Ciprofloxacin
As of the edition of 20 October 2026, Ciprofloxacin is a small molecule: marketed, first approved in 1987 (CH); 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 1995
- Kind
- Small molecule
- Brand name
- Cipro
- First approved
- 25 June 1987 (CH)
- Approvals on record
- 31 in 6 regions
- Holder of the most recent approval
- Laboratorios Salvat; 10 holders in all
- Registered trials
- 160, 23 stopped early
- Disease areas
- Infections; Digestive system; Urinary and reproductive; Cancer; Lungs and airways; Ear, nose and throat
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.
Alk-Abello holds a later exclusivity on its own new formulation or combination product, ending 2029; it does not protect the original drug.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 33 | 23 | 3 | 5 |
| Phase 1 | 34 | 30 | 2 | 1 |
| Phase 2 | 34 | 23 | 5 | 5 |
| Phase 3 | 29 | 19 | 1 | 7 |
| Phase 4 | 30 | 22 | 3 | 5 |
| All trials | 160 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bayer | Applicant, Later holder and Lead sponsor of trials | 1987 to now |
| Alcon | Later holder and Lead sponsor of trials | 1990 to now |
| Novartis | Applicant | 1992 to now |
| Depomed | Acquired holder | 2008 to now |
| Laboratorios Salvat | Later holder | 2009 to now |
| Otonomy | Later holder and Lead sponsor of trials | 2012 to now |
| Alk-Abello | Acquired holder | 2021 to now |
| Sandoz | Acquired holder | 2023 to now |