tipiracil / Trifluridine Oral Tablet

Brand(s)
Lonsurf
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Taiho Pharmaceutical Co., Ltd. (2015-11-04)
Oldest Current Product
2015-09-22
License(s)
NDA
RxNORM
ORAL TABLET\TIPIRACIL:TRIFLURIDINE
FDAOB
ORAL\TABLET\TIPIRACIL HYDROCHLORIDE: TRIFLURIDINE
SPL Active
ORAL\TABLET, FILM COATED\TIPIRACIL HYDROCHLORIDE: TRIFLURIDINE
SPL Moiety
ORAL\TABLET, FILM COATED\TIPIRACIL: TRIFLURIDINE

product(s) by strength(s)

tipiracil 6.14 mg / trifluridine 15 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1648421025LonsurfNDATaiho Pharmaceutical Co., Ltd.2015-09-22TIPIRACIL HYDROCHLORIDE, TRIFLURIDINEORALTABLET, FILM COATEDNDA207981f5beed22-d71d-4c0d-8dca-2c7317d65d85

tipiracil 8.19 mg / trifluridine 20 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1648421020LonsurfNDATaiho Pharmaceutical Co., Ltd.2015-09-22TIPIRACIL HYDROCHLORIDE, TRIFLURIDINEORALTABLET, FILM COATEDNDA207981f5beed22-d71d-4c0d-8dca-2c7317d65d85

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA207981LONSURFTAIHO ONCOLOGY INC2015-09-22p5744475, TREATMENT OF PATIENTS WITH METASTATIC COLORECTAL CANCER WHO HAVE BEEN PREVIOUSLY TREATED WITH FLUOROPYRIMIDINE-, SUBSTANCE
p7799783, TREATMENT OF PATIENTS WITH METASTATIC COLORECTAL CANCER WHO HAVE BEEN PREVIOUSLY TREATED WITH FLUOROPYRIMIDINE-
p6479500, TREATMENT OF PATIENTS WITH METASTATIC COLORECTAL CANCER WHO HAVE BEEN PREVIOUSLY TREATED WITH FLUOROPYRIMIDINE-
NEW CHEMICAL ENTITY [2020-09-22]NDA207981_001, NDA207981_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA207981_001RXTRIFLURIDINE (15MG), TIPIRACIL HYDROCHLORIDE (EQ 6.14MG BASE)ORALTABLETFalse2015-09-22LONSURF
2NDA207981_002RXTIPIRACIL HYDROCHLORIDE (EQ 8.19MG BASE), TRIFLURIDINE (20MG)ORALTABLETTrue2015-09-22LONSURF

patent(s)

#idexpiration dateapplication(s)
1p5744475 (view patent)2016-03-28NDA207981
2p6479500 (view patent)2020-03-16NDA207981
3p7799783 (view patent)2026-12-16NDA207981

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1f5beed22-d71d-4c0d-8dca-2c7317d65d85 (view SPL)These highlights do not include all the information needed to use LONSURF safely and effectively. See full prescribing information for LONSURF. LONSURF (trifluridine and tipiracil) tablets, for oral use Initial U.S. Approval: 2015prescriptionHuman PrescriptionTaiho Pharmaceutical Co., Ltd.ANALYSIS, API MANUFACTURE, MANUFACTURE2015-11-043648421020, 648421025

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII