TheraRadar
Data updated: May 26, 2026

XENLETA (lefamulin acetate)

Priority Review Fast Track
Infectious Disease Approved 2019-08-19
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
1
Priority Reviews
6
Years on Market

Details

Status
Prescription
First Approved
2019-08-19
Patent Cliff
2036

Pro Metrics

Patent cliff and revenue data

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Routes
ORAL, INTRAVENOUS
Dosage Forms
TABLET, SOLUTION

Companies

HONG KONG
Active Ingredient: LEFAMULIN ACETATE

XENLETA Approval History

2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
6 FDA actions from 2019 to 2021
Mar 2021 SUPPL
Label · Labeling
FDA Letter Label
Oct 2020 SUPPL
Label · Labeling
FDA Letter
Aug 2019 ORIGINAL Priority
New Drug · Type 1 - New Molecular Entity
FDA Letter Label

What XENLETA Treats

1 FDA approvals

Originally approved for its first indication in 2019 .

  • Other (1)
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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

View full patent landscape →
4 OB patents · 3 families · 161 international docs across 37 countries

XENLETA Patents & Exclusivity

Latest Patent: Jun 2036
Exclusivity: Aug 2029

Patents (4 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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Deep insights for XENLETA

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2036
  • • 6 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: NDA211672 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.