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Kaletra (LOPINAVIR)
Kaletra blocks the protease enzyme, preventing the HIV virus from replicating.
Kaletra, a protease inhibitor developed by AbbVie Deutschland GmbH Co. KG, is a marketed drug primarily indicated for the treatment of HIV-1 infection. Its key strength lies in its mechanism of action, which effectively blocks the protease enzyme to prevent HIV replication, setting it apart in a competitive landscape dominated by off-patent generics such as lamivudine, zidovudine, abacavir, emtricitabine, and tenofovir disoproxil. The primary risk to Kaletra's market position is the key composition patent expiry in 2028, which could lead to increased competition from generic versions.
At a glance
| Generic name | LOPINAVIR |
|---|---|
| Sponsor | Abbvie Deutschland Gmbh Co. Kg |
| Drug class | Cytochrome P450 3A Inhibitor [EPC] |
| Target | ATP-binding cassette sub-family G member 2 |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 2000 |
Mechanism of action
KALETRA is fixed-dose combination of HIV-1 antiviral drugs lopinavir [see Microbiology 12.4 )] and ritonavir. As co-formulated in KALETRA, ritonavir inhibits the CYP3A-mediated metabolism of lopinavir, thereby providing increased plasma levels of lopinavir.
Approved indications
- HIV-1 Infection Treatment
Common side effects
- Diarrhea
- Nausea
- Vomiting
- Abdominal pain (upper and lower)
- Gastroenteritis and colitis
- Dyspepsia
- Pancreatitis
- Gastroesophageal Reflux Disease (GERD)
- Hemorrhoids
- Flatulence
- Abdominal distension
- Constipation
Drug interactions
- CYP3A substrates
- OATP1B1 substrates
- CYP3A inducers
- CYP3A inhibitors
- fosamprenavir/ritonavir
- indinavir
Key clinical trials
- A Trial of 2 Options for Second Line Combination Antiretroviral Therapy Following Virological Failure of a Standard Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI)+2N(t)RTI First Line Regimen (PHASE4)
- Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV (PHASE2,PHASE3)
- A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments (PHASE4)
- Early Infant HIV Treatment in Botswana (PHASE2,PHASE3)
- Lopinavir/Ritonavir in PLWH With High-Grade AIN (PHASE1)
- Trial to Evaluate the Interest of a Reductive Anti Retroviral Strategy Using Dual Therapy Inspite of Triple Therapy (PHASE3)
- Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy
- A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors (PHASE1,PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Kaletra CI brief — competitive landscape report
- Kaletra updates RSS · CI watch RSS
- Abbvie Deutschland Gmbh Co. Kg portfolio CI