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Last Updated: November 13, 2024

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LONSURF Drug Patent 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 six patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and eighteen patent family members in thirty-three countries.

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

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Drug patent expirations by year for LONSURF
Drug Prices for LONSURF

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Recent Clinical Trials for LONSURF

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

SponsorPhase
Yonsei UniversityPhase 1/Phase 2
TaihoPhase 2
AmgenPhase 3

See all LONSURF clinical trials

Paragraph IV (Patent) Challenges for LONSURF
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 LONSURF

LONSURF is protected by ten US patents and one FDA Regulatory Exclusivity.

Patents protecting LONSURF

Method for treating cancer patients with severe renal impairment
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF METASTATIC COLORECTAL CANCER ALONE OR WITH BEVACIZUMAB IN SEVERELY RENALLY IMPAIRED PATIENTS PREVIOUSLY TREATED WITH FLUOROPYRIMIDINE-, OXALIPLATIN- AND IRINOTECAN THERAPY, AN ANTI-VEGF BIOLOGIC, AND IF RAS WILD-TYPE, ANTI-EGFR THERAPY

Method for treating cancer patients with severe renal impairment
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF METASTATIC GASTRIC OR GJA IN SEVERELY RENALLY IMPAIRED PATIENTS TREATED WITH AT LEAST TWO LINES OF CHEMOTHERAPY THAT INCLUDED A FLUOROPYRIMIDINE, A PLATINUM, A TAXANE OR IRINOTECAN, AND IF APPROPRIATE, HER2/NEU-TARGETED THERAPY

Stable crystal form of tipiracil hydrochloride and crystallization method for the same
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Method for treating cancer patients with severe renal impairment
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF METASTATIC COLORECTAL CANCER ALONE OR WITH BEVACIZUMAB IN SEVERELY RENALLY IMPAIRED PATIENTS PREVIOUSLY TREATED WITH FLUOROPYRIMIDINE-, OXALIPLATIN- AND IRINOTECAN THERAPY, AN ANTI-VEGF BIOLOGIC, AND IF RAS WILD-TYPE, ANTI-EGFR THERAPY

Method for treating cancer patients with severe renal impairment
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF METASTATIC GASTRIC OR GJA IN SEVERELY RENALLY IMPAIRED PATIENTS TREATED WITH AT LEAST TWO LINES OF CHEMOTHERAPY THAT INCLUDED A FLUOROPYRIMIDINE, A PLATINUM, A TAXANE OR IRINOTECAN, AND IF APPROPRIATE, HER2/NEU-TARGETED THERAPY

Stable crystal form of tipiracil hydrochloride and crystallization method for the same
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF METASTATIC COLORECTAL CANCER WITH BEVACIZUMAB IN PATIENTS PREVIOUSLY TREATED WITH FLUOROPYRIMIDINE-, OXALIPLATIN- AND IRINOTECAN-BASED CHEMOTHERAPY, AN ANTI-VEGF BIOLOGICAL THERAPY, AND IF RAS WILD-TYPE, AN ANTI-EGFR THERAPY

Method of administrating an anticancer drug containing .alpha., .alpha., .alpha.-trifluorothymidine and thymidine phosphorylase inhibitor
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULTS WITH METASTATIC GASTRIC OR GJA PREVIOUSLY TREATED WITH AT LEAST TWO PRIOR LINES OF CHEMOTHERAPY THAT INCLUDED A FLUOROPYRIMIDINE, A PLATINUM, EITHER A TAXANE OR IRINOTECAN, AND IF APPROPRIATE, HER2/NEU-TARGETED THERAPY

Method of administrating an anticancer drug containing .alpha., .alpha., .alpha.-trifluorothymidine and thymidine phosphorylase inhibitor
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF PATIENTS WITH METASTATIC COLORECTAL CANCER WHO HAVE BEEN PREVIOUSLY TREATED WITH FLUOROPYRIMIDINE-, OXALIPLATIN- AND IRINOTECAN-BASED CHEMOTHERAPY, AN ANTI-VEGF BIOLOGICAL THERAPY, AND IF RAS WILD-TYPE, AN ANTI-EGFR THERAPY

Method of administrating an anticancer drug containing .alpha., .alpha., .alpha.-trifluorothymidine and thymidine phosphorylase inhibitor
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF METASTATIC COLORECTAL CANCER ALONE OR WITH BEVACIZUMAB IN PATIENTS PREVIOUSLY TREATED WITH FLUOROPYRIMIDINE-, OXALIPLATIN- AND IRINOTECAN-BASED CHEMOTHERAPY, AN ANTI-VEGF BIOLOGICAL THERAPY, AND IF RAS WILD-TYPE, AN ANTI-EGFR THERAPY

FDA Regulatory Exclusivity protecting LONSURF

TREATMENT OF ADULT PATIENTS WITH METASTATIC GASTRIC OR GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA PREVIOUSLY TREATED WITH AT LEAST TWO PRIOR LINES OF CHEMOTHERAPY, AND IF APPROPRIATE, HER2/NEU-TARGETED THERAPY
Exclusivity Expiration: ⤷  Sign Up

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 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-001 Sep 22, 2015 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-002 Sep 22, 2015 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-002 Sep 22, 2015 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
>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 LONSURF

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

International Patents for LONSURF

When does loss-of-exclusivity occur for LONSURF?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 14282281
Patent: Stabilized crystal of tipiracil hydrochloride, and crystallization method for same
Estimated Expiration: ⤷  Sign Up

Patent: 17208215
Patent: Stable crystal form of tipiracil hydrochloride and crystallization method for the same
Estimated Expiration: ⤷  Sign Up

Patent: 18219967
Patent: Stable crystal form of tipiracil hydrochloride and crystallization method for the same
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2015031619
Patent: forma cristalina estável de cloridrato de tipiracil e método de cristalização para a mesma
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 14999
Patent: CRISTAL STABILISE DE CHLORHYDRATE DE TIPIRACIL, ET SON PROCEDE DE CRISTALLISATION (STABLE CRYSTAL FORM OF TIPIRACIL HYDROCHLORIDE AND CRYSTALLIZATION METHOD FOR THE SAME)
Estimated Expiration: ⤷  Sign Up

Patent: 85006
Patent: CRISTAL STABILISE DE CHLORHYDRATE DE TIPIRACIL, ET SON PROCEDE DE CRISTALLISATION (STABLE CRYSTAL FORM OF TIPIRACIL HYDROCHLORIDE AND CRYSTALLIZATION METHOD FOR THE SAME)
Estimated Expiration: ⤷  Sign Up

China

Patent: 4395307
Patent: STABILIZED CRYSTAL OF TIPIRACIL HYDROCHLORIDE, AND CRYSTALLIZATION METHOD FOR SAME
Estimated Expiration: ⤷  Sign Up

Patent: 6967051
Patent: 地匹福林盐酸盐的稳定型晶体及其结晶化方法 (Stable crystal form of tipiracil hydrochloride and crystallization method for the same)
Estimated Expiration: ⤷  Sign Up

Patent: 9912573
Patent: 地匹福林盐酸盐的稳定型晶体及其结晶化方法 (STABILIZED CRYSTAL OF TIPIRACIL HYDROCHLORIDE, AND CRYSTALLIZATION METHOD FOR SAME)
Estimated Expiration: ⤷  Sign Up

Patent: 0746403
Patent: 地匹福林盐酸盐的稳定型晶体及其结晶化方法 (STABILIZED CRYSTAL OF TIPIRACIL HYDROCHLORIDE, AND CRYSTALLIZATION METHOD FOR SAME)
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0211903
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 24868
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 12255
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 12255
Patent: CRISTAL STABILISÉ DE CHLORHYDRATE DE TIPIRACIL, ET SON PROCÉDÉ DE CRISTALLISATION (STABILIZED CRYSTAL OF TIPIRACIL HYDROCHLORIDE, AND CRYSTALLIZATION METHOD FOR SAME)
Estimated Expiration: ⤷  Sign Up

Patent: 05779
Patent: FORME CRISTALLINE STABLE DE CHLORHYDRATE DE TIPIRACIL ET SON PROCÉDÉ DE CRISTALLISATION (STABLE CRYSTAL FORM OF TIPIRACIL HYDROCHLORIDE AND CRYSTALLIZATION METHOD FOR THE SAME)
Estimated Expiration: ⤷  Sign Up

Georgia, Republic of

Patent: 0186841
Patent: STABILIZED CRYSTAL OF TIPIRACIL HYDROCHLORIDE, AND CRYSTALLIZATION METHOD FOR SAME
Estimated Expiration: ⤷  Sign Up

Patent: 0186875
Patent: STABILIZED CRYSTAL OF TIPIRACIL HYDROCHLORIDE, AND CRYSTALLI- ZATION METHOD FOR SAME
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 03071
Patent: 地匹福林鹽酸鹽的穩定型晶體及其結晶化方法 (STABILIZED CRYSTAL OF TIPIRACIL HYDROCHLORIDE, AND CRYSTALLIZATION METHOD FOR SAME)
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 57352
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 2014203877
Patent: チピラシル塩酸塩の安定形結晶及びその結晶化方法
Estimated Expiration: ⤷  Sign Up

Patent: 64409
Estimated Expiration: ⤷  Sign Up

Patent: 26883
Estimated Expiration: ⤷  Sign Up

Patent: 18145204
Patent: チピラシル塩酸塩の安定形結晶及びその結晶化方法 (STABLE FORM CRYSTAL OF TIPIRACIL HYDROCHLORIDE AND CRYSTALLIZATION METHOD THEREFOR)
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 12255
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 3410
Patent: STABLE CRYSTAL FORM OF TIPIRACIL HYDROCHLORIDE AND CRYSTALLIZATION METHOD FOR THE SAME
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 15016986
Patent: FORMA DE CRISTAL ESTABLE DE CLORHIDRATO DE TIPIRACIL, Y METODO DE CRISTALIZACION DEL MISMO. (STABILIZED CRYSTAL OF TIPIRACIL HYDROCHLORIDE, AND CRYSTALLIZATION METHOD FOR SAME.)
Estimated Expiration: ⤷  Sign Up

Morocco

Patent: 668
Patent: Cristal stabilisé de chlorhydrate de tipiracil, et son procédé de cristallisation
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 4090
Patent: Stable crystal form of tipiracil hydrochloride and crystallization method for the same
Estimated Expiration: ⤷  Sign Up

Philippines

Patent: 015502809
Patent: STABLE CRYSTAL FORM OF TIPIRACIL HYDROCHLORIDE AND CRYSTALLIZATION METHOD FOR THE SAME
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 12255
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 12255
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 40417
Patent: СТАБИЛЬНАЯ КРИСТАЛЛИЧЕСКАЯ ФОРМА ТИПИРАЦИЛА ГИДРОХЛОРИДА И СПОСОБ ЕЕ КРИСТАЛЛИЗАЦИИ (STABLE CRYSTALLINE FORM OF TYPIRACYL HYDROCHLORIDE AND METHOD FOR ITS CRYSTALLIZATION)
Estimated Expiration: ⤷  Sign Up

Patent: 74441
Patent: СТАБИЛЬНАЯ КРИСТАЛЛИЧЕСКАЯ ФОРМА ТИПИРАЦИЛА ГИДРОХЛОРИДА И СПОСОБ ЕЕ КРИСТАЛЛИЗАЦИИ (STABLE CRYSTALLINE FORM OF TIPIRACIL HYDROCHLORIDE AND METHOD FOR ITS CRYSTALLIZATION)
Estimated Expiration: ⤷  Sign Up

Patent: 16100972
Patent: СТАБИЛЬНАЯ КРИСТАЛЛИЧЕСКАЯ ФОРМА ТИПИРАЦИЛА ГИДРОХЛОРИДА И СПОСОБ ЕЕ КРИСТАЛЛИЗАЦИИ
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 691
Patent: STABILNI KRISTALNI OBLIK TIPIRACIL HIDROHLORIDA I POSTUPAK KRISTALIZACIJE ISTOG (STABLE CRYSTAL FORM OF TIPIRACIL HYDROCHLORIDE AND CRYSTALLIZATION METHOD FOR THE SAME)
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 201710916Y
Patent: STABLE CRYSTAL FORM OF TIPIRACIL HYDROCHLORIDE AND CRYSTALLIZATION METHOD FOR THE SAME
Estimated Expiration: ⤷  Sign Up

Patent: 201912293U
Patent: STABLE CRYSTAL FORM OF TIPIRACIL HYDROCHLORIDE AND CRYSTALLIZATION METHOD FOR THE SAME
Estimated Expiration: ⤷  Sign Up

Patent: 202007643S
Patent: STABLE CRYSTAL FORM OF TIPIRACIL HYDROCHLORIDE AND CRYSTALLIZATION METHOD FOR THE SAME
Estimated Expiration: ⤷  Sign Up

Patent: 201509189S
Patent: STABLE CRYSTAL FORM OF TIPIRACIL HYDROCHLORIDE AND CRYSTALLIZATION METHOD FOR THE SAME
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 12255
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1806346
Estimated Expiration: ⤷  Sign Up

Patent: 160020560
Patent: 티피라실 염산염의 안정형 결정 및 그 결정화 방법 (STABILIZED CRYSTAL OF TIPIRACIL HYDROCHLORIDE, AND CRYSTALLIZATION METHOD FOR SAME)
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 98408
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 39592
Estimated Expiration: ⤷  Sign Up

Patent: 1534601
Patent: Stabilized crystal of tipiracil hydrochloride, and crystallization method for same
Estimated Expiration: ⤷  Sign Up

Ukraine

Patent: 2626
Patent: СТАБІЛЬНА КРИСТАЛІЧНА ФОРМА ТИПІРАЦИЛУ ГІДРОХЛОРИДУ І СПОСІБ ЇЇ КРИСТАЛІЗАЦІЇ
Estimated Expiration: ⤷  Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering LONSURF around the world.

Country Patent Number Title Estimated Expiration
Singapore 10201710916Y STABLE CRYSTAL FORM OF TIPIRACIL HYDROCHLORIDE AND CRYSTALLIZATION METHOD FOR THE SAME ⤷  Sign Up
European Patent Office 1849470 MÉDICAMENTS ANTICANCÉREUX CONTENANT DE LA ALPHA, ALPHA, ALPHA-TRIFLUOROTHYMIDINE ET UN INHIBITEUR DE LA THYMIDINE PHOSPHORYLASE (ANTICANCER DRUG CONTAINING ALPHA, ALPHA, ALPHA-TRIFLUOROTHYMIDINE AND THYMIDINE PHOSPHORYLASE INHIBITOR) ⤷  Sign Up
Canada 2914999 CRISTAL STABILISE DE CHLORHYDRATE DE TIPIRACIL, ET SON PROCEDE DE CRISTALLISATION (STABLE CRYSTAL FORM OF TIPIRACIL HYDROCHLORIDE AND CRYSTALLIZATION METHOD FOR THE SAME) ⤷  Sign Up
European Patent Office 1080726 AGENTS ATTENUANT LES EFFETS SECONDAIRES (AGENTS FOR RELIEVING SIDE EFFECTS) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for LONSURF

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1849470 300889 Netherlands ⤷  Sign Up PRODUCT NAME: TRIFLURIDINE IN COMBINATIE MET TIPIRACILHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/16/1096 20160427
1849470 2017C/028 Belgium ⤷  Sign Up PRODUCT NAME: LONSURF - TRIFLURIDINE/TIPIRACIL; AUTHORISATION NUMBER AND DATE: EU/1/16/1096 20160427
1849470 CA 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
1849470 PA2017024,C1849470 Lithuania ⤷  Sign Up PRODUCT NAME: TRIFLURIDINAS/TIPIRACILAS; REGISTRATION NO/DATE: EU/1/16/1096 20160425
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.