Last Updated: May 15, 2026

SAXAGLIPTIN - Generic Drug Details

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Recent Clinical Trials for SAXAGLIPTIN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair	PHASE2
UnitedHealthcare	PHASE2
University of Yaounde 1	PHASE1

See all SAXAGLIPTIN clinical trials

Generic filers with tentative approvals for SAXAGLIPTIN

Applicant	Application No.	Strength	Dosage Form
⤷ Start Trial	⤷ Start Trial	5MG;1000MG	TABLET, EXTENDED RELEASE;ORAL
⤷ Start Trial	⤷ Start Trial	2.5MG;1000MG	TABLET, EXTENDED RELEASE;ORAL
⤷ Start Trial	⤷ Start Trial	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
Amneal	SAXAGLIPTIN	saxagliptin hydrochloride	TABLET;ORAL	205941-001	Jul 31, 2023		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Sun Pharm	SAXAGLIPTIN	saxagliptin hydrochloride	TABLET;ORAL	206078-002	Jul 31, 2023		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Astrazeneca Ab	ONGLYZA	saxagliptin hydrochloride	TABLET;ORAL	022350-002	Jul 31, 2009		DISCN	Yes	No	⤷ Start Trial	⤷ Start Trial	Y			⤷ Start Trial
Sun Pharm	SAXAGLIPTIN	saxagliptin hydrochloride	TABLET;ORAL	206078-001	Jul 31, 2023		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Glenmark Pharms Ltd	SAXAGLIPTIN	saxagliptin hydrochloride	TABLET;ORAL	205994-001	Jul 31, 2023	AB	RX	No	No	⤷ 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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