Viloxazine
As of the edition of 20 October 2026, Viloxazine is a small molecule: marketed, first approved in 2021 (US); acts on SLC6A2; US protection ended in 2026.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2021
- Kind
- Small molecule
- Brand name
- Qelbree
- First approved
- 2 April 2021 (US)
- Approvals on record
- 3 in 1 region
- Holder of the most recent approval
- Supernus Pharmaceuticals
- Registered trials
- 13, 1 stopped early
- Disease areas
- Mental health
US protection
US protection ended in 2026.
The last listed US exclusivity ended in 2026. The application that gives this date is held by Supernus 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 product3 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
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Viloxazine.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| SLC6A2 | Sodium-dependent noradrenaline transporter | P23975 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 2 | 2 | 2 | 0 | 0 |
| Phase 3 | 7 | 5 | 1 | 1 |
| Phase 4 | 4 | 3 | 1 | 0 |
| All trials | 13 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Supernus Pharmaceuticals | Originator and Lead sponsor of trials | 2010 to now |