Cefotaxime
As of the edition of 20 October 2026, Cefotaxime is a small molecule: marketed, first approved in 1982 (US); no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1998
- Kind
- Small molecule
- Brand name
- Claforan
- First approved
- 1 January 1982 (US)
- Approvals on record
- 13 in 3 regions
- Holder of the most recent approval
- B. Braun Medical; 4 holders in all
- Registered trials
- 10, 0 stopped early
- Disease areas
- Infections; Digestive system; Ear, nose and throat; Inherited and neonatal; Injuries; Lungs and airways
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.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 3 | 2 | 0 | 0 |
| Phase 1 | 2 | 2 | 0 | 0 |
| Phase 2 | 1 | 1 | 0 | 0 |
| Phase 3 | 1 | 0 | 1 | 0 |
| Phase 4 | 3 | 1 | 0 | 0 |
| All trials | 10 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| B. Braun Medical | Later holder | 2004 to now |
| Sterimax | Acquired holder | 2024 to now |
| Sanofi | Applicant and Earlier holder |