MICAFUNGIN IN SODIUM CHLORIDE 0.9% (micafungin sodium) · Baxter
Micafungin is an echinocandin antifungal indicated for the treatment of candidemia, acute disseminated candidiasis, Candida peritonitis, and abscesses in adult and pediatric patients. In pediatric patients younger than 4 months, use is restricted to these conditions without meningoencephalitis and/or ocular dissemination. Additionally, Micafungin is indicated for the treatment of esophageal candidiasis and the prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation (HSCT) in adults and pediatric patients 4 months of age and older. It has not been adequately studied for endocarditis, osteomyelitis, or meningoencephalitis due to Candida.
How MICAFUNGIN IN SODIUM CHLORIDE 0.9% Works
Micafungin is a member of the echinocandin class of antifungal agents. It works by inhibiting the synthesis of 1,3-beta-D-glucan, an essential component of the fungal cell wall, which is not present in mammalian cells. This results in osmotic instability and cell death in susceptible Candida species.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2023-09-29
- Patent Cliff
- 2037
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
MICAFUNGIN IN SODIUM CHLORIDE 0.9% Approval History
What MICAFUNGIN IN SODIUM CHLORIDE 0.9% Treats
6 indicationsMICAFUNGIN IN SODIUM CHLORIDE 0.9% is approved for 6 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Candidemia
- Disseminated Candidiasis
- Candida Peritonitis
- Abscess
- Esophageal Candidiasis
- Candida Infections
MICAFUNGIN IN SODIUM CHLORIDE 0.9% 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 MICAFUNGIN IN SODIUM CHLORIDE 0.9%
3 of 14FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01344681 | 4-2011-0794 | Ph 2 | completed | Micafungin Versus Intravenous Itraconazole as Empirical Antifungal Therapy for Febrile Neutropenic Patients With Hematological Diseases |
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.
MICAFUNGIN IN SODIUM CHLORIDE 0.9% FDA Label Details
Indications & Usage
FDA Label (PDF)Micafungin for injection is indicated for: Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older [see Clinical Studies and Use in Specific Populations ]. Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age [see Use in Specific Populations ] . Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older [see Clinical Studies ...
MICAFUNGIN IN SODIUM CHLORIDE 0.9% Patents & Exclusivity
Patents (1 active)
Pro Intelligence Preview
Deep insights for MICAFUNGIN IN SODIUM CHLORIDE 0.9%
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2037
- • 9 active patents
Trial Analysis
- • 29 total trials
- • Stage: Mature
Competitive Landscape
- • 14 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