JUBLIA (efinaconazole)
Jublia is a topical solution used for patients with fungal infections of the toenails, a condition known as onychomycosis. It helps individuals whose infections are caused by specific fungi, namely *Trichophyton rubrum* and *Trichophyton mentagrophytes*. This medication is applied directly to the nail to manage the infection at the source.
How JUBLIA Works
This medication works by acting as an azole antifungal to stop the growth of fungi in the toenails. It specifically targets the *Trichophyton rubrum* and *Trichophyton mentagrophytes* organisms to help resolve the infection.
Details
- Status
- Prescription
- First Approved
- 2014-06-06
- Patent Cliff
- 2035
- Routes
- TOPICAL
- Dosage Forms
- SOLUTION
JUBLIA Approval History
What JUBLIA Treats
1 indicationsJUBLIA is approved for 1 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Onychomycosis
JUBLIA Competitive Set
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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 JUBLIA
3 of 8FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02812771 results posted | V01-108A-401 | Ph 4 | completed | Safety and Pharmacokinetics of Efinaconazole Topical Solution in Subjects With Mild to Severe Onychomycosis |
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.
JUBLIA FDA Label Details
Indications & Usage
FDA Label (PDF)JUBLIA is indicated for the treatment of Onychomycosis.
JUBLIA Patents & Exclusivity
Patents (18 active)
Pro Intelligence Preview
Deep insights for JUBLIA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2035
- • 18 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 8 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.