Onabotulinumtoxina
As of the edition of 20 October 2026, Onabotulinumtoxina is a drug: marketed, first approved in 1991 (US); acts on SNAP25; US protection ended in 2026.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1992
- Kind
- Unknown
- Brand name
- Botox
- First approved
- 9 December 1991 (US)
- Approvals on record
- 10 in 2 regions
- Holder of the most recent approval
- AbbVie
- Registered trials
- 243, 28 stopped early
- Disease areas
- Nervous system; Urinary and reproductive; Pregnancy and women's health; Bones, joints and muscles; Heart and blood vessels; Injuries
US protection
US protection ended in 2026.
The orphan exclusivity ended in 2026 (it covers one use only). The application that gives this date is held by AbbVie.
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 product2 listings count towards this date. The exact date and each listing are in the product.
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Target
| Gene | Protein | UniProt |
|---|---|---|
| SNAP25 | Synaptosomal-associated protein 25 | P60880 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 52 | 26 | 9 | 4 |
| Phase 1 | 21 | 7 | 4 | 4 |
| Phase 2 | 55 | 36 | 5 | 6 |
| Phase 3 | 66 | 43 | 9 | 7 |
| Phase 4 | 49 | 24 | 10 | 7 |
| All trials | 243 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| AbbVie | Applicant, Earlier holder and Lead sponsor of trials | 1991 to now |