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Last Updated: January 28, 2021

DrugPatentWatch Database Preview

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 five branded drugs marketed by Boehringer Ingelheim and is included in five 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 has two hundred and twenty-one patent family members in forty-four countries.

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

Recent Clinical Trials for empagliflozin

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

SponsorPhase
EMSPhase 3
Fondazione SchenaPhase 4
University of BariPhase 4

See all empagliflozin clinical trials

Generic filers with tentative approvals for EMPAGLIFLOZIN
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial25MG/5MGTABLET;ORAL
  Start Trial  Start Trial10MG/5MGTABLET; ORAL
  Start Trial  Start TrialUNKNOWNUNKNOWN

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 NDA Submissiondate
JARDIANCE TABLET;ORAL empagliflozin 204629 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 XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-003 Dec 9, 2016 RX Yes No   Start Trial   Start Trial Y   Start Trial
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-002 Dec 9, 2016 RX Yes No   Start Trial   Start Trial   Start Trial
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-004 Dec 9, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Boehringer Ingelheim TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614-003 Jan 27, 2020 RX Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for empagliflozin

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2187879 20/2017 Austria   Start Trial PRODUCT NAME: KOMBINATION VON EMPAGLIFLOZIN UND LINAGLIPTIN ODER PHARMAZEUTISCH VERTRETBARE SALZE; REGISTRATION NO/DATE: EU/1/16/1146 (MITTEILUNG) 20161115
1730131 CA 2014 00054 Denmark   Start Trial PRODUCT NAME: EMPAGLIFLOZIN OG SALTE DERAF, SAERLIGT EMPAGLIFLOZIN; REG. NO/DATE: EU1/14/930/001/018 20140522
1730131 568 Finland   Start Trial
1730131 PA2014035 Lithuania   Start 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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Serving leading biopharmaceutical companies globally:

Medtronic
AstraZeneca
Harvard Business School
McKesson
Johnson and Johnson
Dow

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