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LONSURF Drug Profile
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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.
US ANDA Litigation and Generic Entry Outlook for Lonsurf
Lonsurf was eligible for patent challenges on September 22nd, 2019.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be June 17th, 2034. This may change due to patent challenges or generic licensing.
Summary for LONSURF
| International Patents: | 72 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 4 |
| Clinical Trials: | 31 |
| 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 |
|---|---|
| GERCOR - Multidisciplinary Oncology Cooperative Group | Phase 2 |
| Oregon Health and Science University | Phase 1 |
| Taiho Oncology | 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 |
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
| 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 | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Taiho Oncology | LONSURF | tipiracil hydrochloride; trifluridine | TABLET;ORAL | 207981-001 | Sep 22, 2015 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Taiho Oncology | LONSURF | tipiracil hydrochloride; trifluridine | TABLET;ORAL | 207981-002 | Sep 22, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Taiho Oncology | LONSURF | tipiracil hydrochloride; trifluridine | TABLET;ORAL | 207981-002 | Sep 22, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Taiho Oncology | LONSURF | tipiracil hydrochloride; trifluridine | TABLET;ORAL | 207981-002 | Sep 22, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >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 | 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 |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2006080327 | Start Trial |
| Hungary | E033306 | Start Trial |
| Portugal | 1080726 | Start Trial |
| World Intellectual Property Organization (WIPO) | 0056337 | Start Trial |
| Georgia, Republic of | P20186841 | Start Trial |
| >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 | Start Trial | PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL OR A PHARMACEUTICALLY ACCEPTABLE SALT OF TIPIRACIL; REG. 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 | 17C1028 | France | Start Trial | PRODUCT NAME: TRIFLURIDINE/TIPIRACIL; REGISTRATION NO/DATE: EU/1/16/1096 20160427 |
| 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 | 34/2017 | Austria | Start Trial | PRODUCT NAME: TRIFLURIDIN / TIPIRACIL ODER DEREN PHARMAZEUTISCH WIRKSAMEN SALZE; REGISTRATION NO/DATE: EU/1/16/1096 (MITTEILUNG) 20160427 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
