Levofloxacin anhydrous
As of the edition of 20 October 2026, Levofloxacin anhydrous is a small molecule: marketed, first approved in 1996 (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 2015
- Kind
- Small molecule
- Brand name
- Levaquin
- First approved
- 20 December 1996 (US)
- Approvals on record
- 21 in 7 regions
- Holder of the most recent approval
- Ceolia Pharma Co., Ltd.; 7 holders in all
- Registered trials
- 189, 19 stopped early
- Disease areas
- Infections; Lungs and airways; Urinary and reproductive; Pregnancy and women's health; Cancer; Digestive system
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 | 33 | 18 | 7 | 2 |
| Phase 1 | 15 | 12 | 0 | 1 |
| Phase 2 | 18 | 13 | 3 | 1 |
| Phase 3 | 67 | 50 | 6 | 5 |
| Phase 4 | 56 | 18 | 6 | 10 |
| All trials | 189 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Johnson & Johnson | Acquired holder, Later holder and Lead sponsor of trials | 1931 to now |
| Sanofi | Applicant and Lead sponsor of trials | 1998 to now |
| Santen Pharmaceutical | Later holder and Lead sponsor of trials | 2000 to now |
| Pfizer | Applicant and Lead sponsor of trials | 2001 to now |
| Chiesi Farmaceutici | Applicant | 2015 to now |