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Last Updated: March 19, 2024

Empagliflozin - Generic Drug Details


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What are the generic sources for empagliflozin and what is the scope of freedom to operate?

Empagliflozin is the generic ingredient in seven branded drugs marketed by Zydus Pharms and Boehringer Ingelheim, and is included in seven NDAs. There are twenty-four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Empagliflozin has two hundred and seventy-seven patent family members in forty-five countries.

There are twenty-two drug master file entries for empagliflozin. Four suppliers are listed for this compound. There are thirteen tentative approvals for this compound.

Recent Clinical Trials for empagliflozin

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

SponsorPhase
Central Hospital, Nancy, FrancePhase 3
University of Alabama at BirminghamPhase 2
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Phase 2

See all empagliflozin clinical trials

Generic filers with tentative approvals for EMPAGLIFLOZIN
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial25MG;5MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial10MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial2.5MGTABLET;ORAL

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

Pharmacology for empagliflozin
Paragraph IV (Patent) Challenges for EMPAGLIFLOZIN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
JARDIANCE Tablets empagliflozin 10 mg and 25 mg 204629 14 2018-08-01

US Patents and Regulatory Information for empagliflozin

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 212614-003 Jan 27, 2020 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Boehringer Ingelheim SYNJARDY empagliflozin; metformin hydrochloride TABLET;ORAL 206111-004 Aug 26, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Boehringer Ingelheim SYNJARDY empagliflozin; metformin hydrochloride TABLET;ORAL 206111-003 Aug 26, 2015 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 empagliflozin

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Boehringer Ingelheim International GmbH Jardiance empagliflozin EMEA/H/C/002677
Type 2 diabetes mellitusJardiance is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered in addition to other medicinal products for the treatment of diabetesFor study results with respect to combinations of therapies, effects on glycaemic control, and cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1. of the annex.Heart failureJardiance is indicated in adults for the treatment of symptomatic chronic heart failure. Chronic kidney diseaseJardiance is indicated in adults for the treatment of chronic kidney disease. 
Authorised no no no 2014-05-22
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for empagliflozin

Country Patent Number Title Estimated Expiration
Eurasian Patent Organization 033286 СПОСОБ ЛЕЧЕНИЯ ИЛИ ОТСРОЧКИ РАЗВИТИЯ ХРОНИЧЕСКОЙ БОЛЕЗНИ ПОЧЕК (METHOD OF TREATING OR DELAYING THE PROGRESSION OF CHRONIC KIDNEY DISEASE) ⤷  Try a Trial
Mexico 2007013144 FORMA CRISTALINA DE 1-CLORO-4-((-D-GLUCOPIRANOS-1-IL)-2-[4-((S)- TETRAHIDROFURAN-3-ILOXI)-BENCIL]-BENCENO, UN METODO PARA SU PREPARACION Y EL USO DEL MISMO PARA PREPARAR MEDICAMENTOS. (CRYSTALLINE FORM OF 1-CHLORO-4-(????-D-GLUCOPYRANOS-1-YL)-2-[4-((S) -TETRAHYDROFURAN-3-YLOXY)-BENZYL]-BENZENE, A METHOD FOR ITS PREPARATION AND THE USE THEREOF FOR PREPARING MEDICAMENTS.) ⤷  Try a Trial
Poland 2986304 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for empagliflozin

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1730131 C 2014 039 Romania ⤷  Try a Trial 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
1730131 200 5026-2014 Slovakia ⤷  Try a Trial PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/14/930 20140527
1730131 PA2014035,C1730131 Lithuania ⤷  Try a Trial PRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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