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Last Updated: November 21, 2024

EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE - Generic Drug Details


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

Empagliflozin; linagliptin; metformin hydrochloride is the generic ingredient in one branded drug marketed by Boehringer Ingelheim and is included in one NDA. There are fifteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Empagliflozin; linagliptin; metformin hydrochloride has four hundred and eighty-five patent family members in forty-eight countries.

One supplier is listed for this compound.

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Generic Entry Date for EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, EXTENDED RELEASE;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; METFORMIN HYDROCHLORIDE

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

SponsorPhase
Medanta, The Medicity, IndiaN/A
The First Affiliated Hospital with Nanjing Medical UniversityN/A
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolN/A

See all EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE clinical trials

Pharmacology for EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Paragraph IV (Patent) Challenges for EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TRIJARDY XR Extended-release Tablets empagliflozin; linagliptin; metformin hydrochloride 5 mg/2.5 mg/1 g, 10 mg/5 mg/1 g, 12.5 mg/5 mg/1 g, 25 mg/5 mg/1 g 212614 1 2020-05-26

US Patents and Regulatory Information for EMPAGLIFLOZIN; 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 TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614-001 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 212614-003 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 212614-003 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 212614-004 Jan 27, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Boehringer Ingelheim TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614-001 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 212614-003 Jan 27, 2020 RX Yes No ⤷  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; METFORMIN HYDROCHLORIDE

International Patents for EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE

Country Patent Number Title Estimated Expiration
European Patent Office 3424926 8-[3-AMINO-PIPÉRIDINE-1-YL]-XANTHINE, LEUR FABRICATION ET LEUR UTILISATION EN TANT QUE MÉDICAMENT (8-[3-AMINO-PIPERIDIN-1-YL]-XANTHINS, THEIR PRODUCTION AND UTILISATION AS MEDICINE) ⤷  Sign Up
Mexico 2011008172 COMPOSICION FARMACEUTICA QUE COMPRENDE UN INHIBIDOR DE SGLT2, UN INHIBIDOR DE DPP-IV Y OPCIONALMENTE OTRO AGENTE ANTIDIABETICO, Y USOS DE LA MISMA. (PHARMACEUTICAL COMPOSITION COMPRISING A SGLT2 INHIBITOR, A DPP-IV INHIBITOR AND OPTIONALLY A FURTHER ANTIDIABETIC AGENT AND USES THEREOF.) ⤷  Sign Up
Mexico 2013010187 COMPOSICIONES FARMACEUTICAS QUE COMPRENDEN MERFORMINA Y UN INHIBIDOR DE DPP-4 O UN INHIBIDOR DE SGLT-2. (PHARMACEUTICAL COMPOSITIONS COMPRISING METFORMIN AND A DPP-4 INHIBITOR OR A SGLT-2 INHIBITOR.) ⤷  Sign Up
Japan 5766661 ⤷  Sign Up
Portugal 1730131 ⤷  Sign Up
Eurasian Patent Organization 013079 КРИСТАЛЛИЧЕСКАЯ ФОРМА 1-ХЛОР-4-(β-D-ГЛЮКОПИРАНОЗ-1-ИЛ)-2-[4-((S)-ТЕТРАГИДРОФУРАН-3-ИЛОКСИ)БЕНЗИЛ]БЕНЗОЛА, СПОСОБ ЕЕ ПОЛУЧЕНИЯ И ЕЕ ПРИМЕНЕНИЕ ДЛЯ ПРИГОТОВЛЕНИЯ ЛЕКАРСТВЕННЫХ СРЕДСТВ (CRYSTALLINE FORM OF 1-CHLORO-4(&bgr;-D-GLUCOPYRANOS-1-YL)-2-[4-((S)-TETRAHYDROFURAN-3-YLOXY)-BENZYL]-BENZENE, A METHOD FOR ITS PREPARATION AND THE USE THEREOF FOR PREPARING MEDICAMENTS) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for EMPAGLIFLOZIN; 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
2187879 276 10-2017 Slovakia ⤷  Sign Up PRODUCT NAME: EMPAGLIFLOZIN/LINAGLIPTIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/16/1146 20161115
2187879 17C1016 France ⤷  Sign Up PRODUCT NAME: COMBINAISON D'EMPAGLIFLOZINE ET DE LINAGLIPTINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/16/1146 20161115
1532149 621 Finland ⤷  Sign Up
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
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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