EFINACONAZOLE - Generic Drug Details

What are the generic drug sources for efinaconazole and what is the scope of freedom to operate?

Efinaconazole is the generic ingredient in two branded drugs marketed by Aurobindo Pharma Ltd, Lupin Ltd, Padagis Us, Teva Pharms Usa, Umedica, Zydus Lifesciences, and Bausch, and is included in seven NDAs. There are eighteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Efinaconazole has eighty-five patent family members in twenty-four countries.

There are fourteen drug master file entries for efinaconazole. One supplier is listed for this compound.

Summary for EFINACONAZOLE

International Patents:	85
US Patents:	18
Tradenames:	2
Applicants:	7
NDAs:	7
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	5
Patent Applications:	1,276
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EFINACONAZOLE
What excipients (inactive ingredients) are in EFINACONAZOLE?	EFINACONAZOLE excipients list
DailyMed Link:	EFINACONAZOLE at DailyMed

Recent Clinical Trials for EFINACONAZOLE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Dong-A ST Co., Ltd.	Phase 4
Western University of Health Sciences	Phase 3
Bausch Health Americas, Inc.	Phase 4

See all EFINACONAZOLE clinical trials

Pharmacology for EFINACONAZOLE

Drug Class

Azole Antifungal

Anatomical Therapeutic Chemical (ATC) Classes for EFINACONAZOLE

D01AC	Imidazole and triazole derivatives
D01A	ANTIFUNGALS FOR TOPICAL USE
D01	ANTIFUNGALS FOR DERMATOLOGICAL USE
D	Dermatologicals

Paragraph IV (Patent) Challenges for EFINACONAZOLE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
JUBLIA	Topical Solution	efinaconazole	10%	203567	19	2018-06-06

US Patents and Regulatory Information for EFINACONAZOLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	JUBLIA	efinaconazole	SOLUTION;TOPICAL	203567-001	Jun 6, 2014	AB	RX	Yes	Yes	8,486,978		Y
Bausch	JUBLIA	efinaconazole	SOLUTION;TOPICAL	203567-001	Jun 6, 2014	AB	RX	Yes	Yes	11,872,218
Bausch	JUBLIA	efinaconazole	SOLUTION;TOPICAL	203567-001	Jun 6, 2014	AB	RX	Yes	Yes	9,566,272
Aurobindo Pharma Ltd	EFINACONAZOLE	efinaconazole	SOLUTION;TOPICAL	212066-001	Mar 29, 2021		DISCN	No	No

Expired US Patents for EFINACONAZOLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	JUBLIA	efinaconazole	SOLUTION;TOPICAL	203567-001	Jun 6, 2014	7,214,506

International Patents for EFINACONAZOLE

Country	Patent Number	Title	Estimated Expiration
Mexico	348515	APLICADOR. (APPLICATOR.)
Mexico	2010007230	COMPOSICIONES Y METODOS PARA TRATAR ENFERMEDADES DE LAS UÑAS. (COMPOSITIONS AND METHODS FOR TREATING DISEASES OF THE NAIL.)
Mexico	363386
World Intellectual Property Organization (WIPO)	2015077729

Market Dynamics and Financial Trajectory for Efinaconazole

Last updated: March 12, 2026

Efinaconazole is a topical azole antifungal approved primarily for onychomycosis (nail fungus). Its market landscape has evolved alongside antifungal therapies, influenced by regulatory approvals, patent status, and competitive alternatives.

Market Overview

Efinaconazole was approved by the U.S. Food and Drug Administration (FDA) in 2014 under the brand name Jublia (by Valeant Pharmaceuticals, now Bausch Health). It competes with other topical treatments like ciclopirox and efinaconazole's main oral competitor, terbinafine.

Key Market Drivers

• Prevalence of onychomycosis: Affecting 10-15% of the adult population worldwide, with higher prevalence among the elderly and immunocompromised.
• Limitations of existing treatments: Oral antifungals offer higher efficacy but carry systemic side effects. Topicals face adherence challenges but offer safety advantages.
• Regulatory and patent exclusivity: Patent expiry timelines influence market profitability, with the earliest patents expiring around 2023-2025, opening room for generics.

Regulatory Milestones

Efinaconazole's approval in major markets:

• U.S. (2014): Approved as Jublia.
• Europe (2017): Approved as Efinaconazole.
• Japan (2016): Approved for onychomycosis.

Competitive Landscape

Drug Name	Formulation	Market Share (2022)	Patent Status	Originator
Jublia	Topical Solution	~50% (U.S.)	Patent expiry anticipated 2023-2025	Valeant/Bausch
Tavaborole	Topical Solution	~25%	Patent expiring 2026	Anacor (now part of Pfizer)
Ciclopirox	Topical Solution	~20%	Generic available	Multiple manufacturers
Oral Terbinafine	Oral tablet	Remaining 5%	Off-patent	Multiple

Revenue Trends and Projections

Year	Estimated Global Revenue (USD millions)	Notes
2014	50	Initial launch year
2018	105	Growth slows as market matures
2022	130	Stabilization with competitive pressures
2025 (projected)	150	Expected growth with patent cliff effects and increased adoption

The compound annual growth rate (CAGR) from 2018 to 2022 sits around 8%. Post-patent expiry, generics are projected to capture 60-70% of the market, reducing blockbuster revenues to roughly 40-50% of peak levels.

Patent and Patent Cliff Impact

Patent protection was granted for up to 10 years post-approval. Anticipated generic entry around 2023-2025 is expected to cause revenue decline:

• 2023: Potential 20% drop with initial generics.
• 2024-2025: Market share loss could reach 50% if multiple generics launch simultaneously.

Investment and R&D Outlook

No recent filings claim new formulations or indications for Efinaconazole. Licensing or development of combination therapies remains a strategic focus for competitors. Bausch Health has shown interest in expanding indications, though no formal announcements have emerged.

Regulatory and Commercial Opportunities

Key areas for growth include:

• Expansion into other fungal infections.
• Development of sustained-release formulations.
• Geographic expansion into emerging markets with high onychomycosis prevalence.

Summary

Efinaconazole's market is characterized by steady growth driven by high onychomycosis prevalence and favorable safety profiles, but faces saturation and revenue erosion due to patent expiration and generic competition. Long-term viability depends on market share retention strategies and potential label extensions.

Key Takeaways

• Efinaconazole remains a leading topical antifungal with a 50-60% market share in developed markets.
• Patent expiry between 2023-2025 is expected to lead to significant generic erosion.
• Revenue growth has plateaued, with forecasts indicating stabilization before decline.
• Opportunities exist in expanding indications and entering emerging markets.
• Competition from oral therapies complicates market share retention.

FAQs

1. What are the primary factors influencing Efinaconazole’s market growth?
Prevalence of onychomycosis, safety profile, treatment adherence, patent status, and competition from generics shape growth.

2. When is patent expiration expected, and what implications does this have?
Patents expire around 2023-2025, opening the market for generics, which could reduce revenues by up to 70%.

3. How does Efinaconazole compare with oral antifungal therapies?
Topicals like Efinaconazole have fewer systemic side effects but lower efficacy. Oral therapies offer higher cure rates but with increased safety risks.

4. What opportunities exist for expanding Efinaconazole’s use?
Developing new formulations, combination therapies, or expanding into other fungal infections could provide growth avenues.

5. Which regions offer the greatest expansion potential?
Emerging markets like China, India, and Latin America present significant growth prospects due to high disease prevalence and unmet needs.

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References

[1] U.S. Food and Drug Administration. (2014). Jublia (efinaconazole) topical solution, FDA approval letter.

[2] European Medicines Agency. (2017). Efinaconazole summary of opinion.

[3] MarketWatch. (2022). Onychomycosis treatment market report.

[4] Brandessence Market Research. (2023). Global antifungal drugs market insights.

[5] Bausch Health. (2022). Annual report and product pipeline updates.