Edaravone
As of the edition of 20 October 2026, Edaravone is a small molecule: marketed, first approved in 2001 (JP); US protection ends in 2029.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2022
- Kind
- Small molecule
- Brand name
- Radicava
- First approved
- 4 April 2001 (JP)
- Approvals on record
- 7 in 3 regions
- Holder of the most recent approval
- Mitsubishi Tanabe Pharma; 2 holders in all
- Registered trials
- 50, 2 stopped early
- Disease areas
- Nervous system; Heart and blood vessels; Nutrition and metabolism; Lungs and airways; Cancer; Ear, nose and throat
US protection
US protection ends in 2029.
The last listed US exclusivity ends in 2029. The application that gives this date is held by Shionogi.
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 product1 listing counts towards this date. The exact date and each listing are in the product.
See the exact date and the 1 listing behind itRequest access. Nothing is shown until you do.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 6 | 1 | 1 | 0 |
| Phase 1 | 16 | 14 | 0 | 0 |
| Phase 2 | 11 | 4 | 2 | 0 |
| Phase 3 | 11 | 7 | 1 | 2 |
| Phase 4 | 6 | 1 | 4 | 0 |
| All trials | 50 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Mitsubishi Tanabe Pharma | Originator | 2001 to now |
| Shionogi | Acquired holder and Lead sponsor of trials | 2004 to now |