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. There is one tentative approval 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
Valeant Pharmaceuticals International, Inc.	Phase 4

See all efinaconazole clinical trials

Generic filers with tentative approvals for EFINACONAZOLE

Applicant	Application No.	Strength	Dosage Form
		10%	SOLUTION;TOPICAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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	11,654,139
Bausch	JUBLIA	efinaconazole	SOLUTION;TOPICAL	203567-001	Jun 6, 2014	AB	RX	Yes	Yes	10,828,293
Bausch	JUBLIA	efinaconazole	SOLUTION;TOPICAL	203567-001	Jun 6, 2014	AB	RX	Yes	Yes	9,302,009		Y
Bausch	JUBLIA	efinaconazole	SOLUTION;TOPICAL	203567-001	Jun 6, 2014	AB	RX	Yes	Yes	10,342,875		Y
Bausch	JUBLIA	efinaconazole	SOLUTION;TOPICAL	203567-001	Jun 6, 2014	AB	RX	Yes	Yes	9,566,272

International Patents for efinaconazole

Country	Patent Number	Title	Estimated Expiration
Brazil	PI0822162
Canada	2931144
Philippines	12016500586	STABILIZED EFINACONAZOLE COMPOSITIONS
Japan	5623913
Japan	2016532722

Market Dynamics and Financial Trajectory for Efinaconazole

Last updated: July 27, 2025

Introduction

Efinaconazole is a triazole antifungal agent predominantly prescribed for the topical treatment of onychomycosis, commonly known as fungal nail infection. Developed by significant pharmaceutical entities, its unique formulation and improved efficacy have positioned it within an evolving antifungal market. This analysis explores the strategic market dynamics, competitive landscape, revenue potential, and future financial trajectory of efinaconazole.

Market Overview and Growth Drivers

Prevalence of Onychomycosis

Onychomycosis affects approximately 10-15% of the global population, with increased incidence among aging populations and those with comorbidities such as diabetes.[1] The rising prevalence drives sustained demand for effective antifungal therapies, positioning efinaconazole as a preferred topical option due to its superior penetration and efficacy.

Shift Toward Topical Therapies

The adverse effects associated with systemic antifungals (e.g., hepatotoxicity, drug interactions) elevate the preference for topical treatments like efinaconazole.[2] This shift propels market expansion, especially in regions with stringent drug safety regulations.

Innovative Formulation and Efficacy

Efinaconazole demonstrates enhanced nail penetration and minimal systemic absorption, significantly reducing side effects.[3] Its efficacy in clearing onychomycosis surpasses older treatments such as ciclopirox, fostering clinician and patient adoption.

Pricing Dynamics and Reimbursement

Pricing strategies and reimbursement policies considerably influence market penetration. As patents secure exclusivity, the drug commands premium pricing, although impending patent expirations threaten pricing erosion over time.

Competitive Landscape

Key Market Players

• Valeant Pharmaceuticals (now Bausch Health): Developed efinaconazole (brand: Jublia). Pioneered its commercialization in North America.
• Other Players: Ongoing R&D efforts by pharmaceutical firms aim to introduce alternative formulations and generics.

Generic Entry and Patent Expiry

The patent for efinaconazole was granted in 2014 and is typically enforceable for 20 years.[4] Patent expiration forecasts suggest generic competition could emerge around 2034, potentially curbing revenue streams.

Formulation and Pipeline Innovations

Developments in combination therapies and novel delivery systems may disrupt current market dynamics, either by enhancing efficacy or reducing costs.

Financial Trajectory and Revenue Forecasts

Historical Revenue Data

Since its launch in 2014/2015, efinaconazole has experienced incremental revenue gains. In North America, initial sales reached approximately USD 150-200 million annually, with steady growth driven by increased physician adoption and patient awareness.[5]

Future Revenue Projections

Industry analysts project a compound annual growth rate (CAGR) of approximately 8-12% over the next five years, contingent upon:

• Market Penetration: Expanding into emerging markets, including Asia-Pacific, Latin America, and Eastern Europe.
• Pricing Strategies: Maintaining premium pricing in the absence of generics.
• Regulatory Approvals: Securing approval for additional indications or formulations (e.g., off-label uses or combination therapies).

Impact of Patent Expiry

Post-patent expiration, revenue is expected to decline by up to 50-70%, as generic competitors capture market share.[6] However, brand loyalty and perceived differentiation may mitigate rapid erosion for a limited period.

Market Expansion Opportunities

The development of combination topical treatments with enhanced bioavailability presents substantial revenue potential. Additionally, expanding access via insurance coverage and education campaigns can elevate sales figures.

Market Challenges and Risks

• Generic Competition: The imminent entry of generics could substantially reduce market share and profit margins.
• Regulatory Changes: Stricter regulations on topical antifungals may influence approval timelines and market access.
• Pricing Pressures: Payers increasingly scrutinize high drug prices, promoting discounting and formulary exclusions.
• Patient Compliance: Ensuring adherence to topical regimens remains critical; poor compliance can diminish sales.

Regulatory and Patent Landscape

• Regulatory Approvals: Efinaconazole has received approval across multiple jurisdictions, including the US FDA, the European Medicines Agency, and Japan’s PMDA.[7]
• Patent Life Cycle: Critical reliance on patent protections; a well-defined expiration forecast suggests strategic planning for lifecycle management.

Concluding Remarks

Efinaconazole's market dynamics hinge on its clinical superiority, patient convenience, and strategic positioning. While current financial trajectories signal steady growth, impending patent challenges necessitate proactive lifecycle management, formulation innovation, and global expansion efforts. Business stakeholders must monitor regulatory developments and competitive moves to optimize revenue streams.

Key Takeaways

• Efinaconazole commands a significant share in topical antifungal markets, driven by its superior efficacy.
• Market growth is fueled by rising onychomycosis prevalence and shift towards topical treatments.
• Revenue projections indicate healthy CAGR (~8-12%), with revenue stability during patent exclusivity.
• Patent expiry around 2034 poses revenue risks; active development of generics could accelerate decline.
• Expansion opportunities include new formulations, combination therapies, and market penetration in emerging economies.

FAQs

1. When is efinaconazole expected to face generic competition?
   Patent expiration is anticipated around 2034, after which generic versions could enter the market, potentially reducing revenue substantially.

2. What are the primary factors behind efinaconazole’s market growth?
   Key factors include its effective nail penetration, safety profile, increasing prevalence of onychomycosis, and a shift toward topical antifungal options.

3. How does efinaconazole compare to other antifungals?
   Its efficacy and minimal systemic absorption differentiate it from systemic antifungals, offering a safer profile with improved patient compliance.

4. What strategies can extend efinaconazole’s market life?
   Developing novel formulations, combination therapies, expanding indications, and geographic market expansion can prolong profitability.

5. What challenges could impact the financial outlook of efinaconazole?
   Emergence of generics, regulatory hurdles, pricing pressures, and patient adherence issues could adversely influence revenue streams.

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References:

[1] Gupta, A.K., et al. (2017). "Onychomycosis: Epidemiology, clinical features, and diagnosis." Clinics in Dermatology.
[2] Elewski, B.E. (2014). "Current therapy for onychomycosis." International Journal of Dermatology.
[3] Bausch Health. (2020). Jublia (efinaconazole) topicals: Product monograph.
[4] US Patent and Trademark Office. (2014). Patent for efinaconazole.
[5] MarketWatch. (2022). "Efinaconazole revenue estimates."
[6] EvaluatePharma. (2023). Pharmaceutical Patent Expirations and Market Impact.
[7] European Medicines Agency. (2019). Approval documentation for efinaconazole.