FDA — authorised 7 October 2019
- Application: NDA209819
- Marketing authorisation holder: INDIVIOR
- Indication: Labeling
- Status: approved
🇺🇸 Subutex in United States
FDA authorised Subutex on 7 October 2019
Marketing authorisations
FDA — authorised 4 March 2021
- Application: ANDA090279
- Marketing authorisation holder: RUBICON RESEARCH
- Indication: Labeling
- Status: approved
FDA — authorised 17 May 2022
- Application: ANDA207490
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: BUPRENORPHINE
- Indication: FILM, EXTENDED RELEASE — TRANSDERMAL
- Status: approved
FDA — authorised 12 June 2024
- Application: ANDA207607
- Marketing authorisation holder: MYLAN TECHNOLOGIES
- Indication: Labeling
- Status: approved
Mylan Technologies obtained marketing authorization for Subutex from the FDA on June 12, 2024. This approval was granted under the standard expedited pathway. Subutex is indicated for use in labeling.
FDA — authorised 29 August 2025
- Application: NDA210136
- Marketing authorisation holder: BRAEBURN
- Indication: REMS
- Status: approved
The FDA approved Subutex (buprenorphine) for use under a Risk Evaluation and Mitigation Strategy (REMS) on 29 August 2025. This approval was granted to BRAEBURN, the marketing authorisation holder, following a standard expedited pathway. Subutex is a medication used to treat opioid use disorder.
FDA — authorised 10 December 2025
- Application: ANDA218473
- Marketing authorisation holder: SPECGX LLC
- Status: approved
Subutex in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Subutex approved in United States?
Yes. FDA authorised it on 7 October 2019; FDA authorised it on 4 March 2021; FDA authorised it on 17 May 2022.
Who is the marketing authorisation holder for Subutex in United States?
INDIVIOR holds the US marketing authorisation.