Levetiracetam
As of the edition of 20 October 2026, Levetiracetam is a small molecule: marketed, first approved in 1999 (US); acts on CACNA1B and SV2A; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2015
- Kind
- Small molecule
- Brand name
- Keppra
- First approved
- 30 November 1999 (US)
- Approvals on record
- 36 in 6 regions
- Holder of the most recent approval
- Aché Laboratórios Farmacêuticos; 10 holders in all
- Registered trials
- 203, 18 stopped early
- Disease areas
- Nervous system; Mental health; Cancer; Chemically induced; Heart and blood vessels; Blood and lymph
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Companies that need a new molecule because of this drug
3 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product3 company-target rows are on route B because of Levetiracetam.
See the 3 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 39 | 25 | 5 | 3 |
| Phase 1 | 16 | 15 | 0 | 0 |
| Phase 2 | 62 | 41 | 10 | 8 |
| Phase 3 | 50 | 34 | 10 | 5 |
| Phase 4 | 36 | 26 | 2 | 2 |
| All trials | 203 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| UCB | Originator, Applicant and Lead sponsor of trials | 1998 to now |
| Aprecia Pharmaceuticals | Later holder | 2015 to now |
| Aché Laboratórios Farmacêuticos | Applicant | 2018 to now |
| Sun Pharma Advanced | Later holder | 2018 to now |
| Tripoint Therapeutics | Acquired holder | 2021 to now |
| Hq Specialty Pharma | Acquired holder | 2023 to now |
| Eurofarma Laboratorios | Later holder | 2023 to now |