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Last Updated: August 14, 2024

GLYBURIDE - Generic Drug Details

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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 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:	7,667
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

Drug Prices for GLYBURIDE

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Drug Sales Revenue Trends for GLYBURIDE

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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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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	GLYNASE	glyburide	TABLET;ORAL	020051-004	Sep 24, 1993	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Impax Labs Inc	GLYBURIDE AND METFORMIN HYDROCHLORIDE	glyburide; metformin hydrochloride	TABLET;ORAL	076345-003	Feb 18, 2004	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Pharms	GLYBURIDE AND METFORMIN HYDROCHLORIDE	glyburide; metformin hydrochloride	TABLET;ORAL	206748-001	Feb 29, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Pharms	GLYBURIDE	glyburide	TABLET;ORAL	206749-003	May 10, 2016	AB1	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Pharms	GLYBURIDE AND METFORMIN HYDROCHLORIDE	glyburide; metformin hydrochloride	TABLET;ORAL	206748-002	Feb 29, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Impax Labs Inc	GLYBURIDE	glyburide	TABLET;ORAL	206079-001	Sep 30, 2015	AB2	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Orient Pharma Co Ltd	GLYBURIDE	glyburide	TABLET;ORAL	206483-003	Feb 22, 2019	AB1	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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	GLYNASE	glyburide	TABLET;ORAL	020051-002	Mar 4, 1992	⤷ Sign Up	⤷ Sign Up
Sanofi Aventis Us	DIABETA	glyburide	TABLET;ORAL	017532-002	May 1, 1984	⤷ Sign Up	⤷ Sign Up
Pfizer	MICRONASE	glyburide	TABLET;ORAL	017498-001	May 1, 1984	⤷ Sign Up	⤷ Sign Up
Pfizer	MICRONASE	glyburide	TABLET;ORAL	017498-001	May 1, 1984	⤷ Sign Up	⤷ Sign Up
Pfizer	GLYNASE	glyburide	TABLET;ORAL	020051-002	Mar 4, 1992	⤷ Sign Up	⤷ Sign Up
Pfizer	GLYNASE	glyburide	TABLET;ORAL	020051-001	Mar 4, 1992	⤷ Sign Up	⤷ Sign Up
Pfizer	GLYNASE	glyburide	TABLET;ORAL	020051-002	Mar 4, 1992	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.