Solriamfetol
As of the edition of 20 October 2026, Solriamfetol is a small molecule: marketed, first approved in 2019 (US); US protection ends in 2038.
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
- Sunosi
- First approved
- 17 June 2019 (US)
- Approvals on record
- 3 in 2 regions
- Holder of the most recent approval
- Atnahs Pharma; 2 holders in all
- Registered trials
- 25, 2 stopped early
- Disease areas
- Mental health; Nervous system; Lungs and airways; Bones, joints and muscles; Cancer; Immune system
US protection
US protection ends in 2038.
The last listed US drug-substance patent ends in 2038. The application that gives this date is held by Axsome Therapeutics.
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.
See the exact date and the 4 listings behind itRequest access. Nothing is shown until you do.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 0 | 1 | 0 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 8 | 5 | 2 | 1 |
| Phase 3 | 12 | 5 | 7 | 0 |
| Phase 4 | 3 | 2 | 0 | 1 |
| All trials | 25 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Jazz Pharmaceuticals | Originator and Lead sponsor of trials | 2011 to now |
| Axsome Therapeutics | Acquired holder and Lead sponsor of trials | 2019 to now |
| Atnahs Pharma | Applicant | 2020 to now |