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Last Updated: April 30, 2024

Empagliflozin - Generic Drug Details


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

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-eight 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 Trial25MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial10MGTABLET;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 SYNJARDY empagliflozin; metformin hydrochloride TABLET;ORAL 206111-004 Aug 26, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-002 Jan 30, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-002 Dec 9, 2016 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Boehringer Ingelheim JARDIANCE empagliflozin TABLET;ORAL 204629-001 Aug 1, 2014 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim JARDIANCE empagliflozin TABLET;ORAL 204629-001 Aug 1, 2014 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Boehringer Ingelheim TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614-001 Jan 27, 2020 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
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
>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
Croatia P20100033 ⤷  Try a Trial
Norway 20073875 ⤷  Try a Trial
Hungary E060721 ⤷  Try a Trial
Uruguay 31296 COMPOSICION FARMACÉUTICA QUE COMPRENDE UN DERIVADO DE BENCENO SUSTITUIDO CON GLUCOPIRANOSILO ⤷  Try a Trial
Canada 2812519 COMPOSITION PHARMACEUTIQUE, PROCEDES POUR LE TRAITEMENT ET UTILISATIONS DE CELLE-CI (PHARMACEUTICAL COMPOSITION, METHODS FOR TREATING AND USES THEREOF) ⤷  Try a Trial
European Patent Office 4000608 COMPOSITION PHARMACEUTIQUE, PROCÉDÉS DE TRAITEMENT ET LEURS UTILISATIONS (PHARMACEUTICAL COMPOSITION, METHODS FOR TREATING AND USES THEREOF) ⤷  Try a Trial
Denmark 2981271 ⤷  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 PA2014035 Lithuania ⤷  Try a Trial PRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522
1730131 2014/055 Ireland ⤷  Try a Trial 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
2187879 132017000050485 Italy ⤷  Try a Trial PRODUCT NAME: COMBINAZIONE DI EMPAGLIFLOZIN E LINAGLIPTIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(GLYXAMBI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1146, 20161115
1730131 14C0074 France ⤷  Try a Trial PRODUCT NAME: EMPAGLIFLOZINE ET SES SELS, EN PARTICULIER L'EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930 20140527
1730131 C01730131/02 Switzerland ⤷  Try a Trial PRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015
1730131 CR 2014 00054 Denmark ⤷  Try a Trial PRODUCT NAME: EMPAGLIFLOZIN OG SALTE DERAF, SAERLIGT EMPAGLIFLOZIN; REG. NO/DATE: EU1/14/930/001/018 20140527
2187879 PA2017014,C2187879 Lithuania ⤷  Try a Trial PRODUCT NAME: EMPAGLIFLOZINO IR LINAGLIPTINO ARBA JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS DERINYS; REGISTRATION NO/DATE: EU/1/16/1146/001 - EU/1/16/1146/018 20161111
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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