Moxifloxacin
As of the edition of 20 October 2026, Moxifloxacin is a small molecule: marketed, first approved in 1999 (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 2009
- Kind
- Small molecule
- Brand name
- Avelox
- First approved
- 10 December 1999 (US)
- Approvals on record
- 11 in 5 regions
- Holder of the most recent approval
- Fresenius Kabi; 7 holders in all
- Registered trials
- 275, 20 stopped early
- Disease areas
- Infections; Lungs and airways; Eye; Heart and blood vessels; Immune system; 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 | 29 | 18 | 2 | 6 |
| Phase 1 | 140 | 133 | 1 | 5 |
| Phase 2 | 27 | 17 | 6 | 4 |
| Phase 3 | 49 | 31 | 11 | 1 |
| Phase 4 | 30 | 23 | 1 | 4 |
| All trials | 275 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bayer | Originator, Applicant and Lead sponsor of trials | 1999 to now |
| Alcon | Later holder and Lead sponsor of trials | 2003 to now |
| Novartis | Applicant | 2004 to now |
| Fresenius Kabi | Later holder | 2015 to now |
| Harrow Eye | Acquired holder | 2024 to now |