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Last Updated: November 2, 2024

Empagliflozin; metformin hydrochloride - Generic Drug Details


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

Empagliflozin; metformin hydrochloride is the generic ingredient in three branded drugs marketed by Boehringer Ingelheim and Zydus Pharms, and is included in three NDAs. There are ten patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Empagliflozin; metformin hydrochloride has two hundred and fifty patent family members in forty-five countries.

One supplier is listed for this compound.

Summary for empagliflozin; metformin hydrochloride
Recent Clinical Trials for empagliflozin; metformin hydrochloride

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

SponsorPhase
Novo Nordisk A/SPhase 3
SINA Health Education and Welfare TrustPhase 2/Phase 3
Ain Shams UniversityPhase 1/Phase 2

See all empagliflozin; metformin hydrochloride clinical trials

Pharmacology for empagliflozin; metformin hydrochloride
Paragraph IV (Patent) Challenges for EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SYNJARDY Tablets empagliflozin; metformin hydrochloride 5 mg/500 mg 5 mg/1000 mg 12.5 mg/500 mg 12.5 mg/1000 mg 206111 4 2018-08-01
SYNJARDY XR Extended-release Tablets empagliflozin; metformin hydrochloride 5 mg/1000 mg 10 mg/1000 mg 12.5 mg/1000 mg 25 mg/1000 mg 208658 3 2018-08-01

US Patents and Regulatory Information for empagliflozin; 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 SYNJARDY empagliflozin; metformin hydrochloride TABLET;ORAL 206111-004 Aug 26, 2015 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-002 Dec 9, 2016 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-003 Dec 9, 2016 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-002 Dec 9, 2016 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-004 Dec 9, 2016 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Zydus Pharms EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE empagliflozin; metformin hydrochloride TABLET;ORAL 212198-004 Jul 7, 2022 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim SYNJARDY empagliflozin; metformin hydrochloride TABLET;ORAL 206111-001 Aug 26, 2015 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 empagliflozin; metformin hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-001 Dec 9, 2016 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-003 Dec 9, 2016 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-002 Dec 9, 2016 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-004 Dec 9, 2016 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for empagliflozin; metformin hydrochloride

Country Patent Number Title Estimated Expiration
South Korea 102318207 ⤷  Sign Up
Japan 2018131448 エンパグリフロジンの治療的使用 (THERAPEUTIC USES OF EMPAGLIFLOZIN) ⤷  Sign Up
Malaysia 142108 CRYSTALLINE FORM OF 1-CHLORO-4-(ß-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
Montenegro 01422 DERIVATI BENZOLA SUPSTITUISANI GLUKOPIRANOZILOM, LJEKOVI KOJI SADRŽE NAVEDENA JEDINJENJA, NJIHOVA PRIMJENA I NJIHOV POSTUPAK PROIZVODNJE (GLUCOPYRANOSYL-SUBSTITUTED BENZOL DERIVATIVES, DRUGS CONTAINING SAID COMPOUNDS, THE USE THEREOF AND METHOD FOR THE PRODUCTION THEREOF) ⤷  Sign Up
China 103450129 Glucopyranosyl-substituted benzol derivatives, drugs containing said compounds, the use thereof and method for the production thereof ⤷  Sign Up
Spain 2616606 ⤷  Sign Up
South Korea 20080015424 CRYSTALLINE FORM OF 1-CHLORO-4-(beta;-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; metformin hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1730131 C01730131/01 Switzerland ⤷  Sign Up PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC 63227 12.11.2014
2187879 2017/018 Ireland ⤷  Sign Up PRODUCT NAME: COMBINATION OF: EMPAGLIFLOZIN; AND LINAGLIPTIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTRATION NO/DATE: EU/1/16/1146 20161111
1730131 PA2014035,C1730131 Lithuania ⤷  Sign Up PRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522
1730131 2014/055 Ireland ⤷  Sign Up PRODUCT NAME: EMPAGLIFLOZIN AND SALTS THEREOF, IN PARTICULAR EMPAGLIFLOZIN ((1S)-1,5- ANHYDRO-1-C-(4-CHLORO-3-((4-(((3S)-OXOLAN-3-YL)OXY))PHENYL)METHYL)PHENYL)- D-GLUCITOL); REGISTRATION NO/DATE: EU/1/14/930 20140522
1730131 C01730131/02 Switzerland ⤷  Sign Up PRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015
1730131 C20140033 00134 Estonia ⤷  Sign Up PRODUCT NAME: EMPAGLIFLOSIIN;REG NO/DATE: EU/1/14/930 27.05.2014
1730131 C300696 Netherlands ⤷  Sign Up PRODUCT NAME: EMPAGLIFLOZINE EN ZOUTEN DAARVAN, IN HET BIJZONDER EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930/001-009 20140522
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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