NDAORALCAPSULEPriority Review
Approved
Sep 2000
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
2/8 — Basic
Priority Review
Drug data last refreshed 21h 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 protease inhibitors used to treat HIV-1 infection. Ritonavir acts as a pharmacokinetic booster, enhancing lopinavir levels and efficacy. The combination is administered orally as a capsule and has been a cornerstone therapy in HIV treatment regimens since approval in 2000.
LOE Approaching
As a mature product approaching loss of exclusivity with moderate competitive pressure (30), the brand team is likely focused on lifecycle extension and defending market share against generic and newer competitors.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
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.