TYZAVAN (vancomycin hydrochloride)
Tyzavan is a glycopeptide antibacterial indicated for adult and pediatric patients (1 month and older) for whom appropriate dosing can be achieved. It is used to treat serious infections including septicemia, infective endocarditis, skin and skin structure infections, bone infections, and lower respiratory tract infections. It is specifically indicated for infections caused by methicillin-resistant *Staphylococcus aureus* (MRSA) and for patients who are allergic to penicillin or have failed to respond to other treatments, such as penicillins or cephalosporins. To prevent the development of drug-resistant bacteria, it should only be used for infections proven or strongly suspected to be caused by susceptible bacteria.
How TYZAVAN Works
Vancomycin is a bactericidal glycopeptide that inhibits bacterial cell wall synthesis. It binds with high affinity to the D-alanyl-D-alanine C-terminus of cell wall precursor units. This binding sterically hinders the polymerization of the glycan backbone and the subsequent cross-linking of the peptidoglycan layer, leading to cell wall instability and osmotic lysis. It is primarily active against Gram-positive organisms.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2019-02-15
- Patent Cliff
- 2035
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
TYZAVAN Approval History
What TYZAVAN Treats
5 indicationsTYZAVAN is approved for 5 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Septicemia
- Infective Endocarditis
- Skin and Skin Structure Infections
- Bone Infections
- Lower Respiratory Tract Infections
TYZAVAN 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 TYZAVAN
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05766670 | W81XWH-22-10937 W81XWH-22-10937 | Ph 3 | recruiting | Intramedullary Calcium Sulfate Antibiotic Depot |
| NCT04500275 | A-BR-109-013 | Ph 4 | completed | Topical Vancomycin Over Sternal Edge in Cardiac Surgery |
| NCT06126614 PREVENT-iT | PiT-2023 | Ph 3 | recruiting | Infection Prophylaxis in Total Joint Replacement |
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.
TYZAVAN FDA Label Details
Indications & Usage
FDA Label (PDF)TYZAVAN is indicated for the treatment of Septicemia; Infective Endocarditis; Skin and Skin Structure Infections; Bone Infections; Lower Respiratory Tract Infections.
TYZAVAN Patents & Exclusivity
Patents (6 active)
Pro Intelligence Preview
Deep insights for TYZAVAN
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2035
- • 294 active patents
Trial Analysis
- • 118 total trials
- • Stage: Declining
Competitive Landscape
- • 20 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.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment