Columns: General -- Sales -- Acquisition -- WAC
OSHPD ID | Manufacturer Name | Date Reported | Description | NDC Number | Drug Intro to Market | Patent Expire | Drug Source Type | Supporting Documents | General Comments |
---|---|---|---|---|---|---|---|---|---|
Accord BioPharma, Inc. | Hercessi Intravenous Solution Reconstituted 150 MG | 69448001505 | "There are challenges with estimating the number of patients due to Hercessis multiple indications approved by the FDA. Accord estimates patients using US Population and an annual U.S. incidence rate which results in 37,000 estimated patients for Breast Cancer and 4,800 estimated patients for Gastric Cancer. The US Population is from the Neilsburg Research US population by Gender, July 2024. This incidence rate is derived from the National Cancer Institute Surveillance, Epidemiology, and End Results Program. Cancer Stat Facts: Female Breast Cancer. Available at: https://seer.cancer.gov/statfacts/html/breast.html. Accessed January 15, 2024" | ||||||
Accord BioPharma, Inc. | Hercessi Intravenous Solution Reconstituted 420 MG | 69448001611 | "There are challenges with estimating the number of patients due to Hercessis multiple indications approved by the FDA. Accord estimates patients using US Population and an annual U.S. incidence rate which results in 37,000 estimated patients for Breast Cancer and 4,800 estimated patients for Gastric Cancer. The US Population is from the Neilsburg Research US population by Gender, July 2024. This incidence rate is derived from the National Cancer Institute Surveillance, Epidemiology, and End Results Program. Cancer Stat Facts: Female Breast Cancer. Available at: https://seer.cancer.gov/statfacts/html/breast.html. Accessed January 15, 2024" | ||||||
Akebia Therapeutics, Inc. | VAFSEO TABLETS 1 PACK 60 TABS 150 MG | 59922064160 | U.S. Dialysis Patients Treated for Anemia approximately 500,000 Patients. Akebia does not expect to capture 100% of the eligible treatable patients, but the exact share of patients that will be treated with Vafseo is unknowable at this time. | ||||||
Akebia Therapeutics, Inc. | VAFSEO TABLETS 1 PACK 60 TABS 300 MG | 59922064260 | U.S. Dialysis Patients Treated for Anemia approximately 500,000 Patients. Akebia does not expect to capture 100% of the eligible treatable patients, but the exact share of patients that will be treated with Vafseo is unknowable at this time. | ||||||
Amneal Pharmaceuticals | Everolimus Tablets for Oral Suspension 2mg | 60219227902 | This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house. | ||||||
Amneal Pharmaceuticals | Everolimus Tablets for Oral Suspension 3mg | 60219228002 | This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house. | ||||||
Amneal Pharmaceuticals | Everolimus Tablets for Oral Suspension 5mg | 60219228102 | This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house. | ||||||
Amneal Pharmaceuticals | Mesalamine Delayed-Release Tablets 800mg 180 ct | 65162036018 | This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house. | ||||||
Amneal Pharmaceuticals | Methylene Blue Injection, USP 50mg/10mL | 70121271502 | This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house. | ||||||
ANIP | INZIRQO - Powder, For Suspension - 10mg/ml - 80ml in 1 bottle | 70954052210 | |||||||
Astellas Pharma US, Inc. | VYLOY® (zolbetuximab - clzb) 300mg vial | 00469442530 | Astellas has not released the information requested in column 7 (estimated volume of patients that may be prescribed the drug) in the public domain. Further, Astellas does not believe this information is in the public domain or publicly available. As a result, Astellas is limiting its response to this reporting requirement pursuant to Cal. Health & Safety Code Section 127681(c). | ||||||
Aurobindo Pharma USA, Inc. | Pazopanib Tablets | 59651058208 | https://reports.siera.hcai.ca.gov/api/report/drug-pricing/attachment?id=1056, https://reports.siera.hcai.ca.gov/api/report/drug-pricing/attachment?id=1057 | ||||||
Aurobindo Pharma USA, Inc. | Rivaroxaban 2.5mg tablets - 180s | 59651084918 | https://reports.siera.hcai.ca.gov/api/report/drug-pricing/attachment?id=1058, https://reports.siera.hcai.ca.gov/api/report/drug-pricing/attachment?id=1059 | ||||||
AvKare | Sunitinib Malate 37.5mg Capsule 28ct | 42291090328 | While this drug was uploaded to the databanks back on 10/17/2023, this drug was not sold in the market until 01/08/2025. We were notified of this date of first sale in January 2025 and submitted the drug as soon as we were notified. | ||||||
Avyxa Pharma, LLC | AXTLE (pemetrexed) Injection 100 mg/vial, SDV | 83831013101 | https://reports.siera.hcai.ca.gov/api/report/drug-pricing/attachment?id=1054 | ||||||
Avyxa Pharma, LLC | AXTLE (pemetrexed) Injection 500 mg/vial, SDV | 83831013201 | https://reports.siera.hcai.ca.gov/api/report/drug-pricing/attachment?id=1055 | ||||||
Biocon Biologics Inc. | Yesintek 130 mg/26 mL (5 mg/mL) injection in an SDV | 83257002611 | |||||||
Biocon Biologics Inc. | Yesintek 45 mg/0.5 mL injection in a single-dose prefilled syringe | 83257002341 | |||||||
Biocon Biologics Inc. | Yesintek 45 mg/0.5 mL injection in an SDV | 83257002411 | |||||||
Biocon Biologics Inc. | Yesintek 90 mg/mL injection in a single-dose prefilled syringe | 83257002541 | |||||||
Biocon Limited | Dasatinib Tablets 100mg 30ct | 70377008711 | |||||||
Biocon Limited | Dasatinib Tablets 140mg 30ct | 70377008811 | |||||||
Biocon Limited | Dasatinib Tablets 20mg 60ct | 70377008311 | |||||||
Biocon Limited | Dasatinib Tablets 50mg 60ct | 70377008411 | |||||||
Biocon Limited | Dasatinib Tablets 70mg 60ct | 70377008511 | |||||||
Biocon Limited | Dasatinib Tablets 80mg 30ct | 70377008611 | |||||||
Breckenridge Pharmaceutical | EVEROLIMUS TFOS 2MG 4X7 | 51991099028 | |||||||
Breckenridge Pharmaceutical | EVEROLIMUS TFOS 3MG 4X7 | 51991099128 | |||||||
Breckenridge Pharmaceutical | EVEROLIMUS TFOS 5MG 4X7 | 51991099228 | |||||||
Bristol Myers Squibb | Opdivo Qvantig 600 mg-10,000 unit/5mL (VIAL (ML)) | 00003612001 | Estimated number of patients reflects the 2025 average monthly total patients including new and continuing patients from prior months. | ||||||
Carnegie Pharmaceuticals LLC | E.E.S. 400 ORAL TABLET 400 MG | 80005016108 | |||||||
Carnegie Pharmaceuticals LLC | E.E.S. GRANULES ORAL SUSPENSION RECONSTITUTED 200 MG/5ML 100ML | 80005015218 | |||||||
Carnegie Pharmaceuticals LLC | E.E.S. GRANULES ORAL SUSPENSION RECONSTITUTED 200 MG/5ML 200ML | 80005015334 | |||||||
Carnegie Pharmaceuticals LLC | ERYPED 400 ORAL SUSPENSION RECONSTITUTED 400 MG/5ML 30 TABLETS | 80005015518 | |||||||
Celltrion USA, Inc. | STEQEYMA 130MG/26ML (5mg/mL) Injectable; Subcutaneous Vial | 72606002901 | |||||||
Celltrion USA, Inc. | STEQEYMA 45MG/0.5ML Injectable; Subcutaneous Single-dose prefilled syringe with safety guard | 72606002701 | |||||||
Celltrion USA, Inc. | STEQEYMA 90MG/ML Injectable; Subcutaneous Single-dose prefilled syringe with safety guard | 72606002801 | |||||||
Celltrion USA, Inc. | ADALIMUMAB-AATY STARTER PACK 80 mg/0.8 ml | 72606004006 | |||||||
Chartwell Rx LLC | Promethazine HCL Oral Solution 6.25mg/5mL 20 x 10mL UD | 62135077423 | The information contained in this report is subject to the following limitations and assumptions: Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Chartwell believes is otherwise in the public domain or publicly available. Chartwell did not assume marketing functions from prior owner, and did not receive any historical data from the sellers of the ANDAs. | ||||||
Chartwell Rx LLC | Promethazine HCL Oral Solution 6.25mg/5mL 20 x 5mL UD | 62135077424 | The information contained in this report is subject to the following limitations and assumptions: Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Chartwell believes is otherwise in the public domain or publicly available. Chartwell did not assume marketing functions from prior owner, and did not receive any historical data from the sellers of the ANDAs. | ||||||
Chartwell Rx LLC | Lacosamide Oral Solution USP C-V 10mg/ml 20x10UD | 62135088523 | The information contained in this report is subject to the following limitations and assumptions: Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Chartwell believes is otherwise in the public domain or publicly available. Chartwell did not assume marketing functions from prior owner, and did not receive any historical data from the sellers of the ANDAs. | ||||||
Chartwell Rx LLC | Lacosamide Oral Solution USP C-V 10mg/ml 20x5UD | 62135088524 | The information contained in this report is subject to the following limitations and assumptions: Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Chartwell believes is otherwise in the public domain or publicly available. Chartwell did not assume marketing functions from prior owner, and did not receive any historical data from the sellers of the ANDAs. | ||||||
Chartwell Rx LLC | Memantine HCl Oral Solution 2MG/ML 20x5ML UD | 62135094324 | The information contained in this report is subject to the following limitations and assumptions: Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Chartwell believes is otherwise in the public domain or publicly available. Chartwell did not assume marketing functions from prior owner, and did not receive any historical data from the sellers of the ANDAs. | ||||||
Chartwell Rx LLC | Acyclovir (Base) 200MG/5ML 20x20ML UD | 62135080323 | The information contained in this report is subject to the following limitations and assumptions: Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Chartwell believes is otherwise in the public domain or publicly available. Chartwell did not assume marketing functions from prior owner, and did not receive any historical data from the sellers of the ANDAs. | ||||||
Chartwell Rx LLC | Acyclovir (Base) 200MG/5ML 20x5ML UD | 62135080324 | The information contained in this report is subject to the following limitations and assumptions: Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Chartwell believes is otherwise in the public domain or publicly available. Chartwell did not assume marketing functions from prior owner, and did not receive any historical data from the sellers of the ANDAs. | ||||||
Chartwell Rx LLC | Albuterol (Sulfate) DAA Syrup Regular 2MG/5ML 20x20ML UD | 62135018923 | The information contained in this report is subject to the following limitations and assumptions: Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Chartwell believes is otherwise in the public domain or publicly available. Chartwell did not assume marketing functions from prior owner, and did not receive any historical data from the sellers of the ANDAs. | ||||||
Chartwell Rx LLC | Albuterol (Sulfate) DAA Syrup Regular 2MG/5ML 20x5ML UD | 62135018924 | The information contained in this report is subject to the following limitations and assumptions: Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Chartwell believes is otherwise in the public domain or publicly available. Chartwell did not assume marketing functions from prior owner, and did not receive any historical data from the sellers of the ANDAs. | ||||||
Chartwell Rx LLC | Lamivudine Oral Solution 10MG/ML 20x30ML UD | 62135070624 | The information contained in this report is subject to the following limitations and assumptions: Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Chartwell believes is otherwise in the public domain or publicly available. Chartwell did not assume marketing functions from prior owner, and did not receive any historical data from the sellers of the ANDAs. | ||||||
Chartwell Rx LLC | Citalopram (Hydrobromide) 10MG/5ML 20x10ML UD | 62135054024 | The information contained in this report is subject to the following limitations and assumptions: Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Chartwell believes is otherwise in the public domain or publicly available. Chartwell did not assume marketing functions from prior owner, and did not receive any historical data from the sellers of the ANDAs. | ||||||
Chartwell Rx LLC | Escitalopram Oxalate Oral Solution 5 MG/5ML 20x10ML UD | 62135072924 | The information contained in this report is subject to the following limitations and assumptions: Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Chartwell believes is otherwise in the public domain or publicly available. Chartwell did not assume marketing functions from prior owner, and did not receive any historical data from the sellers of the ANDAs. | ||||||
Chartwell Rx LLC | Oxybutynin Chloride Solution 5 MG/5ML 20x5ML UD | 62135052024 | The information contained in this report is subject to the following limitations and assumptions: Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Chartwell believes is otherwise in the public domain or publicly available. Chartwell did not assume marketing functions from prior owner, and did not receive any historical data from the sellers of the ANDAs. | ||||||
Chartwell Rx LLC | Phenobarbital Elixir 20MG/5ML 20x15ML UD | 62135096222 | The information contained in this report is subject to the following limitations and assumptions: Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Chartwell believes is otherwise in the public domain or publicly available. Chartwell did not assume marketing functions from prior owner, and did not receive any historical data from the sellers of the ANDAs. | ||||||
Chartwell Rx LLC | Phenobarbital Elixir 20MG/5ML 20x5ML UD | 62135096224 | The information contained in this report is subject to the following limitations and assumptions: Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Chartwell believes is otherwise in the public domain or publicly available. Chartwell did not assume marketing functions from prior owner, and did not receive any historical data from the sellers of the ANDAs. | ||||||
Chartwell Rx LLC | Phenobarbital Elixir 20MG/5ML 20x7.5ML UD | 62135096223 | The information contained in this report is subject to the following limitations and assumptions: Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Chartwell believes is otherwise in the public domain or publicly available. Chartwell did not assume marketing functions from prior owner, and did not receive any historical data from the sellers of the ANDAs. | ||||||
Chartwell Rx LLC | Tricitrates (Potassium Salt, Sodium Salt, Citric Acid) 550-500-334MG/5ML 20x5ML UD | 62135043824 | The information contained in this report is subject to the following limitations and assumptions: Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Chartwell believes is otherwise in the public domain or publicly available. Chartwell did not assume marketing functions from prior owner, and did not receive any historical data from the sellers of the ANDAs. | ||||||
Cintex Services LLC | ERGOTAMINE TARTRATE AND CAFFEINE (CAFFEINE; ERGOTAMINE TARTRATE) 100MG;1MG Oral Tablet, 40ct Bottle [Qty: 1] | 24470091740 | US Patients Description: According to the National Institute of Neurological Disorders and Stroke (NINDS), an estimated 39 million Americans experience migraines each year. The American Academy of Neurology reported that 46% of patients were treated with prescription medicine. | ||||||
Daiichi Sankyo, Inc. | "DATROWAY® (datopotamab deruxtecan-dlnk) One 100 mg single-dose vial" | 65597080101 | |||||||
Deciphera Pharmaceuticals, LLC | Romvimza (vimseltinib) Capsule, 30 mg 1 Carton (8 count blister in wallet) | 73207030440 | Currently, the exact population of tenosynovial giant cell tumor "TGCT" patients in the US is not clearly understood. It is estimated that there may be approximately 1,400 incident cases in the US annually. Romvimza may be used in a smaller subset of these patients per its label. The first sale of this package size occured on 2/20/2025. | ||||||
Dr. Reddy's Laboratories, Inc. | Dasatinib 100mg Tablet, 30 | 43598060330 | 1) Dr. Reddys does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Dr. Reddys lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. The number of patients listed is based on the number of patients with leukemia in the US; 2) Product was not acquired; 3) The market introduction date is the date when the product was available for sale. For purchases of this product, the drug was not available for sale in California until this intro date. This was the same date that was filed in our 3-day reports, and the reports submitted to other states under their drug price transparency statutes, as well as the date for purposes of computing government price reporting. | ||||||
Dr. Reddy's Laboratories, Inc. | Dasatinib 140mg Tablet, 30 | 43598060430 | 1) Dr. Reddys does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Dr. Reddys lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. The number of patients listed is based on the number of patients with leukemia in the US; 2) Product was not acquired; 3) The market introduction date is the date when the product was available for sale. For purchases of this product, the drug was not available for sale in California until this intro date. This was the same date that was filed in our 3-day reports, and the reports submitted to other states under their drug price transparency statutes, as well as the date for purposes of computing government price reporting. | ||||||
Dr. Reddy's Laboratories, Inc. | Dasatinib 20mg Tablet, 60 | 43598059960 | 1) Dr. Reddys does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Dr. Reddys lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. The number of patients listed is based on the number of patients with leukemia in the US; 2) Product was not acquired; 3) The market introduction date is the date when the product was available for sale. For purchases of this product, the drug was not available for sale in California until this intro date. This was the same date that was filed in our 3-day reports, and the reports submitted to other states under their drug price transparency statutes, as well as the date for purposes of computing government price reporting. | ||||||
Dr. Reddy's Laboratories, Inc. | Dasatinib 50mg Tablet, 60 | 43598060060 | 1) Dr. Reddys does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Dr. Reddys lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. The number of patients listed is based on the number of patients with leukemia in the US; 2) Product was not acquired; 3) The market introduction date is the date when the product was available for sale. For purchases of this product, the drug was not available for sale in California until this intro date. This was the same date that was filed in our 3-day reports, and the reports submitted to other states under their drug price transparency statutes, as well as the date for purposes of computing government price reporting. | ||||||
Dr. Reddy's Laboratories, Inc. | Dasatinib 70mg Tablet, 60 | 43598060160 | 1) Dr. Reddys does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Dr. Reddys lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. The number of patients listed is based on the number of patients with leukemia in the US; 2) Product was not acquired; 3) The market introduction date is the date when the product was available for sale. For purchases of this product, the drug was not available for sale in California until this intro date. This was the same date that was filed in our 3-day reports, and the reports submitted to other states under their drug price transparency statutes, as well as the date for purposes of computing government price reporting. | ||||||
Dr. Reddy's Laboratories, Inc. | Dasatinib 80mg Tablet, 30 | 43598060230 | 1) Dr. Reddys does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Dr. Reddys lacks sufficient information to determine the total number of patients who may be prescribed its product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. The number of patients listed is based on the number of patients with leukemia in the US; 2) Product was not acquired; 3) The market introduction date is the date when the product was available for sale. For purchases of this product, the drug was not available for sale in California until this intro date. This was the same date that was filed in our 3-day reports, and the reports submitted to other states under their drug price transparency statutes, as well as the date for purposes of computing government price reporting. | ||||||
Fresenius Kabi USA LLC | Calcitonin Salmon Injection Solution Package Size 2ml Package Quantity 1 | 63323086502 | New Product Report is triggered based on 30-day course of therapy. | ||||||
Fresenius Kabi USA LLC | Otulfi® (ustekinumab-aauz) 130mg/26mL Vial for intravenous infusion Package Quantity 1 | 65219082805 | |||||||
Fresenius Kabi USA LLC | Otulfi® (ustekinumab-aauz) 45mg/0.5 mL Prefilled Syringes Package Quantity 1 | 65219082401 | |||||||
Fresenius Kabi USA LLC | Otulfi® (ustekinumab-aauz) 90mg/1mL Prefilled Syringes Package Quantity 1 | 65219082626 | |||||||
Genentech USA | Evrysdi 5mg Tablets 30 Tablets | 50242020201 | |||||||
Glenmark Pharmaceuticals Inc., USA | Phytonadione Injectable Emulsion 10 mg/mL 25 Vials | 68462075825 | The information contained in this report is subject to the following limitations and assumptions: Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Glenmark believes is in the public domain or publicly available. Acquisition fields left blank as drug was developed by Gland but being marketed by Glenmark. Marketing/Pricing Plan not in the public domain or publicly available. To provide its best estimate of U.S. patients who may be prescribed this drug product per year, Glenmark estimated patient populations for each indication of the drug. This product is indicated for coagulation disorders due to faulty formations of factors II, VII, IX and X. It is also given to newborns for prophylaxis treatment of hemorrhagic disease. We estimated potential patients that meet these criteria. For neonate estimated patients, we took the latest data on the number of births in the US (https://www.cdc.gov/nchs/products/databriefs/db507.htm) 3,596,017 for 2023 and rounded up to 3.6 MM. For coagulation disorders with Factor II,VII and X deficiencies, we used the incidents per person based on data from bleeding.org ( https://www.bleeding.org/bleeding-disorders-a-z) and applied to the latest US population data from the US census bureau (https://www.census.gov/library/stories/2024/12/new-year-population.html#:~:text=Population%20size%20(by%20single%20year,%2C%20Fertility%2C%20Mortality%20and%20Migration), Factor II - 1 in 2,000,000 when applied to total population of 341,150,000 (rounded) is 171 patients, Factor VII - 1 per 300,000 (low end of range) and applied to the population figure is 1,137 patients, Factor X - 1 per 500,000 (low end of range) and applied to the population figure is 682 patients. For coagulation disorder with Factor IX deficiency (Hemophilia B), we used the maximum number of persons with hemophilia based on data from bleeding.org ( https://www.bleeding.org/bleeding-disorders-a-z) 33,000 people and used their assumption that one quarter of this population has Hemophilia B or 8,250 patients. Total estimated patients who may be given this product is is 3,610,240. | ||||||
Hikma Pharmaceuticals USA Inc | Mercaptopurine Oral Suspension, 20mg/mL, 100 mL Bottle | 00054458249 | Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product. Hikma has not evaluated the volume of patients in the USA. Mercaptopurine Oral Suspension is indicated as a therapy for patients with acute lymphocytic leukemia. According to the National Cancer Institute, there are approximately 115,294 people living with acute lymphocytic leukemia in the United States. | ||||||
INA Pharmaceutics Inc | Gabarone (Gabapentin) 100MG, 90 ct tabs | 74157001390 | |||||||
INA Pharmaceutics Inc | Gabarone (Gabapentin) 400MG, 90 ct tabs | 74157011190 | |||||||
Incyte Corporation | Niktimvo (axatilimab-csfr) injection 22mg/0.44mL, for intravenous use, 1 vial | 50881002311 | |||||||
Incyte Corporation | Niktimvo (axatilimab-csfr) injection 9mg/0.18mL, for intravenous use, 1 Vial | 50881003412 | |||||||
Ingenus Pharmaceuticals, LLC | Fentanyl 50mcg/hr Transdermal Patch | 50742055205 | |||||||
Ingenus Pharmaceuticals, LLC | Fentanyl 75mcg/hr Transdermal Patch | 50742055405 | |||||||
Ingenus Pharmaceuticals, LLC | Fentanyl 100mcg/hr Transdermal Patch | 50742055605 | |||||||
Ingenus Pharmaceuticals, LLC | Fentanyl 25mcg/hr Transdermal Patch | 50742055005 | The WAC pricing entered is the WAC for a course of therapy. The package WAC of the 25mcg/hr. is $35.00 | ||||||
Ingenus Pharmaceuticals, LLC | Fentanyl 12mcg/hr. Transdermal Patch | 50742054905 | |||||||
Ingenus Pharmaceuticals, LLC | Fentanyl 37.5mcg/hr Transdermal Patch | 50742055105 | |||||||
Ingenus Pharmaceuticals, LLC | Fentanyl Transdermal Patch 62.5mcg/hr. | 50742055305 | |||||||
Ingenus Pharmaceuticals, LLC | Fentanyl Transdermal Patch 87.5mcg/hr. | 50742055505 | |||||||
Lumicell | Lumisight Intravenous Solution Reconstituted 39 MG, 1 Each, Unit-Dose, Vial Qty 10 | 82292004010 | |||||||
Medexus Pharma, Inc | GRAFAPEX (treosulfan) for injection 5g/vial | 59137036501 | |||||||
Merck Sharp & Dohme LLC | PREVYMIS 120 mg/packet oral pellets 30 packets | 00006508501 | Estimated number of Patients: Merck estimates that nationally there are approximately 2,000 patients annually who will undergo qualifying transplants that could potentially make them eligible to receive one of the oral pellet formulations of PREVYMIS, based on the latest publicly available data from Organ Procurement & Transplant Networks databases. Merck does not know how many patients might be prescribed the drug as not all such patients may be a candidate for the oral pellet formulation of PREVYMIS. | ||||||
Merck Sharp & Dohme LLC | PREVYMIS 20 mg/packet pellets 30 packets | 00006508601 | Estimated number of Patients: Merck estimates that nationally there are approximately 2,000 patients annually who will undergo qualifying transplants that could potentially make them eligible to receive one of the oral pellet formulations of PREVYMIS, based on the latest publicly available data from Organ Procurement & Transplant Networks databases. Merck does not know how many patients might be prescribed the drug as not all such patients may be a candidate for the oral pellet formulation of PREVYMIS. | ||||||
Mesoblast Inc. | Ryoncil (remestemcel-l-rknd) 1 Kit (1 Single Use Vial) Target 25 X 10^6 MSCs/ 3.8mL (6.68 x 10^6 MSCs/mL) for resuspension and infusion | 73648011101 | |||||||
Mesoblast Inc. | Ryoncil (remestemcel-l-rknd) 1 Kit (2 Single Use Vials) Target 25 X 10^6 MSCs/ 3.8mL (6.68 x 10^6 MSCs/mL) for resuspension and infusion | 73648011202 | |||||||
Mesoblast Inc. | Ryoncil (remestemcel-l-rknd) 1 Kit (3 Single Use Vials) Target 25 X 10^6 MSCs/ 3.8mL (6.68 x 10^6 MSCs/mL) for resuspension and infusion | 73648011303 | |||||||
Mesoblast Inc. | Ryoncil (remestemcel-l-rknd) 1 Kit (4 Single Use Vials) Target 25 X 10^6 MSCs/ 3.8mL (6.68 x 10^6 MSCs/mL) for resuspension and infusion | 73648011401 | |||||||
Mesoblast Inc. | Ryoncil (remestemcel-l-rknd) 1 Kit (5 Single Use Vials) Target 25 X 10^6 MSCs/ 3.8mL (6.68 x 10^6 MSCs/mL) for resuspension and infusion | 73648011502 | |||||||
Mesoblast Inc. | Ryoncil (remestemcel-l-rknd) 1 Kit (6 Single Use Vials) Target 25 X 10^6 MSCs/ 3.8mL (6.68 x 10^6 MSCs/mL) for resuspension and infusion | 73648011603 | |||||||
Mesoblast Inc. | Ryoncil (remestemcel-l-rknd) 1 Kit (7 Single Use Vials) Target 25 X 10^6 MSCs/ 3.8mL (6.68 x 10^6 MSCs/mL) for resuspension and infusion | 73648011704 | |||||||
Mesoblast Inc. | Ryoncil (remestemcel-l-rknd) 1 Kit (8 Single Use Vials) Target 25 X 10^6 MSCs/ 3.8mL (6.68 x 10^6 MSCs/mL) for resuspension and infusion | 73648011802 | |||||||
Mylan Pharmaceuticals Inc | Ferric Citrate 210mg | 00378289520 | Mylans Ferric Citrate product is an authorized generic of the Auryxia product. Ferric Citrate is indicated for the control of serum phosphorous levels in patients with chronic kidney disease on dialysis. Based on current literature, ~555,000 Americans are currently on dialysis. Of these patients, ~69% experience serum phosphorous levels above normal range (>4.5mg/dl). This means ~382,950 Americans undergoing dialysis for chronic kidney disease are eligible for prescription of Ferric Citrate to control serum phosphorous levels. Ferric Citrate is also indicated for the treatment of iron deficiency anemia in adults with chronic kidney disease not on dialysis. Given that only 555,000 of the ~35,000,000 Americans with chronic kidney disease are currently on dialysis, ~34,945,000 Americans living with chronic kidney disease are not on dialysis. Of these patients, ~15.4% are estimated to have anemia. Thia means ~5,381,530 Americans not undergoing dialysis for chronic kidney disease are eligible for prescription of Ferric Citrate to treat iron deficiency anemia. Altogether between these indications, ~5,764,480 Americans are eligible for prescription of Ferric Citrate 210mg. | ||||||
Neurelis | Valtoco 10 MG Dose Nasal Liquid 10 MG/0.1ML 5 per box | 72252051005 | |||||||
Neurelis | Valtoco 15 MG Dose Nasal Liquid Therapy Pack 2 x 7.5 MG/0.1ML 5 per box | 72252051510 | |||||||
Neurelis | Valtoco 20 MG Dose Nasal Liquid Therapy Pack 2 x 10 MG/0.1ML 5 per box | 72252052010 | |||||||
Neurelis | Valtoco 5 MG Dose Nasal Liquid 5 MG/0.1ML 5 per box | 72252050505 | |||||||
Neurotech Pharmaceuticals, Inc. | ENCELTO (revakinagene taroretcel-lwey, 82958-501-01), a single-dose implant that contains 200,000 to 440,000 allogeneic retinal pigment epithelial cells expressing rhCNTF for intravitreal surgical placement. Opaque semi-permeable capsule. | 82958050101 | |||||||
Novo | ALHEMO (concizumab-mtci) injection 150 mg/1.5 mL (100 mg/mL); 1.5 mL in 1 prefilled pen | 00169208015 | The U.S. Food and Drug Administration (FDA) granted Priority Review designation for ALHEMO® (concizumab-mtci) injection for prophylactic treatment of patients with hemophilia A and B with inhibitors. Because of the unmet medical needs in this population, and based on the Phase 2 clinicial trial results, the FDA granted Breakthrough Therapy designation for ALHEMO® in hemophilia B with inhibitors. For the estimated patients per month requirement, Novo Nordisk utilizes product indication, targeted product profile, services, payer prior authorization requirements as well as the time factor to find the specialists managing undiagnosed patients and get them educated to estimate the number of patients who may be prescribed ALHEMO®. Novo Nordisk has estimated 2 patients per month or a total of 31 patients per year (approximately 25 HBwI patients and 6 HAwI patients) as the average number of patients who may be prescribed ALHEMO® each month in the United States. However, we note that the estimated prevalence of patients with hemophilia in the United States (US) is 33,000 between years 2012 and 2022 per the CDC. This includes both A and B subtypes. The prevalence of the two subtypes in hemophilia patients is approximately 20% have hemophilia B and 80% have hemophilia A. Overall, approximately 5% of each of these two cohorts will develop inhibitors. ALHEMO® is a tissue factor pathway inhibitor (TFPI) antagonist indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A (congenital factor VIII deficiency) with FVIII inhibitors and hemophilia B (congenital factor IX deficiency) with FIX inhibitors. The indication for hemophilia B with inhibitors (HBwI) represents a significant unmet need for the prophylactic treatment of this disease. Since there are limited treatment options and given the small number of total patients affected with HBwI (approximately 1% of the total hemophilia population), we estimate a higher volume of HBwI patients in the US to receive ALHEMO® than HAwI patients, who may have other prophylactic medication treatment options available. Therefore, the estimated number of hemophilia patients who may be prescribed ALHEMO® is much less than the prevalence. The full prescribing information for ALHEMO® is available at https://www.novo-pi.com/alhemo.pdf | ||||||
Novo | ALHEMO (concizumab-mtci) injection 60 mg/1.5 mL (40 mg/mL); 1.5 mL in 1 prefilled pen | 00169208415 | The U.S. Food and Drug Administration (FDA) granted Priority Review designation for ALHEMO® (concizumab-mtci) injection for prophylactic treatment of patients with hemophilia A and B with inhibitors. Because of the unmet medical needs in this population, and based on the Phase 2 clinicial trial results, the FDA granted Breakthrough Therapy designation for ALHEMO® in hemophilia B with inhibitors. For the estimated patients per month requirement, Novo Nordisk utilizes product indication, targeted product profile, services, payer prior authorization requirements as well as the time factor to find the specialists managing undiagnosed patients and get them educated to estimate the number of patients who may be prescribed ALHEMO®. Novo Nordisk has estimated 2 patients per month or a total of 31 patients per year (approximately 25 HBwI patients and 6 HAwI patients) as the average number of patients who may be prescribed ALHEMO® each month in the United States. However, we note that the estimated prevalence of patients with hemophilia in the United States (US) is 33,000 between years 2012 and 2022 per the CDC. This includes both A and B subtypes. The prevalence of the two subtypes in hemophilia patients is approximately 20% have hemophilia B and 80% have hemophilia A. Overall, approximately 5% of each of these two cohorts will develop inhibitors. ALHEMO® is a tissue factor pathway inhibitor (TFPI) antagonist indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A (congenital factor VIII deficiency) with FVIII inhibitors and hemophilia B (congenital factor IX deficiency) with FIX inhibitors. The indication for hemophilia B with inhibitors (HBwI) represents a significant unmet need for the prophylactic treatment of this disease. Since there are limited treatment options and given the small number of total patients affected with HBwI (approximately 1% of the total hemophilia population), we estimate a higher volume of HBwI patients in the US to receive ALHEMO® than HAwI patients, who may have other prophylactic medication treatment options available. Therefore, the estimated number of hemophilia patients who may be prescribed ALHEMO® is much less than the prevalence. The full prescribing information for ALHEMO® is available at https://www.novo-pi.com/alhemo.pdf | ||||||
Novo | ALHEMO (concizumab-mtci) injection 300 mg/3 mL (100 mg/mL); 3 mL in 1 prefilled pen | 00169208103 | The U.S. Food and Drug Administration (FDA) granted Priority Review designation for ALHEMO® (concizumab-mtci) injection for prophylactic treatment of patients with hemophilia A and B with inhibitors. Because of the unmet medical needs in this population, and based on the Phase 2 clinicial trial results, the FDA granted Breakthrough Therapy designation for ALHEMO® in hemophilia B with inhibitors. For the estimated patients per month requirement, Novo Nordisk utilizes product indication, targeted product profile, services, payer prior authorization requirements as well as the time factor to find the specialists managing undiagnosed patients and get them educated to estimate the number of patients who may be prescribed ALHEMO®. Novo Nordisk has estimated 2 patients per month or a total of 31 patients per year (approximately 25 HBwI patients and 6 HAwI patients) as the average number of patients who may be prescribed ALHEMO® each month in the United States. However, we note that the estimated prevalence of patients with hemophilia in the United States (US) is 33,000 between years 2012 and 2022 per the CDC. This includes both A and B subtypes. The prevalence of the two subtypes in hemophilia patients is approximately 20% have hemophilia B and 80% have hemophilia A. Overall, approximately 5% of each of these two cohorts will develop inhibitors. ALHEMO® is a tissue factor pathway inhibitor (TFPI) antagonist indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A (congenital factor VIII deficiency) with FVIII inhibitors and hemophilia B (congenital factor IX deficiency) with FIX inhibitors. The indication for hemophilia B with inhibitors (HBwI) represents a significant unmet need for the prophylactic treatment of this disease. Since there are limited treatment options and given the small number of total patients affected with HBwI (approximately 1% of the total hemophilia population), we estimate a higher volume of HBwI patients in the US to receive ALHEMO® than HAwI patients, who may have other prophylactic medication treatment options available. Therefore, the estimated number of hemophilia patients who may be prescribed ALHEMO® is much less than the prevalence. The full prescribing information for ALHEMO® is available at https://www.novo-pi.com/alhemo.pdf | ||||||
Nuvaila US, LLC | AMJEVITA 20mg/0.2ml PREFILLED SYRINGE 1 Count | 84612039901 | Estimated patients in the United States with a condition that may be prescribed the drug annually. An estimate is provided for the product family (AMJEVITA). | ||||||
Nuvaila US, LLC | AMJEVITA 40mg/0.4ml AUTOINJECTOR 2 Count | 84612048202 | Estimated patients in the United States with a condition that may be prescribed the drug annually. An estimate is provided for the product family (AMJEVITA). | ||||||
Nuvaila US, LLC | AMJEVITA 40mg/0.4ml PREFILLED SYRINGE 2 Count | 84612047902 | Estimated patients in the United States with a condition that may be prescribed the drug annually. An estimate is provided for the product family (AMJEVITA). | ||||||
Nuvaila US, LLC | AMJEVITA 80mg/0.8ml AUTOINJECTOR 2 Count | 84612048102 | Estimated patients in the United States with a condition that may be prescribed the drug annually. An estimate is provided for the product family (AMJEVITA). | ||||||
Nuvaila US, LLC | WEZLANA 130mg/26ml SINGLE DOSE VIAL 1 Count | 84612006601 | Estimated patients in the United States with a condition that may be prescribed the drug annually. An estimate is provided for the product family (WEZLANA). | ||||||
Nuvaila US, LLC | WEZLANA 45mg/0.5ml PREFILLED SYRINGE 1 Count | 84612007601 | Estimated patients in the United States with a condition that may be prescribed the drug annually. An estimate is provided for the product family (WEZLANA). | ||||||
Nuvaila US, LLC | WEZLANA 45mg/0.5ml PREFILLED SYRINGE 1 Count Standard | 84612087601 | Estimated patients in the United States with a condition that may be prescribed the drug annually. An estimate is provided for the product family (WEZLANA). | ||||||
Nuvaila US, LLC | WEZLANA 45mg/0.5ml SINGLE DOSE VIAL 1 Count | 84612005501 | Estimated patients in the United States with a condition that may be prescribed the drug annually. An estimate is provided for the product family (WEZLANA). | ||||||
Nuvaila US, LLC | WEZLANA 45mg/0.5ml SINGLE DOSE VIAL 1 Count Standard | 84612085501 | Estimated patients in the United States with a condition that may be prescribed the drug annually. An estimate is provided for the product family (WEZLANA). | ||||||
Nuvaila US, LLC | WEZLANA 90mg/ml PREFILLED SYRINGE 1 Count | 84612008901 | Estimated patients in the United States with a condition that may be prescribed the drug annually. An estimate is provided for the product family (WEZLANA). | ||||||
Nuvaila US, LLC | WEZLANA 90mg/ml PREFILLED SYRINGE 1 Count Standard | 84612088901 | Estimated patients in the United States with a condition that may be prescribed the drug annually. An estimate is provided for the product family (WEZLANA). | ||||||
PureTek Corporation | VennGel II, Diclofenac Sodium 1% Topical Gel (100gm), Alcohol Pads, Large, 100ct box | 59088022407 | Dispensed by prescription only | ||||||
PureTek Corporation | Fungizyl AL, Dimethyl Sulfoxide 2%, Miconazole Nitrate 2%(1fl oz) | 59088020503 | Dispensed by prescription only | ||||||
PureTek Corporation | Flotrex chewable multivitamins with 0.25mg Fluoride, Vitamin A (as Retinyl Acetate) 750 mcg RAE Vitamin C , Vitamin D3, Vitamin E, Thiamin , Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, 30ct | 59088001754 | Dispensed by prescription only | ||||||
Sagent Pharmaceuticals | Isoproterenol Hydrochloride Injection (0.2mg/ml, 1ml, 10x1ml) | 25021032401 | |||||||
Sagent Pharmaceuticals | Isoproterenol Hydrochloride Injection (0.2mg/ml, 5ml, 10x5ml) | 25021032405 | |||||||
Sagent Pharmaceuticals | Procainamide Hydrochloride Injection (500mg/ml, 2ml, 10x2ml) | 25021032302 | |||||||
Sandoz Inc. | ADALIMUMAB 80MG/0.8ML 2LISY PE BI V1 US | 61314032520 | Adalimumab is a tumor necrosis factor (TNF) blocker indicated for 9 disease states : 1. Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. 2. Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older. 3. Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA. 4. Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS. 5. Crohns Disease (CD): treatment of moderately to severely active Crohns disease in adults and pediatric patients 6 years of age and older. 6. Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. 7. Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. 8. Hidradenitis Suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. 9. Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. Source: Label from USFDA (Drugs@FDA). Link below label (fda.gov) Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product. Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure. | ||||||
Sandoz Inc. | Edaravone 30MG/100ML 2LIBA US | 00781352720 | Amyotrophic Lateral Sclerosis (ALS): ALS is a progressive neurodegenerative disease that affects motor neurons in the brain and spinal cord, causing muscle weakness, severe disability, and eventually death. The condition affects approximately 15,00021,000 people in the United States, according to the ALS Association. The average life expectancy of a person with ALS is about 2-5 years from the time of diagnosis, although some people can live with the disease for more than 5 years. Approximately 5000 people in the United States are diagnosed with ALS each year. There is an estimated 63 patients treated with Edaravone IV in the United States. Source : IQVIA, PIL (Drugs@FDA), Company Website Acquistion date and Acquistion price not applicable as Sandoz did not acquire this product. Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure. | ||||||
Sandoz Inc. | PYZCHIVA 130MG/26ML 26ML LIVI US | 61314065494 | Pychiva is a human interleukin-12 and -23 antagonist indicated for a numer of treatment in Adults with: 1. Moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy 2. Active psoriatic arthritis (PsA) 3. Moderately to severely active Crohns disease (CD) 4. Moderately to severely active ulcerative colitis B. Pediatric patients 6 years and older with : 1. Moderate to severe plaque psoriasis, who are candidates for phototherapy or systemic therapy 2. Active psoriatic arthritis (PsA) There is an estimated 140,685 patients treated with Pychiva in the United States. Source: Label (Drug@FDA, USFDA) Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product. Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure. | ||||||
Sandoz Inc. | PYZCHIVA 45MG/0.5ML 0.5ML LISY US | 61314065101 | Pychiva is a human interleukin-12 and -23 antagonist indicated for a numer of treatment in Adults with: 1. Moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy 2. Active psoriatic arthritis (PsA) 3. Moderately to severely active Crohns disease (CD) 4. Moderately to severely active ulcerative colitis B. Pediatric patients 6 years and older with : 1. Moderate to severe plaque psoriasis, who are candidates for phototherapy or systemic therapy 2. Active psoriatic arthritis (PsA) There is an estimated 140,685 patients treated with Pychiva in the United States. Source: Label (Drug@FDA, USFDA) Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product. Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure. | ||||||
Sandoz Inc. | PYZCHIVA 90MG/1ML 1ML LISY US | 61314065201 | Pychiva is a human interleukin-12 and -23 antagonist indicated for a numer of treatment in Adults with: 1. Moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy 2. Active psoriatic arthritis (PsA) 3. Moderately to severely active Crohns disease (CD) 4. Moderately to severely active ulcerative colitis B. Pediatric patients 6 years and older with : 1. Moderate to severe plaque psoriasis, who are candidates for phototherapy or systemic therapy 2. Active psoriatic arthritis (PsA) There is an estimated 140,685 patients treated with Pychiva in the United States. Source: Label (Drug@FDA, USFDA) Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product. Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure. | ||||||
Solubiomix LLC | Ultramicrosize Griseofulvin, 165 mg, tablet, 30 count | 73308043530 | |||||||
SpringWorks Therapeutics | Gomekli (mirdametinib) 1mg Capsules, 42-ct bottle | 82448013042 | |||||||
SpringWorks Therapeutics | Gomekli (mirdametinib) 1mg tablets, 42-ct bottle | 82448013442 | |||||||
SpringWorks Therapeutics | Gomekli (mirdametinib) 1mg tablets, 84-ct bottle | 82448013484 | |||||||
SpringWorks Therapeutics | Gomekli (mirdametinib) 2mg Capsules, 42-ct bottle | 82448026042 | |||||||
SpringWorks Therapeutics | Gomekli (mirdametinib) 2mg Capsules, 84-ct bottle | 82448026084 | |||||||
Stallergenes Greer USA | PALFORZIA - Each package contains 13 capsules: (Level A) One 0.5 mg capsule (Level B) One 1 mg capsule (Level C) One 0.5 mg capsule; One 1 mg capsule (Level D) Three 1 mg capsules (Level E) Six 1 mg capsules | 22840011407 | |||||||
Stallergenes Greer USA | PALFORZIA - Each package contains fifteen 1mg capsules | 22840012615 | |||||||
SUN PHARMACEUTICALS | Deflazacort Oral Tablets 6mg, 100ct | 70095004001 | |||||||
SUN PHARMACEUTICALS | Deflazacort Oral Tablets, 18mg, 30ct | 70095004130 | |||||||
SUN PHARMACEUTICALS | Deflazacort Oral Tablets, 30mg, 30ct | 70095004230 | |||||||
SUN PHARMACEUTICALS | Deflazacort Oral Tablets, 36mg, 30ct | 70095004330 | |||||||
Syndax Pharmaceuticals, Inc. | REVUFORJ (revumenib) 25mg Package Quantity 30 Tablets | 73555050000 | |||||||
Teva Pharmaceuticals USA | Simlandi Pre-Filled Syringe Kit 80mg/0.8mL | 51759052321 | Research suggests that there are a total of approximately 14,600,000 patients who suffer from the various conditions that Simlandi is indicated to treat | ||||||
Teva Pharmaceuticals USA | Simlandi (2 syringe) Pre-Filled Syringe Kit 20mg/0.2mL | 51759038622 | Research suggests that there are a total of approximately 14,600,000 patients who suffer from the various conditions that Simlandi is indicated to treat | ||||||
Teva Pharmaceuticals USA | SELARSDI Prefilled Syringe 45 mg/0.5 mL | 51759050532 | Research suggests that there are a total of approximately 9,688,000 patients who suffer from the various conditions that Simlandi is indicated to treat | ||||||
Teva Pharmaceuticals USA | SELARSDI Prefilled Syringe 90 mg/mL | 51759060732 | Research suggests that there are a total of approximately 9,688,000 patients who suffer from the various conditions that Simlandi is indicated to treat | ||||||
Teva Pharmaceuticals USA | OCTREOTIDE ACETATE INJ 10MG/VIAL KIT 1 | 00480925708 | Research suggests that as many as 9,330 Americans, in total, suffer from the conditions that this product is indicated to treat. Acquisition fields left blank; Teva developed the product. | ||||||
Teva Pharmaceuticals USA | SELARSDI Single Dose Vial 130mg/26mL | 51759070813 | Research suggests that there are a total of approximately 9,688,000 patients who suffer from the various conditions that Selarsdi is indicated to treat | ||||||
Tilde Sciences LLC | Vecamyl Oral Tablet 2.5 MG, 100 count bottle | 83649055801 | At the point of acquisition, the drug was in shortage. The company worked with the CDMO to identify a new API manufacturer and has been working with the FDA to provide stability data. At this time the company is waiting for FDA approval to relaunch the product. Approval is expected as early as 4/1/2025. | ||||||
Upsher-Smith Laboratories, LLC | Deflazacort 18mg tblt Btl 30ct | 00832081530 | |||||||
Upsher-Smith Laboratories, LLC | Deflazacort 30mg tblt Btl 30ct | 00832081630 | |||||||
Upsher-Smith Laboratories, LLC | Deflazacort 36mg tblt Btl 30ct | 00832081730 | |||||||
Upsher-Smith Laboratories, LLC | Deflazacort 6mg tblt Btl 100ct | 00832081411 | |||||||
Validus Pharmaceuticals | Trazodone Hydrochloride Oral Solution, 10mg/mL Raldesy TM 150ml HDPE Bottle Pack | 30698045502 | Raldesy is the only oral liquid formulation of trazodone hydrochloride | ||||||
Validus Pharmaceuticals | Trazodone Hydrochloride Oral Solution, 10mg/mL Raldesy TM 300ml HDPE Bottle Pack | 30698045501 | Raldesy is the only oral liquid formulation of trazodone hydrochloride | ||||||
Verrica Pharmaceuticals Inc. | YCANTH 0.7% (w/v) 1 applicator | 71349007011 | |||||||
Vertex Pharmaceuticals Incorporated | ALYFTREK (vanzacaftor 10 mg/tezacaftor 50 mg/deutivacaftor 125 mg film-coated tablets) is supplied as a 56-count tablet carton (4 wallets, each wallet containing 14 tablets of vanzacaftor/tezacaftor/deutivacaftor). | 51167012101 | Vertex estimates there are approximately 28,700 cystic fibrosis (CF) patients in the US with CF, ages 6 and older, who are eligible for ALYFTREK based on CF Registry data for 2024. Patients who are eligible for ALYFTREK have at least one F508del mutation, or another responsive mutation in the CFTR gene, and may also be eligible for other cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapies. | ||||||
Vertex Pharmaceuticals Incorporated | ALYFTREK (vanzacaftor 4 mg/tezacaftor 20 mg/deutivacaftor 50 mg film-coated tablets) is supplied as a 84-count tablet carton (4 wallets, each wallet containing 21 tablets of vanzacaftor/tezacaftor/deutivacaftor) | 51167013501 | Vertex estimates there are approximately 28,700 cystic fibrosis (CF) patients in the US with CF, ages 6 and older, who are eligible for ALYFTREK based on CF Registry data for 2024. Patients who are eligible for ALYFTREK have at least one F508del mutation, or another responsive mutation in the CFTR gene, and may also be eligible for other cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapies. | ||||||
XGen Pharmaceuticals DJB | Nelarabine Injection 250mg/50mL Vial | 39822065001 | |||||||
XGen Pharmaceuticals DJB | Nelarabine Injection 250mg/50mL x 6 | 39822065006 | |||||||
Zydus Pharmaceuticals (USA) Inc. | Beizray (Docet) Inj 80mg/4mL (160mg Kit) | 83513001001 | Acquisition date and price are not applicable. Zydus has entered 937,639 in the Estimated Number of Patients column, however: (1). Zydus role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state nor nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4). Beizray is indicated for the treatment of patients with locally advanced or metastatic breast cancer, locally advanced or metastatic non-small cell lung cancer after failure or prior platinum based chemotherapy, for the tratment of patients with metastatic castration resistant prostate cancer, for the treatment of patients with advanced gastric adenocarcinoma and also for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck. The following websites were used to come up with our patient estimate - (https://www.cancer.gov/types/breast/hp/breast-treatment-pdq#:~:text=Incidence%20and%20Mortality,-Estimated%20new%20cases&text=Breast%20cancer%20is%20the%20most,section%20in%20Breast%20Cancer%20Screening.), (https://www.cdc.gov/united-states-cancer-statistics/publications/prostate-cancer-stat-bite.html#:~:text=What%20to%20know,males%20died%20from%20prostate%20cancer), (https://www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html#:~:text=Overall%2C%20the%20chance%20that%20a,the%20past%20decade%20in%20women.), (https://www.cancer.org/cancer/types/stomach-cancer/about/key-statistics.html#:~:text=About%2030%2C300%20new%20cases%20of,risk%20factors%20for%20stomach%20cancer), (https://www.cancer.gov/types/head-and-neck/head-neck-fact-sheet#:~:text=Researchers%20estimated%20that%20more%20than,cancer%20are%20much%20less%20common.) | ||||||
Zydus Pharmaceuticals (USA) Inc. | Dasatinib 100mg Tablets 30 Count | 70710174503 | This is an AB rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has entered 70,000 in the Estimated Number of Patients column, however: (1). Zydus role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state nor nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4). Dasatinib is indicated for the treatment of newly diagnosed or previously treated Philadelphia chromosome positive chronic myeloid leukemia (Ph + CML). As per the Novartis Scemblix website (https://us.scemblix.com/about-ph-cml/ph-cml-chronic-phase) as of 2021, it was estimated that nearly 70,000 people in the United States were living with Ph+CML. For this reason we have put in a number of 70,000 in estimated number of patients. | ||||||
Zydus Pharmaceuticals (USA) Inc. | Dasatinib 140mg Tablets 30 Count | 70710174603 | This is an AB rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has entered 70,000 in the Estimated Number of Patients column, however: (1). Zydus role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state nor nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4). Dasatinib is indicated for the treatment of newly diagnosed or previously treated Philadelphia chromosome positive chronic myeloid leukemia (Ph + CML). As per the Novartis Scemblix website (https://us.scemblix.com/about-ph-cml/ph-cml-chronic-phase) as of 2021, it was estimated that nearly 70,000 people in the United States were living with Ph+CML. For this reason we have put in a number of 70,000 in estimated number of patients. | ||||||
Zydus Pharmaceuticals (USA) Inc. | Dasatinib 20mg Tablets 30 Count | 70710174106 | This is an AB rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has entered 70,000 in the Estimated Number of Patients column, however: (1). Zydus role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state nor nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4). Dasatinib is indicated for the treatment of newly diagnosed or previously treated Philadelphia chromosome positive chronic myeloid leukemia (Ph + CML). As per the Novartis Scemblix website (https://us.scemblix.com/about-ph-cml/ph-cml-chronic-phase) as of 2021, it was estimated that nearly 70,000 people in the United States were living with Ph+CML. For this reason we have put in a number of 70,000 in estimated number of patients. | ||||||
Zydus Pharmaceuticals (USA) Inc. | Dasatinib 50mg Tablets 30 Count | 70710174206 | This is an AB rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has entered 70,000 in the Estimated Number of Patients column, however: (1). Zydus role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state nor nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4). Dasatinib is indicated for the treatment of newly diagnosed or previously treated Philadelphia chromosome positive chronic myeloid leukemia (Ph + CML). As per the Novartis Scemblix website (https://us.scemblix.com/about-ph-cml/ph-cml-chronic-phase) as of 2021, it was estimated that nearly 70,000 people in the United States were living with Ph+CML. For this reason we have put in a number of 70,000 in estimated number of patients. | ||||||
Zydus Pharmaceuticals (USA) Inc. | Dasatinib 70mg Tablets 30 Count | 70710174306 | This is an AB rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has entered 70,000 in the Estimated Number of Patients column, however: (1). Zydus role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state nor nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4). Dasatinib is indicated for the treatment of newly diagnosed or previously treated Philadelphia chromosome positive chronic myeloid leukemia (Ph + CML). As per the Novartis Scemblix website (https://us.scemblix.com/about-ph-cml/ph-cml-chronic-phase) as of 2021, it was estimated that nearly 70,000 people in the United States were living with Ph+CML. For this reason we have put in a number of 70,000 in estimated number of patients. | ||||||
Zydus Pharmaceuticals (USA) Inc. | Dasatinib 80mg Tablets 30 Count | 70710174403 | This is an AB rated generic product that was developed by Zydus. Acquisition date and price are not applicable. Zydus has entered 70,000 in the Estimated Number of Patients column, however: (1). Zydus role as generic manufacturer is to provide products to our customers, not to determine what conditions our products will be used or the number of patients in the US that could potentially have the condition for which our products treat. (2). We do not estimate the number of patients that may be prescribed our products neither by state nor nationally. Manufacturing volumes are based on an estimated market share along with IQVIA data and/or usages provided by our customers. Our manufactured volumes are based on national level data and we do not break these estimates down to a patient or state level. If IQVIA has a data point that states an estimated number of patients, it is not data that Zydus subscribes to. Zydus feels that by entering IQVIA TRx data into "Estimated Number of Patients" column, it would be a misrepresentation of IQVIA's data as TRx is defined as the counts of total (new plus refill) prescriptions dispensed by pharmacists and not as the estimated number of patients. (3). Zydus neither collects nor uses estimated patient information in our normal course of business. (4). Dasatinib is indicated for the treatment of newly diagnosed or previously treated Philadelphia chromosome positive chronic myeloid leukemia (Ph + CML). As per the Novartis Scemblix website (https://us.scemblix.com/about-ph-cml/ph-cml-chronic-phase) as of 2021, it was estimated that nearly 70,000 people in the United States were living with Ph+CML. For this reason we have put in a number of 70,000 in estimated number of patients. | ||||||
None | None | None | |||||||
None | None | None |