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Last Updated: September 21, 2021

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Empagliflozin; linagliptin - Generic Drug Details

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

Empagliflozin; linagliptin is the generic ingredient in two branded drugs marketed by Boehringer Ingelheim and is included in two NDAs. There are seventeen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Empagliflozin; linagliptin has five hundred and forty-four patent family members in forty-seven countries.

There are twenty-two drug master file entries for empagliflozin; linagliptin. One supplier is listed for this compound. There are two tentative approvals for this compound.

Recent Clinical Trials for empagliflozin; linagliptin

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

SponsorPhase
Oslo University HospitalPhase 2
The Research Council of NorwayPhase 2
University of OsloPhase 2

See all empagliflozin; linagliptin clinical trials

Generic filers with tentative approvals for EMPAGLIFLOZIN; LINAGLIPTIN
Applicant Application No. Strength Dosage Form
⤷  Try it Free⤷  Try it Free25MG/5MGTABLET;ORAL
⤷  Try it Free⤷  Try it Free10MG/5MGTABLET; ORAL
⤷  Try it Free⤷  Try it Free25MG; 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.

Paragraph IV (Patent) Challenges for EMPAGLIFLOZIN; LINAGLIPTIN
Tradename Dosage Ingredient NDA Submissiondate
GLYXAMBI TABLET;ORAL empagliflozin; linagliptin 206073 2018-08-01

US Patents and Regulatory Information for empagliflozin; linagliptin

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 it Free ⤷  Try it Free Y Y ⤷  Try it Free
Boehringer Ingelheim TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614-003 Jan 27, 2020 RX Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-002 Jan 30, 2015 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Boehringer Ingelheim TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614-003 Jan 27, 2020 RX Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Boehringer Ingelheim TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614-004 Jan 27, 2020 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Boehringer Ingelheim TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614-002 Jan 27, 2020 RX Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
>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; linagliptin

Supplementary Protection Certificates for empagliflozin; linagliptin

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1730131 C300696 Netherlands ⤷  Try it Free PRODUCT NAME: EMPAGLIFLOZINE EN ZOUTEN DAARVAN, IN HET BIJZONDER EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930/001-009 20140522
1730131 CR 2014 00054 Denmark ⤷  Try it Free PRODUCT NAME: EMPAGLIFLOZIN OG SALTE DERAF, SAERLIGT EMPAGLIFLOZIN; REG. NO/DATE: EU1/14/930/001/018 20140527
1730131 568 Finland ⤷  Try it Free
2187879 2017/018 Ireland ⤷  Try it Free PRODUCT NAME: COMBINATION OF: EMPAGLIFLOZIN; AND LINAGLIPTIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTRATION NO/DATE: EU/1/16/1146 20161111
1532149 C20110018 00046 Estonia ⤷  Try it Free PRODUCT NAME: TRAJENTA-LINAGLIPTIN; REG NO/DATE: FINAL 24.08.2011
1730131 C01730131/03 Switzerland ⤷  Try it Free PRODUCT NAME: EMPAGLIFLOZIN UND LINAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66132 29.03.2017
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
Dow
Boehringer Ingelheim
Baxter
AstraZeneca
McKesson

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