cobicistat / darunavir Oral Tablet

Brand(s)
Prezcobix
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Janssen Products, Lp (2015-01-28)
Oldest Current Product
2015-01-31
License(s)
NDA
RxNORM
ORAL TABLET\COBICISTAT:DARUNAVIR
FDAOB
ORAL\TABLET\COBICISTAT: DARUNAVIR ETHANOLATE
SPL Active
ORAL\TABLET, FILM COATED\COBICISTAT: DARUNAVIR ETHANOLATE
SPL Moiety
ORAL\TABLET, FILM COATED\COBICISTAT: DARUNAVIR

product(s) by strength(s)

cobicistat 150 mg / darunavir 800 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1596760575PrezcobixNDAJanssen Products, Lp2015-01-31COBICISTAT, DARUNAVIR ETHANOLATEORALTABLET, FILM COATEDNDA2053959c38fdb6-d0ba-4f16-a0e3-85d9ec334d9f

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA205395PREZCOBIXJANSSEN PRODUCTS LP2015-01-29pRE43596, SUBSTANCE
p5843946, TREATMENT OF HIV-1 INFECTION IN ADULTS WITH NO DARUNAVIR RESISTANCE-ASSOCIATED SUBSTITUTIONS, SUBSTANCE
p8597876, TREATMENT OF HIV-1 INFECTION IN ADULTS WITH NO DARUNAVIR RESISTANCE-ASSOCIATED SUBSTITUTIONS
p8148374, TREATMENT OF HIV-1 INFECTION IN ADULTS WITH NO DARUNAVIR RESISTANCE-ASSOCIATED SUBSTITUTIONS, SUBSTANCE
p7470506, TREATMENT OF HIV-1 INFECTION IN ADULTS WITH NO DARUNAVIR RESISTANCE-ASSOCIATED SUBSTITUTIONS
pRE42889, SUBSTANCE
p8518987, SUBSTANCE
p7700645, SUBSTANCE
pRE43802, TREATMENT OF HIV-1 INFECTION IN ADULTS WITH NO DARUNAVIR RESISTANCE-ASSOCIATED SUBSTITUTIONS
NDA205395_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA205395_001RXCOBICISTAT (150MG), DARUNAVIR ETHANOLATE (EQ 800MG BASE)ORALTABLETTrue2015-01-29PREZCOBIX

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5843946 (view patent)2015-12-01NDA205395, NDA021976, NDA202895darunavir Oral Suspension
darunavir Oral Tablet
2p7470506 (view patent)2019-06-23NDA205395, NDA021976, NDA202895darunavir Oral Suspension
darunavir Oral Tablet
3p7700645 (view patent)2026-12-26NDA205395, NDA021976, NDA202895darunavir Oral Suspension
darunavir Oral Tablet
4p8148374 (view patent)2029-09-03NDA205395, NDA203094, NDA203100, NDA206353cobicistat / elvitegravir / emtricitabine / tenofovir disoproxil Oral Tablet
cobicistat Oral Tablet
Atazanavir / cobicistat Oral Tablet
5p8518987 (view patent)2024-02-16NDA205395, NDA021976, NDA202895darunavir Oral Suspension
darunavir Oral Tablet
6p8597876 (view patent)2019-06-23NDA205395, NDA021976, NDA202895darunavir Oral Suspension
darunavir Oral Tablet
7pRE42889 (view patent)2016-10-19NDA205395, NDA021976, NDA202895darunavir Oral Suspension
darunavir Oral Tablet
8pRE43596 (view patent)2017-05-09NDA205395, NDA021976, NDA202895darunavir Oral Suspension
darunavir Oral Tablet
9pRE43802 (view patent)2016-10-19NDA205395, NDA021976, NDA202895darunavir Oral Suspension
darunavir Oral Tablet

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
19c38fdb6-d0ba-4f16-a0e3-85d9ec334d9f (view SPL)These highlights do not include all the information needed to use PREZCOBIX safely and effectively. See full prescribing information for PREZCOBIX. PREZCOBIX (darunavir and cobicistat) tablets, for oral use. Initial U.S. Approval: 2015prescriptionHuman PrescriptionJanssen Products, LpANALYSIS, API MANUFACTURE, MANUFACTURE2015-01-281596760575

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