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Last Updated: November 21, 2024

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 three branded drugs marketed by Boehringer Ingelheim, Sunshine, and Zydus Pharms, and is included in four NDAs. There are eleven 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 eighty-nine patent family members in forty-five countries.

One supplier is listed for this compound. There are two tentative approvals for this compound.

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

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

SponsorPhase
Medanta, The Medicity, IndiaN/A
Dong Wha Pharmaceutical Co. Ltd.Phase 1
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolN/A

See all LINAGLIPTIN; METFORMIN HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up2.5MG; 1GTABLET;ORAL
⤷  Sign Up⤷  Sign Up2.5MG; 850MGTABLET;ORAL
⤷  Sign Up⤷  Sign Up2.5MG; 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 Strength NDA ANDAs Submitted Submissiondate
JENTADUETO XR Extended-release Tablets linagliptin; metformin hydrochloride 2.5 mg/1000 mg 5 mg/1000 mg 208026 1 2018-03-28
JENTADUETO Tablets linagliptin; metformin hydrochloride 2.5 mg/500 mg 2.5 mg/850 mg 2.5 mg/1000 mg 201281 8 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 XR linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208026-001 May 27, 2016 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim JENTADUETO linagliptin; metformin hydrochloride TABLET;ORAL 201281-001 Jan 30, 2012 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim JENTADUETO linagliptin; metformin hydrochloride TABLET;ORAL 201281-001 Jan 30, 2012 AB RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Boehringer Ingelheim JENTADUETO linagliptin; metformin hydrochloride TABLET;ORAL 201281-002 Jan 30, 2012 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 linagliptin; metformin hydrochloride TABLET;ORAL 201281-003 Jan 30, 2012 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim JENTADUETO linagliptin; metformin hydrochloride TABLET;ORAL 201281-002 Jan 30, 2012 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim JENTADUETO linagliptin; metformin hydrochloride TABLET;ORAL 201281-003 Jan 30, 2012 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim JENTADUETO linagliptin; metformin hydrochloride TABLET;ORAL 201281-001 Jan 30, 2012 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for LINAGLIPTIN; METFORMIN HYDROCHLORIDE

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Boehringer Ingelheim International GmbH Jentadueto linagliptin, metformin hydrochloride EMEA/H/C/002279
Treatment of adult patients with type-2 diabetes mellitus:Jentadueto is indicated as an adjunct to diet and exercise to improve glycaemic control in adult patients inadequately controlled on their maximal tolerated dose of metformin alone, or those already being treated with the combination of linagliptin and metformin.Jentadueto is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.
Authorised no no no 2012-07-19
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for LINAGLIPTIN; METFORMIN HYDROCHLORIDE

Country Patent Number Title Estimated Expiration
Eurasian Patent Organization 036618 СПОСОБ ТЕРАПЕВТИЧЕСКОГО ЛЕЧЕНИЯ ВЫРАЖЕННОГО ДИАБЕТА 2 ТИПА С ПОМОЩЬЮ ИНГИБИТОРА DPP IV (METHOD OF THERAPEUTIC TREATMENT OF MANIFEST TYPE 2 DIABETES USING DPP IV INHIBITOR) ⤷  Sign Up
Taiwan I520738 ⤷  Sign Up
Japan 6139004 ⤷  Sign Up
Taiwan 200944209 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for LINAGLIPTIN; METFORMIN HYDROCHLORIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1532149 PA2012022 Lithuania ⤷  Sign Up PRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720
1532149 C300569 Netherlands ⤷  Sign Up 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 CA 2011 00030 Denmark ⤷  Sign Up
1532149 11C0052 France ⤷  Sign Up PRODUCT NAME: LINAGLIPTINE SES ENANTIOMERES ET SELS; REGISTRATION NO/DATE: EU/1/11/707/001 20110830
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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