boceprevir Oral Capsule

Brand(s)
Victrelis
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Merck Sharp & Dohme Corp. (2015-08-31)
Oldest Current Product
2011-05-13
License(s)
NDA
RxNORM
ORAL CAPSULE\BOCEPREVIR
FDAOB
ORAL\CAPSULE\BOCEPREVIR
SPL Active
ORAL\CAPSULE\BOCEPREVIR
SPL Moiety
ORAL\CAPSULE\BOCEPREVIR

product(s) by strength(s)

boceprevir 200 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000850314VictrelisNDAMerck Sharp & Dohme Corp.2011-05-13BOCEPREVIRORALCAPSULENDA202258ae879ebe-b620-4829-b6f8-74b58da1c771

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA202258VICTRELISMERCK SHARP AND DOHME CORP2011-05-13pRE43298, TREATMENT OF CHRONIC HEPATITIS C (CHC) GENOTYPE 1 INFECTION IN COMBINATION WITH PEGINTERFERON ALFA AND RIBAVIRIN IN ADULT PATIENTS (>=18 YEARS OF AGE) WITH COMPENSATED LIVER DISEASE, SUBSTANCE
p8119602, TREATMENT OF CHRONIC HEPATITIS C (CHC) GENOTYPE 1 INFECTION
p7772178, TREATMENT OF CHRONIC HEPATITIS C (CHC) GENOTYPE 1 INFECTION IN COMBINATION WITH PEGINTERFERON ALFA AND RIBAVIRIN IN ADULT PATIENTS (>=18 YEARS OF AGE) WITH COMPENSATED LIVER DISEASE, SUBSTANCE
UPDATES TO THE CLINICAL STUDIES SECTION 14 [2016-02-27]
NEW CHEMICAL ENTITY [2016-05-13]
NEW PATIENT POPULATION [2016-02-13]
NDA202258_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA202258_001RXBOCEPREVIR (200MG)ORALCAPSULETrue2011-05-13VICTRELIS

patent(s)

#idexpiration dateapplication(s)
1p7772178 (view patent)2027-11-11NDA202258
2p8119602 (view patent)2027-03-17NDA202258
3pRE43298 (view patent)2022-02-22NDA202258

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1ae879ebe-b620-4829-b6f8-74b58da1c771 (view SPL)These highlights do not include all the information needed to use VICTRELIS safely and effectively. See full prescribing information for VICTRELIS. VICTRELIS (boceprevir) capsules, for oral use Initial U.S. Approval: 2011prescriptionHuman PrescriptionMerck Sharp & Dohme Corp.2015-08-3133000850314

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