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Last Updated: November 8, 2024

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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

See all saxagliptin clinical trials

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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca Ab	ONGLYZA	saxagliptin hydrochloride	TABLET;ORAL	022350-001	Jul 31, 2009		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Glenmark Pharms Ltd	SAXAGLIPTIN	saxagliptin hydrochloride	TABLET;ORAL	205994-002	Jul 31, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan	SAXAGLIPTIN	saxagliptin hydrochloride	TABLET;ORAL	205980-001	Jul 31, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glenmark Pharms Ltd	SAXAGLIPTIN	saxagliptin hydrochloride	TABLET;ORAL	205994-001	Jul 31, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal	SAXAGLIPTIN	saxagliptin hydrochloride	TABLET;ORAL	205941-002	Jul 31, 2023		DISCN	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
>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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