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Last Updated: November 13, 2019

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LINAGLIPTIN; METFORMIN HYDROCHLORIDE - Generic Drug Details

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What are the generic sources for linagliptin; metformin hydrochloride and what is the scope of freedom to operate?

Linagliptin; metformin hydrochloride is the generic ingredient in two branded drugs marketed by Boehringer Ingelheim and is included in two NDAs. There are fifteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Linagliptin; metformin hydrochloride has three hundred and sixty-five patent family members in forty-five countries.

There are nineteen drug master file entries for linagliptin; metformin hydrochloride. Two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Recent Clinical Trials for LINAGLIPTIN; METFORMIN HYDROCHLORIDE

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

SponsorPhase
Hospital Regional de Alta Especialidad del BajioPhase 3
Universidad de GuanajuatoPhase 3
Sihuan Pharmaceutical Holdings Group Ltd.Phase 3

See all LINAGLIPTIN; METFORMIN HYDROCHLORIDE clinical trials

Recent Litigation for LINAGLIPTIN; METFORMIN HYDROCHLORIDE

Identify potential future generic entrants

District Court Litigation
Case NameDate
BOEHRINGER INGELHEIM PHARMACEUTICALS INC. v. SUN PHARMACEUTICAL INDUSTRIES LTD2016-03-29
In re: Depomed, Inc.2015-12-30
Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.2015-09-15

See all LINAGLIPTIN; METFORMIN HYDROCHLORIDE litigation

PTAB Litigation
PetitionerDate
Mylan Pharmaceuticals Inc.2016-08-10
Mylan Pharmaceuticals Inc.2016-08-10
Endo Pharmaceutical Inc.2014-04-17

See all LINAGLIPTIN; METFORMIN HYDROCHLORIDE litigation

Generic filers with tentative approvals for LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial2.5MG;1GMTABLET;ORAL
  Start Trial  Start Trial2.5MG;850MGTABLET;ORAL
  Start Trial  Start Trial2.5MG;500MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Paragraph IV (Patent) Challenges for LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
JENTADUETO XR TABLET, EXTENDED RELEASE;ORAL linagliptin; metformin hydrochloride 208026 2018-03-28
JENTADUETO TABLET;ORAL linagliptin; metformin hydrochloride 201281 2015-05-04

US Patents and Regulatory Information for LINAGLIPTIN; METFORMIN HYDROCHLORIDE

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 linagliptin; metformin hydrochloride TABLET;ORAL 201281-003 Jan 30, 2012 RX Yes Yes   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 linagliptin; metformin hydrochloride TABLET;ORAL 201281-002 Jan 30, 2012 RX Yes No   Start Trial   Start Trial   Start Trial
Boehringer Ingelheim JENTADUETO linagliptin; metformin hydrochloride TABLET;ORAL 201281-001 Jan 30, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
Boehringer Ingelheim JENTADUETO linagliptin; metformin hydrochloride TABLET;ORAL 201281-003 Jan 30, 2012 RX Yes Yes   Start Trial   Start Trial   Start Trial
Boehringer Ingelheim JENTADUETO linagliptin; metformin hydrochloride TABLET;ORAL 201281-001 Jan 30, 2012 RX Yes No   Start Trial   Start Trial Y 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 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 LINAGLIPTIN; METFORMIN HYDROCHLORIDE

Supplementary Protection Certificates for LINAGLIPTIN; METFORMIN HYDROCHLORIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1532149 CR 2011 00030 Denmark   Start Trial PRODUCT NAME: LINAGLIPTIN OG SALTE DERAF; NAT. REG. NO/DATE: EU/1/11/707/001-011 20110830; FIRST REG. NO/DATE: EU EU/1/11/707/001-0011 20110830
1532149 118 5013-2011 Slovakia   Start Trial PRODUCT NAME: LINAGLIPTIN; REGISTRATION NO/DATE: EU/1/11/707/001 - EU/1/11/707/011 20110824
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 PA2012022 Lithuania   Start Trial PRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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McKinsey
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AstraZeneca
Baxter
Dow

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