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Last Updated: December 3, 2022

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, 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.

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
University of KentuckyPhase 1
Medical College of WisconsinPhase 4
Ironwood Pharmaceuticals, Inc.Phase 1

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Pharmacology for glyburide
Drug Class Sulfonylurea
Medical Subject Heading (MeSH) Categories for glyburide

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
Pfizer MICRONASE glyburide TABLET;ORAL 017498-003 May 1, 1984 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Teva GLYBURIDE glyburide TABLET;ORAL 074388-001 Aug 29, 1995 AB1 RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Teva GLYBURIDE AND METFORMIN HYDROCHLORIDE glyburide; metformin hydrochloride TABLET;ORAL 076821-002 Jan 27, 2005 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pfizer GLYNASE glyburide TABLET;ORAL 020051-004 Sep 24, 1993 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Actavis Elizabeth GLYBURIDE glyburide TABLET;ORAL 075947-002 Nov 14, 2002 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Impax Labs Inc GLYBURIDE AND METFORMIN HYDROCHLORIDE glyburide; metformin hydrochloride TABLET;ORAL 076731-003 Nov 19, 2004 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Pfizer GLYNASE glyburide TABLET;ORAL 020051-004 Sep 24, 1993 See Plans and Pricing See Plans and Pricing
Pfizer MICRONASE glyburide TABLET;ORAL 017498-003 May 1, 1984 See Plans and Pricing See Plans and Pricing
Pfizer MICRONASE glyburide TABLET;ORAL 017498-002 May 1, 1984 See Plans and Pricing See Plans and Pricing
Sanofi Aventis Us DIABETA glyburide TABLET;ORAL 017532-002 May 1, 1984 See Plans and Pricing See Plans and Pricing
Sanofi Aventis Us DIABETA glyburide TABLET;ORAL 017532-002 May 1, 1984 See Plans and Pricing See Plans and Pricing
Pfizer GLYNASE glyburide TABLET;ORAL 020051-003 Sep 24, 1993 See Plans and Pricing See Plans and Pricing
>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.