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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Cantor Fitzgerald
Accenture
Baxter
Argus Health
McKesson
Merck
AstraZeneca
Deloitte
Julphar

Generated: November 18, 2017

DrugPatentWatch Database Preview

DUETACT Drug Profile

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Which patents cover Duetact, and when can generic versions of Duetact launch?

Duetact is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and thirty-two patent family members in thirty-six countries and fourteen supplementary protection certificates in eight countries.

The generic ingredient in DUETACT is glimepiride; pioglitazone hydrochloride. There are fourteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the glimepiride; pioglitazone hydrochloride profile page.
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
DUETACT
glimepiride; pioglitazone hydrochloride
TABLET;ORAL021925-001Jul 28, 2006ABRXYesYes► Subscribe► Subscribe ► Subscribe
Takeda Pharms Usa
DUETACT
glimepiride; pioglitazone hydrochloride
TABLET;ORAL021925-002Jul 28, 2006ABRXYesNo► Subscribe► Subscribe ► Subscribe
Takeda Pharms Usa
DUETACT
glimepiride; pioglitazone hydrochloride
TABLET;ORAL021925-001Jul 28, 2006ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Takeda Pharms Usa
DUETACT
glimepiride; pioglitazone hydrochloride
TABLET;ORAL021925-001Jul 28, 2006ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Takeda Pharms Usa
DUETACT
glimepiride; pioglitazone hydrochloride
TABLET;ORAL021925-002Jul 28, 2006ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Takeda Pharms Usa
DUETACT
glimepiride; pioglitazone hydrochloride
TABLET;ORAL021925-002Jul 28, 2006ABRXYesNo► Subscribe► SubscribeY ► Subscribe
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Expired Patents for Tradename: DUETACT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms Usa
DUETACT
glimepiride; pioglitazone hydrochloride
TABLET;ORAL021925-002Jul 28, 2006► Subscribe► Subscribe
Takeda Pharms Usa
DUETACT
glimepiride; pioglitazone hydrochloride
TABLET;ORAL021925-002Jul 28, 2006► Subscribe► Subscribe
Takeda Pharms Usa
DUETACT
glimepiride; pioglitazone hydrochloride
TABLET;ORAL021925-001Jul 28, 2006► Subscribe► Subscribe
Takeda Pharms Usa
DUETACT
glimepiride; pioglitazone hydrochloride
TABLET;ORAL021925-002Jul 28, 2006► Subscribe► Subscribe
Takeda Pharms Usa
DUETACT
glimepiride; pioglitazone hydrochloride
TABLET;ORAL021925-001Jul 28, 2006► Subscribe► Subscribe
Takeda Pharms Usa
DUETACT
glimepiride; pioglitazone hydrochloride
TABLET;ORAL021925-002Jul 28, 2006► Subscribe► Subscribe
Takeda Pharms Usa
DUETACT
glimepiride; pioglitazone hydrochloride
TABLET;ORAL021925-002Jul 28, 2006► Subscribe► Subscribe
Takeda Pharms Usa
DUETACT
glimepiride; pioglitazone hydrochloride
TABLET;ORAL021925-002Jul 28, 2006► Subscribe► Subscribe
Takeda Pharms Usa
DUETACT
glimepiride; pioglitazone hydrochloride
TABLET;ORAL021925-001Jul 28, 2006► Subscribe► Subscribe
Takeda Pharms Usa
DUETACT
glimepiride; pioglitazone hydrochloride
TABLET;ORAL021925-001Jul 28, 2006► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for DUETACT

Drugname Dosage Strength RLD Submissiondate
pioglitazone hydrochloride and glimepirideTablets30 mg/2 mg and 30 mg/4 mgDuetact12/22/2009

Non-Orange Book Patents for Tradename: DUETACT

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
6,133,293 Pharmaceutical composition► Subscribe
6,288,090 Pharmaceutical composition► Subscribe
6,225,326 Pharmaceutical composition► Subscribe
6,239,153 Pharmaceutical composition► Subscribe
7,538,125Pharmaceutical composition► Subscribe
6,211,205 Pharmaceutical composition► Subscribe
6,323,225 Pharmaceutical composition► Subscribe
5,952,356 Pharmaceutical composition► Subscribe
6,218,409 Pharmaceutical composition► Subscribe
6,103,742 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: DUETACT

Country Document Number Estimated Expiration
Russian Federation2006118786► Subscribe
Cyprus1117176► Subscribe
Czech Republic9601811► Subscribe
Canada2531834► Subscribe
Japan2005154418► Subscribe
Norway962606► Subscribe
European Patent Office1174135► Subscribe
World Intellectual Property Organization (WIPO)2005041962► Subscribe
Taiwan200524641► Subscribe
New Zealand546337► 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: DUETACT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0258Netherlands► Subscribe300258, 20160620, EXPIRES: 20210619
C/GB07/009United Kingdom► SubscribeSPC/GB07/009: 20070126
C 038/2006Ireland► SubscribeSPC 038/2006: 20070528, EXPIRES: 20210619
0861666/01Switzerland► SubscribeFORMER REPRESENTATIVE: BOHEST AG, CH
606Luxembourg► Subscribe91606, EXPIRES: 20210620
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
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
2007 00001Denmark► Subscribe
298Luxembourg► Subscribe91298, EXPIRES: 20210620
C026/2009Ireland► SubscribeSPC026/2009: 20101001, EXPIRES: 20210619
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Serving leading biopharmaceutical companies globally:

Harvard Business School
Cipla
Chinese Patent Office
Cantor Fitzgerald
Dow
Merck
Healthtrust
Mallinckrodt
Covington
Novartis

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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