DrugPatentWatch Database Preview
LONSURF Drug 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 three patents protecting this drug.
The generic ingredient in LONSURF is tipiracil hydrochloride; trifluridine. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the tipiracil hydrochloride; trifluridine profile page.
Summary for LONSURF
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 3 |
| Clinical Trials: | 11 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information 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.
Pharmacology for LONSURF
| Ingredient-type | Nucleoside Analog |
| Drug Class | Nucleoside Analog Antiviral Nucleoside Metabolic Inhibitor Thymidine Phosphorylase Inhibitor |
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors Thymidine Phosphorylase Inhibitors |
US Patents and Regulatory Information for LONSURF
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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 a Free Trial | ➤ Try a Free Trial |
| Taiho Oncology | LONSURF | tipiracil hydrochloride; trifluridine | TABLET;ORAL | 207981-002 | Sep 22, 2015 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Non-Orange Book US Patents for LONSURF
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 7,799,783 | Method of administrating an anticancer drug containing .alpha., .alpha., .alpha.-trifluorothymidine and thymidine phosphorylase inhibitor | ➤ Try a Free Trial |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for LONSURF
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Japan | WO2014203877 | ➤ Try a Free Trial |
| China | 1144587 | ➤ Try a Free Trial |
| Portugal | 1080726 | ➤ Try a Free Trial |
| Cyprus | 1119393 | ➤ Try a Free Trial |
| China | 1297350 | ➤ Try a Free Trial |
| Russian Federation | 2394581 | ➤ Try a Free Trial |
| Singapore | 11201509189S | ➤ Try a Free Trial |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for LONSURF
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2017024 | Lithuania | ➤ Try a Free Trial | PRODUCT NAME: TRIFLURIDINAS/TIPIRACILAS; REGISTRATION NO/DATE: EU/1/16/1096 20160425 |
| 2017 00036 | Denmark | ➤ Try a Free Trial | PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL OR A PHARMACEUTICALLY ACCEPTABLE SALT OF TIPIRACIL; REG. NO/DATE: EU/1/16/1096 20160427 |
| /2017 | Austria | ➤ Try a Free Trial | PRODUCT NAME: TRIFLURIDIN / TIPIRACIL ODER DEREN PHARMAZEUTISCH WIRKSAMEN SALZE; REGISTRATION NO/DATE: EU/1/16/1096 (MITTEILUNG) 20160427 |
| 2017000052 | Germany | ➤ Try a Free Trial | PRODUCT NAME: TRIFLURIDIN IN KOMBINATION MIT TIPIRACIL ODER EINEM SALZ VON TIPIRACIL WIE TIPIRACIL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/16/1096 20160425 |
| 0889 | Netherlands | ➤ Try a Free Trial | PRODUCT NAME: TRIFLURIDINE IN COMBINATIE MET TIPIRACILHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/16/1096 20160427 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
