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Glyburide - Generic Drug Details

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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, Epic Pharma Llc, Heritage Pharms Inc, Impax Labs Inc, Orient Pharma Co Ltd, Swiss Pharm, Teva, Zydus Pharms, Dava Pharms Inc, Hikma, Mylan, Yaopharma Co Ltd, Pharmacia And Upjohn, and Bristol Myers Squibb, and is included in twenty-seven NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

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

Summary for glyburide

US Patents:	1
Tradenames:	7
Applicants:	17
NDAs:	27
Drug Master File Entries:	20
Suppliers / Packagers:	27
Bulk Api Vendors:	124
Clinical Trials:	65
Patent Applications:	6,951
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
Ironwood Pharmaceuticals, Inc.	Phase 1
Medical College of Wisconsin	Phase 4
The University of Texas Health Science Center, Houston	Phase 4

See all glyburide clinical trials

Pharmacology for glyburide

Drug Class

Sulfonylurea

Medical Subject Heading (MeSH) Categories for glyburide

Hypoglycemic Agents

Paragraph IV (Patent) Challenges for GLYBURIDE

Tradename	Dosage	Ingredient	NDA	Submissiondate
GLYNASE	TABLET;ORAL	glyburide	020051

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
Teva	GLYBURIDE (MICRONIZED)	glyburide	TABLET;ORAL	074686-001	Apr 20, 1999	AB	RX	No	No
Epic Pharma Llc	GLYBURIDE	glyburide	TABLET;ORAL	076257-001	Jun 27, 2002	AB1	RX	No	No
Heritage Pharms Inc	GLYBURIDE AND METFORMIN HYDROCHLORIDE	glyburide; metformin hydrochloride	TABLET;ORAL	079009-003	Jun 3, 2009		DISCN	No	No

Expired US Patents for glyburide

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