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Generated: October 19, 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 Heritage Pharms Inc, Actavis Elizabeth, Teva, Impax Labs Inc, Zydus Pharms Usa Inc, Aurobindo Pharma, and Bristol Myers Squibb, 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 forty patent family members in twenty-six countries.

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

Summary for Generic Name: glyburide; metformin hydrochloride

US Patents:1
Tradenames:2
Applicants:7
NDAs:8
Drug Master File Entries: see list20
Suppliers / Packagers: see list23
Bulk Api Vendors: see list3
Clinical Trials: see list4,023
Drug Prices:see low prices
DailyMed Link:glyburide; metformin hydrochloride at DailyMed

Pharmacology for Ingredient: 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
Aurobindo Pharma
GLYBURIDE AND METFORMIN HYDROCHLORIDE
glyburide; metformin hydrochloride
TABLET;ORAL077870-002Nov 14, 2007ABRXNoYes► Subscribe► Subscribe► Subscribe
Zydus Pharms Usa Inc
GLYBURIDE AND METFORMIN HYDROCHLORIDE
glyburide; metformin hydrochloride
TABLET;ORAL206748-003Feb 29, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Heritage Pharms Inc
GLYBURIDE AND METFORMIN HYDROCHLORIDE
glyburide; metformin hydrochloride
TABLET;ORAL079009-003Jun 3, 2009ABRXNoNo► Subscribe► Subscribe► Subscribe
Teva
GLYBURIDE AND METFORMIN HYDROCHLORIDE
glyburide; metformin hydrochloride
TABLET;ORAL076821-003Jan 27, 2005DISCNNoNo► Subscribe► Subscribe► Subscribe
Aurobindo Pharma
GLYBURIDE AND METFORMIN HYDROCHLORIDE
glyburide; metformin hydrochloride
TABLET;ORAL077870-003Nov 14, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Actavis Elizabeth
GLYBURIDE AND METFORMIN HYDROCHLORIDE
glyburide; metformin hydrochloride
TABLET;ORAL076716-002Jun 28, 2005ABRXNoNo► Subscribe► Subscribe► Subscribe
Bristol Myers Squibb
GLUCOVANCE
glyburide; metformin hydrochloride
TABLET;ORAL021178-003Jul 31, 2000DISCNYesNo► Subscribe► SubscribeY► Subscribe
Impax Labs Inc
GLYBURIDE AND METFORMIN HYDROCHLORIDE
glyburide; metformin hydrochloride
TABLET;ORAL076731-003Nov 19, 2004DISCNNoNo► Subscribe► Subscribe► Subscribe
Impax Labs Inc
GLYBURIDE AND METFORMIN HYDROCHLORIDE
glyburide; metformin hydrochloride
TABLET;ORAL076345-002Feb 18, 2004ABRXNoNo► Subscribe► Subscribe► Subscribe
Actavis Elizabeth
GLYBURIDE AND METFORMIN HYDROCHLORIDE
glyburide; metformin hydrochloride
TABLET;ORAL076716-001Jun 28, 2005ABRXNoNo► 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
Morocco24930► Subscribe
Australia753604► Subscribe
Japan2003292443► Subscribe
African Intellectual Property Organization (OAPI)11400► Subscribe
European Patent Office1011684► Subscribe
Slovenia974356► Subscribe
Russian Federation2286788► Subscribe
TaiwanI245632► Subscribe
World Intellectual Property Organization (WIPO)0003742► Subscribe
New Zealand503248► 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:

Johnson and Johnson
Merck
Daiichi Sankyo
Cipla
Medtronic
Healthtrust
Moodys
UBS
McKinsey
US Department of Justice

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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