US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|
| ONGENTYS | 25MG; 50MG | capsule · oral | AMNEAL | Prescription | 24 Apr 2020 |
EMA European Union — centrally authorised medicines
Ongentys Bial - Portela Cª, S.A. · Authorised · authorised 24 Jun 2016 · ATC N04
Therapeutic indication (EMA)
Ongentys is indicated as adjunctive therapy to preparations of levodopa/ DOPA decarboxylase inhibitors (DDCI) in adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.Ongentys is indicated as adjunctive therapy to preparations of levodopa/ DOPA decarboxylase inhibitors (DDCI) in adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.
Ontilyv Bial Portela & Companhia S.A. · Lapsed · authorised 21 Feb 2022 · ATC N04;N04BX04
Therapeutic indication (EMA)
Ontilyv is indicated as adjunctive therapy to preparations of levodopa/ DOPA decarboxylase inhibitors (DDCI) in adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|
| US NADAC | ONGENTYS 25 MG CAPSULE | $24.66795 | per EA | 5 Jan 2026 |
| US NADAC | ONGENTYS 50 MG CAPSULE | $24.76028 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Opicapone 50mg capsules | £59.00 | 30 capsule | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.