Data updated: Mar 10, 2026
XENLETA
LEFAMULIN ACETATE
Approved 2019-08-19
1
Indication
--
Phase 3 Trials
1
Priority Reviews
6
Years on Market
Details
- Status
- Prescription
- First Approved
- 2019-08-19
- Routes
- INTRAVENOUS, ORAL
- Dosage Forms
- SOLUTION, TABLET
XENLETA Approval History
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What XENLETA Treats
1 FDA approvalsOriginally approved for its first indication in 2019 .
- Other (1)
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
XENLETA FDA Label Details
ProXENLETA Patents & Exclusivity
Latest Patent: Jun 2036
Exclusivity: Aug 2029
Patents (6 active)
US12121582
Expires Jun 14, 2036
US8071643
Expires Mar 25, 2033
US9120727
Expires May 23, 2031
US8153689
Expires Mar 19, 2028
Exclusivity
NCE
Until Aug 2024
GAIN
Until Aug 2029
NCE
Until Aug 2024
GAIN
Until Aug 2029
Source: FDA Orange Book
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.