GLYBURIDE - Generic Drug Details

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

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, Impax Labs Inc, Orient Pharma Co Ltd, Teva, Zydus Pharms, Hikma, Natco Pharma, 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 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:	20
Raw Ingredient (Bulk) Api Vendors:	152
Clinical Trials:	74
Patent Applications:	7,057
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
Impax Labs Inc	GLYBURIDE AND METFORMIN HYDROCHLORIDE	glyburide; metformin hydrochloride	TABLET;ORAL	076731-003	Nov 19, 2004		DISCN	No	No
Cadila Pharms Ltd	GLYBURIDE	glyburide	TABLET;ORAL	203379-002	Jan 4, 2019	AB1	RX	No	No
Strides Pharma	GLYBURIDE (MICRONIZED)	glyburide	TABLET;ORAL	074591-002	Dec 22, 1997		DISCN	No	No
Hikma	GLYBURIDE (MICRONIZED)	glyburide	TABLET;ORAL	075890-003	Jul 31, 2003		DISCN	No	No
Aurobindo Pharma	GLYBURIDE AND METFORMIN HYDROCHLORIDE	glyburide; metformin hydrochloride	TABLET;ORAL	077870-003	Nov 14, 2007	AB	RX	No	No
Impax Labs Inc	GLYBURIDE AND METFORMIN HYDROCHLORIDE	glyburide; metformin hydrochloride	TABLET;ORAL	076345-003	Feb 18, 2004	AB	RX	No	No
Strides Pharma	GLYBURIDE (MICRONIZED)	glyburide	TABLET;ORAL	074591-003	Dec 22, 1997		DISCN	No	No

Expired US Patents for GLYBURIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	MICRONASE	glyburide	TABLET;ORAL	017498-002	May 1, 1984
Pfizer	GLYNASE	glyburide	TABLET;ORAL	020051-001	Mar 4, 1992
Sanofi Aventis Us	DIABETA	glyburide	TABLET;ORAL	017532-003	May 1, 1984
Pfizer	MICRONASE	glyburide	TABLET;ORAL	017498-002	May 1, 1984
Pfizer	MICRONASE	glyburide	TABLET;ORAL	017498-003	May 1, 1984
Sanofi Aventis Us	DIABETA	glyburide	TABLET;ORAL	017532-003	May 1, 1984
Sanofi Aventis Us	DIABETA	glyburide	TABLET;ORAL	017532-001	May 1, 1984