Cefiderocol
As of the edition of 20 October 2026, Cefiderocol is a small molecule: marketed, first approved in 2019 (US); US protection ends in 2035.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2023
- Kind
- Small molecule
- Brand name
- Fetroja
- First approved
- 14 November 2019 (US)
- Approvals on record
- 3 in 3 regions
- Holder of the most recent approval
- Shionogi; 2 holders in all
- Registered trials
- 19, 1 stopped early
- Disease areas
- Infections; Lungs and airways; Digestive system; Inherited and neonatal; Injuries; Pregnancy and women's health
US protection
US protection ends in 2035.
The last listed US drug-substance patent ends in 2035. 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 product6 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 6 listings behind itRequest access. Nothing is shown until you do.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 1 | 0 | 0 |
| Phase 1 | 6 | 4 | 1 | 1 |
| Phase 2 | 5 | 5 | 0 | 0 |
| Phase 3 | 3 | 2 | 1 | 0 |
| Phase 4 | 3 | 1 | 2 | 0 |
| All trials | 19 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Shionogi | Originator, Applicant and Lead sponsor of trials | 2019 to now |