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LONSURF Drug Profile
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» See Plans and PricingWhen 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.
This drug has eighty-three patent family members in thirty-one 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.
US ANDA Litigation and 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.
Indicators of Generic Entry
Summary for LONSURF
| International Patents: | 83 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 4 |
| Clinical Trials: | 33 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for LONSURF |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for LONSURF |
| DailyMed Link: | LONSURF at DailyMed |
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 |
|---|---|
| GERCOR - Multidisciplinary Oncology Cooperative Group | Phase 2 |
| Roswell Park Cancer Institute | Phase 2 |
| OHSU Knight Cancer Institute | Phase 1 |
Pharmacology 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
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 | Start Trial | Start Trial |
| Taiho Oncology | LONSURF | tipiracil hydrochloride; trifluridine | TABLET;ORAL | 207981-002 | Sep 22, 2015 | Start Trial | Start Trial |
| Taiho Oncology | LONSURF | tipiracil hydrochloride; trifluridine | TABLET;ORAL | 207981-001 | Sep 22, 2015 | Start Trial | Start Trial |
| Taiho Oncology | LONSURF | tipiracil hydrochloride; trifluridine | TABLET;ORAL | 207981-002 | Sep 22, 2015 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for LONSURF
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Portugal | 1849470 | Start Trial |
| Taiwan | 201728328 | Start Trial |
| Singapore | 10201912293U | Start Trial |
| European Patent Office | 0763529 | Start Trial |
| Japan | WO2006080327 | Start Trial |
| Spain | 2203683 | Start Trial |
| Taiwan | I362265 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for LONSURF
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1849470 | 17C1028 | France | Start Trial | PRODUCT NAME: TRIFLURIDINE/TIPIRACIL; REGISTRATION NO/DATE: EU/1/16/1096 20160427 |
| 1849470 | 122017000052 | Germany | Start Trial | PRODUCT NAME: TRIFLURIDIN IN KOMBINATION MIT TIPIRACIL ODER EINEM SALZ VON TIPIRACIL WIE TIPIRACIL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/16/1096 20160425 |
| 1849470 | LUC00036 | Luxembourg | Start Trial | 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 | Lithuania | Start Trial | PRODUCT NAME: TRIFLURIDINAS/TIPIRACILAS; REGISTRATION NO/DATE: EU/1/16/1096 20160425 |
| 1849470 | 132017000102371 | Italy | Start Trial | 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 | 34/2017 | Austria | Start Trial | PRODUCT NAME: TRIFLURIDIN / TIPIRACIL ODER DEREN PHARMAZEUTISCH WIRKSAMEN SALZE; REGISTRATION NO/DATE: EU/1/16/1096 (MITTEILUNG) 20160427 |
| 1849470 | 2017C/028 | Belgium | Start Trial | PRODUCT NAME: LONSURF - TRIFLURIDINE/TIPIRACIL; AUTHORISATION NUMBER AND DATE: EU/1/16/1096 20160427 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
