abacavir / dolutegravir / Lamivudine Oral Tablet

Brand(s)
Triumeq
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Viiv Healthcare Company (2015-09-28)
Oldest Current Product
2014-08-22
License(s)
NDA
RxNORM
ORAL TABLET\ABACAVIR:DOLUTEGRAVIR:LAMIVUDINE
FDAOB
ORAL\TABLET\ABACAVIR SULFATE: DOLUTEGRAVIR SODIUM: LAMIVUDINE
SPL Active
ORAL\TABLET, FILM COATED\ABACAVIR SULFATE: DOLUTEGRAVIR SODIUM: LAMIVUDINE
SPL Moiety
ORAL\TABLET, FILM COATED\ABACAVIR: DOLUTEGRAVIR: LAMIVUDINE

product(s) by strength(s)

abacavir 600 mg / dolutegravir 50 mg / lamivudine 300 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1497020231TriumeqNDAViiv Healthcare Company2014-08-22ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINEORALTABLET, FILM COATEDNDA2055512997739a-aa91-42aa-a206-a70e2db7b84f

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA205551TRIUMEQVIIV HEALTHCARE CO2014-08-22p6294540, TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION., SUBSTANCE
p8129385, SUBSTANCE
p6417191, TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION., SUBSTANCE
p5905082, SUBSTANCE
NEW CHEMICAL ENTITY [2018-08-12]NDA205551_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA205551_001RXABACAVIR SULFATE (EQ 600MG BASE), LAMIVUDINE (300MG), DOLUTEGRAVIR SODIUM (EQ 50MG BASE)ORALTABLETTrue2014-08-22TRIUMEQ

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5905082 (view patent)2016-05-18NDA205551, NDA020564, NDA020596, NDA020857, NDA021003, NDA021205, NDA021652abacavir / Lamivudine Oral Tablet
abacavir / Lamivudine / Zidovudine Oral Tablet
Lamivudine Oral Tablet
Lamivudine / Zidovudine Oral Tablet
Lamivudine Oral Solution
2p6294540 (view patent)2018-05-14NDA205551, NDA020977, NDA020978, NDA021205, NDA021652abacavir / Lamivudine Oral Tablet
abacavir / Lamivudine / Zidovudine Oral Tablet
abacavir Oral Solution
abacavir Oral Tablet
3p6417191 (view patent)2016-03-28NDA205551, NDA021205, NDA021652abacavir / Lamivudine Oral Tablet
abacavir / Lamivudine / Zidovudine Oral Tablet
4p8129385 (view patent)2027-10-05NDA205551, NDA204790dolutegravir Oral Tablet

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
12997739a-aa91-42aa-a206-a70e2db7b84f (view SPL)These highlights do not include all the information needed to use TRIUMEQ safely and effectively. See full prescribing information for TRIUMEQ.TRIUMEQ (abacavir, dolutegravir, and lamivudine) tablets for oral useInitial U.S. Approval: 2014prescriptionHuman PrescriptionViiv Healthcare Company2015-09-285497020231

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