Cefditoren pivoxil
As of the edition of 20 October 2026, Cefditoren pivoxil is a small molecule: marketed, first approved in 2001 (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 2001
- Kind
- Small molecule
- Brand name
- Spectracef
- First approved
- 29 August 2001 (US)
- Approvals on record
- 3 in 2 regions
- Holder of the most recent approval
- Vansen Pharma; 2 holders in all
- Registered trials
- 3, 0 stopped early
- Disease areas
- Infections; Lungs and airways; Pregnancy and women's health; Urinary and reproductive
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 | 1 | 1 | 0 | 0 |
| Phase 3 | 1 | 1 | 0 | 0 |
| Phase 4 | 1 | 1 | 0 | 0 |
| All trials | 3 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Vansen Pharma | Acquired holder | 2012 to now |
| Meiji Seika Pharma | Applicant |