FDA — authorised 11 August 2022
- Application: ANDA213692
- Marketing authorisation holder: TEVA PHARMS USA INC
- Local brand name: BREXPIPRAZOLE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 OPC-34712 in United States
FDA authorised OPC-34712 on 11 August 2022 · 10 US adverse-event reports
Marketing authorisations
FDA — authorised 26 September 2022
- Application: ANDA213570
- Marketing authorisation holder: SANDOZ
- Local brand name: BREXPIPRAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 January 2023
- Application: ANDA213660
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: BREXPIPRAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 January 2023
- Application: ANDA213562
- Marketing authorisation holder: AMNEAL
- Local brand name: BREXPIPRAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 February 2023
- Application: ANDA213718
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: BREXPIPRAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 March 2023
- Application: ANDA213512
- Marketing authorisation holder: LUPIN
- Local brand name: BREXPIPRAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 October 2023
- Application: ANDA213758
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: BREXPIPRAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 November 2023
- Application: ANDA213659
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: BREXPIPRAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 November 2023
- Application: ANDA213669
- Marketing authorisation holder: HETERO LABS LTD V
- Local brand name: BREXPIPRAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 November 2023
- Application: ANDA213782
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: BREXPIPRAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 January 2025
- Application: ANDA213683
- Marketing authorisation holder: ALEMBIC
- Local brand name: BREXPIPRAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 February 2025
- Application: ANDA213731
- Marketing authorisation holder: APOTEX
- Local brand name: BREXPIPRAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA213587
- Marketing authorisation holder: PRINSTON PHARMA INC
- Local brand name: BREXPIPRAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA213477
- Marketing authorisation holder: ZENARA
- Local brand name: BREXPIPRAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA213740
- Marketing authorisation holder: MSN PHARMS INC
- Local brand name: BREXPIPRAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA213788
- Marketing authorisation holder: ACCORD HLTHCARE INC
- Local brand name: BREXPIPRAZOLE
- 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: 23 April 2025 – 23 April 2026
- Total reports: 10
Most-reported reactions
- Arthralgia — 1 report (10%)
- Bone Pain — 1 report (10%)
- Bronchitis — 1 report (10%)
- Chest Pain — 1 report (10%)
- Conjunctivitis — 1 report (10%)
- Deposit Eye — 1 report (10%)
- Dysphagia — 1 report (10%)
- Eye Pruritus — 1 report (10%)
- Gastric Ulcer Haemorrhage — 1 report (10%)
- General Physical Health Deterioration — 1 report (10%)
OPC-34712 in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Psychiatry/Neurology approved in United States
Frequently asked questions
Is OPC-34712 approved in United States?
Yes. FDA authorised it on 11 August 2022; FDA authorised it on 26 September 2022; FDA authorised it on 10 January 2023.
Who is the marketing authorisation holder for OPC-34712 in United States?
TEVA PHARMS USA INC holds the US marketing authorisation.