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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
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 |
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 |
|---|---|
| Servier | Phase 2 |
| Dominik Paul Modest | Phase 2 |
| AHS Cancer Control Alberta | Phase 2 |
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
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 |
International Patents for LONSURF
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Morocco | 38668 | ⤷ Try it Free |
| Philippines | 12015502809 | ⤷ Try it Free |
| Japan | 4049477 | ⤷ Try it Free |
| Russian Federation | 2727598 | ⤷ Try it Free |
| China | 101107001 | ⤷ Try it Free |
| Singapore | 11201509189S | ⤷ Try it Free |
| World Intellectual Property Organization (WIPO) | 2014203877 | ⤷ Try it Free |
| >Country | >Patent Number | >Estimated 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 |
