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Last Updated: January 31, 2023

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 five patents protecting this drug and one Paragraph IV challenge.

This drug has eighty-nine patent family members in thirty-two 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.

DrugPatentWatch® Generic Entry Outlook for Lonsurf

Lonsurf was eligible for patent challenges on September 22, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 17, 2034. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Summary for LONSURF
Drug patent expirations by year for LONSURF
Drug Prices for LONSURF

See drug prices for LONSURF

DrugPatentWatch® Estimated 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.

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 six US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of LONSURF is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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

Patents protecting LONSURF

Method for treating cancer patients with severe renal impairment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING CANCER BY DETECTING A CREATININE CLEARANCE OF A PATIENT AND ADMINISTERING LONSURF

Stable crystal form of tipiracil hydrochloride and crystallization method for the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Method for treating cancer patients with severe renal impairment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING CANCER BY DETECTING A CREATININE CLEARANCE OF A PATIENT AND ADMINISTERING LONSURF

Stable crystal form of tipiracil hydrochloride and crystallization method for the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Method of administrating an anticancer drug containing .alpha., .alpha., .alpha.-trifluorothymidine and thymidine phosphorylase inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 APPROPIATE, HER2/NEU-TARGETED THERAPY

Method of administrating an anticancer drug containing .alpha., .alpha., .alpha.-trifluorothymidine and thymidine phosphorylase inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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

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: See Plans and Pricing

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: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-001 Sep 22, 2015 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-001 Sep 22, 2015 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-002 Sep 22, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

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: See Plans and Pricing

Patent: 17208215
Estimated Expiration: See Plans and Pricing

Patent: 18219967
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2015031619
Estimated Expiration: See Plans and Pricing

Canada

Patent: 14999
Estimated Expiration: See Plans and Pricing

Patent: 85006
Estimated Expiration: See Plans and Pricing

China

Patent: 4395307
Estimated Expiration: See Plans and Pricing

Patent: 6967051
Estimated Expiration: See Plans and Pricing

Patent: 9912573
Estimated Expiration: See Plans and Pricing

Patent: 0746403
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0211903
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 12255
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 12255
Estimated Expiration: See Plans and Pricing

Patent: 05779
Estimated Expiration: See Plans and Pricing

Georgia, Republic of

Patent: 0186841
Estimated Expiration: See Plans and Pricing

Patent: 0186875
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 03071
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 57352
Estimated Expiration: See Plans and Pricing

Japan

Patent: 2014203877
Estimated Expiration: See Plans and Pricing

Patent: 64409
Estimated Expiration: See Plans and Pricing

Patent: 26883
Estimated Expiration: See Plans and Pricing

Patent: 18145204
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 12255
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 3410
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 15016986
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 668
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 4090
Estimated Expiration: See Plans and Pricing

Philippines

Patent: 015502809
Estimated Expiration: See Plans and Pricing

Poland

Patent: 12255
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 12255
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 40417
Estimated Expiration: See Plans and Pricing

Patent: 74441
Estimated Expiration: See Plans and Pricing

Patent: 16100972
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 691
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 201710916Y
Estimated Expiration: See Plans and Pricing

Patent: 201912293U
Estimated Expiration: See Plans and Pricing

Patent: 202007643S
Estimated Expiration: See Plans and Pricing

Patent: 201509189S
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 12255
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1806346
Estimated Expiration: See Plans and Pricing

Patent: 160020560
Estimated Expiration: See Plans and Pricing

Spain

Patent: 98408
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 39592
Estimated Expiration: See Plans and Pricing

Patent: 1534601
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 2626
Estimated Expiration: See Plans and Pricing

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
World Intellectual Property Organization (WIPO) 2006080327 See Plans and Pricing
Singapore 10202007643S STABLE CRYSTAL FORM OF TIPIRACIL HYDROCHLORIDE AND CRYSTALLIZATION METHOD FOR THE SAME See Plans and Pricing
Russian Federation 2674441 СТАБИЛЬНАЯ КРИСТАЛЛИЧЕСКАЯ ФОРМА ТИПИРАЦИЛА ГИДРОХЛОРИДА И СПОСОБ ЕЕ КРИСТАЛЛИЗАЦИИ (STABLE CRYSTALLINE FORM OF TIPIRACIL HYDROCHLORIDE AND METHOD FOR ITS CRYSTALLIZATION) See Plans and Pricing
Russian Federation 2016100972 СТАБИЛЬНАЯ КРИСТАЛЛИЧЕСКАЯ ФОРМА ТИПИРАЦИЛА ГИДРОХЛОРИДА И СПОСОБ ЕЕ КРИСТАЛЛИЗАЦИИ See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for LONSURF

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1849470 2017/033 Ireland See Plans and Pricing PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/16/1096 20160425
1849470 2017C/028 Belgium See Plans and Pricing PRODUCT NAME: LONSURF - TRIFLURIDINE/TIPIRACIL; AUTHORISATION NUMBER AND DATE: EU/1/16/1096 20160427
1849470 300889 Netherlands See Plans and Pricing PRODUCT NAME: TRIFLURIDINE IN COMBINATIE MET TIPIRACILHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/16/1096 20160427
1849470 1790063-0 Sweden See Plans and Pricing PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL HYDROCHLORIDE; REG. NO/DATE: EU/1/16/1096 20160427
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Boehringer Ingelheim
Express Scripts
Dow
Mallinckrodt

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.