lopinavir / Ritonavir Oral Solution

Brand(s)
Kaletra
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Abbvie Inc. (2015-11-10)
Oldest Current Product
2010-06-18
License(s)
NDA
RxNORM
ORAL SOLUTION\LOPINAVIR:RITONAVIR
FDAOB
ORAL\SOLUTION\LOPINAVIR: RITONAVIR
SPL Active
ORAL\SOLUTION\LOPINAVIR: RITONAVIR
SPL Moiety
ORAL\SOLUTION\LOPINAVIR: RITONAVIR

product(s) by strength(s)

lopinavir 80 mg/ml / ritonavir 20 mg/ml oral solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000743956KaletraNDAAbbvie Inc.2010-06-18LOPINAVIR, RITONAVIRORALSOLUTIONNDA0212518290add3-4449-4e58-6c97-8fe1eec972e3

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA021251KALETRAABBVIE INC2000-09-15p6703403, TREATMENT OF HIV INFECTION IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS/ TREATMENT OF HIV INFECTION
p6911214, TREATMENT OF HIV INFECTION IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS, SUBSTANCE
p5914332, TREATMENT OF HIV INFECTION IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS/ INHIBITING PROTEASE WITH LOPINAVIR AND INHIBITING AN HIV INFECTION WITH LOPINAVIIR, SUBSTANCE
p6037157, TREATMENT OF HIV INFECTION IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS/ METHOD FOR INHIBITING CYTOCHROME P450 MONOOXYGENASE WITH RITONAVIR AND A METHOD FOR IMPROVING THE PHARMCOKINETICS OF A DRUG THAT IS MTABOLIZED BY CYTOCHROME P450 MONOOXYGENASE BY ADMIN THE DRUG AND RITONAVIR
p5648497
p8501219, SUBSTANCE
p6284767, TREATMENT OF HIV INFECTION IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS/ USE OF LOPINAVIR IN COMBINATION WITH REVERSE TRANSCRIPTASE INHIBITORS FOR TREATING HIV INFECTION AND IN COMBO WITH OTHER HIV PROTEASE INHIBITORS, SUBSTANCE
NDA021251_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA021251_001RXRITONAVIR (20MG/ML), LOPINAVIR (80MG/ML)ORALSOLUTIONTrue2000-09-15KALETRA

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5648497 (view patent)2014-07-15NDA021251, NDA020659, NDA020680, NDA020945, NDA021226, NDA021906, NDA022417lopinavir / Ritonavir Oral Tablet
Ritonavir Oral Tablet
Ritonavir Oral Capsule
Ritonavir Oral Solution
2p5914332 (view patent)2015-12-13NDA021251, NDA021226, NDA021906lopinavir / Ritonavir Oral Tablet
3p6037157 (view patent)2016-06-26NDA021251, NDA020659, NDA020945, NDA021226, NDA021906, NDA021976, NDA022417, NDA202895, NDA206619, NDA207931darunavir Oral Suspension
ombitasvir / paritaprevir / Ritonavir Oral Tablet
darunavir Oral Tablet
lopinavir / Ritonavir Oral Tablet
Ritonavir Oral Tablet
Ritonavir Oral Capsule
Ritonavir Oral Solution
4p6284767 (view patent)2016-02-15NDA021251, NDA021226, NDA021906lopinavir / Ritonavir Oral Tablet
5p6703403 (view patent)2016-06-26NDA021251, NDA020659, NDA020945, NDA021226, NDA021906, NDA021976, NDA022417, NDA202895, NDA206619, NDA207931darunavir Oral Suspension
ombitasvir / paritaprevir / Ritonavir Oral Tablet
darunavir Oral Tablet
lopinavir / Ritonavir Oral Tablet
Ritonavir Oral Tablet
Ritonavir Oral Capsule
Ritonavir Oral Solution
6p6911214 (view patent)2021-11-28NDA021251
7p8501219 (view patent)2021-11-28NDA021251

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)in other drug docs
18290add3-4449-4e58-6c97-8fe1eec972e3 (view SPL)These highlights do not include all the information needed to use KALETRA safely and effectively. See full prescribing information for KALETRA. KALETRA (lopinavir and ritonavir) tablet, for oral use KALETRA (lopinavir and ritonavir) oral solutionInitial U.S. Approval: 2000prescriptionHuman PrescriptionAbbvie Inc.2015-11-101567000743956, 000740522, 000746799lopinavir / Ritonavir Oral Tablet

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