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Last Updated: August 7, 2020

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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, Epic Pharma Llc, Heritage Pharms Inc, Impax Labs Inc, Orient Pharma Co Ltd, Pharmadax Inc, 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-six 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
Pharmacia And Upjohn GLYNASE glyburide TABLET;ORAL 020051-004 Sep 24, 1993 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Hikma GLYBURIDE (MICRONIZED) glyburide TABLET;ORAL 075890-001 Jul 31, 2003 AB RX No No   Start Trial   Start Trial   Start Trial
Heritage Pharms Inc GLYBURIDE glyburide TABLET;ORAL 090937-001 Feb 28, 2011 AB1 RX 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
Sanofi Aventis Us DIABETA glyburide TABLET;ORAL 017532-003 May 1, 1984   Start Trial   Start Trial
Sanofi Aventis Us DIABETA glyburide TABLET;ORAL 017532-003 May 1, 1984   Start Trial   Start Trial
Pharmacia And Upjohn MICRONASE glyburide TABLET;ORAL 017498-001 May 1, 1984   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:

Harvard Business School
Johnson and Johnson
Colorcon
Baxter
Boehringer Ingelheim
AstraZeneca

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