Saxagliptin - Generic Drug Details
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Recent Clinical Trials for saxagliptin
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Erlangen-Nürnberg Medical School | Phase 4 |
Ain Shams University | N/A |
Sabyasachi Sen | Phase 3 |
Generic filers with tentative approvals for SAXAGLIPTIN
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 5MG;1000MG | TABLET, EXTENDED RELEASE;ORAL |
⤷ Sign Up | ⤷ Sign Up | 2.5MG;1000MG | TABLET, EXTENDED RELEASE;ORAL |
⤷ Sign Up | ⤷ Sign Up | 5MG;500MG | TABLET, EXTENDED RELEASE;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
US Patents and Regulatory Information for saxagliptin
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mylan | SAXAGLIPTIN | saxagliptin hydrochloride | TABLET;ORAL | 205980-002 | Jul 31, 2023 | AB | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Sun Pharm | SAXAGLIPTIN | saxagliptin hydrochloride | TABLET;ORAL | 206078-001 | Jul 31, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Amneal | SAXAGLIPTIN | saxagliptin hydrochloride | TABLET;ORAL | 205941-001 | Jul 31, 2023 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Astrazeneca Ab | ONGLYZA | saxagliptin hydrochloride | TABLET;ORAL | 022350-002 | Jul 31, 2009 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |