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Serving 500+ biopharmaceutical companies globally:

Dow
Moodys
Covington
Boehringer Ingelheim
Medtronic
McKesson
US Army
Fish and Richardson
Harvard Business School
US Department of Justice

Generated: August 21, 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 Mylan Pharms Inc, Teva Pharms Usa, Lupin Ltd, 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 thirteen NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Pioglitazone hydrochloride has seventy-one patent family members in twenty-five countries.

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

Summary for Generic Name: pioglitazone hydrochloride

Tradenames:2
Patents:1
Applicants:13
NDAs:13
Drug Master File Entries: see list27
Suppliers / Packagers: see list34
Bulk Api Vendors: see list82
Clinical Trials: see list2,630
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
► Subscribe► Subscribe15MGTABLET; ORAL
► Subscribe► Subscribe45MGTABLET; ORAL
► Subscribe► Subscribe30MGTABLET; ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Accord Hlthcare
PIOGLITAZONE HYDROCHLORIDE
pioglitazone hydrochloride
TABLET;ORAL200044-003Feb 13, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
Cipla Ltd
PIOGLITAZONE HYDROCHLORIDE
pioglitazone hydrochloride
TABLET;ORAL076798-003Oct 26, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Aurobindo Pharma Ltd
PIOGLITAZONE HYDROCHLORIDE
pioglitazone hydrochloride
TABLET;ORAL200268-002Feb 13, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
Takeda Pharms Usa
ACTOS
pioglitazone hydrochloride
TABLET;ORAL021073-003Jul 15, 1999ABRXYesYes► Subscribe► Subscribe ► Subscribe
Torrent Pharms Ltd
PIOGLITAZONE HYDROCHLORIDE
pioglitazone hydrochloride
TABLET;ORAL091298-002Feb 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;ORAL021073-002Jul 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
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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
6,239,153 Pharmaceutical composition► Subscribe
6,156,773 Pharmaceutical composition► Subscribe
6,169,100 Pharmaceutical composition► Subscribe
6,133,295 Pharmaceutical composition► Subscribe
6,150,383 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
Japan4809806► Subscribe
Hong Kong1041203► Subscribe
Cyprus2424► Subscribe
Germany69637988► Subscribe
European Patent Office1174135► 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/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/GB07/009United Kingdom► SubscribeSPC/GB07/009: 20070126
298Luxembourg► Subscribe91298, EXPIRES: 20210620
0861666/01Switzerland► 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 500+ biopharmaceutical companies globally:

Fuji
McKinsey
Daiichi Sankyo
Merck
Cerilliant
Mallinckrodt
Moodys
Express Scripts
Cantor Fitzgerald
Dow

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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