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Serving leading biopharmaceutical companies globally:

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Generated: October 20, 2017

DrugPatentWatch Database Preview

ACTOS Drug Profile

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Which patents cover Actos, and what generic Actos alternatives are available?

Actos is a drug marketed by Takeda Pharms Usa and is included in one NDA. There is one patent protecting this drug.

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

The generic ingredient in ACTOS is pioglitazone hydrochloride. There are twenty-seven drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the pioglitazone hydrochloride profile page.

Summary for Tradename: ACTOS

US Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list12
Bulk Api Vendors: see list73
Clinical Trials: see list69
Patent Applications: see list2,024
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:ACTOS at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Takeda Pharms Usa
ACTOS
pioglitazone hydrochloride
TABLET;ORAL021073-001Jul 15, 1999ABRXYesNo► Subscribe► Subscribe ► Subscribe
Takeda Pharms Usa
ACTOS
pioglitazone hydrochloride
TABLET;ORAL021073-002Jul 15, 1999ABRXYesNo► Subscribe► Subscribe ► Subscribe
Takeda Pharms Usa
ACTOS
pioglitazone hydrochloride
TABLET;ORAL021073-003Jul 15, 1999ABRXYesYes► Subscribe► Subscribe ► Subscribe
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Expired Patents for Tradename: ACTOS

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 Tradename: ACTOS

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 Tradename: ACTOS

Country Document Number Estimated Expiration
China1145783► Subscribe
Hungary9601698► Subscribe
Russian Federation2327455► Subscribe
Japan3973280► Subscribe
Australia5603496► Subscribe
Slovakia79496► Subscribe
Russian Federation2286148► Subscribe
JapanH0967271► Subscribe
Argentina005641► Subscribe
Argentina091289► 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: ACTOS

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
01C/011Belgium► SubscribePRODUCT NUMBER: PIOGLITAZONE; NAT. REGISTRATION NO/DATE: EU/1/001/150/001 20001018; FIRST REGISTRATION NO: CH 55378 01 20000927
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
0861666/01Switzerland► SubscribeFORMER REPRESENTATIVE: BOHEST AG, CH
2009 00045Denmark► Subscribe
298Luxembourg► Subscribe91298, EXPIRES: 20210620
C0006France► SubscribePRODUCT NAME: PIOGLITAZONE/METFORMINE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/06/354/001 DU 20060728; REGISTRATION NO/DATE AT EEC: EU/1/06/354/001 DU 20060728
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
2007 00001Denmark► Subscribe
C 038/2006Ireland► SubscribeSPC 038/2006: 20070528, EXPIRES: 20210619
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Serving leading biopharmaceutical companies globally:

Harvard Business School
Argus Health
Medtronic
McKinsey
Farmers Insurance
Boehringer Ingelheim
Teva
Merck
Deloitte
Healthtrust

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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