efavirenz / emtricitabine / tenofovir disoproxil Oral Tablet

Brand(s)
Atripla
Category(s)
prescription
SPL Type(s)
Human Prescription, Human Prescription with Highlights
Master SPL
Bristol Myers Squibb & Gilead Sciences, Llc (2015-01-30)
Oldest Current Product
2006-07-20
License(s)
NDA, EXPORT ONLY
RxNORM
ORAL TABLET\EFAVIRENZ:EMTRICITABINE:TENOFOVIR DISOPROXIL
FDAOB
ORAL\TABLET\EFAVIRENZ: EMTRICITABINE: TENOFOVIR DISOPROXIL FUMARATE
SPL Active
ORAL\TABLET, FILM COATED\EFAVIRENZ: EMTRICITABINE: TENOFOVIR DISOPROXIL FUMARATE
SPL Moiety
ORAL\TABLET, FILM COATED\EFAVIRENZ: EMTRICITABINE: TENOFOVIR
ORAL\TABLET, FILM COATED\EFAVIRENZ: EMTRICITABINE: TENOFOVIR ANHYDROUS

product(s) by strength(s)

efavirenz 600 mg / emtricitabine 200 mg / tenofovir disoproxil fumarate 300 mg oral tablet

export only product(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1619581601AtriplaEXPORT ONLYGilead Sciences, Inc.2006-07-20EFAVIRENZ, EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATEORALTABLET, FILM COATED7af4b5e9-f5bb-410c-8370-f74e04e7683b

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1155840101AtriplaNDABristol Myers Squibb & Gilead Sciences, Llc2006-07-20EFAVIRENZ, EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATEORALTABLET, FILM COATEDNDA0219372e97aa6d-09f7-46df-9499-63db7e9bac35

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1353560064AtriplaNDALake Erie Medical Dba Quality Care Products Llc2006-07-20EFAVIRENZ, EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATEORALTABLET, FILM COATED155840101NDA0219375c6c7ba4-6d42-4e07-a127-b3cf72c866ad
2538080208AtriplaNDAState Of Florida Doh Central Pharmacy2009-07-01EFAVIRENZ, EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATEORALTABLET, FILM COATED155840101NDA021937076da359-b3d0-44f7-8c0e-662f5b7a8668
3548685643AtriplaNDAPhysicians Total Care, Inc.2012-10-16EFAVIRENZ, EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATEORALTABLET, FILM COATED155840101NDA0219372096a07e-8601-4bdc-ba5a-338a40cd02e9

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA021937ATRIPLAGILEAD SCIENCES INC2006-07-12p6703396, SUBSTANCE
p5814639, SUBSTANCE
p5922695, TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER/ TREATMENT OF HIV-1 INFECTION IN ADULTS
p6939964
p8716264, TREATMENT OF HIV INFECTION, SUBSTANCE
p5914331
p6639071
p8592397, TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER/ TREATMENT OF HIV-1 INFECTION IN ADULTS, SUBSTANCE
p9018192, TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER/ TREATMENT OF HIV-1 INFECTION IN ADULTS
p5977089, TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER/ TREATMENT OF HIV-1 INFECTION IN ADULTS, SUBSTANCE
p6043230, TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER/ TREATMENT OF HIV-1 INFECTION IN ADULTS
p6642245, TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER/ TREATMENT OF HIV-1 INFECTION IN ADULTS
p8598185, SUBSTANCE
p5663169, TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER/ TREATMENT OF HIV-1 INFECTION IN ADULTS
p5935946, TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER/ TREATMENT OF HIV-1 INFECTION IN ADULTS, SUBSTANCE
NDA021937_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA021937_001RXEFAVIRENZ (600MG), TENOFOVIR DISOPROXIL FUMARATE (300MG), EMTRICITABINE (200MG)ORALTABLETTrue2006-07-12ATRIPLA

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5663169 (view patent)2014-09-02NDA021937, NDA020972, NDA021360efavirenz Oral Tablet
efavirenz Oral Capsule
2p5814639 (view patent)2015-09-29NDA021937, NDA021500, NDA021752, NDA021896, NDA202123, NDA203100emtricitabine Oral Solution
emtricitabine / tenofovir disoproxil Oral Tablet
cobicistat / elvitegravir / emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine / Rilpivirine / tenofovir disoproxil Oral Tablet
emtricitabine Oral Capsule
3p5914331 (view patent)2017-07-02NDA021937, NDA021500, NDA021752, NDA021896, NDA202123, NDA203100emtricitabine Oral Solution
emtricitabine / tenofovir disoproxil Oral Tablet
cobicistat / elvitegravir / emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine / Rilpivirine / tenofovir disoproxil Oral Tablet
emtricitabine Oral Capsule
4p5922695 (view patent)2017-07-25NDA021937, NDA021356, NDA021752, NDA022577, NDA202123, NDA203100tenofovir disoproxil Oral Powder
emtricitabine / tenofovir disoproxil Oral Tablet
cobicistat / elvitegravir / emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine / Rilpivirine / tenofovir disoproxil Oral Tablet
tenofovir disoproxil Oral Tablet
5p5935946 (view patent)2017-07-25NDA021937, NDA021356, NDA021752, NDA022577, NDA202123, NDA203100tenofovir disoproxil Oral Powder
emtricitabine / tenofovir disoproxil Oral Tablet
cobicistat / elvitegravir / emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine / Rilpivirine / tenofovir disoproxil Oral Tablet
tenofovir disoproxil Oral Tablet
6p5977089 (view patent)2017-07-25NDA021937, NDA021356, NDA021752, NDA022577, NDA202123, NDA203100tenofovir disoproxil Oral Powder
emtricitabine / tenofovir disoproxil Oral Tablet
cobicistat / elvitegravir / emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine / Rilpivirine / tenofovir disoproxil Oral Tablet
tenofovir disoproxil Oral Tablet
7p6043230 (view patent)2017-07-25NDA021937, NDA021356, NDA021752, NDA022577, NDA202123, NDA203100tenofovir disoproxil Oral Powder
emtricitabine / tenofovir disoproxil Oral Tablet
cobicistat / elvitegravir / emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine / Rilpivirine / tenofovir disoproxil Oral Tablet
tenofovir disoproxil Oral Tablet
8p6639071 (view patent)2018-02-14NDA021937, NDA020972, NDA021360efavirenz Oral Tablet
efavirenz Oral Capsule
9p6642245 (view patent)2020-11-04NDA021937, NDA021500, NDA021752, NDA021896, NDA202123, NDA203100emtricitabine Oral Solution
emtricitabine / tenofovir disoproxil Oral Tablet
cobicistat / elvitegravir / emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine / Rilpivirine / tenofovir disoproxil Oral Tablet
emtricitabine Oral Capsule
10p6703396 (view patent)2021-03-09NDA021937, NDA021500, NDA021752, NDA021896, NDA202123, NDA203100emtricitabine Oral Solution
emtricitabine / tenofovir disoproxil Oral Tablet
cobicistat / elvitegravir / emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine / Rilpivirine / tenofovir disoproxil Oral Tablet
emtricitabine Oral Capsule
11p6939964 (view patent)2018-01-20NDA021937, NDA020972, NDA021360efavirenz Oral Tablet
efavirenz Oral Capsule
12p8592397 (view patent)2024-01-13NDA021937, NDA021752, NDA202123, NDA203100emtricitabine / tenofovir disoproxil Oral Tablet
cobicistat / elvitegravir / emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine / Rilpivirine / tenofovir disoproxil Oral Tablet
13p8598185 (view patent)2028-05-01NDA021937
14p8716264 (view patent)2024-01-13NDA021937, NDA021752, NDA202123, NDA203100emtricitabine / tenofovir disoproxil Oral Tablet
cobicistat / elvitegravir / emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine / Rilpivirine / tenofovir disoproxil Oral Tablet
15p9018192 (view patent)2026-06-13NDA021937

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1076da359-b3d0-44f7-8c0e-662f5b7a8668 (view SPL)These highlights do not include all the information needed to use ATRIPLA safely and effectively. See full prescribing information for ATRIPLA. ATRIPLA (efavirenz/emtricitabine/tenofovir disoproxil fumarate) tablets Initial U.S. Approval: 2006prescriptionHuman Prescription with HighlightsState Of Florida Doh Central Pharmacyrepack2010-03-122538080208
22096a07e-8601-4bdc-ba5a-338a40cd02e9 (view SPL)These highlights do not include all the information needed to use ATRIPLA safely and effectively. See full prescribing information for ATRIPLA. ATRIPLA (efavirenz/emtricitabine/tenofovir disoproxil fumarate) tablets, for oral use Initial U.S. Approval: 2006prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2013-05-033548685643
32e97aa6d-09f7-46df-9499-63db7e9bac35 (view SPL)These highlights do not include all the information needed to use ATRIPLA safely and effectively. See full prescribing information for ATRIPLA. ATRIPLA (efavirenz/emtricitabine/tenofovir disoproxil fumarate) tablets, for oral use Initial U.S. Approval: 2006prescriptionHuman PrescriptionBristol Myers Squibb & Gilead Sciences, Llc2015-01-3017155840101
45c6c7ba4-6d42-4e07-a127-b3cf72c866ad (view SPL)These highlights do not include all the information needed to use ATRIPLA safely and effectively. See full prescribing information for ATRIPLA. ATRIPLA (efavirenz/emtricitabine/tenofovir disoproxil fumarate) tablets Initial U.S. Approval: 2006prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel2012-11-131353560064
57af4b5e9-f5bb-410c-8370-f74e04e7683b (view SPL)These highlights do not include all the information needed to use ATRIPLA safely and effectively. See full prescribing information for ATRIPLA. ATRIPLA (efavirenz/emtricitabine/tenofovir disoproxil fumarate) Tablets, for oral use GILEAD ACCESS PROGRAM Initial U.S. Approval: 2006prescriptionHuman PrescriptionGilead Sciences, Inc.2014-09-301619581601

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