FDA — authorised 7 April 2020
- Application: ANDA090471
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: LOPINAVIR; RITONAVIR
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Lopinavir / Ritonavir in United States
FDA authorised Lopinavir / Ritonavir on 7 April 2020 · 5,535 US adverse-event reports
Marketing authorisations
FDA
- Application: ANDA091203
- Marketing authorisation holder: CIPLA LIMITED
- Local brand name: LOPINAVIR; RITONAVIR
- Indication: SOLUTION — ORAL
- Status: approved
FDA
- Application: ANDA091202
- Marketing authorisation holder: MYLAN PHARMA
- Local brand name: LOPINAVIR; RITONAVIR
- Indication: TABLET — ORAL
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 22 April 2025 – 22 April 2026
- Total reports: 5,535
Most-reported reactions
- Off Label Use — 2,129 reports (38.46%)
- Drug Interaction — 967 reports (17.47%)
- Foetal Exposure During Pregnancy — 544 reports (9.83%)
- Virologic Failure — 373 reports (6.74%)
- Product Use In Unapproved Indication — 297 reports (5.37%)
- Pathogen Resistance — 252 reports (4.55%)
- Maternal Exposure During Pregnancy — 248 reports (4.48%)
- Depression — 245 reports (4.43%)
- Diarrhoea — 242 reports (4.37%)
- Electrocardiogram Qt Prolonged — 238 reports (4.3%)
Other Infectious Disease approved in United States
Frequently asked questions
Is Lopinavir / Ritonavir approved in United States?
Yes. FDA authorised it on 7 April 2020; FDA has authorised it; FDA has authorised it.
Who is the marketing authorisation holder for Lopinavir / Ritonavir in United States?
AUROBINDO PHARMA LTD holds the US marketing authorisation.