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Last Updated: January 17, 2022

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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 five patents protecting this drug and one Paragraph IV challenge.

This drug has seventy-eight patent family members in twenty-nine countries.

The generic ingredient in LONSURF is tipiracil hydrochloride; trifluridine. There are two drug master file entries 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
International Patents:78
US Patents:5
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 16
Clinical Trials: 48
Patent Applications: 22
Formulation / Manufacturing:see details
Drug Prices: Drug price information for LONSURF
What excipients (inactive ingredients) are in LONSURF?LONSURF excipients list
DailyMed Link:LONSURF at DailyMed
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
ServierPhase 2
Dominik Paul ModestPhase 2
AHS Cancer Control AlbertaPhase 2

See all LONSURF clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for LONSURF
Paragraph IV (Patent) Challenges for LONSURF
Tradename Dosage Ingredient NDA Submissiondate
LONSURF TABLET;ORAL tipiracil hydrochloride; trifluridine 207981 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 ⤷  Try it Free.

This potential generic entry date is based on patent ⤷  Try it Free.

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: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free
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: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free

Method for treating cancer patients with severe renal impairment
Patent Number: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free
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: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free

Method of administrating an anticancer drug containing .alpha., .alpha., .alpha.-trifluorothymidine and thymidine phosphorylase inhibitor
Patent Number: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free
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: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free
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: ⤷  Try it Free

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 it Free

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 it Free ⤷  Try it Free ⤷  Try it Free
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-001 Sep 22, 2015 RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-001 Sep 22, 2015 RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-002 Sep 22, 2015 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-001 Sep 22, 2015 RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-002 Sep 22, 2015 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-002 Sep 22, 2015 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y Y ⤷  Try it Free
>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 207981-001 Sep 22, 2015 ⤷  Try it Free ⤷  Try it Free
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-001 Sep 22, 2015 ⤷  Try it Free ⤷  Try it Free
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-002 Sep 22, 2015 ⤷  Try it Free ⤷  Try it Free
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-002 Sep 22, 2015 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for LONSURF

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1849470 PA2017024 Lithuania ⤷  Try it Free PRODUCT NAME: TRIFLURIDINAS/TIPIRACILAS; REGISTRATION NO/DATE: EU/1/16/1096 20160425
1849470 132017000102371 Italy ⤷  Try it Free 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 1790063-0 Sweden ⤷  Try it Free PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL HYDROCHLORIDE; REG. NO/DATE: EU/1/16/1096 20160427
1849470 LUC00036 Luxembourg ⤷  Try it Free 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 PA2017024,C1849470 Lithuania ⤷  Try it Free PRODUCT NAME: TRIFLURIDINAS/TIPIRACILAS; REGISTRATION NO/DATE: EU/1/16/1096 20160425
1849470 2017/033 Ireland ⤷  Try it Free PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/16/1096 20160425
1849470 122017000052 Germany ⤷  Try it Free PRODUCT NAME: TRIFLURIDIN IN KOMBINATION MIT TIPIRACIL ODER EINEM SALZ VON TIPIRACIL WIE TIPIRACIL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/16/1096 20160425
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Colorcon
Boehringer Ingelheim
Express Scripts
Dow
Mallinckrodt

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