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Last Updated: August 4, 2020

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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 patent protection?

Linagliptin; metformin hydrochloride is the generic ingredient in two branded drugs marketed by Boehringer Ingelheim and is included in two NDAs. There are twelve 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 fifty-one patent family members in forty-five countries.

There are nineteen drug master file entries for linagliptin; metformin hydrochloride. One supplier is 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

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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim JENTADUETO XR linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208026-001 May 27, 2016   Start Trial   Start Trial
Boehringer Ingelheim JENTADUETO linagliptin; metformin hydrochloride TABLET;ORAL 201281-001 Jan 30, 2012   Start Trial   Start Trial
Boehringer Ingelheim JENTADUETO XR linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208026-001 May 27, 2016   Start Trial   Start Trial
Boehringer Ingelheim JENTADUETO linagliptin; metformin hydrochloride TABLET;ORAL 201281-002 Jan 30, 2012   Start Trial   Start Trial
Boehringer Ingelheim JENTADUETO XR linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208026-002 May 27, 2016   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for linagliptin; metformin hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1532149 132013902118390 Italy   Start Trial PRODUCT NAME: LINAGLIPTIN + METFORMINA CLORIDRATO(JENTADUETO); AUTHORISATION NUMBER(S) AND DATE(S): DA EU/1/12/780/001 A EU/1/12/780/027, 20120720
1084705 CA 2014 00065 Denmark   Start Trial PRODUCT NAME: LINAGLIPTIN; REG. NO/DATE: EU/1/11/707/001-011 20110824
1532149 CA 2011 00030 Denmark   Start Trial
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 91889 Luxembourg   Start Trial 91889, EXPIRES: 20260824
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
AstraZeneca
Moodys
Express Scripts
Harvard Business School
Baxter

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