TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE - Generic Drug Details
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What are the generic drug sources for tipiracil hydrochloride; trifluridine and what is the scope of patent protection?
Tipiracil hydrochloride; trifluridine
is the generic ingredient in two branded drugs marketed by Taiho Oncology and Natco, and is included in two NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.Tipiracil hydrochloride; trifluridine has one hundred and eighteen patent family members in thirty-three countries.
One supplier is listed for this compound.
Summary for TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE
International Patents: | 118 |
US Patents: | 6 |
Tradenames: | 2 |
Applicants: | 2 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 57 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE |
DailyMed Link: | TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE at DailyMed |
Recent Clinical Trials for TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
The First Affiliated Hospital with Nanjing Medical University | Phase 2 |
Sun Yat-sen University | Phase 2 |
Yonsei University | Phase 1/Phase 2 |
See all TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE clinical trials
Pharmacology for TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE
Drug Class | Nucleoside Analog Antiviral Nucleoside Metabolic Inhibitor Thymidine Phosphorylase Inhibitor |
Mechanism of Action | Nucleic Acid Synthesis Inhibitors Thymidine Phosphorylase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE
Paragraph IV (Patent) Challenges for TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
LONSURF | Tablets | tipiracil hydrochloride; trifluridine | 15 mg/6.14 mg and 20 mg/8.19 mg | 207981 | 4 | 2019-09-23 |
US Patents and Regulatory Information for TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE
Expired US Patents for TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE
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 | ⤷ Sign Up | ⤷ Sign Up |
Taiho Oncology | LONSURF | tipiracil hydrochloride; trifluridine | TABLET;ORAL | 207981-002 | Sep 22, 2015 | ⤷ Sign Up | ⤷ Sign Up |
Taiho Oncology | LONSURF | tipiracil hydrochloride; trifluridine | TABLET;ORAL | 207981-002 | Sep 22, 2015 | ⤷ Sign Up | ⤷ Sign Up |
Taiho Oncology | LONSURF | tipiracil hydrochloride; trifluridine | TABLET;ORAL | 207981-001 | Sep 22, 2015 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 2014203877 | ⤷ Sign Up | |
Singapore | 10201912293U | STABLE CRYSTAL FORM OF TIPIRACIL HYDROCHLORIDE AND CRYSTALLIZATION METHOD FOR THE SAME | ⤷ Sign Up |
China | 101107001 | Anticancer drug containing alpha, alpha, alpha-trifluorothymidine and thymidine phosphorylase inhibitor | ⤷ Sign Up |
Japan | 5576591 | ⤷ Sign Up | |
South Korea | 102412690 | ⤷ Sign Up | |
European Patent Office | 3012255 | CRISTAL STABILISÉ DE CHLORHYDRATE DE TIPIRACIL, ET SON PROCÉDÉ DE CRISTALLISATION (STABILIZED CRYSTAL OF TIPIRACIL HYDROCHLORIDE, AND CRYSTALLIZATION METHOD FOR SAME) | ⤷ Sign Up |
Russian Federation | 2394581 | ПРОТИВОРАКОВОЕ ЛЕКАРСТВЕННОЕ СРЕДСТВО, СОДЕРЖАЩЕЕ α,α,α-ТРИФТОРТИМИДИН И ИНГИБИТОР ТИМИДИНФОСФОРИЛАЗЫ (ANTICANCER MEDICINE, CONTAINING ,,-TRIFLUOROTHYMIDINE AND THYMIDINE PHOSPHORYLASE INHIBITOR) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1849470 | PA2017024,C1849470 | Lithuania | ⤷ Sign Up | PRODUCT NAME: TRIFLURIDINAS/TIPIRACILAS; REGISTRATION NO/DATE: EU/1/16/1096 20160425 |
1849470 | 122017000052 | Germany | ⤷ Sign Up | PRODUCT NAME: TRIFLURIDIN IN KOMBINATION MIT TIPIRACIL ODER EINEM SALZ VON TIPIRACIL WIE TIPIRACIL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/16/1096 20160425 |
1849470 | 132017000102371 | Italy | ⤷ Sign Up | 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 | ⤷ Sign Up | PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL HYDROCHLORIDE; REG. NO/DATE: EU/1/16/1096 20160427 |
1849470 | C 2017 032 | Romania | ⤷ Sign Up | PRODUCT NAME: TRIFLURIDINA IN COMBINATIE CU TIPIRACIL SAU O SARE ACCEPTABILA FARMACEUTIC DE TIPIRACIL CUM AR FI CLORHIDRAT DE TIPIRACIL; NATIONAL AUTHORISATION NUMBER: EU/1/16/1096; DATE OF NATIONAL AUTHORISATION: 20160425; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/16/1096; DATE OF FIRST AUTHORISATION IN EEA: 20160425 |
1849470 | 2017C/028 | Belgium | ⤷ Sign Up | PRODUCT NAME: LONSURF - TRIFLURIDINE/TIPIRACIL; AUTHORISATION NUMBER AND DATE: EU/1/16/1096 20160427 |
1849470 | 300889 | Netherlands | ⤷ Sign Up | PRODUCT NAME: TRIFLURIDINE IN COMBINATIE MET TIPIRACILHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/16/1096 20160427 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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