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Azathioprine - Generic Drug Details
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What are the generic sources for azathioprine and what is the scope of freedom to operate?
Azathioprine
is the generic ingredient in four branded drugs marketed by Aaipharma Llc, Alkem Labs Ltd, Amneal, Rising, Zydus Pharms Usa, Sebela Ireland Ltd, West-ward Pharms Int, and Casper Pharma Llc, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.There are sixteen drug master file entries for azathioprine. Eleven suppliers are listed for this compound.
Summary for azathioprine
US Patents: | 0 |
Tradenames: | 4 |
Applicants: | 8 |
NDAs: | 8 |
Drug Master File Entries: | 16 |
Suppliers / Packagers: | 11 |
Bulk Api Vendors: | 109 |
Clinical Trials: | 272 |
Patent Applications: | 7,356 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for azathioprine |
Drug Sales Revenues: | Drug sales revenues for azathioprine |
What excipients (inactive ingredients) are in azathioprine? | azathioprine excipients list |
DailyMed Link: | azathioprine at DailyMed |
Recent Clinical Trials for azathioprine
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Affiliated Hospital of Jilin University, Changchun,China | N/A |
Sichuan Province People's Hospital | N/A |
Chinese SLE Treatment And Research Group | N/A |
Pharmacology for azathioprine
Drug Class | Purine Antimetabolite |
Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for azathioprine
US Patents and Regulatory Information for azathioprine
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Zydus Pharms Usa | AZATHIOPRINE | azathioprine | TABLET;ORAL | 077621-002 | Sep 5, 2008 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Alkem Labs Ltd | AZATHIOPRINE | azathioprine | TABLET;ORAL | 208687-002 | Mar 27, 2020 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Alkem Labs Ltd | AZATHIOPRINE | azathioprine | TABLET;ORAL | 208687-001 | Mar 27, 2020 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Alkem Labs Ltd | AZATHIOPRINE | azathioprine | TABLET;ORAL | 208687-003 | Mar 27, 2020 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
West-ward Pharms Int | AZATHIOPRINE SODIUM | azathioprine sodium | INJECTABLE;INJECTION | 074419-001 | Mar 31, 1995 | RX | No | Yes | Start Trial | Start Trial | Start Trial | ||||
>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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