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
Summary for LONSURF
International Patents: | 89 |
US Patents: | 5 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 14 |
Clinical Trials: | 55 |
Patent Applications: | 27 |
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 |


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
Sponsor | Phase |
---|---|
Yonsei University | Phase 1/Phase 2 |
Taiho | Phase 2 |
Amgen | Phase 3 |
Pharmacology for LONSURF
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
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 | See Plans and Pricing | See Plans and Pricing |
Taiho Oncology | LONSURF | tipiracil hydrochloride; trifluridine | TABLET;ORAL | 207981-002 | Sep 22, 2015 | See Plans and Pricing | See Plans and Pricing |
Taiho Oncology | LONSURF | tipiracil hydrochloride; trifluridine | TABLET;ORAL | 207981-002 | Sep 22, 2015 | See Plans and Pricing | See Plans and Pricing |
Taiho Oncology | LONSURF | tipiracil hydrochloride; trifluridine | TABLET;ORAL | 207981-001 | Sep 22, 2015 | See Plans and Pricing | See Plans and Pricing |
>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: 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 |