ZEVTERA (ceftobiprole medocaril sodium)
Zevtera is a cephalosporin antibiotic used to manage serious bacterial infections in both adults and children. It helps patients with Staphylococcus aureus bloodstream infections, including those that involve right-sided heart valve infections. Healthcare providers also use it to treat severe skin infections in adults and community-acquired pneumonia in patients as young as three months old. To help prevent the rise of drug-resistant organisms, this medication is used specifically for infections proven or strongly suspected to be caused by bacteria.
How ZEVTERA Works
Zevtera works as a cephalosporin antibacterial drug to combat various gram-positive and gram-negative microorganisms. It functions by targeting specific bacteria in the blood, skin, and lungs to stop the progression of the infection. This antibacterial activity is effective against several pathogens, including methicillin-resistant Staphylococcus aureus (MRSA) in specific infection types.
Details
- Status
- Prescription
- First Approved
- 2024-04-03
- Patent Cliff
- 2034
- Routes
- INTRAVENOUS
- Dosage Forms
- POWDER
ZEVTERA Approval History
What ZEVTERA Treats
5 indicationsZEVTERA is approved for 5 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Staphylococcus Aureus Bloodstream Infection
- Bacteremia
- Infective Endocarditis
- Acute Bacterial Skin and Skin Structure Infections
- Community-Acquired Bacterial Pneumonia
ZEVTERA 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 ZEVTERA
3 of 13FDA-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.
ZEVTERA FDA Label Details
Indications & Usage
FDA Label (PDF)ZEVTERA is indicated for the treatment of Staphylococcus Aureus Bloodstream Infection; Bacteremia; Infective Endocarditis; Acute Bacterial Skin and Skin Structure Infections; Community-Acquired Bacterial Pneumonia.
ZEVTERA Patents & Exclusivity
Exclusivity
Track ZEVTERA with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.