Delafloxacin
As of the edition of 20 October 2026, Delafloxacin is a small molecule: marketed, first approved in 2017 (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 2019
- Kind
- Small molecule
- Brand name
- Baxdela
- First approved
- 19 June 2017 (US)
- Approvals on record
- 3 in 2 regions
- Holder of the most recent approval
- A. Menarini Industrie Farmaceutiche Riunite; 2 holders in all
- Registered trials
- 12, 3 stopped early
- Disease areas
- Infections; Lungs and airways; Skin and connective tissue; Bones, joints and muscles; Urinary and reproductive
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 Melinta Therapeutics.
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 product12 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 12 listings behind itRequest access. Nothing is shown until you do.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 0 | 1 | 0 |
| Phase 1 | 4 | 3 | 0 | 1 |
| Phase 2 | 2 | 2 | 0 | 0 |
| Phase 3 | 5 | 3 | 0 | 2 |
| All trials | 12 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Melinta Therapeutics | Originator, Applicant and Lead sponsor of trials | 2008 to now |
| A. Menarini Industrie Farmaceutiche Riunite | Applicant | 2019 to now |