Armodafinil
As of the edition of 20 October 2026, Armodafinil is a small molecule: marketed, first approved in 2007 (US); acts on SLC6A3; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2020
- Kind
- Small molecule
- Brand name
- Nuvigil
- First approved
- 15 June 2007 (US)
- Approvals on record
- 6 in 2 regions
- Holder of the most recent approval
- TEVA FARMACĂUTICA LTDA.; 2 holders in all
- Registered trials
- 43, 9 stopped early
- Disease areas
- Nervous system; Mental health; Cancer; Lungs and airways; Immune system; 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
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 Armodafinil.
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 |
|---|---|---|
| SLC6A3 | Sodium-dependent dopamine transporter | Q01959 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 5 | 1 | 0 | 4 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 9 | 8 | 0 | 1 |
| Phase 3 | 21 | 18 | 0 | 3 |
| Phase 4 | 7 | 6 | 0 | 1 |
| All trials | 43 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Teva | Earlier holder and Lead sponsor of trials | 2004 to now |
| Nuvo Pharmaceuticals Dac | Acquired holder | 2025 to now |