FDA — authorised 27 December 2016
- Application: ANDA207407
- Marketing authorisation holder: LANNETT CO INC
- Local brand name: LOPINAVIR AND RITONAVIR
- Indication: SOLUTION — ORAL
- Status: approved
🇺🇸 Lopinavir and ritonavir in United States
FDA authorised Lopinavir and ritonavir on 27 December 2016
Marketing authorisations
FDA — authorised 4 June 2021
- Application: ANDA091677
- Marketing authorisation holder: HETERO LABS LTD III
- Local brand name: LOPINAVIR AND RITONAVIR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 March 2022
- Application: ANDA213857
- Marketing authorisation holder: LAURUS
- Status: approved
FDA — authorised 25 July 2024
- Application: ANDA204739
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: LOPINAVIR AND RITONAVIR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 December 2025
- Application: ANDA214696
- Marketing authorisation holder: MICRO LABS
- Local brand name: LOPINAVIR AND RITONAVIR
- Indication: TABLET — ORAL
- Status: approved
The FDA approved Micro Labs' application (ANDA214696) for Lopinavir and ritonavir tablets on 11 December 2025. This approval allows Micro Labs to market Lopinavir and ritonavir under the brand name LOPINAVIR AND RITONAVIR in the United States. The indication approved is for oral administration.
FDA
- Status: approved
Lopinavir and ritonavir in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Lopinavir and ritonavir approved in United States?
Yes. FDA authorised it on 27 December 2016; FDA authorised it on 4 June 2021; FDA authorised it on 21 March 2022.
Who is the marketing authorisation holder for Lopinavir and ritonavir in United States?
LANNETT CO INC holds the US marketing authorisation.