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Last Updated: July 19, 2024

Empagliflozin; linagliptin - Generic Drug Details


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What are the generic sources for empagliflozin; linagliptin and what is the scope of patent protection?

Empagliflozin; linagliptin is the generic ingredient in two branded drugs marketed by Boehringer Ingelheim and is included in two NDAs. There are nineteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Empagliflozin; linagliptin has five hundred and sixty-two patent family members in forty-seven countries.

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

Summary for empagliflozin; linagliptin
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for empagliflozin; linagliptin
Generic Entry Date for empagliflozin; linagliptin*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for empagliflozin; linagliptin

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

SponsorPhase
Diabetes & Endocrinology FoundationN/A
Medanta, The Medicity, IndiaN/A
The First Affiliated Hospital with Nanjing Medical UniversityN/A

See all empagliflozin; linagliptin clinical trials

Generic filers with tentative approvals for EMPAGLIFLOZIN; LINAGLIPTIN
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up25MG;5MGTABLET;ORAL
⤷  Sign Up⤷  Sign Up25MG/5MGTABLET;ORAL
⤷  Sign Up⤷  Sign Up10MG/5MGTABLET; ORAL

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

Paragraph IV (Patent) Challenges for EMPAGLIFLOZIN; LINAGLIPTIN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
GLYXAMBI Tablets empagliflozin; linagliptin 10 mg/5 mg and 25 mg/5 mg 206073 9 2018-08-01

US Patents and Regulatory Information for empagliflozin; linagliptin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614-002 Jan 27, 2020 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Boehringer Ingelheim TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614-002 Jan 27, 2020 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-002 Jan 30, 2015 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Boehringer Ingelheim TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614-003 Jan 27, 2020 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-002 Jan 30, 2015 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-002 Jan 30, 2015 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  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 empagliflozin; linagliptin

EU/EMA Drug Approvals for empagliflozin; linagliptin

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Boehringer Ingelheim International GmbH Glyxambi empagliflozin, linagliptin EMEA/H/C/003833
Glyxambi, fixed dose combination of empagliflozin and linagliptin, is indicated in adults aged 18 years and older with type 2 diabetes mellitus:to improve glycaemic control when metformin and/or sulphonylurea (SU) and one of the monocomponents of Glyxambi do not provide adequate glycaemic control;when already being treated with the free combination of empagliflozin and linagliptin.
Authorised no no no 2016-11-11
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for empagliflozin; linagliptin

Country Patent Number Title Estimated Expiration
Taiwan 200808323 Use of DPP IV inhibitors ⤷  Sign Up
China 104095854 Uses of DPP-IV inhibitors ⤷  Sign Up
Canada 2908635 USAGES THERAPEUTIQUES D'EMPAGLIFLOZINE (THERAPEUTIC USES OF EMPAGLIFLOZIN) ⤷  Sign Up
Israel 218714 GLUCOPYRANOSYL-SUBSTITUTED BENZOL DERIVATIVES, DRUGS CONTAINING SAID COMPOUNDS, THE USE THEREOF AND METHOD FOR THE PRODUCTION THEREOF ⤷  Sign Up
Japan 2015180686 DPPIVインヒビターの使用 (USES OF DPP IV INHIBITORS) ⤷  Sign Up
India 1132DEN2015 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for empagliflozin; linagliptin

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1532149 C20110018 00046 Estonia ⤷  Sign Up PRODUCT NAME: TRAJENTA-LINAGLIPTIN; REG NO/DATE: FINAL 24.08.2011
1730131 C 2014 039 Romania ⤷  Sign Up PRODUCT NAME: EMPAGLIFOZIN SI SARURILE ACESTUIA, IN SPECIAL EMPAGLIFOZIN(1S)-1,5-ANHIDRO-1-C-{4-CLORO-3-[(4-{[(3S)-OXOLAN-3-IL]OXI}FENIL)METIL}-D-GLUCITOL; NATIONAL AUTHORISATION NUMBER: EU/1/14/930; DATE OF NATIONAL AUTHORISATION: 20140522; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/930; DATE OF FIRST AUTHORISATION IN EEA: 20140522
2187879 C20170016 00337 Estonia ⤷  Sign Up PRODUCT NAME: EMPAGLIFLOSIIN/LINAGLIPTIIN;REG NO/DATE: EU/1/16/1146 15.11.2016
1730131 C01730131/05 Switzerland ⤷  Sign Up PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 63227 30.06.2022
1730131 C20140033 00134 Estonia ⤷  Sign Up PRODUCT NAME: EMPAGLIFLOSIIN;REG NO/DATE: EU/1/14/930 27.05.2014
1730131 14C0074 France ⤷  Sign Up PRODUCT NAME: EMPAGLIFLOZINE ET SES SELS, EN PARTICULIER L'EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930 20140527
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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