Lefamulin
As of the edition of 20 October 2026, Lefamulin is a small molecule: marketed, first approved in 2019 (US); US protection ends in 2033.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2020
- Kind
- Small molecule
- Brand name
- Xenleta
- First approved
- 19 August 2019 (US)
- Approvals on record
- 3 in 2 regions
- Holder of the most recent approval
- Venipharm; 2 holders in all
- Registered trials
- 7, 1 stopped early
- Disease areas
- Infections; Lungs and airways; Digestive system; Inherited and neonatal
US protection
US protection ends in 2033.
The last listed US drug-substance patent ends in 2033. The application that gives this date is held by Hong Kong King Friend Industrial.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
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Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 3 | 3 | 0 | 0 |
| Phase 2 | 2 | 1 | 0 | 1 |
| Phase 3 | 2 | 2 | 0 | 0 |
| All trials | 7 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Venipharm | Applicant | 2020 to now |
| Hong Kong King Friend Industrial | Acquired holder | 2025 to now |