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Boehringer Ingelheim
Queensland Health
Healthtrust
Argus Health
McKesson
Farmers Insurance
Merck
Covington
Citi

Generated: November 14, 2018

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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 tipiracil hydrochloride; trifluridine patent protection?

Tipiracil hydrochloride; trifluridine is the generic ingredient in one branded drug marketed by Taiho Oncology and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for tipiracil hydrochloride; trifluridine. One supplier is listed for this compound.

Summary for tipiracil hydrochloride; trifluridine

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 207981-001 Sep 22, 2015 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-002 Sep 22, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-001 Sep 22, 2015 RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-002 Sep 22, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-001 Sep 22, 2015 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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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 207981-001 Sep 22, 2015 ➤ Sign Up ➤ Sign Up
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-002 Sep 22, 2015 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for tipiracil hydrochloride; trifluridine

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0889 Netherlands ➤ Sign Up PRODUCT NAME: TRIFLURIDINE IN COMBINATIE MET TIPIRACILHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/16/1096 20160427
2017 00036 Denmark ➤ Sign Up PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL OR A PHARMACEUTICALLY ACCEPTABLE SALT OF TIPIRACIL; REG. NO/DATE: EU/1/16/1096 20160427
/2017 Austria ➤ Sign Up PRODUCT NAME: TRIFLURIDIN / TIPIRACIL ODER DEREN PHARMAZEUTISCH WIRKSAMEN SALZE; REGISTRATION NO/DATE: EU/1/16/1096 (MITTEILUNG) 20160427
2017000052 Germany ➤ Sign Up PRODUCT NAME: TRIFLURIDIN IN KOMBINATION MIT TIPIRACIL ODER EINEM SALZ VON TIPIRACIL WIE TIPIRACIL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/16/1096 20160425
2017024 Lithuania ➤ Sign Up PRODUCT NAME: TRIFLURIDINAS/TIPIRACILAS; REGISTRATION NO/DATE: EU/1/16/1096 20160425
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Queensland Health
Healthtrust
Argus Health
McKesson
Farmers Insurance
Merck
Covington
Citi

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