Opicapone
As of the edition of 20 October 2026, Opicapone is a small molecule: marketed, first approved in 2016 (EU); acts on COMT; US protection ends in 2032.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2020
- Kind
- Small molecule
- Brand name
- Ongentys
- First approved
- 24 June 2016 (EU)
- Approvals on record
- 5 in 3 regions
- Holder of the most recent approval
- Ono Pharmaceutical; 3 holders in all
- Withdrawn from market
- 21 February 2025 (in some regions)
- Registered trials
- 46, 0 stopped early
- Disease areas
- Nervous system
US protection
US protection ends in 2032.
The last listed US drug-substance patent ends in 2032. The application that gives this date is held by Amneal Pharmaceuticals.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product6 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 6 listings behind itRequest access. Nothing is shown until you do.
Companies that need a new molecule because of this drug
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Opicapone.
See the 2 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| COMT | Catechol O-methyltransferase | P21964 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 3 | 2 | 1 | 0 |
| Phase 1 | 32 | 32 | 0 | 0 |
| Phase 2 | 2 | 2 | 0 | 0 |
| Phase 3 | 4 | 4 | 0 | 0 |
| Phase 4 | 5 | 5 | 0 | 0 |
| All trials | 46 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bial | Applicant and Lead sponsor of trials | 2007 to now |
| Neurocrine | Applicant and Lead sponsor of trials | 2018 to now |
| Ono Pharmaceutical | Applicant | 2020 to now |
| Amneal Pharmaceuticals | Acquired holder | 2024 to now |