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Last Updated: April 24, 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.

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

Anatomical Therapeutic Chemical (ATC) Classes for LONSURF
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Method for treating cancer patients with severe renal impairment
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  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
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
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
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-002 Sep 22, 2015 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
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
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
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-002 Sep 22, 2015 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
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
>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 ⤷  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
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 207981-001 Sep 22, 2015 ⤷  Try a Trial ⤷  Try a Trial
>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
Estimated Expiration: ⤷  Try a Trial

Patent: 17208215
Estimated Expiration: ⤷  Try a Trial

Patent: 18219967
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2015031619
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 14999
Estimated Expiration: ⤷  Try a Trial

Patent: 85006
Estimated Expiration: ⤷  Try a Trial

China

Patent: 4395307
Estimated Expiration: ⤷  Try a Trial

Patent: 6967051
Estimated Expiration: ⤷  Try a Trial

Patent: 9912573
Estimated Expiration: ⤷  Try a Trial

Patent: 0746403
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0211903
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 24868
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 12255
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 12255
Estimated Expiration: ⤷  Try a Trial

Patent: 05779
Estimated Expiration: ⤷  Try a Trial

Georgia, Republic of

Patent: 0186841
Estimated Expiration: ⤷  Try a Trial

Patent: 0186875
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 03071
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 57352
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 2014203877
Estimated Expiration: ⤷  Try a Trial

Patent: 64409
Estimated Expiration: ⤷  Try a Trial

Patent: 26883
Estimated Expiration: ⤷  Try a Trial

Patent: 18145204
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 12255
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 3410
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 15016986
Estimated Expiration: ⤷  Try a Trial

Morocco

Patent: 668
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 4090
Estimated Expiration: ⤷  Try a Trial

Philippines

Patent: 015502809
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 12255
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 12255
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 40417
Estimated Expiration: ⤷  Try a Trial

Patent: 74441
Estimated Expiration: ⤷  Try a Trial

Patent: 16100972
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 691
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 201710916Y
Estimated Expiration: ⤷  Try a Trial

Patent: 201912293U
Estimated Expiration: ⤷  Try a Trial

Patent: 202007643S
Estimated Expiration: ⤷  Try a Trial

Patent: 201509189S
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 12255
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1806346
Estimated Expiration: ⤷  Try a Trial

Patent: 160020560
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 98408
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 39592
Estimated Expiration: ⤷  Try a Trial

Patent: 1534601
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 2626
Estimated Expiration: ⤷  Try a Trial

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
Taiwan 201536319 Antitumor agent and antitumor effect enhancer ⤷  Try a Trial
Hungary E057352 ⤷  Try a Trial
China 1297350 ⤷  Try a Trial
Australia 681321 ⤷  Try a Trial
Cyprus 1119393 ⤷  Try a Trial
Lithuania C1849470 ⤷  Try a Trial
Portugal 763529 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for LONSURF

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1849470 132017000102371 Italy ⤷  Try a Trial PRODUCT NAME: TRIFLURDINA IN COMBINAZIONE CON TIPIRACILE O UN SALE DI TIPIRACILE QUALE TIPIRACILE IDROCLORURO(LONSURF); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1096, 20160427
1849470 LUC00036 Luxembourg ⤷  Try a Trial PRODUCT NAME: TRIFLURIDINE COMBINEE AU TIPIRACIL OU UN SEL DE TIPIRACIL TEL QUE L'HYDROCHLORURE DE TIPIRACIL; AUTHORISATION NUMBER AND DATE: EU/1/16/1096 20160427
1849470 SPC/GB17/049 United Kingdom ⤷  Try a Trial PRODUCT NAME: TRIFLURIDINE WITH TIPACRIL HYDROCHLORIDE; REGISTERED: UK EU/1/16/1096/001(NI) 20160427; UK EU/1/16/1096/002(NI) 20160427; UK EU/1/16/1096/003(NI) 20160427; UK EU/1/16/1096/004(NI) 20160427; UK EU/1/16/1096/005(NI) 20160427; UK EU/1/16/1096/006(NI) 20160427; UK PLGB 05815/0112 20160427; UK PLGB 05815/0113 20160427
1849470 300889 Netherlands ⤷  Try a Trial PRODUCT NAME: TRIFLURIDINE IN COMBINATIE MET TIPIRACILHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/16/1096 20160427
1849470 122017000052 Germany ⤷  Try a Trial PRODUCT NAME: TRIFLURIDIN IN KOMBINATION MIT TIPIRACIL ODER EINEM SALZ VON TIPIRACIL WIE TIPIRACIL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/16/1096 20160425
1849470 C 2017 032 Romania ⤷  Try a Trial PRODUCT NAME: TRIFLURIDINA IN COMBINATIE CU TIPIRACIL SAU O SARE ACCEPTABILA FARMACEUTIC DE TIPIRACIL CUM AR FI CLORHIDRAT DE TIPIRACIL; NATIONAL AUTHORISATION NUMBER: EU/1/16/1096; DATE OF NATIONAL AUTHORISATION: 20160425; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/16/1096; DATE OF FIRST AUTHORISATION IN EEA: 20160425
1849470 PA2017024,C1849470 Lithuania ⤷  Try a Trial 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.