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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
US Army
Citi
Baxter
US Department of Justice
Express Scripts
Colorcon
Medtronic
Harvard Business School

Generated: September 18, 2018

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LONSURF Drug Profile

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When do Lonsurf patents expire, and when can generic versions of Lonsurf launch?

Lonsurf is a drug marketed by Taiho Oncology and is included in one NDA. There are three patents protecting this drug.

The generic ingredient in LONSURF is tipiracil hydrochloride; trifluridine. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the tipiracil hydrochloride; trifluridine profile page.

Drug patent expirations by year for LONSURF
Generic Entry Opportunity Date for LONSURF
Generic Entry Date for LONSURF*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for LONSURF

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 ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-002 Sep 22, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-001 Sep 22, 2015 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-002 Sep 22, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-001 Sep 22, 2015 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-001 Sep 22, 2015 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-002 Sep 22, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
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 LONSURF

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

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Non-Orange Book US Patents for LONSURF

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,799,783 Method of administrating an anticancer drug containing .alpha., .alpha., .alpha.-trifluorothymidine and thymidine phosphorylase inhibitor ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for LONSURF

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

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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
US Army
Citi
Baxter
US Department of Justice
Express Scripts
Colorcon
Medtronic
Harvard Business School

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