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Last Updated: January 21, 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 fifteen patents protecting this drug and two Paragraph IV challenges.

This drug has three hundred and thirty-eight 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

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

Drug patent expirations by year for JENTADUETO
Drug Prices for JENTADUETO

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Recent Clinical Trials for JENTADUETO

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Boehringer IngelheimPhase 1

See all JENTADUETO clinical trials

Recent Litigation for JENTADUETO

Identify potential future generic entrants

District Court Litigation
Case NameDate
BOEHRINGER INGELHEIM PHARMACEUTICALS INC. v. SUN PHARMACEUTICAL INDUSTRIES LTD2016-03-29
Boehringer Ingelheim Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc.2015-08-25
BOEHRINGER INGELHEIM PHARMACEUTICALS INC. v. HEC PHARM CO., LTD.2015-08-04

See all JENTADUETO litigation

PTAB Litigation
PetitionerDate
Mylan Pharmaceuticals Inc.2016-08-10
Mylan Pharmaceuticals Inc.2016-08-10

See all JENTADUETO litigation

Pharmacology for JENTADUETO
Synonyms for JENTADUETO
1-carbamimidamido-N,N-dimethylmethanimidamide; 8-((3R)-3-aminopiperidin-1-yl)-7-(but-2-yn-1-yl)-3-methyl-1-((4-methylquinazolin-2-yl)methyl)purine-2,6-dione
1198772-26-7
DTXSID50152609
Jentadueto Xr
Linagliptin / metformin
Linagliptin mixture with metformin
Metformin / linagliptin
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   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 208026-001 May 27, 2016 RX Yes No   Start Trial   Start Trial   Start Trial
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 XR linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208026-002 May 27, 2016 RX Yes Yes   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
>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

Supplementary Protection Certificates for JENTADUETO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1084705 SPC/GB14/084 United Kingdom   Start Trial PRODUCT NAME: LINAGLIPTIN; REGISTERED: UK EU/1/11/707/001-011 20110830
1532149 92128 Luxembourg   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-DION, LES ENANTIOMERES ET LEURS SELS, EN PARTICULIER LA LINAGLIPTINE COMBINEE AVEC DU CHLORHYDRATE DE METFORMINE. LINAGLIPTINE
1532149 8/2012 Austria   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-DION UND DESSEN SALZE, INSBES. LINAGLIPTIN; REGISTRATION NO/DATE: EU/1/11/707/001-011 (MITTEILUNG) 20110830
1532149 C300569 Netherlands   Start Trial PRODUCT NAME: LINAGLIPTINE, DESGEWENST IN DE VORM VAN EEN ZOUT, IN COMBINATIE MET METFORMINEHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/12/780/001-028 20120720
1532149 C300504 Netherlands   Start Trial PRODUCT NAME: LINAGLIPTINE, DESGEWENST IN DE VORM VAN ZOUT; REGISTRATION NO/DATE: EU/1/11/707/001-011 20110824
1084705 C01084705/04 Switzerland   Start Trial PRODUCT NAME: LINAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 61893 08.03.2012
1532149 C01532149/01 Switzerland   Start Trial PRODUCT NAME: LINAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 61893 08.03.2012
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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