GLYBURIDE; METFORMIN HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for glyburide; metformin hydrochloride and what is the scope of freedom to operate?

Glyburide; metformin hydrochloride is the generic ingredient in two branded drugs marketed by Bristol Myers Squibb, Actavis Elizabeth, Aurobindo Pharma, Heritage, Impax Labs Inc, Teva, and Zydus Pharms, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

Eleven suppliers are listed for this compound.

Summary for GLYBURIDE; METFORMIN HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	7
NDAs:	8
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	6
Clinical Trials:	25
Patent Applications:	74
DailyMed Link:	GLYBURIDE; METFORMIN HYDROCHLORIDE at DailyMed

Recent Clinical Trials for GLYBURIDE; METFORMIN HYDROCHLORIDE

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

Sponsor	Phase
The University of Texas Health Science Center, Houston	Phase 4
University of Illinois at Chicago	Phase 3
Texas Tech University Health Sciences Center	Phase 3

See all GLYBURIDE; METFORMIN HYDROCHLORIDE clinical trials

Pharmacology for GLYBURIDE; METFORMIN HYDROCHLORIDE

Drug Class

Biguanide Sulfonylurea

Anatomical Therapeutic Chemical (ATC) Classes for GLYBURIDE; METFORMIN HYDROCHLORIDE

A10BA	Biguanides
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

US Patents and Regulatory Information for GLYBURIDE; METFORMIN HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Impax Labs Inc	GLYBURIDE AND METFORMIN HYDROCHLORIDE	glyburide; metformin hydrochloride	TABLET;ORAL	076731-001	Nov 19, 2004		DISCN	No	No
Impax Labs Inc	GLYBURIDE AND METFORMIN HYDROCHLORIDE	glyburide; metformin hydrochloride	TABLET;ORAL	076731-002	Nov 19, 2004		DISCN	No	No
Zydus Pharms	GLYBURIDE AND METFORMIN HYDROCHLORIDE	glyburide; metformin hydrochloride	TABLET;ORAL	206748-002	Feb 29, 2016	AB	RX	No	No
Aurobindo Pharma	GLYBURIDE AND METFORMIN HYDROCHLORIDE	glyburide; metformin hydrochloride	TABLET;ORAL	077870-003	Nov 14, 2007	AB	RX	No	No
Heritage	GLYBURIDE AND METFORMIN HYDROCHLORIDE	glyburide; metformin hydrochloride	TABLET;ORAL	079009-002	Jun 3, 2009	AB	RX	No	No
Impax Labs Inc	GLYBURIDE AND METFORMIN HYDROCHLORIDE	glyburide; metformin hydrochloride	TABLET;ORAL	076345-001	Feb 18, 2004	AB	RX	No	No

Expired US Patents for GLYBURIDE; METFORMIN HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	GLUCOVANCE	glyburide; metformin hydrochloride	TABLET;ORAL	021178-001	Jul 31, 2000
Bristol Myers Squibb	GLUCOVANCE	glyburide; metformin hydrochloride	TABLET;ORAL	021178-003	Jul 31, 2000
Bristol Myers Squibb	GLUCOVANCE	glyburide; metformin hydrochloride	TABLET;ORAL	021178-002	Jul 31, 2000