PYRAZINAMIDE - Generic Drug Details
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What are the generic sources for pyrazinamide and what is the scope of freedom to operate?
Pyrazinamide
is the generic ingredient in one branded drug marketed by Hikma, Macleods Pharms Ltd, and Novitium Pharma, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.There are seven drug master file entries for pyrazinamide. Eight suppliers are listed for this compound.
Summary for PYRAZINAMIDE
US Patents: | 0 |
Tradenames: | 1 |
Applicants: | 3 |
NDAs: | 3 |
Drug Master File Entries: | 7 |
Finished Product Suppliers / Packagers: | 8 |
Raw Ingredient (Bulk) Api Vendors: | 152 |
Clinical Trials: | 125 |
Patent Applications: | 7,081 |
Drug Prices: | Drug price trends for PYRAZINAMIDE |
What excipients (inactive ingredients) are in PYRAZINAMIDE? | PYRAZINAMIDE excipients list |
DailyMed Link: | PYRAZINAMIDE at DailyMed |
Recent Clinical Trials for PYRAZINAMIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Madras Medical College | Phase 3 |
All India Institute of Medical Sciences, Jodhpur | Phase 3 |
Rural Development Trust Hospital | Phase 3 |
Pharmacology for PYRAZINAMIDE
Drug Class | Antimycobacterial |
Medical Subject Heading (MeSH) Categories for PYRAZINAMIDE
Anatomical Therapeutic Chemical (ATC) Classes for PYRAZINAMIDE
US Patents and Regulatory Information for PYRAZINAMIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hikma | PYRAZINAMIDE | pyrazinamide | TABLET;ORAL | 081319-001 | Jun 30, 1992 | AB | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Novitium Pharma | PYRAZINAMIDE | pyrazinamide | TABLET;ORAL | 080157-001 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Macleods Pharms Ltd | PYRAZINAMIDE | pyrazinamide | TABLET;ORAL | 212541-001 | Jul 27, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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