elvitegravir Oral Tablet

Brand(s)
Vitekta
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Gilead Sciences, Inc. (2015-07-31)
Oldest Current Product
2014-09-24
License(s)
NDA
RxNORM
ORAL TABLET\ELVITEGRAVIR
FDAOB
ORAL\TABLET\ELVITEGRAVIR
SPL Active
ORAL\TABLET, FILM COATED\ELVITEGRAVIR
SPL Moiety
ORAL\TABLET, FILM COATED\ELVITEGRAVIR

product(s) by strength(s)

elvitegravir 150 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1619581302VitektaNDAGilead Sciences, Inc.2014-09-24ELVITEGRAVIRORALTABLET, FILM COATEDNDA203093be87c3bc-97bb-49cb-8053-9b0c756a1965

elvitegravir 85 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1619581301VitektaNDAGilead Sciences, Inc.2014-09-24ELVITEGRAVIRORALTABLET, FILM COATEDNDA203093be87c3bc-97bb-49cb-8053-9b0c756a1965

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA203093VITEKTAGILEAD SCIENCES INC2014-09-24p7635704, TREATMENT OF HIV INFECTION, SUBSTANCE
p7176220, TREATMENT OF HIV INFECTION, SUBSTANCE
p8981103, SUBSTANCE
NEW PRODUCT [2017-09-24]NDA203093_001, NDA203093_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA203093_001RXELVITEGRAVIR (85MG)ORALTABLETFalse2014-09-24VITEKTA
2NDA203093_002RXELVITEGRAVIR (150MG)ORALTABLETTrue2014-09-24VITEKTA

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p7176220 (view patent)2023-11-20NDA203093, NDA203100cobicistat / elvitegravir / emtricitabine / tenofovir disoproxil Oral Tablet
2p7635704 (view patent)2026-10-26NDA203093, NDA203100cobicistat / elvitegravir / emtricitabine / tenofovir disoproxil Oral Tablet
3p8981103 (view patent)2026-10-26NDA203093, NDA203100cobicistat / elvitegravir / emtricitabine / tenofovir disoproxil Oral Tablet

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1be87c3bc-97bb-49cb-8053-9b0c756a1965 (view SPL)These highlights do not include all the information needed to use VITEKTA safely and effectively. See full prescribing information for VITEKTA. VITEKTA (elvitegravir) tablets, for oral use Initial U.S. Approval: 2012prescriptionHuman PrescriptionGilead Sciences, Inc.2015-07-312619581301, 619581302

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