Wednesday, July 8, 2026

Drug profile · INN

lopinavir

lopinavir (KALETRA) is a human immunodeficiency virus type 1 protease inhibitor. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved Antiinfectives for systemic use (J05) J05AR10
US status approved
Patents linked 0
Pipeline programs 2
News articles 0
Drug details — lopinavir
US status
approved
Class
Antiinfectives for systemic use (J05)
Route
ORAL
Patents
0
Programs
2
Data quality
0.84

Quick answer

lopinavir (KALETRA) is a human immunodeficiency virus type 1 protease inhibitor. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN lopinavir
Brand KALETRA
Mechanism Human immunodeficiency virus type 1 protease inhibitor
Target Human immunodeficiency virus type 1 protease
Therapeutic class Antiinfectives for systemic use (J05)
Route ORAL
Formulation CAPSULE
ATC code J05AR10

Mechanism of action

Human immunodeficiency virus type 1 protease inhibitor

Primary target: Human immunodeficiency virus type 1 protease

Approval history

Authority Status Date
FDA approved
EMA approved

Pipeline programs

  1. Tenofovir/lamivudine/lopinavir-ritonavir Phase 2 · Chinese Academy of · HIV
  2. Lopinavir/Ritonavir 200 mg/50 mg Film Tablet Phase 1 · BRIGHT MINDS BIOSCIENCES · Bioequivalence

Related & competitor drugs

  1. atazanavir sulfate Antiinfectives for systemic use (J05)
  2. colistimethate sodium Antiinfectives for systemic use (J01)
  3. covid-19 mrna vaccine Antiinfectives for systemic use (J07)
  4. daptomycin Antiinfectives for systemic use (J01)
  5. darunavir Antiinfectives for systemic use (J05)
  6. dengue tetravalent vaccine (live, attenuated) Antiinfectives for systemic use (J07)

Frequently asked questions

What is lopinavir?

lopinavir (KALETRA) is a human immunodeficiency virus type 1 protease inhibitor. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for lopinavir?

KALETRA is a marketed brand name for lopinavir. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of lopinavir?

lopinavir has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.