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DUETACT Drug Profile

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Which patents cover Duetact, and what substitute generic drugs are available?

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 twenty-four patent family members in thirty-six 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.

Summary for Tradename: DUETACT

Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Bulk Api Vendors: see list72
Patent Applications: see list9,865
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:DUETACT at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Takeda Pharms Usa
DUETACT
glimepiride; pioglitazone hydrochloride
TABLET;ORAL021925-001Jul 28, 2006RXYesYes6,303,640► Subscribe ► Subscribe
Takeda Pharms Usa
DUETACT
glimepiride; pioglitazone hydrochloride
TABLET;ORAL021925-002Jul 28, 2006RXYesNo6,303,640► Subscribe ► Subscribe
Takeda Pharms Usa
DUETACT
glimepiride; pioglitazone hydrochloride
TABLET;ORAL021925-001Jul 28, 2006RXYesYes8,071,130► SubscribeY ► Subscribe
Takeda Pharms Usa
DUETACT
glimepiride; pioglitazone hydrochloride
TABLET;ORAL021925-001Jul 28, 2006RXYesYes7,700,128► SubscribeY ► Subscribe
Takeda Pharms Usa
DUETACT
glimepiride; pioglitazone hydrochloride
TABLET;ORAL021925-002Jul 28, 2006RXYesNo7,700,128► 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, 20067,538,125► Subscribe
Takeda Pharms Usa
DUETACT
glimepiride; pioglitazone hydrochloride
TABLET;ORAL021925-002Jul 28, 20066,303,640► Subscribe
Takeda Pharms Usa
DUETACT
glimepiride; pioglitazone hydrochloride
TABLET;ORAL021925-001Jul 28, 20064,687,777► Subscribe
Takeda Pharms Usa
DUETACT
glimepiride; pioglitazone hydrochloride
TABLET;ORAL021925-002Jul 28, 20064,687,777► Subscribe
Takeda Pharms Usa
DUETACT
glimepiride; pioglitazone hydrochloride
TABLET;ORAL021925-001Jul 28, 20067,538,125► Subscribe
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Paragraph IV activity 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
6,384,062 Pharmaceutical composition► Subscribe
6,133,295 Pharmaceutical composition► Subscribe
6,225,326 Pharmaceutical composition► Subscribe
6,911,459 Pharmaceutical composition► Subscribe
6,271,243 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
South Africa9605190► Subscribe
China1530106► Subscribe
Luxembourg91298► Subscribe
European Patent Office1677792► Subscribe
Norway317341► 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
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
C 038/2006Ireland► SubscribeSPC 038/2006: 20070528, EXPIRES: 20210619
C026/2009Ireland► SubscribeSPC026/2009: 20101001, EXPIRES: 20210619
298Luxembourg► Subscribe91298, EXPIRES: 20210620
1174135/01Switzerland► SubscribeFORMER REPRESENTATIVE: BOHEST AG, CH
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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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