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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Express Scripts
Teva
Healthtrust
Queensland Health
Merck
McKesson
Deloitte
QuintilesIMS

Generated: August 15, 2018

DrugPatentWatch Database Preview

Glyburide; metformin hydrochloride - Generic Drug Details

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What are the generic drug sources for glyburide; metformin hydrochloride and what is the scope of glyburide; metformin hydrochloride freedom to operate?

Glyburide; metformin hydrochloride is the generic ingredient in two branded drugs marketed by Bristol Myers Squibb, Actavis Elizabeth, Aurobindo Pharma, Heritage Pharms Inc, Impax Labs Inc, Teva, and Zydus Pharms Usa Inc, and is included in eight NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Glyburide; metformin hydrochloride has thirty-nine patent family members in twenty-six countries.

There are twenty drug master file entries for glyburide; metformin hydrochloride. Twenty-one suppliers are listed for this compound.

Summary for glyburide; metformin hydrochloride
International Patents:39
US Patents:1
Tradenames:2
Applicants:7
NDAs:8
Drug Master File Entries: 20
Suppliers / Packagers: 21
Bulk Api Vendors: 3
Clinical Trials: 23
DailyMed Link:glyburide; metformin hydrochloride at DailyMed
Pharmacology for glyburide; metformin hydrochloride
Synonyms for glyburide; metformin hydrochloride
338752-31-1
5-chloro-N-[2-[4-(cyclohexylcarbamoylsulfamoyl)phenyl]ethyl]-2-methoxybenzamide; 3-(diaminomethylidene)-1,1-dimethylguanidine; hydrochloride
AC1L43NM
Benzamide, 5-chloro-N-(2-(4-((((cyclohexylamino)carbonyl)amino)sulfonyl)phenyl)ethyl)-2-methoxy-, mixt. with N,N-dimethylimidodicarbonimidic diamide monohydrochloride
C23H28ClN3O5S.C4H11N5.Cl
DTXSID00187507
Glucovance
Glyburide and metformin hydrochloride
Glyburide mixture with metformin
Glyburide mixture with Metformin HCl
Glyburide mixture with Metformin hydrochloride
Glyburide-metformin
Glyburide-metformin hydrochloride mixt.
Glyburide-metformin hydrochloride mixture
LS-178556
SCHEMBL7187343

US Patents and Regulatory Information for glyburide; metformin hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Zydus Pharms Usa Inc GLYBURIDE AND METFORMIN HYDROCHLORIDE glyburide; metformin hydrochloride TABLET;ORAL 206748-001 Feb 29, 2016 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Impax Labs Inc GLYBURIDE AND METFORMIN HYDROCHLORIDE glyburide; metformin hydrochloride TABLET;ORAL 076345-002 Feb 18, 2004 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Actavis Elizabeth GLYBURIDE AND METFORMIN HYDROCHLORIDE glyburide; metformin hydrochloride TABLET;ORAL 076716-002 Jun 28, 2005 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Teva GLYBURIDE AND METFORMIN HYDROCHLORIDE glyburide; metformin hydrochloride TABLET;ORAL 076821-003 Jan 27, 2005 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Bristol Myers Squibb GLUCOVANCE glyburide; metformin hydrochloride TABLET;ORAL 021178-002 Jul 31, 2000 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Impax Labs Inc GLYBURIDE AND METFORMIN HYDROCHLORIDE glyburide; metformin hydrochloride TABLET;ORAL 076345-003 Feb 18, 2004 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Heritage Pharms Inc GLYBURIDE AND METFORMIN HYDROCHLORIDE glyburide; metformin hydrochloride TABLET;ORAL 079009-001 Jun 3, 2009 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for glyburide; metformin hydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
RE38629 Solid oral dosage form comprising a combination of metformin and glibenclamide ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Patents for glyburide; metformin hydrochloride

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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
US Department of Justice
Mallinckrodt
Harvard Business School
Deloitte
Citi
Farmers Insurance
UBS
Chubb

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 verifification 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.