FDA — authorised 23 April 2018
- Application: NDA204441
- Marketing authorisation holder: OTSUKA
- Local brand name: JYNARQUE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 OPC-41061 in United States
FDA authorised OPC-41061 on 23 April 2018
Marketing authorisations
FDA — authorised 19 May 2020
- Application: ANDA211891
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: TOLVAPTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 May 2020
- Application: ANDA207605
- Marketing authorisation holder: APOTEX
- Local brand name: TOLVAPTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 July 2021
- Application: ANDA205646
- Marketing authorisation holder: HETERO LABS LTD V
- Local brand name: TOLVAPTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 February 2022
- Application: ANDA206119
- Marketing authorisation holder: PH HEALTH
- Local brand name: TOLVAPTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 June 2023
- Application: ANDA216949
- Marketing authorisation holder: MSN
- Local brand name: TOLVAPTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 April 2025
- Application: ANDA216063
- Marketing authorisation holder: LUPIN
- Local brand name: TOLVAPTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 November 2025
- Application: ANDA218381
- Marketing authorisation holder: APOTEX
- Local brand name: TOLVAPTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 April 2026
- Application: ANDA220147
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: TOLVAPTAN
- Indication: TABLET — ORAL
- Status: approved
OPC-41061 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 OPC-41061 approved in United States?
Yes. FDA authorised it on 23 April 2018; FDA authorised it on 19 May 2020; FDA authorised it on 19 May 2020.
Who is the marketing authorisation holder for OPC-41061 in United States?
OTSUKA holds the US marketing authorisation.