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Last Updated: August 8, 2020

DrugPatentWatch Database Preview

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, 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

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

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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
Cadila Pharms Ltd GLYBURIDE glyburide TABLET;ORAL 203379-003 Jan 4, 2019 AB1 RX No No   Start Trial   Start Trial   Start Trial
Actavis Elizabeth GLYBURIDE AND METFORMIN HYDROCHLORIDE glyburide; metformin hydrochloride TABLET;ORAL 076716-001 Jun 28, 2005 AB RX No No   Start Trial   Start Trial   Start Trial
Epic Pharma Llc GLYBURIDE glyburide TABLET;ORAL 076257-003 Jun 27, 2002 AB1 RX No No   Start Trial   Start Trial   Start Trial
Zydus Pharms GLYBURIDE AND METFORMIN HYDROCHLORIDE glyburide; metformin hydrochloride TABLET;ORAL 206748-001 Feb 29, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan GLYBURIDE (MICRONIZED) glyburide TABLET;ORAL 074792-003 Aug 17, 1999 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
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
Sanofi Aventis Us DIABETA glyburide TABLET;ORAL 017532-002 May 1, 1984   Start Trial   Start Trial
Pharmacia And Upjohn GLYNASE glyburide TABLET;ORAL 020051-002 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:

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