emtricitabine / Rilpivirine / tenofovir disoproxil Oral Tablet

Brand(s)
Complera
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Gilead Sciences, Inc. (2015-05-07)
Oldest Current Product
2011-08-10
License(s)
NDA, EXPORT ONLY
RxNORM
ORAL TABLET\EMTRICITABINE:RILPIVIRINE:TENOFOVIR DISOPROXIL
FDAOB
ORAL\TABLET\EMTRICITABINE: RILPIVIRINE HYDROCHLORIDE: TENOFOVIR DISOPROXIL FUMARATE
SPL Active
ORAL\TABLET, FILM COATED\EMTRICITABINE: RILPIVIRINE HYDROCHLORIDE: TENOFOVIR DISOPROXIL FUMARATE
SPL Moiety
ORAL\TABLET, FILM COATED\EMTRICITABINE: RILPIVIRINE: TENOFOVIR ANHYDROUS

product(s) by strength(s)

emtricitabine 200 mg / rilpivirine 25 mg / tenofovir disoproxil fumarate 300 mg oral tablet

export only product(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1619581102CompleraEXPORT ONLYGilead Sciences, Inc.2011-08-10EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, TENOFOVIR DISOPROXIL FUMARATEORALTABLET, FILM COATED9176bf31-c889-47bd-861c-f2d3fc37ab8d

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1619581101CompleraNDAGilead Sciences, Inc.2011-08-10EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, TENOFOVIR DISOPROXIL FUMARATEORALTABLET, FILM COATEDNDA202123d637cfab-f1e8-4eb3-a1b3-f85ca3bec612

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548686360CompleraNDAPhysicians Total Care, Inc.2013-02-01EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, TENOFOVIR DISOPROXIL FUMARATEORALTABLET, FILM COATED619581101NDA20212354c8bec2-d565-489c-8d7c-afd3cdf78df5

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA202123COMPLERAGILEAD SCIENCES INC2011-08-10p6703396, SUBSTANCE
p7067522, SUBSTANCE
p5922695, TREATMENT OF HIV INFECTION
p8841310, TREATMENT OF HIV INFECTION, SUBSTANCE
p8080551, SUBSTANCE
p5914331
p8592397, TREATMENT OF HIV INFECTION, SUBSTANCE
p5977089, TREATMENT OF HIV INFECTION, SUBSTANCE
p6043230, TREATMENT OF HIV INFECTION
p6642245, TREATMENT OF HIV INFECTION
p5814639, SUBSTANCE
p6838464, SUBSTANCE
p8101629, SUBSTANCE
p8716264, TREATMENT OF HIV INFECTION, SUBSTANCE
p5935946, TREATMENT OF HIV INFECTION, SUBSTANCE
p7125879, TREATMENT OF HIV INFECTION, SUBSTANCE
NEW PATIENT POPULATION [2016-12-13]
NEW CHEMICAL ENTITY [2016-05-20]
NDA202123_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA202123_001RXRILPIVIRINE HYDROCHLORIDE (EQ 25MG BASE), TENOFOVIR DISOPROXIL FUMARATE (300MG), EMTRICITABINE (200MG)ORALTABLETTrue2011-08-10COMPLERA

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5814639 (view patent)2015-09-29NDA202123, NDA021500, NDA021752, NDA021896, NDA021937, NDA203100efavirenz / emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine Oral Solution
emtricitabine / tenofovir disoproxil Oral Tablet
cobicistat / elvitegravir / emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine Oral Capsule
2p5914331 (view patent)2017-07-02NDA202123, NDA021500, NDA021752, NDA021896, NDA021937, NDA203100efavirenz / emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine Oral Solution
emtricitabine / tenofovir disoproxil Oral Tablet
cobicistat / elvitegravir / emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine Oral Capsule
3p5922695 (view patent)2017-07-25NDA202123, NDA021356, NDA021752, NDA021937, NDA022577, NDA203100efavirenz / emtricitabine / tenofovir disoproxil Oral Tablet
tenofovir disoproxil Oral Powder
emtricitabine / tenofovir disoproxil Oral Tablet
cobicistat / elvitegravir / emtricitabine / tenofovir disoproxil Oral Tablet
tenofovir disoproxil Oral Tablet
4p5935946 (view patent)2017-07-25NDA202123, NDA021356, NDA021752, NDA021937, NDA022577, NDA203100efavirenz / emtricitabine / tenofovir disoproxil Oral Tablet
tenofovir disoproxil Oral Powder
emtricitabine / tenofovir disoproxil Oral Tablet
cobicistat / elvitegravir / emtricitabine / tenofovir disoproxil Oral Tablet
tenofovir disoproxil Oral Tablet
5p5977089 (view patent)2017-07-25NDA202123, NDA021356, NDA021752, NDA021937, NDA022577, NDA203100efavirenz / emtricitabine / tenofovir disoproxil Oral Tablet
tenofovir disoproxil Oral Powder
emtricitabine / tenofovir disoproxil Oral Tablet
cobicistat / elvitegravir / emtricitabine / tenofovir disoproxil Oral Tablet
tenofovir disoproxil Oral Tablet
6p6043230 (view patent)2017-07-25NDA202123, NDA021356, NDA021752, NDA021937, NDA022577, NDA203100efavirenz / emtricitabine / tenofovir disoproxil Oral Tablet
tenofovir disoproxil Oral Powder
emtricitabine / tenofovir disoproxil Oral Tablet
cobicistat / elvitegravir / emtricitabine / tenofovir disoproxil Oral Tablet
tenofovir disoproxil Oral Tablet
7p6642245 (view patent)2020-11-04NDA202123, NDA021500, NDA021752, NDA021896, NDA021937, NDA203100efavirenz / emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine Oral Solution
emtricitabine / tenofovir disoproxil Oral Tablet
cobicistat / elvitegravir / emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine Oral Capsule
8p6703396 (view patent)2021-03-09NDA202123, NDA021500, NDA021752, NDA021896, NDA021937, NDA203100efavirenz / emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine Oral Solution
emtricitabine / tenofovir disoproxil Oral Tablet
cobicistat / elvitegravir / emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine Oral Capsule
9p6838464 (view patent)2021-02-26NDA202123, NDA202022Rilpivirine Oral Tablet
10p7067522 (view patent)2019-12-20NDA202123, NDA202022Rilpivirine Oral Tablet
11p7125879 (view patent)2022-08-09NDA202123, NDA202022Rilpivirine Oral Tablet
12p8080551 (view patent)2023-04-11NDA202123, NDA202022Rilpivirine Oral Tablet
13p8101629 (view patent)2022-08-09NDA202123, NDA202022Rilpivirine Oral Tablet
14p8592397 (view patent)2024-01-13NDA202123, NDA021752, NDA021937, NDA203100efavirenz / emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine / tenofovir disoproxil Oral Tablet
cobicistat / elvitegravir / emtricitabine / tenofovir disoproxil Oral Tablet
15p8716264 (view patent)2024-01-13NDA202123, NDA021752, NDA021937, NDA203100efavirenz / emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine / tenofovir disoproxil Oral Tablet
cobicistat / elvitegravir / emtricitabine / tenofovir disoproxil Oral Tablet
16p8841310 (view patent)2025-12-09NDA202123

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
154c8bec2-d565-489c-8d7c-afd3cdf78df5 (view SPL)These highlights do not include all the information needed to use COMPLERA safely and effectively. See full prescribing information for COMPLERA. COMPLERA (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) tablets, for oral use Initial U.S. Approval: 2011prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2013-03-151548686360
29176bf31-c889-47bd-861c-f2d3fc37ab8d (view SPL)These highlights do not include all the information needed to use COMPLERA safely and effectively. See full prescribing information for COMPLERA. COMPLERA (emtricitabine, rilpivirine, tenofovir disoproxil fumarate) tablets, for oral use GILEAD ACCESS PROGRAMInitial U.S. Approval: 2011prescriptionHuman PrescriptionGilead Sciences, Inc.2014-10-011619581102
3d637cfab-f1e8-4eb3-a1b3-f85ca3bec612 (view SPL)These highlights do not include all the information needed to use COMPLERA safely and effectively. See full prescribing information for COMPLERA. COMPLERA (emtricitabine, rilpivirine, tenofovir disoproxil fumarate) tablets, for oral use Initial U.S. Approval: 2011prescriptionHuman PrescriptionGilead Sciences, Inc.2015-05-0711619581101

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