Glyburide - Generic Drug Details

What are the generic sources for glyburide and what is the scope of patent protection?

Glyburide is the generic ingredient in seven branded drugs marketed by Sanofi Aventis Us, Actavis Elizabeth, Aurobindo Pharma, Cadila Pharms Ltd, Chartwell Rx, Epic Pharma Llc, Heritage Pharms, Impax Labs Inc, Orient Pharma Co Ltd, Teva, Zydus Pharms, Hikma, Mylan, Strides Pharma, Pfizer, and Bristol Myers Squibb, and is included in twenty-seven NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty drug master file entries for glyburide. Twenty-one suppliers are listed for this compound.

Summary for glyburide

US Patents:	0
Tradenames:	7
Applicants:	16
NDAs:	27
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	21
Raw Ingredient (Bulk) Api Vendors:	152
Clinical Trials:	74
Patent Applications:	7,173
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for glyburide
Drug Sales Revenues:	Drug sales revenues for glyburide
What excipients (inactive ingredients) are in glyburide?	glyburide excipients list
DailyMed Link:	glyburide at DailyMed

See drug prices for glyburide

See drug sales revenues for glyburide

Recent Clinical Trials for glyburide

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

Sponsor	Phase
University of Maryland, Baltimore	Phase 2
University of Kentucky	Phase 1
Medical College of Wisconsin	Phase 4

See all glyburide clinical trials

Pharmacology for glyburide

Drug Class

Sulfonylurea

Medical Subject Heading (MeSH) Categories for glyburide

Hypoglycemic Agents

US Patents and Regulatory Information for glyburide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol Myers Squibb	GLUCOVANCE	glyburide; metformin hydrochloride	TABLET;ORAL	021178-001	Jul 31, 2000		DISCN	Yes	No
Actavis Elizabeth	GLYBURIDE AND METFORMIN HYDROCHLORIDE	glyburide; metformin hydrochloride	TABLET;ORAL	076716-001	Jun 28, 2005	AB	RX	No	No
Strides Pharma	GLYBURIDE (MICRONIZED)	glyburide	TABLET;ORAL	074591-001	Dec 22, 1997		DISCN	No	No
Pfizer	MICRONASE	glyburide	TABLET;ORAL	017498-003	May 1, 1984		DISCN	Yes	No
Heritage Pharms	GLYBURIDE	glyburide	TABLET;ORAL	090937-001	Feb 28, 2011	AB1	RX	No	No
Chartwell Rx	GLYBURIDE	glyburide	TABLET;ORAL	203581-001	Apr 14, 2016		DISCN	No	No

Expired US Patents for glyburide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	DIABETA	glyburide	TABLET;ORAL	017532-001	May 1, 1984
Sanofi Aventis Us	DIABETA	glyburide	TABLET;ORAL	017532-001	May 1, 1984
Pfizer	GLYNASE	glyburide	TABLET;ORAL	020051-001	Mar 4, 1992
Sanofi Aventis Us	DIABETA	glyburide	TABLET;ORAL	017532-001	May 1, 1984
Pfizer	GLYNASE	glyburide	TABLET;ORAL	020051-001	Mar 4, 1992
Pfizer	MICRONASE	glyburide	TABLET;ORAL	017498-002	May 1, 1984