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Last Updated: August 2, 2021

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EMPAGLIFLOZIN - Generic Drug Details

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What are the generic drug 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 eighteen 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-three 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 six tentative approvals for this compound.

Recent Clinical Trials for EMPAGLIFLOZIN

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

SponsorPhase
EMSPhase 3
DiacompPhase 4
Children's Memorial Health Institute, PolandPhase 2

See all EMPAGLIFLOZIN clinical trials

Generic filers with tentative approvals for EMPAGLIFLOZIN
Applicant Application No. Strength Dosage Form
⤷  Free Forever Trial⤷  Free Forever Trial12.5MG; 1GMTABLET;ORAL
⤷  Free Forever Trial⤷  Free Forever Trial12.5MG; 500MGTABLET;ORAL
⤷  Free Forever Trial⤷  Free Forever Trial5MG; 1GTABLET;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 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 TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614-002 Jan 27, 2020 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Boehringer Ingelheim JARDIANCE empagliflozin TABLET;ORAL 204629-001 Aug 1, 2014 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Boehringer Ingelheim TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614-003 Jan 27, 2020 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever 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
1730131 C300696 Netherlands ⤷  Free Forever Trial PRODUCT NAME: EMPAGLIFLOZINE EN ZOUTEN DAARVAN, IN HET BIJZONDER EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930/001-009 20140522
2187879 300872 Netherlands ⤷  Free Forever Trial PRODUCT NAME: COMBINATIE VAN EMPAGLIFLOZINE EN LINAGLIPTINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/16/1146 20161115
2187879 CA 2017 00019 Denmark ⤷  Free Forever Trial PRODUCT NAME: KOMBINATION AF EMPAGLIFLOZIN OG LINAGLIPTIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/16/1146/001-018 20161115
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School
McKesson
Colorcon
Baxter
Johnson and Johnson
Express Scripts

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