DrugPatentWatch Database Preview
LONSURF Drug Profile
When do Lonsurf patents expire, and what generic alternatives are available?
Lonsurf is a drug marketed by Taiho Oncology and is included in one NDA. There are three patents protecting this drug.
This drug has seventy-two patent family members in thirty 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.
Summary for LONSURF
| International Patents: | 72 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 4 |
| Clinical Trials: | 23 |
| 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.
Recent Clinical Trials for LONSURF
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Baylor Research Institute | Phase 2 |
| Indiana University | Phase 1 |
| Taiho Oncology, Inc. | Phase 1 |
Pharmacology for LONSURF
Synonyms for LONSURF
| 1-((2R,4S,5R)-4-hydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl)-5-(trifluoromethyl)pyrimidine-2,4(1H,3H)-dione compound with 5-chloro-6-((2-iminopyrrolidin-1-yl)methyl)pyrimidine-2,4(1H,3H)-dione (1:1) hydrochloride |
| AC-30108 |
| EX-A1755 |
| TAS 102 |
| Thymidine, alpha,alpha,alpha-trifluoro-, mixt. with 5-chloro-6-((2-imino-1-pyrrolidinyl)methyl)-2,4(1H,3H)-pyrimidinedione monohydrochloride |
| Tipiracil / Trifluridine |
| Tipiracil hydrochloride / Trifluridine |
| Tipiracil hydrochloride mixture with Trifluridine |
| Viroptic mixture with 5-CIMU |
US Patents and Regulatory Information for LONSURF
| 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 | RX | Yes | No | See Pricing | See Pricing | See Pricing | ||||
| Taiho Oncology | LONSURF | tipiracil hydrochloride; trifluridine | TABLET;ORAL | 207981-001 | Sep 22, 2015 | RX | Yes | No | See Pricing | See Pricing | See Pricing | ||||
| Taiho Oncology | LONSURF | tipiracil hydrochloride; trifluridine | TABLET;ORAL | 207981-001 | Sep 22, 2015 | RX | Yes | No | See Pricing | See Pricing | Y | Y | See Pricing | ||
| Taiho Oncology | LONSURF | tipiracil hydrochloride; trifluridine | TABLET;ORAL | 207981-002 | Sep 22, 2015 | RX | Yes | Yes | See Pricing | See Pricing | See Pricing | ||||
| Taiho Oncology | LONSURF | tipiracil hydrochloride; trifluridine | TABLET;ORAL | 207981-002 | Sep 22, 2015 | RX | Yes | Yes | See Pricing | See Pricing | See Pricing | ||||
| >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 | 207981-001 | Sep 22, 2015 | See Pricing | See Pricing |
| Taiho Oncology | LONSURF | tipiracil hydrochloride; trifluridine | TABLET;ORAL | 207981-002 | Sep 22, 2015 | See Pricing | See Pricing |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for LONSURF
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| China | 101107001 | See Pricing |
| Australia | 772486 | See Pricing |
| Japan | WO2014203877 | See Pricing |
| European Patent Office | 1849470 | See Pricing |
| Hungary | E033306 | See Pricing |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for LONSURF
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1849470 | CA 2017 00036 | Denmark | See Pricing | PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL OR A PHARMACEUTICALLY ACCEPTABLE SALT OF TIPIRACIL; REG. NO/DATE: EU/1/16/1096 20160427 |
| 1849470 | 1790063-0 | Sweden | See Pricing | PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL HYDROCHLORIDE; REG. NO/DATE: EU/1/16/1096 20160427 |
| 1849470 | 122017000052 | Germany | See Pricing | PRODUCT NAME: TRIFLURIDIN IN KOMBINATION MIT TIPIRACIL ODER EINEM SALZ VON TIPIRACIL WIE TIPIRACIL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/16/1096 20160425 |
| 1849470 | 2017/033 | Ireland | See Pricing | PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/16/1096 20160425 |
| 1849470 | LUC00036 | Luxembourg | See Pricing | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
