SAXAGLIPTIN Drug Patent Profile

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Saxagliptin is a drug marketed by Amneal, Aurobindo Pharma, Glenmark Pharms Ltd, Mylan, and Sun Pharm. and is included in seven NDAs.

The generic ingredient in SAXAGLIPTIN is metformin hydrochloride; saxagliptin hydrochloride. There are forty-nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the metformin hydrochloride; saxagliptin hydrochloride profile page.

A generic version of SAXAGLIPTIN was approved as metformin hydrochloride; saxagliptin hydrochloride by DR REDDYS LABS SA on August 9^th, 2023.

US Patents:	0
Applicants:	5
NDAs:	7
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	103
Clinical Trials:	121
Patent Applications:	3,751
Formulation / Manufacturing:	see details
DailyMed Link:	SAXAGLIPTIN at DailyMed

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

Drug Class	Dipeptidyl Peptidase 4 Inhibitor
Mechanism of Action	Dipeptidyl Peptidase 4 Inhibitors

A10BH	Dipeptidyl peptidase 4 (DPP-4) inhibitors
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

SAXAGLIPTIN is protected by zero US patents and one FDA Regulatory Exclusivity.

PATENT CHALLENGE
Exclusivity Expiration: ⤷ Try a Trial

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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	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mylan	SAXAGLIPTIN	saxagliptin hydrochloride	TABLET;ORAL	205980-001	Jul 31, 2023	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Aurobindo Pharma	SAXAGLIPTIN	saxagliptin hydrochloride	TABLET;ORAL	205972-002	Jul 31, 2023	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mylan	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205981-003	Jul 31, 2023	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mylan	SAXAGLIPTIN	saxagliptin hydrochloride	TABLET;ORAL	205980-002	Jul 31, 2023	AB	RX	No	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sun Pharm	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	206081-001	Jul 31, 2023	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration