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Last Updated: April 27, 2024

Glyburide - Generic Drug Details

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What are the generic drug 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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cadila Pharms Ltd	GLYBURIDE	glyburide	TABLET;ORAL	203379-003	Jan 4, 2019	AB1	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Zydus Pharms	GLYBURIDE	glyburide	TABLET;ORAL	206749-003	May 10, 2016	AB1	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sanofi Aventis Us	GLYBURIDE (MICRONIZED)	glyburide	TABLET;ORAL	020055-001	Apr 17, 1992		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Bristol Myers Squibb	GLUCOVANCE	glyburide; metformin hydrochloride	TABLET;ORAL	021178-001	Jul 31, 2000		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Pfizer	MICRONASE	glyburide	TABLET;ORAL	017498-002	May 1, 1984		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for glyburide

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

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