FDA — authorised 31 May 2018
- Application: NDA207924
- Marketing authorisation holder: ELI LILLY AND CO
- Local brand name: OLUMIANT
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Baricitinib 4 MG in United States
FDA authorised Baricitinib 4 MG on 31 May 2018
Marketing authorisations
FDA — authorised 22 July 2024
- Application: ANDA217542
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: BARICITINIB
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 August 2025
- Application: ANDA217585
- Marketing authorisation holder: MSN
- Local brand name: OLUMIANT
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
Baricitinib 4 MG 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 Baricitinib 4 MG approved in United States?
Yes. FDA authorised it on 31 May 2018; FDA authorised it on 22 July 2024; FDA authorised it on 8 August 2025.
Who is the marketing authorisation holder for Baricitinib 4 MG in United States?
ELI LILLY AND CO holds the US marketing authorisation.