Eslicarbazepine acetate
As of the edition of 20 October 2026, Eslicarbazepine acetate is a small molecule: marketed, first approved in 2009 (EU); acts on SCN10A, SCN11A and SCN1A and 7 more; US protection ended in 2026.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2013
- Kind
- Small molecule
- Brand name
- Aptiom
- First approved
- 21 April 2009 (EU)
- Approvals on record
- 5 in 2 regions
- Holder of the most recent approval
- Sumitomo Pharma; 2 holders in all
- Withdrawn from market
- 24 July 2012 (in some regions)
- Registered trials
- 58, 5 stopped early
- Disease areas
- Nervous system; Hormones
US protection
US protection ended in 2026.
The last listed US drug-substance patent ended in 2026. The application that gives this date is held by Sumitomo Pharma.
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 product4 listings count towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
2 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product2 company-target rows are on route B because of Eslicarbazepine acetate.
See the 2 company-target rows on route B for this drug, with the facts behind eachRequest 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 | 4 | 2 | 1 | 0 |
| Phase 1 | 31 | 30 | 0 | 1 |
| Phase 2 | 10 | 9 | 0 | 1 |
| Phase 3 | 12 | 9 | 0 | 3 |
| Phase 4 | 1 | 1 | 0 | 0 |
| All trials | 58 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bial | Applicant and Lead sponsor of trials | 2000 to now |
| Sumitomo Pharma | Applicant, Acquired holder and Lead sponsor of trials | 2009 to now |