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Serving leading biopharmaceutical companies globally:

Novartis
Cantor Fitzgerald
Daiichi Sankyo
Queensland Health
Johnson and Johnson
Fuji
Healthtrust
Covington
Colorcon
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Generated: December 11, 2017

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Pioglitazone hydrochloride - Generic Drug Details

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What are the generic sources for pioglitazone hydrochloride and what is the scope of pioglitazone hydrochloride patent protection?

Pioglitazone hydrochloride
is the generic ingredient in two branded drugs marketed by Takeda Pharms Usa, Accord Hlthcare, Aurobindo Pharma Ltd, Breckenridge Pharm, Cipla Ltd, Dr Reddys Labs Ltd, Lupin Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Puracap Pharm Llc, Sandoz, Teva Pharms Usa, Torrent Pharms Ltd, and Zydus Pharms Usa Inc, and is included in fourteen NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Pioglitazone hydrochloride has seventy-four patent family members in twenty-five countries and sixteen supplementary protection certificates in nine countries.

There are twenty-seven drug master file entries for pioglitazone hydrochloride. Thirty-three suppliers are listed for this compound. There are two tentative approvals for this compound.

Tentative approvals for PIOGLITAZONE HYDROCHLORIDE

Applicant Application No. Strength Dosage Form
u► Subscribe15MGTABLET; ORAL
u► Subscribe45MGTABLET; ORAL
u► Subscribe30MGTABLET; ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Lupin LtdPIOGLITAZONE HYDROCHLORIDEpioglitazone hydrochlorideTABLET;ORAL204133-002Apr 7, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Teva Pharms UsaPIOGLITAZONE HYDROCHLORIDEpioglitazone hydrochlorideTABLET;ORAL077210-002Jan 10, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Puracap Pharm LlcPIOGLITAZONE HYDROCHLORIDEpioglitazone hydrochlorideTABLET;ORAL206738-003Oct 6, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Dr Reddys Labs LtdPIOGLITAZONE HYDROCHLORIDEpioglitazone hydrochlorideTABLET;ORAL078383-002Mar 12, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Mylan Pharms IncPIOGLITAZONE HYDROCHLORIDEpioglitazone hydrochlorideTABLET;ORAL076801-002Aug 17, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Takeda Pharms UsaACTOSpioglitazone hydrochlorideTABLET;ORAL021073-001Jul 15, 1999ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Puracap Pharm LlcPIOGLITAZONE HYDROCHLORIDEpioglitazone hydrochlorideTABLET;ORAL206738-001Oct 6, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Breckenridge PharmPIOGLITAZONE HYDROCHLORIDEpioglitazone hydrochlorideTABLET;ORAL078472-001Feb 13, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Mylan Pharms IncPIOGLITAZONE HYDROCHLORIDEpioglitazone hydrochlorideTABLET;ORAL076801-001Aug 17, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
SandozPIOGLITAZONE HYDROCHLORIDEpioglitazone hydrochlorideTABLET;ORAL078670-001Feb 13, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: pioglitazone hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms UsaACTOSpioglitazone hydrochlorideTABLET;ORAL021073-002Jul 15, 1999► Subscribe► Subscribe
Takeda Pharms UsaACTOSpioglitazone hydrochlorideTABLET;ORAL021073-002Jul 15, 1999► Subscribe► Subscribe
Takeda Pharms UsaACTOSpioglitazone hydrochlorideTABLET;ORAL021073-001Jul 15, 1999► Subscribe► Subscribe
Takeda Pharms UsaACTOSpioglitazone hydrochlorideTABLET;ORAL021073-002Jul 15, 1999► Subscribe► Subscribe
Takeda Pharms UsaACTOSpioglitazone hydrochlorideTABLET;ORAL021073-003Jul 15, 1999► Subscribe► Subscribe
Takeda Pharms UsaACTOSpioglitazone hydrochlorideTABLET;ORAL021073-003Jul 15, 1999► Subscribe► Subscribe
Takeda Pharms UsaACTOSpioglitazone hydrochlorideTABLET;ORAL021073-002Jul 15, 1999► Subscribe► Subscribe
Takeda Pharms UsaACTOSpioglitazone hydrochlorideTABLET;ORAL021073-003Jul 15, 1999► Subscribe► Subscribe
Takeda Pharms UsaACTOSpioglitazone hydrochlorideTABLET;ORAL021073-003Jul 15, 1999► Subscribe► Subscribe
Takeda Pharms UsaACTOSpioglitazone hydrochlorideTABLET;ORAL021073-001Jul 15, 1999► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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: pioglitazone hydrochloride

Country Document Number Estimated Expiration
Cyprus2424► Subscribe
Russian Federation2223760► Subscribe
European Patent Office0861666► Subscribe
Norway20004345► Subscribe
Germany69637988► Subscribe
Hong Kong1041203► Subscribe
China1289082► Subscribe
Norway314065► Subscribe
Russian Federation2323004► Subscribe
Argentina005641► 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: 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
01C/011Belgium► SubscribePRODUCT NUMBER: PIOGLITAZONE; NAT. REGISTRATION NO/DATE: EU/1/001/150/001 20001018; FIRST REGISTRATION NO: CH 55378 01 20000927
0861666/01Switzerland► SubscribeFORMER REPRESENTATIVE: BOHEST AG, CH
7Finland► Subscribe
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
C/GB01/016United Kingdom► SubscribePRODUCT NAME: PIOGLITAZONE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE HYDROCHLORIDE SALT; REGISTERED: CH IKS 55 378 01 20000927; CH IKS 55 378 02 20000927; CH IKS 55 378 03 20000927; UK EU/1/00/151/001 20001011; UK EU/1/00/151/002 20001011; UK EU/1/00/151/003 20001011; UK EU/1/00/151/004 20001011; UK EU/1/00/151/005 20001011; UK EU/1/00/151/006 20001011
C026/2009Ireland► SubscribeSPC026/2009: 20101001, EXPIRES: 20210619
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Serving leading biopharmaceutical companies globally:

US Department of Justice
Accenture
McKesson
US Army
Farmers Insurance
Express Scripts
Federal Trade Commission
QuintilesIMS
Healthtrust
Argus 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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