Cefepime
As of the edition of 20 October 2026, Cefepime is a small molecule: marketed, first approved in 1996 (US); no US protection of its own is listed.
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
- Maxipime
- First approved
- 18 January 1996 (US)
- Approvals on record
- 10 in 2 regions
- Holder of the most recent approval
- WOCKHARDT BIO AG; 6 holders in all
- Registered trials
- 33, 6 stopped early
- Disease areas
- Infections; Blood and lymph; Lungs and airways; Pregnancy and women's health; Urinary and reproductive; Cancer
US protection
No US protection of its own is listed.
The FDA registers list no drug-substance patent or exclusivity of its own that counts for this drug.
WOCKHARDT BIO AG holds a later exclusivity on its own new formulation or combination product, ending 2036; it does not protect the original drug.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 3 | 2 | 0 | 1 |
| Phase 1 | 11 | 10 | 0 | 0 |
| Phase 2 | 2 | 1 | 1 | 0 |
| Phase 3 | 10 | 4 | 0 | 3 |
| Phase 4 | 7 | 4 | 0 | 2 |
| All trials | 33 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bristol Myers Squibb | Earlier holder | 1996 to now |
| Baxter Healthcare | Later holder | 2008 to now |
| B. Braun Medical | Later holder | 2010 to now |
| Pfizer | Acquired holder | 2011 to now |
| Advanz Pharma | Acquired holder | 2024 to now |