Vemurafenib Oral Tablet

Brand(s)
Zelboraf
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Genentech, Inc. (2015-08-20)
Oldest Current Product
2011-08-17
License(s)
NDA
RxNORM
ORAL TABLET\VEMURAFENIB
FDAOB
ORAL\TABLET\VEMURAFENIB
SPL Active
ORAL\TABLET, FILM COATED\VEMURAFENIB
SPL Moiety
ORAL\TABLET, FILM COATED\VEMURAFENIB

product(s) by strength(s)

vemurafenib 240 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1502420090ZelborafNDAGenentech, Inc.2011-08-17VEMURAFENIBORALTABLET, FILM COATEDNDA20242938eea320-7e0c-485a-bc30-98c3c45e2763

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA202429ZELBORAFHOFFMANN LA ROCHE INC2011-08-17p7504509, SUBSTANCE
p8741920, SUBSTANCE
p7863288, SUBSTANCE
p8143271, SUBSTANCE
p8470818, TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAFV600E MUTATION AS DETECTED BY AN FDA APPROVED TEST
NEW CHEMICAL ENTITY [2016-08-17]
ORPHAN DRUG EXCLUSIVITY [2018-08-17]
NDA202429_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA202429_001RXVEMURAFENIB (240MG)ORALTABLETTrue2011-08-17ZELBORAF

patent(s)

#idexpiration dateapplication(s)
1p7504509 (view patent)2026-10-22NDA202429
2p7863288 (view patent)2029-06-20NDA202429
3p8143271 (view patent)2026-06-21NDA202429
4p8470818 (view patent)2026-08-02NDA202429
5p8741920 (view patent)2030-07-27NDA202429

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
138eea320-7e0c-485a-bc30-98c3c45e2763 (view SPL)These highlights do not include all the information needed to use ZELBORAF safely and effectively. See full prescribing information for ZELBORAF. ZELBORAF (vemurafenib) tablet for oral useInitial U.S. Approval: 2011prescriptionHuman PrescriptionGenentech, Inc.ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2015-08-2012502420090

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