10-13: LITFULO™ was not acquired; therefore, Columns 10-13 are intentionally left blank. |
None |
| Pfizer |
00069050502 |
NGENLA 24mg SSOL 1x1.2mL PFP US |
Brand |
FDA |
2023-07-31 |
1992.0000 |
None |
1 |
70000 |
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 there are approximately 70,000 patients in the United States that could potentially receive NGENLA® for the long-term treatment of pediatric growth hormone deficiency. Comment regarding Fields 8-9: NGENLA™ did not receive breakthrough status and did not receive priority review; therefore, Columns 8-9 are intentionally left blank. Comment regarding Fields 10-13: NGENLA™ was not acquired; therefore, Columns 10-13 are intentionally left blank. |
None |
| Pfizer |
00069052002 |
NGENLA 60mg SSOL 1x1.2mL PFP US |
Brand |
FDA |
2023-07-31 |
4980.0000 |
None |
1 |
70000 |
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 there are approximately 70,000 patients in the United States that could potentially receive NGENLA® for the long-term treatment of pediatric growth hormone deficiency. Comment regarding Fields 8-9: NGENLA™ did not receive breakthrough status and did not receive priority review; therefore, Columns 8-9 are intentionally left blank. Comment regarding Fields 10-13: NGENLA™ was not acquired; therefore, Columns 10-13 are intentionally left blank. |
None |
| Pfizer |
00069252202 |
ELREXFIO 44 mg/1.1 mL (40 mg/mL) in a Single-Dose Vial |
Brand |
FDA |
2023-08-15 |
7555.6800 |
None |
1 |
1200 |
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 1,200 patients in the United States that could potentially receive ELREXFIO™ for the treatment of adult patients with RRMM who have received at least four prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Comment regarding Fields 10-13: ELREXFIO™ was not acquired; therefore, Columns 10-13 are intentionally left blank. |
None |
| Pfizer |
00069449402 |
ELREXFIO 76 mg/1.9 mL (40 mg/mL) in a Single-Dose Vial |
Brand |
FDA |
2023-08-15 |
13050.7200 |
None |
1 |
1200 |
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 1,200 patients in the United States that could potentially receive ELREXFIO™ for the treatment of adult patients with RRMM who have received at least four prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Comment regarding Fields 10-13: ELREXFIO™ was not acquired; therefore, Columns 10-13 are intentionally left blank. |
None |
| Pfizer |
00069033302 |
ABRILADA 20mg/0.4ml SSOL 1x2 PFS US |
Generic |
FDA |
2023-10-18 |
6576.4900 |
None |
1 |
100000 |
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 there are approximately 100,000 patients in the United States that could potentially receive ABRILADA™ for the treatment of all approved indications. Comment regarding Field 8 - ABRILADA™ did not receive breakthrough status; therefore, Column 8 is intentionally left blank. Comment regarding Field 9 - ABRILADA™ did not receive priority review; therefore, Column 9 is intentionally left blank. Comment regarding Fields 10-13: ABRILADA™ was not acquired; therefore, Columns 10-13 are intentionally left blank. |
None |
| Pfizer |
00069032501 |
ABRILADA 40mg/0.8ml SSOL 1x1 PFP US |
Generic |
FDA |
2023-10-18 |
3288.2500 |
None |
1 |
100000 |
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 there are approximately 100,000 patients in the United States that could potentially receive ABRILADA™ for the treatment of all approved indications. Comment regarding Field 8 - ABRILADA™ did not receive breakthrough status; therefore, Column 8 is intentionally left blank. Comment regarding Field 9 - ABRILADA™ did not receive priority review; therefore, Column 9 is intentionally left blank. Comment regarding Fields 10-13: ABRILADA™ was not acquired; therefore, Columns 10-13 are intentionally left blank. |
None |
| Pfizer |
00069032502 |
ABRILADA 40mg/0.8ml SSOL 1x2 PFP US |
Generic |
FDA |
2023-10-18 |
6576.4900 |
None |
1 |
100000 |
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 there are approximately 100,000 patients in the United States that could potentially receive ABRILADA™ for the treatment of all approved indications. Comment regarding Field 8 - ABRILADA™ did not receive breakthrough status; therefore, Column 8 is intentionally left blank. Comment regarding Field 9 - ABRILADA™ did not receive priority review; therefore, Column 9 is intentionally left blank. Comment regarding Fields 10-13: ABRILADA™ was not acquired; therefore, Columns 10-13 are intentionally left blank. |
None |
| Pfizer |
00069032802 |
ABRILADA 40mg/0.8ml SSOL 1x2 PFS US |
Generic |
FDA |
2023-10-18 |
6576.4900 |
None |
1 |
100000 |
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 there are approximately 100,000 patients in the United States that could potentially receive ABRILADA™ for the treatment of all approved indications. Comment regarding Field 8 - ABRILADA™ did not receive breakthrough status; therefore, Column 8 is intentionally left blank. Comment regarding Field 9 - ABRILADA™ did not receive priority review; therefore, Column 9 is intentionally left blank. Comment regarding Fields 10-13: ABRILADA™ was not acquired; therefore, Columns 10-13 are intentionally left blank. |
None |
| Pfizer |
00069531720 |
PAXLOVID (nirmatrelvir tablets and ritonavir tablets) 150 mg/100 mg Dose Pack |
Brand |
FDA |
2023-10-18 |
1390.0000 |
None |
1 |
34000000 |
None |
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 34M patients in the United States that could potentially receive PAXLOVID™ to treat mild-to-moderate coronavirus disease 2019 (COVID 19) in adults who are at high risk for progression to severe COVID 19, including hospitalization or death. Comment regarding Field 8 - PAXLOVID™ did not receive breakthrough status; therefore, Column 8 is intentionally left blank. Comment regarding Fields 10-13: PAXLOVID™ was not acquired; therefore, Columns 10-13 are intentionally left blank. |
None |
| Pfizer |
00069532130 |
PAXLOVID (nirmatrelvir tablets and ritonavir tablets) 300 mg/100 mg Dose Pack |
Brand |
FDA |
2023-10-18 |
1390.0000 |
None |
1 |
34000000 |
None |
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 34M patients in the United States that could potentially receive PAXLOVID™ to treat mild-to-moderate coronavirus disease 2019 (COVID 19) in adults who are at high risk for progression to severe COVID 19, including hospitalization or death. Comment regarding Field 8 - PAXLOVID™ did not receive breakthrough status; therefore, Column 8 is intentionally left blank. Comment regarding Fields 10-13: PAXLOVID™ was not acquired; therefore, Columns 10-13 are intentionally left blank. |
None |
| Pfizer |
00069027430 |
VELSIPITY 2MG TFC 1X30 PBTL US |
Brand |
FDA |
2023-10-19 |
6164.3800 |
None |
1 |
633000 |
None |
None |
2022-03-11 |
670000000.0000 |
None |
On March 11, 2022, we acquired Arena, a clinical stage company, for $100 per share in cash. The total fair value of the consideration transferred was $6.6 billion ($6.2 billion, net of cash acquired). In addition, $138 million in payments to Arena employees for the fair value of previously unvested long-term incentive awards was recognized as post-closing compensation expense and recorded in Restructuring charges and certain acquisition-related costs. |
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 415,000 patients in the United States that could potentially receive VELSIPTY™ for the treatment of moderate to severe ulcerative colitis. Comment regarding Fields 8-9: VELSIPTY™ did not receive breakthrough status and did not receive priority review; therefore, Columns 8-9 are intentionally left blank. Comment regarding Field 11 - The acquisition price is $6,700,000,000. The system would not allow us to enter the full acquisition price. |
None |
| Pfizer |
00069150060 |
XALKORI 150mg CAP 1x60 BTL US |
Brand |
FDA |
2023-11-20 |
15868.4800 |
None |
1 |
100 |
1 |
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 there are approximately 100 new patients annually in the United States that could potentially receive the pellet formulation of XALKORI. This includes pediatric patients receiving XALKORI for the treatment of ALK+ ALCL and ALK+ IMT and adult patients receiving treatment for ROS1 and ALK+ mNSCLC who cannot swallow. Comment regarding Field 9 - XALKORI® did not receive priority review; therefore, Column 9 is intentionally left blank. Comment regarding Fields 10-13: XALKORI® was not acquired; therefore, Columns 10-13 are intentionally left blank. |
None |
| Pfizer |
00069025160 |
XALKORI 20mg CAP 1x60 BTL US |
Brand |
FDA |
2023-11-20 |
2242.7400 |
None |
1 |
100 |
1 |
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 there are approximately 100 new patients annually in the United States that could potentially receive the pellet formulation of XALKORI. This includes pediatric patients receiving XALKORI for the treatment of ALK+ ALCL and ALK+ IMT and adult patients receiving treatment for ROS1 and ALK+ mNSCLC who cannot swallow. Comment regarding Field 9 - XALKORI® did not receive priority review; therefore, Column 9 is intentionally left blank. Comment regarding Fields 10-13: XALKORI® was not acquired; therefore, Columns 10-13 are intentionally left blank. |
None |
| Pfizer |
00069050760 |
XALKORI 50mg CAP 1x60 BTL US |
Brand |
FDA |
2023-11-20 |
5289.4900 |
None |
1 |
100 |
1 |
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 there are approximately 100 new patients annually in the United States that could potentially receive the pellet formulation of XALKORI. This includes pediatric patients receiving XALKORI for the treatment of ALK+ ALCL and ALK+ IMT and adult patients receiving treatment for ROS1 and ALK+ mNSCLC who cannot swallow. Comment regarding Field 9 - XALKORI® did not receive priority review; therefore, Column 9 is intentionally left blank. Comment regarding Fields 10-13: XALKORI® was not acquired; therefore, Columns 10-13 are intentionally left blank. |
None |
| Pharmaceutical Associates, Inc |
00121494800 |
Potassium Chloride Oral Solution USP 10% Rx - 20mEq/15mL 100/cs |
Generic |
FDA |
2023-03-17 |
1205.0000 |
None |
1 |
13000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Pharmaceutical Associates, Inc |
00121189600 |
Potassium Chloride Oral Solution USP 10% Rx - 40mEq/30mL 100/cs |
Generic |
FDA |
2023-03-17 |
1849.0000 |
None |
1 |
13000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Pharming Healthcare Inc |
71274017060 |
Joenja 70mg Tablets 60 Count Bottle |
Brand |
FDA |
2023-04-03 |
45000.0000 |
None |
1 |
400 |
None |
1 |
2019-08-13 |
20000000.0000 |
None |
None |
None |
None |
| Piramal Critical Care |
66794023741 |
Doxycycline for Injection, USP, 20 mL vial, 100mg, Single use vial, 1 carton of 10 vials |
Generic |
FDA |
2023-06-16 |
251.0000 |
"For Doxycycline, Piramal conducts the following marketing activities; telemarketing and direct to HCP’s notifications via email and sales representatives visits conducting calls on HCP’s where sell sheets are provided. Piramal marketing activities are minimal since this is a generic product; and the spend on marketing activities on an annual basis is the following amounts: Direct to consumer was $0; Direct to physician (HCPs) was $3,250.00.
Piramal conducts market research utilizing IQVIA data to determine the competitive landscape for any new product launch. We review this information and determine how many generic manufacturers are in the market and determine a market share position based on this approach. We establish our WAC pricing by reviewing IQVIA data and setting our WAC at a competitive rate by researching all competitive WAC pricing for both brand and generic competitors and then we establish a commercial contract price of 70% below current Average Manufacturer Selling Price (AMSP). WAC was set at 1% below Average WAC Price (AWP) of the existing market. Additionally, multiple factors are considered for selecting a product beyond the pricing; such as the difficulties in producing the product, distribution cost for speciality products, administrative costs related to contracts, chargeback management, as well as the value this product would bring to patients. " |
None |
1596000 |
None |
None |
None |
None |
None |
None |
None |
None |
| PureTek Corporation |
59088043510 |
Diclofenac Sodium Topical Solution 1.5%, w/w 5fl oz (150ml) |
Generic |
FDA |
2023-01-16 |
1308.0000 |
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 |
750000 |
None |
None |
None |
None |
None |
None |
Dispensed by prescription only |
None |
| PureTek Corporation |
59088073000 |
Triasil, Triamcinolone Acetonide Ointment USP, 0.025%, 80g+ Gauze pads, sterile, 20ct + silicon Tape roll (1ct) |
Brand |
Medispan |
2023-01-20 |
2888.0000 |
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 |
59088069816 |
Urea 39.5% Cream (8oz) |
Generic |
Medispan |
2023-01-20 |
1581.2000 |
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 |
1500000 |
None |
None |
None |
None |
None |
None |
Dispensed by prescription only |
None |
| PureTek Corporation |
59088064354 |
Dexatran Multivitamin (30ct), Vit C 200mg, Thiamin 10 mg, Riboflavin 6 mg, Niacin 30 mg, Vitamin B6 5 mg, Folate 1667 mcg DFE, Vitamin B12 15 mcg, Pantothenic Acid 10 mg, Iron 18 mg, Magnesium 6.9 mg, Zinc 18.2 mg, Copper 0.8 mg, Manganese 1.3 mg |
Brand |
Medispan |
2023-02-20 |
1800.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
725000 |
None |
None |
None |
None |
None |
None |
Dispensed by prescription only |
None |
| PureTek Corporation |
59088021016 |
Urea 39.5% + 2% Salicylic Acid Cream (8oz)_ Urea 39.5%_ Salicylic Acid 2% |
Brand |
Medispan |
2023-03-24 |
3370.4000 |
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 |
500000 |
None |
None |
None |
None |
None |
None |
Dispensed by prescription only |
None |
| PureTek Corporation |
59088020903 |
Hydroxym Gel (1oz), Hydrocortisone 2% |
Brand |
Medispan |
2023-07-14 |
1158.4000 |
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 |
250000 |
None |
None |
None |
None |
None |
None |
Dispensed by prescription only |
None |
| PureTek Corporation |
59088090554 |
Lidocan (30ct), Lidocaine Patch 5%, Lidocaine 700mg (50mg per gram adhesive) in an aqueous base. |
Generic |
FDA |
2023-07-19 |
1540.0000 |
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 |
700000 |
None |
None |
None |
None |
None |
None |
Dispensed by prescription only |
None |
| PureTek Corporation |
59088073100 |
Xyliderm, Lidocan (30ct), Alcohol Prep Pads Sterile (200ct), Xrylix Sheets (30ct) |
Brand |
Medispan |
2023-07-19 |
2560.0000 |
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 |
200000 |
None |
None |
None |
None |
None |
None |
Dispensed by prescription only |
None |
| PureTek Corporation |
59088080100 |
Lextol,Penetral Cream (Capsaicin 0.025%), Diclofenac Sodium Topical Solution (1.5% w/w, 5fl oz./ 150ml) |
Brand |
Medispan |
2023-08-30 |
2349.6000 |
While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising.
There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. |
None |
275000 |
None |
None |
None |
None |
None |
None |
RX |
None |
| PureTek Corporation |
59088064003 |
Micomitin Antifungal Liquid (1fl oz), Tolnaftate 1% |
Brand |
Medispan |
2023-08-30 |
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 |
325000 |
None |
None |
None |
None |
None |
None |
Dispensed by prescription only |
None |
| PureTek Corporation |
59088030803 |
Lidotral 5% with Menthol Spray (1fl oz/ 30 ml), Lidocaine HCI 5%, Menthol 3% |
Brand |
Medispan |
2023-10-11 |
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 |
725000 |
None |
None |
None |
None |
None |
None |
RX, Dispensed by prescription only |
None |
| PureTek Corporation |
59088021403 |
Salicate Serum, Salicylic Acid 10% |
Brand |
Medispan |
2023-10-13 |
1581.2000 |
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 |
650000 |
None |
None |
None |
None |
None |
None |
RX, Dispensed by prescription only |
None |
| PureTek Corporation |
59088090754 |
Lidocan III (30ct), Lidocaine Patch 5%, Lidocaine 700mg (50mg per gram adhesive) in an aqueous base |
Generic |
FDA |
2023-10-17 |
828.0000 |
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 |
795000 |
None |
None |
None |
None |
None |
None |
RX, Dispensed by prescription only |
None |
| PureTek Corporation |
59088044301 |
Mycozyl AL (10ml), Miconatate 1% antifungal liquid |
Brand |
Medispan |
2023-10-17 |
917.0000 |
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 |
675000 |
None |
None |
None |
None |
None |
None |
RX, Dispensed by prescription only |
None |
| PureTek Corporation |
59088090854 |
Lidocan II Patch (30ct), Lidocaine 5% patch (30ct) |
Brand |
Medispan |
2023-10-23 |
1540.0000 |
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 |
825000 |
None |
None |
None |
None |
None |
None |
RX, Dispensed by prescription only |
None |
| PureTek Corporation |
59088020207 |
Menticam Cream (3oz), Camphor 4% Menthol 7.5% Methyl salicylate 10% |
Brand |
Medispan |
2023-10-26 |
828.0000 |
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 |
625000 |
None |
None |
None |
None |
None |
None |
RX, Dispensed by prescription only |
None |
| PureTek Corporation |
59088020307 |
Menticam Gel (3.5oz), Camphor 4% Menthol 7.5% Methyl salicylate 10% |
Brand |
Medispan |
2023-10-26 |
828.0000 |
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 |
625000 |
None |
None |
None |
None |
None |
None |
RX, Dispensed by prescription only |
None |
| PureTek Corporation |
59088015854 |
Davimet M (30ct) chewable tablets, Vit A 750 mcg RAE, Vit C 60mg, Vit D3 10 mcg, Vit E 10mg, Thiamin 1.05mg, Riboflavin 1.2mg, Niacin 13.5 mg, Vit B6 1.05mg, Folate 1700 mcg DFE, B12 4.5 mcg |
Brand |
Medispan |
2023-11-30 |
828.0000 |
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 |
825000 |
None |
None |
None |
None |
None |
None |
RX, Dispensed by prescription only |
None |
| PureTek Corporation |
59088030154 |
Folixate (30ct) tablets, Folate 1700 mcg DFE, Vit D3 125 mcg |
Brand |
Medispan |
2023-12-05 |
828.0000 |
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 |
875000 |
None |
None |
None |
None |
None |
None |
RX, Dispensed by prescription only |
None |
| PureTek Corporation |
59088000454 |
Bolsitol Capsules (30ct), Lactobacillus Plantarum 299V, 10 billion CFU |
Brand |
Medispan |
2023-12-06 |
828.0000 |
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 |
675000 |
None |
None |
None |
None |
None |
None |
RX, Dispensed by prescription only |
None |
| PureTek Corporation |
59088022705 |
Salycim Cream (2oz), Salicylic Acid 6% |
Brand |
Medispan |
2023-12-06 |
828.0000 |
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 |
575000 |
None |
None |
None |
None |
None |
None |
RX, Dispensed by prescription only |
None |
| PureTek Corporation |
59088026403 |
Mycozyl HC (1fl oz), Tolnaftate 1%, Hydrocortisone 0.667% |
Brand |
Medispan |
2023-12-11 |
828.0000 |
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 |
1250000 |
None |
None |
None |
None |
None |
None |
RX, Dispensed by prescription only |
None |
| PureTek Corporation |
59088065931 |
Livita Liquid Multivitamin for Adults (480ml), Vit A, Vit C, Vit D3, Vit E, Thiamin, Riboflavin, Niacin, Vit B6, Folate, Vit b12, Biotin, Pantothenic Acid, Choline, Calcium, Magnesium, Zinc |
Brand |
Medispan |
2023-12-15 |
1680.0000 |
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 |
1500000 |
None |
None |
None |
None |
None |
None |
RX, Dispensed by prescription only |
None |
| PureTek Corporation |
59088066016 |
Livita Liquid Multivitamin for Children |
Brand |
Medispan |
2023-12-15 |
1500.0000 |
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 |
1500000 |
None |
None |
None |
None |
None |
None |
RX, Dispensed by prescription only |
None |
| PureTek Corporation |
59088015654 |
Menatrol (30ct) capsules, |
Brand |
Medispan |
2023-12-18 |
828.0000 |
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 |
2500000 |
None |
None |
None |
None |
None |
None |
RX, Dispensed by prescription only |
None |