NDAORALTABLETPriority Review
Approved
Oct 2005
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
KALETRA (lopinavir and ritonavir) by AbbVie is hiv protease inhibitors [moa]. First approved in 2005.
Drug data last refreshed 13h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
KALETRA is a fixed-dose combination of lopinavir and ritonavir, two HIV protease inhibitors that work synergistically to block viral replication. It is indicated for treatment of HIV-1 infection in combination with other antiretroviral agents. The drug has been a cornerstone of HIV therapy since its approval in 2005, particularly in resource-limited settings.
$0.5MPart D
LOE ApproachingDeclining
Mature product with minimal team expansion; commercial roles increasingly focused on specialty/emerging markets and lifecycle management.
Mechanism of Action
HIV Protease Inhibitors
Pharmacologic Class:
Protease Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study to Assess Effectiveness and Safety of Fixed Dose Combination of Lopinavir/Ritonavir (LPV/r) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Patients After Switching From Kaletra in the Routine Clinical Settings of Russian Federation
Started Nov 2019
239 enrolled
HIV-1 Infection
Real-life Effectiveness of the Kaletra Adherence Support Assistance (KASA) Program
Started Jun 2012
173 enrolled
Human Immunodeficiency Virus Infection
Treatment Perception of QD (Once a Day) Dosed Kaletra (Tablets)
Started Jun 2011
97 enrolled
Human Immunodeficiency Virus Infection
Drug Use Investigation of Kaletra Tablets (Once Daily Administration) on Patients With HIV-infection
Started Jun 2011
236 enrolled
Human Immunodeficiency Virus Infection
Kaletra and Maraviroc in Antiretroviral Therapy (ART)-Naive Patients (KALMAR Study)
Started Apr 2010
1 enrolled
HIV Infections
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.