Ofloxacin
As of the edition of 20 October 2026, Ofloxacin is a small molecule: marketed, first approved in 1986 (FR).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2000
- Kind
- Small molecule
- Brand name
- Floxin
- First approved
- 30 July 1986 (FR)
- Approvals on record
- 14 in 5 regions
- Holder of the most recent approval
- AbbVie; 7 holders in all
- Registered trials
- 16, 2 stopped early
- Disease areas
- Eye; Infections; Ear, nose and throat; Immune system; Urinary and reproductive; Blood and lymph
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 6 | 5 | 1 | 0 |
| Phase 1 | 1 | 0 | 0 | 0 |
| Phase 3 | 4 | 2 | 1 | 1 |
| Phase 4 | 5 | 2 | 0 | 1 |
| All trials | 16 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| AbbVie | Applicant and Later holder | 1993 to now |
| Daiichi Sankyo | Later holder and Lead sponsor of trials | 1997 to now |
| Johnson & Johnson | Acquired holder | 2003 to now |