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Last Updated: November 22, 2024

LINAGLIPTIN AND METFORMIN HYDROCHLORIDE Drug Patent Profile


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When do Linagliptin And Metformin Hydrochloride patents expire, and when can generic versions of Linagliptin And Metformin Hydrochloride launch?

Linagliptin And Metformin Hydrochloride is a drug marketed by Sunshine and Zydus Pharms and is included in two NDAs.

The generic ingredient in LINAGLIPTIN AND METFORMIN HYDROCHLORIDE 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.

DrugPatentWatch® Litigation and Generic Entry Outlook for Linagliptin And Metformin Hydrochloride

A generic version of LINAGLIPTIN AND METFORMIN HYDROCHLORIDE was approved as linagliptin; metformin hydrochloride by SUNSHINE on August 30th, 2021.

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Summary for LINAGLIPTIN AND METFORMIN HYDROCHLORIDE
US Patents:0
Applicants:2
NDAs:2
Clinical Trials: 61
DailyMed Link:LINAGLIPTIN AND METFORMIN HYDROCHLORIDE at DailyMed
Drug patent expirations by year for LINAGLIPTIN AND METFORMIN HYDROCHLORIDE
Recent Clinical Trials for LINAGLIPTIN AND METFORMIN HYDROCHLORIDE

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

SponsorPhase
Medanta, The Medicity, IndiaN/A
Dong Wha Pharmaceutical Co. Ltd.Phase 1
Wuxi People's HospitalN/A

See all LINAGLIPTIN AND METFORMIN HYDROCHLORIDE clinical trials

US Patents and Regulatory Information for LINAGLIPTIN AND METFORMIN HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sunshine LINAGLIPTIN AND METFORMIN HYDROCHLORIDE linagliptin; metformin hydrochloride TABLET;ORAL 208336-003 Aug 30, 2021 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus Pharms LINAGLIPTIN AND METFORMIN HYDROCHLORIDE linagliptin; metformin hydrochloride TABLET;ORAL 208449-003 Mar 30, 2023 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sunshine LINAGLIPTIN AND METFORMIN HYDROCHLORIDE linagliptin; metformin hydrochloride TABLET;ORAL 208336-001 Aug 30, 2021 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sunshine LINAGLIPTIN AND METFORMIN HYDROCHLORIDE linagliptin; metformin hydrochloride TABLET;ORAL 208336-002 Aug 30, 2021 AB RX No 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

EU/EMA Drug Approvals for LINAGLIPTIN AND 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

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