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JENTADUETO XR Drug Profile

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Jentadueto Xr is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from one supplier. There are sixteen patents protecting this drug.

This drug has three hundred and forty-six patent family members in forty-five countries.

The generic ingredient in JENTADUETO XR is linagliptin; metformin hydrochloride. There are fifteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the linagliptin; metformin hydrochloride profile page.

Summary for Tradename: JENTADUETO XR

Patents:16
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Formulation / Manufacturing:see details
Drug Prices: :see details

Pharmacology for Tradename: JENTADUETO XR

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim
JENTADUETO XR
linagliptin; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL208026-002May 27, 2016RXYes9,155,705► subscribeY ► subscribe
Boehringer Ingelheim
JENTADUETO XR
linagliptin; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL208026-002May 27, 2016RXYes9,415,016► subscribeY ► subscribe
Boehringer Ingelheim
JENTADUETO XR
linagliptin; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL208026-002May 27, 2016RXYes6,488,962► subscribeY ► subscribe
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Expired Patents for Tradename: JENTADUETO XR

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim
JENTADUETO XR
linagliptin; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL208026-002May 27, 20166,635,280► subscribe
Boehringer Ingelheim
JENTADUETO XR
linagliptin; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL208026-001May 27, 20166,340,475► subscribe
Boehringer Ingelheim
JENTADUETO XR
linagliptin; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL208026-001May 27, 20166,635,280► subscribe
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Non-Orange Book Patents for Tradename: JENTADUETO XR

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
8,232,281Uses of DPP-IV inhibitors► subscribe
7,820,815Process for the preparation of chiral 8-(-3-aminopiperidin-1-yl) xanthines► subscribe
8,664,2328-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions► 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: JENTADUETO XR

Country Document Number Estimated Expiration
New Zealand523214► subscribe
Portugal1532149► subscribe
European Patent Office2407168► 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: JENTADUETO XR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014 00065Denmark► subscribePRODUCT NAME: LINAGLIPTIN; REG. NO/DATE: EU/1/11/707/001-011 20110830
00706Netherlands► subscribePRODUCT NAME: VILDAGLIPTINE; REGISTRATION NO/DATE: EU/1/07/414/001-017 20070926
2014044Lithuania► subscribePRODUCT NAME: LINAGLIPTINUM; REGISTRATION NO/DATE: EU/1/11/707/001-011 20110824
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