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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
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UBS
Healthtrust
Teva
US Army
Cerilliant
Fuji
Julphar
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Generated: December 11, 2017

DrugPatentWatch Database Preview

Glimepiride; pioglitazone hydrochloride - Generic Drug Details

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

Glimepiride; pioglitazone hydrochloride
is the generic ingredient in two branded drugs marketed by Takeda Pharms Usa and Sandoz, and is included in two NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Glimepiride; pioglitazone hydrochloride has one hundred and thirty-two patent family members in thirty-six countries and fourteen supplementary protection certificates in eight countries.

There are fourteen drug master file entries for glimepiride; pioglitazone hydrochloride. Three suppliers are listed for this compound.

Summary for glimepiride; pioglitazone hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Takeda Pharms UsaDUETACTglimepiride; pioglitazone hydrochlorideTABLET;ORAL021925-001Jul 28, 2006ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
SandozPIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDEglimepiride; pioglitazone hydrochlorideTABLET;ORAL201049-001Jan 4, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Takeda Pharms UsaDUETACTglimepiride; pioglitazone hydrochlorideTABLET;ORAL021925-002Jul 28, 2006ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Takeda Pharms UsaDUETACTglimepiride; pioglitazone hydrochlorideTABLET;ORAL021925-001Jul 28, 2006ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Takeda Pharms UsaDUETACTglimepiride; pioglitazone hydrochlorideTABLET;ORAL021925-002Jul 28, 2006ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
SandozPIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDEglimepiride; pioglitazone hydrochlorideTABLET;ORAL201049-002Jan 4, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Takeda Pharms UsaDUETACTglimepiride; pioglitazone hydrochlorideTABLET;ORAL021925-001Jul 28, 2006ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Takeda Pharms UsaDUETACTglimepiride; pioglitazone hydrochlorideTABLET;ORAL021925-002Jul 28, 2006ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
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Expired Orange Book Patents for Generic Ingredient: glimepiride; pioglitazone hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms UsaDUETACTglimepiride; pioglitazone hydrochlorideTABLET;ORAL021925-002Jul 28, 2006► Subscribe► Subscribe
Takeda Pharms UsaDUETACTglimepiride; pioglitazone hydrochlorideTABLET;ORAL021925-002Jul 28, 2006► Subscribe► Subscribe
Takeda Pharms UsaDUETACTglimepiride; pioglitazone hydrochlorideTABLET;ORAL021925-001Jul 28, 2006► Subscribe► Subscribe
Takeda Pharms UsaDUETACTglimepiride; pioglitazone hydrochlorideTABLET;ORAL021925-002Jul 28, 2006► Subscribe► Subscribe
Takeda Pharms UsaDUETACTglimepiride; pioglitazone hydrochlorideTABLET;ORAL021925-002Jul 28, 2006► Subscribe► Subscribe
Takeda Pharms UsaDUETACTglimepiride; pioglitazone hydrochlorideTABLET;ORAL021925-001Jul 28, 2006► Subscribe► Subscribe
Takeda Pharms UsaDUETACTglimepiride; pioglitazone hydrochlorideTABLET;ORAL021925-001Jul 28, 2006► Subscribe► Subscribe
Takeda Pharms UsaDUETACTglimepiride; pioglitazone hydrochlorideTABLET;ORAL021925-001Jul 28, 2006► Subscribe► Subscribe
Takeda Pharms UsaDUETACTglimepiride; pioglitazone hydrochlorideTABLET;ORAL021925-002Jul 28, 2006► Subscribe► Subscribe
Takeda Pharms UsaDUETACTglimepiride; pioglitazone hydrochlorideTABLET;ORAL021925-001Jul 28, 2006► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: glimepiride; pioglitazone 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
6,211,205 Pharmaceutical composition► Subscribe
6,172,090 Pharmaceutical composition► Subscribe
6,133,293 Pharmaceutical composition► Subscribe
6,211,207 Pharmaceutical composition► Subscribe
6,599,923 Pharmaceutical composition► Subscribe
6,911,459 Pharmaceutical composition► Subscribe
6,169,100 Pharmaceutical composition► Subscribe
6,384,062 Pharmaceutical composition► Subscribe
6,329,404 Pharmaceutical composition► Subscribe
6,166,042 Pharmaceutical composition► 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: glimepiride; pioglitazone hydrochloride

Country Document Number Estimated Expiration
Cyprus2424► Subscribe
Georgia, Republic ofP20084570► Subscribe
China101384251► Subscribe
Norway20062515► Subscribe
European Patent Office1962811► Subscribe
Russian Federation2223760► Subscribe
Israel174201► Subscribe
Taiwan200524641► Subscribe
European Patent Office0861666► Subscribe
BrazilPI0620020► 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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Supplementary Protection Certificates for Tradename: GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
298Luxembourg► Subscribe91298, EXPIRES: 20210620
2009 00045Denmark► Subscribe
1174135/01Switzerland► SubscribeFORMER REPRESENTATIVE: BOHEST AG, CH
0861666/01Switzerland► SubscribeFORMER REPRESENTATIVE: BOHEST AG, CH
C/GB10/011United Kingdom► SubscribePRODUCT NAME: THE COMBINATION OF PIOGLITAZONE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, ESPECIALLY THE HYDROCHLORIDE SALT, AND GLIMEPIRIDE.; REGISTERED: UK EU/1/06/366/001 20070108; UK EU/1/06/366/002 20070108; UK EU/1/06/366/003 20070108; UK EU/1/06/366/004 20070108; UK EU/1/06/366/005 20070108; UK EU/1/06/366/006 20070108; UK EU/1/06/366/019 20070108; UK EU/1/06/366/020 20070108; UK EU/1/06/366/021 20070108; UK EU/1/06/366/022 20070108; UK EU/1/06/366/013 20070108; UK EU/1/06/366/014 20070108; UK EU/1/06/366/015 20070108; UK EU/1/06/366/016 20070108; UK EU/1/06/366/017 20070108; UK EU/1/06/366/018 20070108; UK EU/1/06/366/007 20070108; UK EU/1/06/366/008 20070108; UK EU
2007 00001Denmark► Subscribe
7Finland► Subscribe
C026/2009Ireland► SubscribeSPC026/2009: 20101001, EXPIRES: 20210619
C 038/2006Ireland► SubscribeSPC 038/2006: 20070528, EXPIRES: 20210619
C/GB07/009United Kingdom► SubscribeSPC/GB07/009: 20070126
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

McKesson
Moodys
Medtronic
Julphar
AstraZeneca
Covington
Chinese Patent Office
US Army
Deloitte
Queensland Health

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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