TheraRadar
Data updated: May 26, 2026

JUBLIA (efinaconazole)

Infectious Disease Approved 2014-06-06

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.

Source: FDA Label • BAUSCH • Azole Antifungal

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.

2
Indications
--
Phase 3 Trials
11
Years on Market

Details

Status
Prescription
First Approved
2014-06-06
Patent Cliff
2035

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Routes
TOPICAL
Dosage Forms
SOLUTION

Companies

Active Ingredient: EFINACONAZOLE

JUBLIA Approval History

2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
8 FDA actions from 2014 to 2022 · 1 indication expansions
Mar 2022 SUPPL
Label · Labeling
Apr 2020 SUPPL
Efficacy
Sep 2016 SUPPL
Label · Labeling

What JUBLIA Treats

1 indications

JUBLIA is approved for 1 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Onychomycosis
Source: FDA Label

JUBLIA Competitive Set

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Indication competitors

3

Same indication, different mechanism — what else might this patient receive?

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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.

Drugs Similar to JUBLIA

3 of 8

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

CICLOPIROX
CICLOPIROX
1 shared
PADAGIS US
Shared indications:
Onychomycosis
FULVICIN P/G
GRISEOFULVIN, ULTRAMICROSIZE
1 shared
CHARTWELL RX
Shared indications:
Onychomycosis
FULVICIN P/G 165
GRISEOFULVIN, ULTRAMICROSIZE
1 shared
CHARTWELL RX
Shared indications:
Onychomycosis
📋

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

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Key Completed Trials

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Trial Timeline

Full development history with FDA approval milestones

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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.

View full patent landscape →
18 OB patents · 6 families · 158 international docs across 25 countries

JUBLIA Patents & Exclusivity

Latest Patent: Apr 2035

Patents (18 active)

US10478601 Expires Apr 25, 2035
US10342875 Expires Oct 2, 2034
US11654139 Expires Oct 2, 2034
US10828293 Expires Oct 2, 2034
US10864274 Expires Oct 2, 2034
US9662394 Expires Oct 2, 2034
US8486978 Expires Oct 24, 2030
US9302009 Expires Oct 24, 2030
US8039494 Expires Jul 8, 2030
US9861698 Expires Jul 8, 2030
US10105444 Expires Jul 8, 2030
US9566272 Expires Jan 3, 2028
US9877955 Expires Jan 3, 2028
US10512640 Expires Jan 3, 2028
US11213519 Expires Jan 3, 2028
US11872218 Expires Jan 3, 2028
US10828369 Expires Jan 3, 2028
US7214506 Expires Feb 22, 2026
Source: FDA Orange Book

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Patent Timeline

  • Cliff: 2035
  • 18 active patents

Trial Analysis

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  • Development stage analysis

Competitive Landscape

  • 8 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.