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Atazanavir sulfateis the generic ingredient in three branded drugs marketed by Amneal, Aurobindo Pharma Ltd, Cipla, Laurus Labs Ltd, Mylan, Teva Pharms Usa, Zydus Pharms, Bristol Myers Squibb, and Bristol-myers Squibb, and is included in ten NDAs. There are two patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.
There are twenty-five drug master file entries for atazanavir sulfate. Thirteen suppliers are listed for this compound. There are six tentative approvals for this compound.
Summary for atazanavir sulfate
|Drug Master File Entries:||25|
|Finished Product Suppliers / Packagers:||13|
|Raw Ingredient (Bulk) Api Vendors:||66|
|Formulation / Manufacturing:||see details|
|Drug Prices:||Drug price trends for atazanavir sulfate|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for atazanavir sulfate|
|What excipients (inactive ingredients) are in atazanavir sulfate?||atazanavir sulfate excipients list|
|DailyMed Link:||atazanavir sulfate at DailyMed|
Recent Clinical Trials for atazanavir sulfate
Identify potential brand extensions & 505(b)(2) entrants
|ViiV Healthcare||Phase 4|
Generic filers with tentative approvals for ATAZANAVIR SULFATE
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for atazanavir sulfate
|Drug Class||Protease Inhibitor |
|Mechanism of Action||HIV Protease Inhibitors |
UDP Glucuronosyltransferases Inhibitors
Cytochrome P450 3A4 Inhibitors
Cytochrome P450 3A Inhibitors
Cytochrome P450 2C8 Inhibitors
Medical Subject Heading (MeSH) Categories for atazanavir sulfate
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