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DUETACT Drug Profile

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Duetact is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from two suppliers. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and twenty-two 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:7
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Formulation / Manufacturing:see details
Drug Prices: :see details
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Takeda Pharms Usa
DUETACT
glimepiride; pioglitazone hydrochloride
TABLET;ORAL021925-001Jul 28, 2006RXYes6,150,383► subscribe ► subscribe
Takeda Pharms Usa
DUETACT
glimepiride; pioglitazone hydrochloride
TABLET;ORAL021925-001Jul 28, 2006RXYes7,700,128► subscribeY ► subscribe
Takeda Pharms Usa
DUETACT
glimepiride; pioglitazone hydrochloride
TABLET;ORAL021925-001Jul 28, 2006RXYes6,329,404► 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;ORAL021925-001Jul 28, 20066,329,404► subscribe
Takeda Pharms Usa
DUETACT
glimepiride; pioglitazone hydrochloride
TABLET;ORAL021925-002Jul 28, 20066,329,404► subscribe
Takeda Pharms Usa
DUETACT
glimepiride; pioglitazone hydrochloride
TABLET;ORAL021925-001Jul 28, 20066,303,640► 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
6,288,090 Pharmaceutical composition► subscribe
6,225,326 Pharmaceutical composition► subscribe
6,274,605 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
TaiwanI238064► subscribe
Norway314065► subscribe
TaiwanI384985► 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
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
606Luxembourg► subscribe91606, EXPIRES: 20210620
2009 00045Denmark► subscribe
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