GLYBURIDE Drug Patent Profile

When do Glyburide patents expire, and what generic alternatives are available?

Glyburide is a drug marketed by 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, Sanofi Aventis Us, and Strides Pharma. and is included in twenty-three NDAs.

The generic ingredient in GLYBURIDE is glyburide; metformin hydrochloride. There are twenty drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the glyburide; metformin hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Glyburide

A generic version of GLYBURIDE was approved as glyburide; metformin hydrochloride by IMPAX LABS INC on February 18^th, 2004.

Summary for GLYBURIDE

US Patents:	0
Applicants:	14
NDAs:	23
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	152
Clinical Trials:	74
Patent Applications:	2,229
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information 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
Sanofi Aventis Us	GLYBURIDE (MICRONIZED)	glyburide	TABLET;ORAL	020055-003	Mar 8, 2000		DISCN	No	No
Chartwell Rx	GLYBURIDE (MICRONIZED)	glyburide	TABLET;ORAL	075174-002	Jun 22, 1998		DISCN	No	No
Teva	GLYBURIDE (MICRONIZED)	glyburide	TABLET;ORAL	074686-004	Apr 20, 1999	AB	RX	No	No
Impax Labs Inc	GLYBURIDE AND METFORMIN HYDROCHLORIDE	glyburide; metformin hydrochloride	TABLET;ORAL	076731-001	Nov 19, 2004		DISCN	No	No
Strides Pharma	GLYBURIDE (MICRONIZED)	glyburide	TABLET;ORAL	074591-004	Dec 22, 1997		DISCN	No	No
Actavis Elizabeth	GLYBURIDE AND METFORMIN HYDROCHLORIDE	glyburide; metformin hydrochloride	TABLET;ORAL	076716-001	Jun 28, 2005	AB	RX	No	No
Aurobindo Pharma	GLYBURIDE AND METFORMIN HYDROCHLORIDE	glyburide; metformin hydrochloride	TABLET;ORAL	077870-003	Nov 14, 2007	AB	RX	No	No