EMBLAVEO (avibactam sodium)
Emblaveo is an antibacterial combination used for adults with complicated intra-abdominal infections. It helps patients who have few or no other medical options available to manage their condition. When used alongside metronidazole, this medication helps clear infections caused by specific gram-negative bacteria such as E. coli and Klebsiella species. To help prevent the spread of drug-resistant bacteria, it is used only when a bacterial infection is confirmed or strongly suspected.
How EMBLAVEO Works
This medication works by combining a monobactam antibacterial with a beta-lactamase inhibitor. The antibacterial component targets the bacteria while the inhibitor helps prevent the bacteria from using enzymes to defend against the drug. This combined action allows the medication to eliminate susceptible gram-negative microorganisms.
Details
- Status
- Prescription
- First Approved
- 2025-02-07
- Patent Cliff
- 2032
- Routes
- INTRAVENOUS
- Dosage Forms
- POWDER
EMBLAVEO Approval History
What EMBLAVEO Treats
1 indicationsEMBLAVEO is approved for 1 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Complicated Intra-abdominal Infections
EMBLAVEO 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 EMBLAVEO
3 of 6FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01430910 | D4280C00011 | Ph 1 | completed | A Study to Assess the Levels of Two Antibiotics in the Blood When Given Together and Separately |
Active Pipeline
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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.
EMBLAVEO FDA Label Details
Indications & Usage
FDA Label (PDF)EMBLAVEO is indicated for the treatment of Complicated Intra-abdominal Infections.
EMBLAVEO Patents & Exclusivity
Patents (7 active)
Exclusivity
Pro Intelligence Preview
Deep insights for EMBLAVEO
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2032
- • 7 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 6 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.