Cenobamate
As of the edition of 20 October 2026, Cenobamate is a small molecule: marketed, first approved in 2020 (US); acts on SCN10A, SCN11A and SCN1A and 7 more; US protection ends in 2032.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2026
- Kind
- Small molecule
- Brand name
- Xcopri
- First approved
- 10 March 2020 (US)
- Approvals on record
- 9 in 3 regions
- Holder of the most recent approval
- Eurofarma Laboratorios; 3 holders in all
- Registered trials
- 20, 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 SK Life Science.
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.
Targets
| Gene | Protein | UniProt |
|---|---|---|
| SCN1A | Sodium channel protein type 1 subunit alpha | P35498 |
| SCN4A | Sodium channel protein type 4 subunit alpha | P35499 |
| SCN7A | Sodium channel protein type 7 subunit alpha | Q01118 |
| SCN5A | Sodium channel protein type 5 subunit alpha | Q14524 |
| SCN9A | Sodium channel protein type 9 subunit alpha | Q15858 |
| SCN2A | Sodium channel protein type 2 subunit alpha | Q99250 |
| SCN3A | Sodium channel protein type 3 subunit alpha | Q9NY46 |
| SCN11A | Sodium channel protein type 11 subunit alpha | Q9UI33 |
| SCN8A | Sodium channel protein type 8 subunit alpha | Q9UQD0 |
| SCN10A | Sodium channel protein type 10 subunit alpha | Q9Y5Y9 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 0 | 1 | 0 |
| Phase 1 | 7 | 6 | 1 | 0 |
| Phase 2 | 4 | 3 | 1 | 0 |
| Phase 3 | 6 | 4 | 2 | 0 |
| Phase 4 | 1 | 0 | 1 | 0 |
| All trials | 20 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| SK Life Science | Originator and Lead sponsor of trials | 2020 to now |
| Angelini Pharma | Applicant | 2021 to now |
| Eurofarma Laboratorios | Applicant | 2026 to now |