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Last Updated: June 6, 2020

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JENTADUETO Drug Profile


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When do Jentadueto patents expire, and what generic alternatives are available?

Jentadueto is a drug marketed by Boehringer Ingelheim and is included in two NDAs. There are twelve patents protecting this drug and two Paragraph IV challenges.

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

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

US ANDA Litigation and Generic Entry Outlook for Jentadueto

Jentadueto was eligible for patent challenges on May 2, 2015.

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (linagliptin; metformin hydrochloride), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Paragraph IV (Patent) Challenges for JENTADUETO
Tradename Dosage Ingredient NDA Submissiondate
JENTADUETO TABLET;ORAL linagliptin; metformin hydrochloride 201281 2015-05-04

US Patents and Regulatory Information for JENTADUETO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim JENTADUETO XR linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208026-001 May 27, 2016 RX Yes No   Start Trial   Start Trial Y   Start Trial
Boehringer Ingelheim JENTADUETO linagliptin; metformin hydrochloride TABLET;ORAL 201281-002 Jan 30, 2012 RX Yes No   Start Trial   Start Trial   Start Trial
Boehringer Ingelheim JENTADUETO XR linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208026-002 May 27, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Boehringer Ingelheim JENTADUETO XR linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208026-002 May 27, 2016 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for JENTADUETO

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim JENTADUETO linagliptin; metformin hydrochloride TABLET;ORAL 201281-001 Jan 30, 2012   Start Trial   Start Trial
Boehringer Ingelheim JENTADUETO linagliptin; metformin hydrochloride TABLET;ORAL 201281-003 Jan 30, 2012   Start Trial   Start Trial
Boehringer Ingelheim JENTADUETO linagliptin; metformin hydrochloride TABLET;ORAL 201281-003 Jan 30, 2012   Start Trial   Start Trial
Boehringer Ingelheim JENTADUETO linagliptin; metformin hydrochloride TABLET;ORAL 201281-001 Jan 30, 2012   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for JENTADUETO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1532149 91889 Luxembourg   Start Trial 91889, EXPIRES: 20260824
1084705 PA2014042 Lithuania   Start Trial PRODUCT NAME: VILDAGLIPTINUM; REGISTRATION NO/DATE: EU/1/07/414/001-010, 2007 09 26 EU/1/07/414/018 20070926
1532149 2011C/038 Belgium   Start Trial PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2--YLMETHYL)-3,7-DIHYDROPURIN-2,6-DIONE SES ENANTIOMERES OU L'UN DES SES SELS, EN PARTICULIER LA LINAGLIPTINE; AUTHORISATION NUMBER AND DATE: EU/1/11/707/001 20110830
1084705 C300705 Netherlands   Start Trial PRODUCT NAME: SITAGLIPTINE; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070321
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
Boehringer Ingelheim
McKinsey
Medtronic
Johnson and Johnson
Moodys

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