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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Chubb
Cipla
Moodys
Medtronic
UBS
AstraZeneca
Mallinckrodt
Argus Health
Merck

Generated: December 17, 2017

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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-two suppliers are listed for this compound.

Summary for glyburide; metformin hydrochloride

Pharmacology 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
TevaGLYBURIDE AND METFORMIN HYDROCHLORIDEglyburide; metformin hydrochlorideTABLET;ORAL076821-001Jan 27, 2005DISCNNoNo► Subscribe► Subscribe► Subscribe
Zydus Pharms Usa IncGLYBURIDE AND METFORMIN HYDROCHLORIDEglyburide; metformin hydrochlorideTABLET;ORAL206748-003Feb 29, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
TevaGLYBURIDE AND METFORMIN HYDROCHLORIDEglyburide; metformin hydrochlorideTABLET;ORAL076821-003Jan 27, 2005DISCNNoNo► Subscribe► Subscribe► Subscribe
Zydus Pharms Usa IncGLYBURIDE AND METFORMIN HYDROCHLORIDEglyburide; metformin hydrochlorideTABLET;ORAL206748-002Feb 29, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Aurobindo PharmaGLYBURIDE AND METFORMIN HYDROCHLORIDEglyburide; metformin hydrochlorideTABLET;ORAL077870-003Nov 14, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Heritage Pharms IncGLYBURIDE AND METFORMIN HYDROCHLORIDEglyburide; metformin hydrochlorideTABLET;ORAL079009-002Jun 3, 2009ABRXNoNo► Subscribe► Subscribe► Subscribe
Actavis ElizabethGLYBURIDE AND METFORMIN HYDROCHLORIDEglyburide; metformin hydrochlorideTABLET;ORAL076716-003Jun 28, 2005ABRXNoNo► Subscribe► Subscribe► Subscribe
Impax Labs IncGLYBURIDE AND METFORMIN HYDROCHLORIDEglyburide; metformin hydrochlorideTABLET;ORAL076731-002Nov 19, 2004DISCNNoNo► Subscribe► Subscribe► Subscribe
TevaGLYBURIDE AND METFORMIN HYDROCHLORIDEglyburide; metformin hydrochlorideTABLET;ORAL076821-002Jan 27, 2005DISCNNoNo► Subscribe► Subscribe► Subscribe
Aurobindo PharmaGLYBURIDE AND METFORMIN HYDROCHLORIDEglyburide; metformin hydrochlorideTABLET;ORAL077870-001Nov 14, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: glyburide; metformin hydrochloride

Country Document Number Estimated Expiration
Austria250418► Subscribe
Canada2303537► Subscribe
China1146427► Subscribe
European Patent Office2269613► Subscribe
Brazil9906600► Subscribe
European Patent Office0974356► Subscribe
European Patent Office1435240► Subscribe
Argentina065970► Subscribe
European Patent Office1011684► Subscribe
Portugal974356► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Medtronic
Teva
McKesson
US Department of Justice
Express Scripts
Cerilliant
Fish and Richardson
Citi
McKinsey

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.

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