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.
DrugPatentWatch® Litigation and Generic Entry Outlook for Lonsurf
A generic version of LONSURF was approved as tipiracil hydrochloride; trifluridine by NATCO on June 13th, 2023.
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Summary for LONSURF
| International Patents: | 118 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 13 |
| Clinical Trials: | 55 |
| Patent Applications: | 19 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for LONSURF |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for LONSURF |
| What excipients (inactive ingredients) are in LONSURF? | LONSURF excipients list |
| DailyMed Link: | LONSURF at DailyMed |
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 | 207981-001 | Sep 22, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| Taiho Oncology | LONSURF | tipiracil hydrochloride; trifluridine | TABLET;ORAL | 207981-002 | Sep 22, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| Finland | 3042669 | ⤷ Sign Up | |
| Australia | 2014282281 | Stabilized crystal of tipiracil hydrochloride, and crystallization method for same | ⤷ Sign Up |
| Philippines | 12015502809 | STABLE CRYSTAL FORM OF TIPIRACIL HYDROCHLORIDE AND CRYSTALLIZATION METHOD FOR THE SAME | ⤷ Sign Up |
| Lithuania | C1849470 | ⤷ 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 | 34/2017 | Austria | ⤷ Sign Up | PRODUCT NAME: TRIFLURIDIN / TIPIRACIL ODER DEREN PHARMAZEUTISCH WIRKSAMEN SALZE; REGISTRATION NO/DATE: EU/1/16/1096 (MITTEILUNG) 20160427 |
| 1849470 | PA2017024,C1849470 | Lithuania | ⤷ Sign Up | PRODUCT NAME: TRIFLURIDINAS/TIPIRACILAS; REGISTRATION NO/DATE: EU/1/16/1096 20160425 |
| 1849470 | 17C1028 | France | ⤷ Sign Up | PRODUCT NAME: TRIFLURIDINE/TIPIRACIL; REGISTRATION NO/DATE: EU/1/16/1096 20160427 |
| 1849470 | 2017/033 | Ireland | ⤷ Sign Up | PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL HYDROCHLORIDE; 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.
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