cobicistat / elvitegravir / emtricitabine / tenofovir disoproxil Oral Tablet

Brand(s)
Stribild
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Gilead Sciences, Inc. (2015-08-03)
Oldest Current Product
2012-08-27
License(s)
NDA, EXPORT ONLY
RxNORM
ORAL TABLET\COBICISTAT:ELVITEGRAVIR:EMTRICITABINE:TENOFOVIR DISOPROXIL
FDAOB
ORAL\TABLET\COBICISTAT: ELVITEGRAVIR: EMTRICITABINE: TENOFOVIR DISOPROXIL FUMARATE
SPL Active
ORAL\TABLET, FILM COATED\COBICISTAT: ELVITEGRAVIR: EMTRICITABINE: TENOFOVIR DISOPROXIL FUMARATE
SPL Moiety
ORAL\TABLET, FILM COATED\COBICISTAT: ELVITEGRAVIR: EMTRICITABINE: TENOFOVIR ANHYDROUS

product(s) by strength(s)

cobicistat 150 mg / elvitegravir 150 mg / emtricitabine 200 mg / tenofovir disoproxil fumarate 300 mg oral tablet

export only product(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1619581202StribildEXPORT ONLYGilead Sciences, Inc.2012-08-27COBICISTAT, ELVITEGRAVIR, EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATEORALTABLET, FILM COATEDd52f7766-068f-4a2f-b748-356ff60450f7

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1619581201StribildNDAGilead Sciences, Inc.2012-08-27COBICISTAT, ELVITEGRAVIR, EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATEORALTABLET, FILM COATEDNDA20310074ae2a93-b267-444c-8f0f-a2a6522260ee

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1538080887StribildNDAState Of Florida Doh Central Pharmacy2014-01-01COBICISTAT, ELVITEGRAVIR, EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATEORALTABLET, FILM COATED619581201NDA203100144067b2-0532-476a-996e-e4a0a9d09b05

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA203100STRIBILDGILEAD SCIENCES INC2012-08-27p6703396, SUBSTANCE
p5814639, SUBSTANCE
p5922695, TREATMENT OF HIV INFECTION
p8633219, TREATMENT OF HIV INFECTION, SUBSTANCE
p8148374, TREATMENT OF HIV INFECTION USING A COMPOSITION CONTAINING A PHARMACOKNIETIC ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENASE, SUBSTANCE
p8592397, TREATMENT OF HIV INFECTION, SUBSTANCE
p5977089, TREATMENT OF HIV INFECTION, SUBSTANCE
p6043230, TREATMENT OF HIV INFECTION
p6642245, TREATMENT OF HIV INFECTION
p7635704, TREATMENT OF HIV INFECTION, SUBSTANCE
p7176220, TREATMENT OF HIV INFECTION, SUBSTANCE
p8716264, TREATMENT OF HIV INFECTION, SUBSTANCE
p5914331
p5935946, TREATMENT OF HIV INFECTION, SUBSTANCE
p8981103, SUBSTANCE
NEW PRODUCT [2015-08-27]
EXPANDED INDICATION TO INCLUDE PATIENTS WHO ARE VIROLOGICALLY-SUPPRESSED (HIV-1 RNA <50 COPIES/ML) ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS WITH NO HISTORY OF TREATMENT FAILURE IN ORDER TO REPLACE THEIR CURRENT REGIMEN [2017-12-17]
NDA203100_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA203100_001RXCOBICISTAT (150MG), ELVITEGRAVIR (150MG), EMTRICITABINE (200MG), TENOFOVIR DISOPROXIL FUMARATE (300MG)ORALTABLETTrue2012-08-27STRIBILD

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5814639 (view patent)2015-09-29NDA203100, NDA021500, NDA021752, NDA021896, NDA021937, NDA202123efavirenz / emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine Oral Solution
emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine / Rilpivirine / tenofovir disoproxil Oral Tablet
emtricitabine Oral Capsule
2p5914331 (view patent)2017-07-02NDA203100, NDA021500, NDA021752, NDA021896, NDA021937, NDA202123efavirenz / emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine Oral Solution
emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine / Rilpivirine / tenofovir disoproxil Oral Tablet
emtricitabine Oral Capsule
3p5922695 (view patent)2017-07-25NDA203100, NDA021356, NDA021752, NDA021937, NDA022577, NDA202123efavirenz / emtricitabine / tenofovir disoproxil Oral Tablet
tenofovir disoproxil Oral Powder
emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine / Rilpivirine / tenofovir disoproxil Oral Tablet
tenofovir disoproxil Oral Tablet
4p5935946 (view patent)2017-07-25NDA203100, NDA021356, NDA021752, NDA021937, NDA022577, NDA202123efavirenz / emtricitabine / tenofovir disoproxil Oral Tablet
tenofovir disoproxil Oral Powder
emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine / Rilpivirine / tenofovir disoproxil Oral Tablet
tenofovir disoproxil Oral Tablet
5p5977089 (view patent)2017-07-25NDA203100, NDA021356, NDA021752, NDA021937, NDA022577, NDA202123efavirenz / emtricitabine / tenofovir disoproxil Oral Tablet
tenofovir disoproxil Oral Powder
emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine / Rilpivirine / tenofovir disoproxil Oral Tablet
tenofovir disoproxil Oral Tablet
6p6043230 (view patent)2017-07-25NDA203100, NDA021356, NDA021752, NDA021937, NDA022577, NDA202123efavirenz / emtricitabine / tenofovir disoproxil Oral Tablet
tenofovir disoproxil Oral Powder
emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine / Rilpivirine / tenofovir disoproxil Oral Tablet
tenofovir disoproxil Oral Tablet
7p6642245 (view patent)2020-11-04NDA203100, NDA021500, NDA021752, NDA021896, NDA021937, NDA202123efavirenz / emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine Oral Solution
emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine / Rilpivirine / tenofovir disoproxil Oral Tablet
emtricitabine Oral Capsule
8p6703396 (view patent)2021-03-09NDA203100, NDA021500, NDA021752, NDA021896, NDA021937, NDA202123efavirenz / emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine Oral Solution
emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine / Rilpivirine / tenofovir disoproxil Oral Tablet
emtricitabine Oral Capsule
9p7176220 (view patent)2023-11-20NDA203100, NDA203093elvitegravir Oral Tablet
10p7635704 (view patent)2026-10-26NDA203100, NDA203093elvitegravir Oral Tablet
11p8148374 (view patent)2029-09-03NDA203100, NDA203094, NDA205395, NDA206353cobicistat Oral Tablet
cobicistat / darunavir Oral Tablet
Atazanavir / cobicistat Oral Tablet
12p8592397 (view patent)2024-01-13NDA203100, NDA021752, NDA021937, NDA202123efavirenz / emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine / Rilpivirine / tenofovir disoproxil Oral Tablet
13p8633219 (view patent)2031-10-11NDA203100
14p8716264 (view patent)2024-01-13NDA203100, NDA021752, NDA021937, NDA202123efavirenz / emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine / Rilpivirine / tenofovir disoproxil Oral Tablet
15p8981103 (view patent)2026-10-26NDA203100, NDA203093elvitegravir Oral Tablet

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1144067b2-0532-476a-996e-e4a0a9d09b05 (view SPL)These highlights do not include all the information needed to use STRIBILD safely and effectively. See full prescribing information for STRIBILD. STRIBILD (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate) tablets, for oral useInitial U.S. Approval: 2012prescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2014-03-061538080887
274ae2a93-b267-444c-8f0f-a2a6522260ee (view SPL)These highlights do not include all the information needed to use STRIBILD safely and effectively. See full prescribing information for STRIBILD. STRIBILD (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate) tablets, for oral useInitial U.S. Approval: 2012prescriptionHuman PrescriptionGilead Sciences, Inc.2015-08-037619581201
3d52f7766-068f-4a2f-b748-356ff60450f7 (view SPL)These highlights do not include all the information needed to use STRIBILD safely and effectively. See full prescribing information for STRIBILD. STRIBILD (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate) tablets, for oral useGILEAD ACCESS PROGRAMInitial U.S. Approval: 2012prescriptionHuman PrescriptionGilead Sciences, Inc.2015-06-242619581202

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