simeprevir Oral Capsule

Brand(s)
Olysio
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Janssen Products, Lp (2015-10-12)
Oldest Current Product
2013-11-22
License(s)
NDA
RxNORM
ORAL CAPSULE\SIMEPREVIR
FDAOB
ORAL\CAPSULE\SIMEPREVIR SODIUM
SPL Active
ORAL\CAPSULE\SIMEPREVIR
SPL Moiety
ORAL\CAPSULE\SIMEPREVIR

product(s) by strength(s)

simeprevir 150 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1596760225OlysioNDAJanssen Products, Lp2013-11-22SIMEPREVIRORALCAPSULENDA2051231816fd68-0ed7-4a37-84bb-e298c5ab6e28

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA205123OLYSIOJANSSEN PRODUCTS LP2013-11-22p8754106, METHOD OF TREATING HEPATITIS C
p8148399, METHOD OF TREATING HEPATITIS C, SUBSTANCE
p9040562, METHOD OF TREATING HEPATITIS C, SUBSTANCE
p8741926, METHOD OF TREATING HEPATITIS C
p8349869, METHOD OF TREATING HEPATITIS C, SUBSTANCE
p7671032, SUBSTANCE
EXPANDED INDICATION TO INCLUDE THE TREATMENT OF CHRONIC HEPATITIS C GENOTYPE 4 [2018-10-05]
NEW CHEMICAL ENTITY [2018-11-22]
FOR USE IN COMBINATION WITH SOFOSBUVIR FOR THE TREATMENT OF PATIENTS WITH CHRONIC HEPATITIS C VIRUS GENOTYPE 1 INFECTION [2017-11-05]
DOSING RECOMMENDATIONS FOR THE TREATMENT OF CHRONIC HEPATITIS C IN PATIENTS CO-INFECTED WITH HIV-1 [2018-10-05]
NDA205123_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA205123_001RXSIMEPREVIR SODIUM (EQ 150MG BASE)ORALCAPSULETrue2013-11-22OLYSIO

patent(s)

#idexpiration dateapplication(s)
1p7671032 (view patent)2025-05-19NDA205123
2p8148399 (view patent)2029-09-05NDA205123
3p8349869 (view patent)2026-07-28NDA205123
4p8741926 (view patent)2026-07-28NDA205123
5p8754106 (view patent)2026-07-28NDA205123
6p9040562 (view patent)2026-07-28NDA205123

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11816fd68-0ed7-4a37-84bb-e298c5ab6e28 (view SPL)These highlights do not include all the information needed to use OLYSIO safely and effectively. See full prescribing information for OLYSIO. OLYSIO (simeprevir) capsules, for oral use Initial U.S. Approval: 2013prescriptionHuman PrescriptionJanssen Products, LpANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2015-10-128596760225

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