Table: q1_q4_2021_prescription_drugs_intro_to_market , manufacturer_name like P*

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manufacturer_name ndc_number drug_product_description date_introduced_to_market wac_at_introduction marketing_pricing_plan_description marketing_pricing_plan_non_public_indicator estimated_number_of_patients breakthrough_therapy_indicator priority_review_indicator acquisition_date acquisition_price acquisition_price_non_public_indicator acquisition_price_comment general_comments supporting_documents
Padagis US LLC 00574093125 Doxorubicin Hydrochloride Liposome Injection 50 mg/25 mL (2mg/mL) 25mL 2021-10-25 1515.6000 Product is be priced to deliver value to the market as compared to the Brand referenced drug. None 39976 None None None None None None As a generic manufacturer, Padagis does not have information available to accurately determinate the number of patients that could potentially have a condition for which the drug may be prescribed. Padagis neither collects nor uses estimated patient information and does not believe there is publicly available data that accurately represents the number of patients for all indications. Based on NSP data available to Padagis, Padagis estimates that approximately 39,976 Total Units were sold for this drug in the past 12 months, but number of units sold should not be misinterpreted as an accurate estimate of the number of patients with a condition for which the new drug may be prescribed, as dosage and therapy may vary across individual patients. None
Par Pharmaceutical 00254205301 Chlorzoxazone Tablets 375mg 100s 2021-06-10 370.0000 None 1 None None None None None None None The information contained in this report is subject to the following limitations and assumptions. (1) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank. (2) Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Par notes that this product is indicated adjunct to other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The World Health Organization (“WHO”) indicates approximately 1,710,000,000 people have musculoskeletal conditions world-wide (see https://www.who.int/news-room/fact-sheets/detail/musculoskeletal-conditions#:~:text=%20Musculoskeletal%20conditions%20include%20conditions%20that%20affect%3A%20,body%20areas%20or%20systems%2C%20such%20as...%20More%20 ). However, WHO does not specify the number of patients diagnosed each month or year with musculoskeletal conditions. Further, Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level. Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s Chlorzoxazone Tablets because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states: “Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at: https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market. Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank. (3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank. None
Par Pharmaceutical 49884015576 Varenicline Tablets .5mg 56s 2021-09-16 364.5200 None 1 None None None None None None None The information contained in this report is subject to the following limitations and assumptions. (1) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank. (2) Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Par notes that this product is indicated as an aid to smoking cessation treatment. The Centers for Disease Control and Prevention (“CDC”) indicates that in 2015 22.7 million adult smokers in the United States wanted to quit smoking. https://www.cdc.gov/tobacco/data_statistics/fact_sheets/cessation/smoking-cessation-fast-facts/index.html However, CDC does not specify the number of smokers intending to quit each month or year. Further, Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level. Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s Varenicline Tablets because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states: “Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at: https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market. Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank. (3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank. None
Par Pharmaceutical 49884055601 Isosorbide Dinitrate Tablets, USP 40mg 100s 2021-12-13 1335.3700 None 1 None None None None None None None The information contained in this report is subject to the following limitations and assumptions. (1) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank. (2) Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Moreover, Par notes that because this product is a generic, Par did not consider, nor did it identify, the estimated patient population in determining market need for the product. Accordingly, Par is unable to provide an estimate of the average number of patients who may be treated by this product beyond publicly available data. Par notes that this product is indicated for the prevention of angina pectoris due to coronary artery disease. The Centers for Disease Control and Prevention (“CDC”) estimates that 18.2 million adults in the United States have coronary artery disease and the Mayo Clinic notes that angina is a common symptom of coronary artery disease. ( https://www.cdc.gov/heartdisease/facts.htm, https://www.mayoclinic.org/diseases-conditions/angina/symptoms-causes/syc-20369373 ) The CDC did not indicate how many cases of coronary artery disease occur each month. Par is therefore unable to provide any additional detail regarding the Estimated Number of Patients who may be prescribed Par’s Isosorbide because the information is not in the public domain. Thus, we understand our initial filings to be consistent with the statute, Cal. Health & Safety Code § 127681(c), which allows a manufacturer to “limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.” Subdivision (b) of the same requires the number of estimated patients to be included in new drug reports. This limitation is further noted on the OSHPD’s webpage titled “Prescription Drugs Introduced to Market” that contains the most recent published new drug reports. This webpage states: “Manufacturers may withhold information that is not in the public domain.” See Prescription Drugs Introduced to Market, available at: https://data.chhs.ca.gov/dataset/prescription-drugs-introduced-to-market. Accordingly, for the foregoing reasons, Par has left the “estimated number of patients” data field blank. (3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank. None
Pfizer 00069102902 XELJANZ 1MG/ML ORSOL 1X240ML PBTL US 2021-02-08 3944.3900 None 1 3000 None None None None None None Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Pfizer estimates that in total, approximately 3,000 patients across the United States, could potentially receive the Oral Solution formulation. Comment regarding Fields 10-13: Xeljanz Oral Solution was not acquired; therefore, Columns 10 – 13 are intentionally left blank. None
Pfizer 00409012001 Daptomycin for Injection 350mg per Vial (1’s) 2021-10-04 50.0000 None 1 393466 None None None None None None Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Approximately 393,466 patients are estimated to receive Daptomycin annually. Comment regarding Fields 10-13: Daptomycin was not acquired; therefore, Columns 10 – 13 are intentionally left blank. None
Pfizer 00409012201 Daptomycin for Injection 500mg per Vial (1’s) 2021-10-04 79.0000 None 1 393466 None None None None None None Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Approximately 393,466 patients are estimated to receive Daptomycin annually. Comment regarding Fields 10-13: Daptomycin was not acquired; therefore, Columns 10 – 13 are intentionally left blank. None
PharmaEssentia USA Corporation 73536050001 BESREMi (Ropeginterferon alfa-2b-njft) 500 mcg/ml single use vial 2021-12-03 6988.0000 None 1 161110 None 1 None None None None None None
Piramal Critical Care 66794023444 Dexmedetomidine Hydrochloride Injection, USP 200 mcg/50mL (4 mcg/mL) 2021-08-15 720.0000 Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Piramal Critical Care’s Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is priced responsibly and in line with current market conditions. None 750315 None None None None None None Pursuant to CA Health & Safety Code §127681 (c), Piramal is limiting its response to that which is otherwise in the public domain or publicly available. The Estimated Patient amount is based on the number of eaches sold in the last 12 month period from July 2020 through June 2021. This number does not account for multiple vials dosed to a single patient as this information is not readily available. This product was not acquired; however, Piramal's marketing rights were in-licensed. Piramal does not believe this information is publicly available and has not released this information in the public domain. None
Piramal Critical Care 66794023541 Dexmedetomidine Hydrochloride Injection, USP 400 mcg/100mL (4 mcg/mL) 2021-08-15 720.0000 Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Piramal Critical Care’s Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is priced responsibly and in line with current market conditions. None 3237152 None None None None None None Pursuant to CA Health & Safety Code §127681 (c), Piramal is limiting its response to that which is otherwise in the public domain or publicly available. The Estimated Patient amount is based on the number of eaches sold in the last 12 month period from July 2020 through June 2021. This number does not account for multiple vials dosed to a single patient as this information is not readily available. This product was not acquired; however, Piramal's marketing rights were in-licensed. Piramal does not believe this information is publicly available and has not released this information in the public domain. None
Primus Pharmaceuticals Inc 68040071428 Sernivo® Spray; Betamethasone dipropionate 0.05% 2021-08-02 997.5000 None 1 45000 None None 2021-03-11 None 1 None None https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=554, https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=555
Progenics Pharmaceuticals, Inc. 71258002200 PYLARIFY® (piflufolastat F 18) Injection 2021-05-26 4600.0000 Product will be marketed in the US and the pricing model will be consistant with our WAC Pricing through December 31, 2021 None 250000 None 1 None None None None Brand New Product to Market, we do not have estimate of usage yet. None
Puma Biotechnology, Inc. 70437024033 Nerlynx (neratinib) 40mg 133 count bottle 2021-06-21 12940.0000 None 1 3350 None None None None None None None None
PureTek Corporation 59088077200 Sumansetron, sumatriptan tablets USP 50mg (9ct) + Ondansetron tablets USP 4mg (30ct) 2021-01-01 3352.8000 While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. None 0 None None None None None None None None
PureTek Corporation 59088017554 Probitrol, capsules, 31 billion, 30ct 2021-01-04 1744.0000 While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. None 0 None None None None None None None None
PureTek Corporation 59088017457 Promerol, capsules, 31 billion, 30ct 2021-01-04 3136.0000 While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. None 0 None None None None None None None None
PureTek Corporation 59088017354 Vitranol Fe, caplets, multivitamin + iron, 30ct 2021-01-04 1800.0000 While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. None 0 None None None None None None None None
PureTek Corporation 59088017754 Venexa Fe, multivitamin + iron (30CT) 2021-01-29 1930.0000 While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. None 150000 None None None None None None None None
PureTek Corporation 59088017654 Venexa, caplets, multivitamin, 30ct 2021-01-29 1544.0000 While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. None 0 None None None None None None None None
PureTek Corporation 59088017854 Pretrate, prenatal/postnatal multivitamin, (30ct) caplets 2021-02-01 1460.0000 While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. None 2000000 None None None None None None 0 None
PureTek Corporation 59088017954 Lacterol (30ct), probiotic (30ct) 2021-02-10 1962.0000 While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. None 100000 None None None None None None Dispensed by prescription None
PureTek Corporation 59088018158 Foltin-Z, multivitamin (60ct) 2021-02-11 1740.0000 While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. None 150000 None None None None None None None None
PureTek Corporation 59088018258 Ribotin- E, multivitamin (60ct) caplets 2021-02-11 1740.0000 While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. None 150000 None None None None None None None None
PureTek Corporation 59088018058 Zintrexyl-C, multivitamin (60ct) 2021-02-11 1740.0000 While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. None 150000 None None None None None None None None
PureTek Corporation 59088018354 Probitran, probiotic (30ct) 2021-05-03 1962.0000 While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. None 100000 None None None None None None dispensed by prescription None
PureTek Corporation 59088018454 Purefoltin, Folic acid 1mg + Vitamin D3 5,000 IU (30ct) 2021-05-03 2200.0000 While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. None 300000 None None None None None None None None
PureTek Corporation 59088018654 Ventrixyl, multivitamin (30ct) 2021-06-04 1800.0000 While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. None 150000 None None None None None None None None
PureTek Corporation 59088046607 Lidogel, Lidocaine HCI 2.8% Gel, (100g) 2021-07-21 1516.0000 While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. None 250000 None None None None None None 0 None
PureTek Corporation 59088018754 Ventrixyl Fe, Multivitamin (30ct) tablets 2021-08-11 1800.0000 While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. None 150000 None None None None None None None None
PureTek Corporation 59088019454 Probinate, probiotic, (30ct) capsules 2021-08-20 1480.0000 While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. None 100000 None None None None None None None None
PureTek Corporation 59088019354 Vitramyn, multivitamin (30ct) caplets 2021-08-20 1800.0000 While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. None 150000 None None None None None None None None
PureTek Corporation 59088018554 Folditam, Folic Acid 1mg + Vit D3 10,000IU, tablets (30ct) 2021-09-02 1704.0000 While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. None 2000000 None None None None None None None None
PureTek Corporation 59088043207 Radiaura Skin Recovery Cream, Lidocaine HCI 3%_ Hydrocotisone Acetate 0.5%, cream (85g) 2021-09-02 1123.8100 While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. None 500000 None None None None None None None None
PureTek Corporation 59088048058 Foliflex Multivitamin, 30ct caplets 2021-10-14 1392.0000 While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. None 350000 None None None None None None Dispensed by prescription only None
PureTek Corporation 59088047507 Lidorex. Lidocaie HCI 2.8% Gel, 3.5oz (100g) 2021-10-14 1516.0000 While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. None 275000 None None None None None None Dispensed by prescription only None
PureTek Corporation 59088020054 Foltamin, Folic Acid 1mg + Vitamin D3 5000IU, tablets (30ct) 2021-11-29 1760.0000 While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. None 300000 None None None None None None Dispensed by prescription only None
PureTek Corporation 59088071500 Lidotor, Lidocaine 2.5%/Prilocaine 2.5% cream USP 30gm + Occlusive Dressing (5ct) 2021-11-29 1820.0000 While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. None 150000 None None None None None None Dispensed by prescription only None
PureTek Corporation 59088019954 Probisol, 2 Strain AcidoBifido 31 Billion, capsules (30ct) 2021-11-29 1569.6000 While specific marketing and pricing plans are not available in the public domain, generally we are marketing in the US with print distribution and digital advertising. There will be no direct-to-consumer marketing such as TV ads, magazine or journal ads. This drug is marketed through the use of licensed wholesalers that distribute the products. None 250000 None None None None None None Dispensed by prescription only None