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Serving leading biopharmaceutical companies globally:

Colorcon
Novartis
Harvard Business School
Express Scripts
McKinsey
McKesson
Farmers Insurance
Chubb
Boehringer Ingelheim
Mallinckrodt

Generated: October 21, 2017

DrugPatentWatch Database Preview

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 Mylan Pharms Inc, Teva Pharms Usa, Lupin Ltd, Puracap Pharm Llc, Accord Hlthcare, Zydus Pharms Usa Inc, Macleods Pharms Ltd, Aurobindo Pharma Ltd, Sandoz, Breckenridge Pharm, Takeda Pharms Usa, Dr Reddys Labs Ltd, Cipla Ltd, and Torrent Pharms Ltd, 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.

Summary for Generic Name: pioglitazone hydrochloride

US Patents:1
Tradenames:2
Applicants:14
NDAs:14
Drug Master File Entries: see list27
Suppliers / Packagers: see list33
Bulk Api Vendors: see list82
Clinical Trials: see list2,660
Patent Applications: see list3,338
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:pioglitazone hydrochloride at DailyMed

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 Product Substance Delist Req. Exclusivity Expiration
Mylan Pharms Inc
PIOGLITAZONE HYDROCHLORIDE
pioglitazone hydrochloride
TABLET;ORAL076801-003Aug 17, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Pharms Inc
PIOGLITAZONE HYDROCHLORIDE
pioglitazone hydrochloride
TABLET;ORAL076801-002Aug 17, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Sandoz
PIOGLITAZONE HYDROCHLORIDE
pioglitazone hydrochloride
TABLET;ORAL078670-001Feb 13, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
Zydus Pharms Usa Inc
PIOGLITAZONE HYDROCHLORIDE
pioglitazone hydrochloride
TABLET;ORAL202456-002Feb 13, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
Cipla Ltd
PIOGLITAZONE HYDROCHLORIDE
pioglitazone hydrochloride
TABLET;ORAL076798-003Oct 26, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Cipla Ltd
PIOGLITAZONE HYDROCHLORIDE
pioglitazone hydrochloride
TABLET;ORAL076798-001Oct 26, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Breckenridge Pharm
PIOGLITAZONE HYDROCHLORIDE
pioglitazone hydrochloride
TABLET;ORAL078472-002Feb 13, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
Teva Pharms Usa
PIOGLITAZONE HYDROCHLORIDE
pioglitazone hydrochloride
TABLET;ORAL077210-003Jan 10, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
Macleods Pharms Ltd
PIOGLITAZONE HYDROCHLORIDE
pioglitazone hydrochloride
TABLET;ORAL202467-001Feb 6, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
Sandoz
PIOGLITAZONE HYDROCHLORIDE
pioglitazone hydrochloride
TABLET;ORAL078670-003Feb 13, 2013ABRXNoNo► 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 Usa
ACTOS
pioglitazone hydrochloride
TABLET;ORAL021073-003Jul 15, 1999► Subscribe► Subscribe
Takeda Pharms Usa
ACTOS
pioglitazone hydrochloride
TABLET;ORAL021073-001Jul 15, 1999► Subscribe► Subscribe
Takeda Pharms Usa
ACTOS
pioglitazone hydrochloride
TABLET;ORAL021073-003Jul 15, 1999► Subscribe► Subscribe
Takeda Pharms Usa
ACTOS
pioglitazone hydrochloride
TABLET;ORAL021073-002Jul 15, 1999► Subscribe► Subscribe
Takeda Pharms Usa
ACTOS
pioglitazone hydrochloride
TABLET;ORAL021073-002Jul 15, 1999► Subscribe► Subscribe
Takeda Pharms Usa
ACTOS
pioglitazone hydrochloride
TABLET;ORAL021073-002Jul 15, 1999► Subscribe► Subscribe
Takeda Pharms Usa
ACTOS
pioglitazone hydrochloride
TABLET;ORAL021073-002Jul 15, 1999► Subscribe► Subscribe
Takeda Pharms Usa
ACTOS
pioglitazone hydrochloride
TABLET;ORAL021073-001Jul 15, 1999► Subscribe► Subscribe
Takeda Pharms Usa
ACTOS
pioglitazone hydrochloride
TABLET;ORAL021073-001Jul 15, 1999► Subscribe► Subscribe
Takeda Pharms Usa
ACTOS
pioglitazone hydrochloride
TABLET;ORAL021073-002Jul 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
6,271,243 Pharmaceutical composition► Subscribe
6,121,294 Pharmaceutical composition► Subscribe
6,288,090 Pharmaceutical composition► Subscribe
6,172,090 Pharmaceutical composition► Subscribe
6,169,100 Pharmaceutical composition► Subscribe
6,166,043 Pharmaceutical composition► Subscribe
6,211,205 Pharmaceutical composition► Subscribe
5,952,356 Pharmaceutical composition► Subscribe
7,538,125Pharmaceutical composition► Subscribe
6,133,295 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
Portugal1174135► Subscribe
Russian Federation2003130978► Subscribe
Slovakia79496► Subscribe
Russian Federation2327455► Subscribe
Argentina065389► Subscribe
European Patent Office2292268► Subscribe
Norway317341► Subscribe
Argentina061195► Subscribe
South Korea20080005162► Subscribe
Germany122007000002► 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
C 038/2006Ireland► SubscribeSPC 038/2006: 20070528, EXPIRES: 20210619
0258Netherlands► Subscribe300258, 20160620, EXPIRES: 20210619
C/GB07/009United Kingdom► SubscribeSPC/GB07/009: 20070126
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
298Luxembourg► Subscribe91298, EXPIRES: 20210620
606Luxembourg► Subscribe91606, EXPIRES: 20210620
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
1Finland► Subscribe
1174135/01Switzerland► SubscribeFORMER REPRESENTATIVE: BOHEST AG, CH
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School
Healthtrust
Cerilliant
Dow
Medtronic
Federal Trade Commission
Accenture
Queensland Health
Chinese Patent Office
Merck

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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