Besifloxacin
As of the edition of 20 October 2026, Besifloxacin is a small molecule: marketed, first approved in 2009 (US); US protection ends in 2031.
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
- Besivance
- First approved
- 28 May 2009 (US)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- Bausch Health
- Registered trials
- 13, 2 stopped early
- Disease areas
- Eye; Infections
US protection
US protection ends in 2031.
The last listed US drug-substance patent ends in 2031. The application that gives this date is held by Bausch Health.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product1 listing counts towards this date. The exact date and each listing are in the product.
See the exact date and the 1 listing behind itRequest access. Nothing is shown until you do.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 1 | 0 | 0 |
| Phase 1 | 5 | 5 | 0 | 0 |
| Phase 2 | 1 | 1 | 0 | 0 |
| Phase 3 | 6 | 4 | 0 | 2 |
| All trials | 13 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bausch Health | Originator and Lead sponsor of trials | 2004 to now |