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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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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