AVYCAZ (avibactam sodium) · AbbVie
AVYCAZ is a combination of ceftazidime (a cephalosporin) and avibactam (a beta-lactamase inhibitor) indicated for the treatment of adult and pediatric patients (at least 31 weeks gestational age) with complicated urinary tract infections (cUTI) including pyelonephritis, and hospital-acquired or ventilator-associated bacterial pneumonia (HABP/VABP). It is also indicated for complicated intra-abdominal infections (cIAI) when used **in combination with metronidazole**. To maintain antibacterial stewardship, AVYCAZ should only be used for infections proven or strongly suspected to be caused by susceptible Gram-negative bacteria.
How AVYCAZ Works
AVYCAZ consists of two active components: ceftazidime and avibactam. Ceftazidime is a bactericidal cephalosporin that inhibits bacterial cell wall synthesis by binding to essential penicillin-binding proteins (PBPs). Avibactam is a non-beta-lactam beta-lactamase inhibitor that protects ceftazidime from degradation by certain beta-lactamases, including Ambler Class A (e.g., KPC), Class C (e.g., AmpC), and some Class D (e.g., OXA-48) enzymes. This combination restores ceftazidime's activity against many resistant Gram-negative pathogens.
Details
- Status
- Prescription
- First Approved
- 2015-02-25
- Patent Cliff
- 2032
- Routes
- INTRAVENOUS
- Dosage Forms
- POWDER
AVYCAZ Approval History
What AVYCAZ Treats
5 indicationsAVYCAZ is approved for 5 conditions since its original approval in 2015. 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
AVYCAZ Competitive Set
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Indication competitors
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Other CDER-designated drugs from the same sponsor (2016–2025).
Active Pipeline
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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.
AVYCAZ FDA Label Details
Indications & Usage
FDA Label (PDF)AVYCAZ is a combination of ceftazidime, a cephalosporin, and avibactam, a beta-lactamase inhibitor, indicated for the treatment of the following infections caused by designated susceptible Gram-negative microorganisms in adult and pediatric patients (at least 31 weeks gestational age): Complicated Intra-abdominal Infections (cIAI), used in combination with metronidazole Complicated Urinary Tract Infections (cUTI), including Pyelonephritis Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia (HABP/VABP) To reduce the development of drug-resistant bacteria and main...
AVYCAZ Patents & Exclusivity
Patents (7 active)
Exclusivity
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Deep insights for AVYCAZ
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2032
- • 10 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.