Efinaconazole

Treats onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton…. Sold as Jublia. Every FDA application for this active ingredient: 1 branded and 7 generic.

As of Nov 14, 2026, FDA lists 8 applications for Efinaconazole (sold as Jublia), first approved Jun 6, 2014, with 1 new use approved and 0 published complete response letters.

First approved: Jun 6, 2014
Applications: 8
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $136M
First approved in Japan: Jul 4, 2014

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Jublia	Part D	$136M	+15%	37,275

Approvals in Japan (PMDA)

First approved in Japan 1 month after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

Clenafin Topical, new ingredientA drug with a new active ingredient indicated for the treatment of tinea unguium caused by dermatophyte (trichophyton ). · Kaken Pharmaceutical Co., Ltd. · Jul 4, 2014 · Review report

Clinical Trials

1 open or ongoing study names this ingredient as an intervention, including as a comparator; newest first. See all

Study	Phase	Status	Posted
A Phase 2 Study to Assess the Effectiveness of Topical Terbinafine in Participants With Mild to Moderate Onychomycosis of the ToenailsOnychomycosis of Toenail · Onyx Axiom	Phase 2	Not yet recruiting	Feb 2, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Jun 6, 2014	JubliaNDA 203567 · New molecular entity	Bausch	7	Marketed
Dec 16, 2020	EfinaconazoleANDA 211827	Teva Pharms USA	0	Marketed
Dec 16, 2020	EfinaconazoleANDA 211851	Padagis US	1	Discontinued
Mar 29, 2021	EfinaconazoleANDA 212066	Aurobindo Pharma Ltd	2	Discontinued
Jun 21, 2021	EfinaconazoleANDA 211969	Nivagen Pharms Inc	1	Marketed
Mar 2, 2022	EfinaconazoleANDA 212169	Lupin	1	Discontinued
Jul 15, 2022	EfinaconazoleANDA 212178	Zydus Lifesciences	1	Discontinued
Feb 23, 2026	EfinaconazoleANDA 212027	Alembic	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA