ZERBAXA (ceftolozane sulfate)
ZERBAXA is indicated for the treatment of Complicated Intra-abdominal Infections; Complicated Urinary Tract Infections; Pyelonephritis; Hospital-acquired Bacterial Pneumonia; Ventilator-associated Bacterial Pneumonia.
How ZERBAXA Works
Ceftolozane is a cephalosporin that exerts bactericidal activity by binding to important penicillin-binding proteins (PBPs), resulting in the inhibition of bacterial cell wall synthesis and subsequent cell death. Tazobactam is a beta-lactamase inhibitor that irreversibly binds to some beta-lactamases (such as certain molecular class A and C enzymes), protecting ceftolozane from hydrolysis and extending its activity against bacteria that produce these resistance enzymes.
Details
- Status
- Prescription
- First Approved
- 2014-12-19
- Patent Cliff
- 2035
- Routes
- INTRAVENOUS
- Dosage Forms
- POWDER
ZERBAXA Approval History
What ZERBAXA Treats
5 indicationsZERBAXA is approved for 5 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Complicated Intra-abdominal Infections
- Complicated Urinary Tract Infections
- Pyelonephritis
- Hospital-acquired Bacterial Pneumonia
- Ventilator-associated Bacterial Pneumonia
ZERBAXA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to ZERBAXA
3 of 17FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
ZERBAXA FDA Label Details
Indications & Usage
FDA Label (PDF)ZERBAXA is indicated for the treatment of Complicated Intra-abdominal Infections; Complicated Urinary Tract Infections; Pyelonephritis; Hospital-acquired Bacterial Pneumonia; Ventilator-associated Bacterial Pneumonia.
ZERBAXA Patents & Exclusivity
Patents (12 active)
Pro Intelligence Preview
Deep insights for ZERBAXA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2035
- • 26 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 17 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.