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Last Updated: February 28, 2021

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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.

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

SponsorPhase
Ironwood Pharmaceuticals, Inc.Phase 1
Medical College of WisconsinPhase 4
The University of Texas Health Science Center, HoustonPhase 4

See all glyburide clinical trials

Pharmacology for glyburide
Drug ClassSulfonylurea
Medical Subject Heading (MeSH) Categories for glyburide
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   Start Trial   Start Trial   Start Trial
Epic Pharma Llc GLYBURIDE glyburide TABLET;ORAL 076257-001 Jun 27, 2002 AB1 RX No No   Start Trial   Start Trial   Start Trial
Heritage Pharms Inc GLYBURIDE AND METFORMIN HYDROCHLORIDE glyburide; metformin hydrochloride TABLET;ORAL 079009-003 Jun 3, 2009 DISCN No No   Start Trial   Start Trial   Start 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

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

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Serving leading biopharmaceutical companies globally:

Dow
Medtronic
McKesson
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McKinsey
Boehringer Ingelheim

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