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Last Updated: March 28, 2024

TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE - Generic Drug Details


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What are the generic drug sources for tipiracil hydrochloride; trifluridine and what is the scope of freedom to operate?

Tipiracil hydrochloride; trifluridine is the generic ingredient in two branded drugs marketed by Taiho Oncology and Natco, and is included in two NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Tipiracil hydrochloride; trifluridine has one hundred and eighteen patent family members in thirty-three countries.

One supplier is listed for this compound.

Summary for TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE
Recent Clinical Trials for TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE

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

SponsorPhase
Yonsei UniversityPhase 1/Phase 2
Merck Sharp & Dohme LLCPhase 3
Bristol-Myers SquibbPhase 3

See all TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE clinical trials

Paragraph IV (Patent) Challenges for TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
LONSURF Tablets tipiracil hydrochloride; trifluridine 15 mg/6.14 mg and 20 mg/8.19 mg 207981 4 2019-09-23

US Patents and Regulatory Information for TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-002 Sep 22, 2015 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Natco TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE tipiracil hydrochloride; trifluridine TABLET;ORAL 214008-001 Jun 13, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-001 Sep 22, 2015 AB 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

Expired US Patents for TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-002 Sep 22, 2015 ⤷  Try a Trial ⤷  Try a Trial
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-001 Sep 22, 2015 ⤷  Try a Trial ⤷  Try a Trial
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-002 Sep 22, 2015 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1849470 2017C/028 Belgium ⤷  Try a Trial PRODUCT NAME: LONSURF - TRIFLURIDINE/TIPIRACIL; AUTHORISATION NUMBER AND DATE: EU/1/16/1096 20160427
1849470 CA 2017 00036 Denmark ⤷  Try a Trial PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL OR A PHARMACEUTICALLY ACCEPTABLE SALT OF TIPIRACIL; REG. NO/DATE: EU/1/16/1096 20160427
1849470 300889 Netherlands ⤷  Try a Trial PRODUCT NAME: TRIFLURIDINE IN COMBINATIE MET TIPIRACILHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/16/1096 20160427
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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