NDAINTRAVENOUSSOLUTIONPriority Review
Approved
Aug 2019
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
2/8 — Basic
Priority Review
Drug data last refreshed 3h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
XENLETA (lefamulin acetate) is an intravenous pleuromutilin antibiotic approved in 2019 for treating bacterial infections, representing a novel mechanism of action in the antibiotic class. The drug targets bacterial protein synthesis and is indicated for community-acquired bacterial pneumonia (CABP) and other serious gram-positive infections. It addresses an unmet need in IV antibiotic therapy with a distinct pharmacological profile.
Peak9.6 years to LOE
Product is in peak commercial phase with established market presence; commercial teams are focused on maximizing penetration and defending market share in the IV antibiotic space.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Career Relevance
Working on XENLETA positions you in a mature, peak-revenue product with stable market dynamics but limited organic growth runway given LOE approaching in 4-9 years. This role emphasizes commercial excellence, market defense, and lifecycle management rather than launch momentum or clinical development expansion.
Brand ManagerField Sales Representative
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.