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:	143
Clinical Trials:	73
Patent Applications:	6,933
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 Kentucky	Phase 1
Medical College of Wisconsin	Phase 4
Ironwood Pharmaceuticals, Inc.	Phase 1

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
Pfizer	MICRONASE	glyburide	TABLET;ORAL	017498-003	May 1, 1984		DISCN	Yes	No
Teva	GLYBURIDE	glyburide	TABLET;ORAL	074388-001	Aug 29, 1995	AB1	RX	No	No
Teva	GLYBURIDE AND METFORMIN HYDROCHLORIDE	glyburide; metformin hydrochloride	TABLET;ORAL	076821-002	Jan 27, 2005		DISCN	No	No
Pfizer	GLYNASE	glyburide	TABLET;ORAL	020051-004	Sep 24, 1993	AB	RX	Yes	Yes
Actavis Elizabeth	GLYBURIDE	glyburide	TABLET;ORAL	075947-002	Nov 14, 2002		DISCN	No	No
Impax Labs Inc	GLYBURIDE AND METFORMIN HYDROCHLORIDE	glyburide; metformin hydrochloride	TABLET;ORAL	076731-003	Nov 19, 2004		DISCN	No	No

Expired US Patents for glyburide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	GLYNASE	glyburide	TABLET;ORAL	020051-004	Sep 24, 1993
Pfizer	MICRONASE	glyburide	TABLET;ORAL	017498-003	May 1, 1984
Pfizer	MICRONASE	glyburide	TABLET;ORAL	017498-002	May 1, 1984
Sanofi Aventis Us	DIABETA	glyburide	TABLET;ORAL	017532-002	May 1, 1984
Sanofi Aventis Us	DIABETA	glyburide	TABLET;ORAL	017532-002	May 1, 1984
Pfizer	GLYNASE	glyburide	TABLET;ORAL	020051-003	Sep 24, 1993