Ceftobiprole medocaril free acid
As of the edition of 20 October 2026, Ceftobiprole medocaril free acid is a small molecule: marketed, first approved in 2014 (ES); US protection ends in 2034.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2024
- Kind
- Small molecule
- Brand name
- Zevtera
- First approved
- 25 April 2014 (ES)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- Istx; 2 holders in all
- Registered trials
- 12, 3 stopped early
- Disease areas
- Infections; Lungs and airways; Skin and connective tissue; Blood and lymph; Digestive system; Inherited and neonatal
US protection
US protection ends in 2034.
The last listed US exclusivity ends in 2034. The application that gives this date is held by Istx.
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 product2 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 2 listings behind itRequest access. Nothing is shown until you do.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 1 | 0 | 0 |
| Phase 1 | 1 | 0 | 0 | 1 |
| Phase 2 | 2 | 1 | 0 | 1 |
| Phase 3 | 8 | 7 | 0 | 1 |
| All trials | 12 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Istx | Acquired holder | 2025 to now |