Naftifine hydrochloride - Generic Drug Details

What are the generic sources for naftifine hydrochloride and what is the scope of freedom to operate?

Naftifine hydrochloride is the generic ingredient in two branded drugs marketed by Amneal, Sun Pharma Canada, Xiromed, and Legacy Pharma, and is included in nine NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Naftifine hydrochloride has three patent family members in three countries.

There are seven drug master file entries for naftifine hydrochloride. Four suppliers are listed for this compound.

Summary for naftifine hydrochloride

International Patents:	3
US Patents:	6
Tradenames:	2
Applicants:	4
NDAs:	9
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	9
Patent Applications:	1,433
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for naftifine hydrochloride
What excipients (inactive ingredients) are in naftifine hydrochloride?	naftifine hydrochloride excipients list
DailyMed Link:	naftifine hydrochloride at DailyMed

Recent Clinical Trials for naftifine hydrochloride

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

Sponsor	Phase
GenZum Life Sciences LLC	Phase 3
Semler Research Center Pvt. Ltd.	Phase 3
Genzum Life Sciences	Phase 3

See all naftifine hydrochloride clinical trials

Pharmacology for naftifine hydrochloride

Drug Class

Allylamine Antifungal

Anatomical Therapeutic Chemical (ATC) Classes for naftifine hydrochloride

D01AE	Other antifungals for topical use
D01A	ANTIFUNGALS FOR TOPICAL USE
D01	ANTIFUNGALS FOR DERMATOLOGICAL USE
D	Dermatologicals

Paragraph IV (Patent) Challenges for NAFTIFINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NAFTIN	Gel	naftifine hydrochloride	2%	204286	1	2015-02-04

US Patents and Regulatory Information for naftifine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Legacy Pharma	NAFTIN	naftifine hydrochloride	GEL;TOPICAL	204286-001	Jun 27, 2013	AB	RX	Yes	Yes	10,695,303		Y
Legacy Pharma	NAFTIN	naftifine hydrochloride	GEL;TOPICAL	204286-001	Jun 27, 2013	AB	RX	Yes	Yes	10,166,205		Y
Legacy Pharma	NAFTIN	naftifine hydrochloride	GEL;TOPICAL	204286-001	Jun 27, 2013	AB	RX	Yes	Yes	10,729,667		Y
Sun Pharma Canada	NAFTIFINE HYDROCHLORIDE	naftifine hydrochloride	GEL;TOPICAL	208201-001	Apr 10, 2019	AB	RX	No	No
Amneal	NAFTIFINE HYDROCHLORIDE	naftifine hydrochloride	CREAM;TOPICAL	206960-001	Apr 10, 2017	AB	RX	No	No

Expired US Patents for naftifine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Legacy Pharma	NAFTIN	naftifine hydrochloride	CREAM;TOPICAL	019599-001	Feb 29, 1988	4,282,251
Legacy Pharma	NAFTIN	naftifine hydrochloride	GEL;TOPICAL	019356-001	Jun 18, 1990	4,828,251
Legacy Pharma	NAFTIN	naftifine hydrochloride	GEL;TOPICAL	019356-001	Jun 18, 1990	4,282,251

International Patents for naftifine hydrochloride

Country	Patent Number	Title	Estimated Expiration
Australia	2014212201	Topical compositions and methods for making and using same
Canada	2899725
World Intellectual Property Organization (WIPO)	2014121048
Australia	2014212201
Canada	2899725	COMPOSITIONS TOPIQUES ET PROCEDES DE PREPARATION ET D'UTILISATION CORRESPONDANTS (TOPICAL COMPOSITIONS AND METHODS FOR MAKING AND USING SAME)

Market Dynamics and Financial Trajectory for Naftifine Hydrochloride

Last updated: July 27, 2025

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Introduction

Naftifine hydrochloride is an antifungal agent primarily used to treat dermatophyte infections, including tinea corporis, tinea cruris, tinea pedis, and candidiasis. Among topical antifungals, naftifine hydrochloride demonstrates a strong efficacy profile, distinct pharmacokinetics, and a growing adoption rate driven by rising dermatological conditions worldwide. Analyzing its market dynamics and financial trajectory offers insights into potential investment opportunities, R&D focus, and competitive landscapes in the antifungal sector.

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Pharmaceutical Profile and Therapeutic Applications

Naftifine hydrochloride operates by inhibiting squalene epoxidase, a key enzyme in fungal ergosterol biosynthesis, leading to fungal cell membrane disruption. Its topical formulation enables high local drug concentrations with minimal systemic absorption, thereby reducing adverse effects primarily associated with systemic antifungal agents (e.g., griseofulvin, itraconazole).

The drug's applications extend primarily within the dermatological domain, with off-label uses emerging due to its broad-spectrum antifungal activity. The product formulations include creams, gels, and solutions, tailored to different infection sites.

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Market Drivers

Rising Incidence of Fungal Infections

The increasing prevalence of dermatophyte infections correlates with evolving lifestyle and environmental factors. Urbanization, higher population density, and climate change facilitate the spread and persistence of fungal pathogens. The global burden of superficial fungal infections affects an estimated 20-25% of the population, with developing regions reporting higher incidences due to poorer hygiene and limited access to healthcare (source: WHO).

Growing Dermatological Disease Awareness

Heightened awareness campaigns and improved diagnostics facilitate early detection, leading to increased prescriptions of antifungal agents like naftifine hydrochloride. Dermatological wellness trends also drive consumer demand for over-the-counter formulations.

Regulatory and Patent Developments

The expiration of patents for several antifungal agents has created an environment ripe for the entry of generic naftifine hydrochloride products, increasing market accessibility and driving revenues. Regulatory approvals in emerging markets expand the geographic footprint, fueling market expansion.

Competitive Advantage of Topical Formulations

Compared to systemic antifungals, topical agents such as naftifine offer a favorable safety profile, promoting their preference among clinicians for localized infections. This advantage further boosts adoption rates, especially for recurrent or mild infections.

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Market Challenges

Limited Product Differentiation

Generic naftifine hydrochloride formulations face commoditization, leading to price competition. Differentiation based on formulation technology or combination therapies becomes essential for market share gains.

Competition from Other Antifungals

Broad-spectrum agents like terbinafine, clotrimazole, and newer antifungal classes offer substantial competition. The efficacy, safety, and pricing profiles influence prescribing patterns considerably.

Regulatory Barriers and Intellectual Property

While patent cliffs facilitate generic entry, some formulations or combinations may still be protected, creating barriers for new entrants and affecting market dynamics.

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Financial Trajectory

Market Valuation and Size Projections

The global topical antifungal market was valued at approximately $2 billion in 2022, with projections indicating a compound annual growth rate (CAGR) of around 4-6% over the next five years, driven primarily by naftifine hydrochloride and similar agents (source: Grand View Research).

Estimated market share for naftifine hydrochloride remains modest, mainly held by key regional players and generics. The segment is expected to grow proportionally as dermatophyte infections increase and more formulations reach emerging markets.

Revenue Trends

In established markets such as North America and Europe, naftifine products hold a steady, albeit competitive, revenue flow dominated by patent expirations and generics. The financial trajectory for innovators hinges on strategic differentiation, patent preservation, and expansion into new indications.

Emerging markets present considerable growth potential, with revenue opportunities spanning APAC, Latin America, and Africa where dermatological needs are surging. Investments in local manufacturing and regulatory alignments will influence revenue streams.

Pricing Dynamics and Reimbursement

Pricing strategies are affected by local regulatory policies, market maturity, and competitive pressures. In markets with publicly financed healthcare systems, reimbursement policies substantially influence sales volume and profitability.

Despite the commoditization trend, premium formulations blending naftifine with novel excipients or in combination therapies can command higher prices, potentially improving margins.

Research & Development Impact

R&D investments aim to enhance formulations, improve bioavailability, and expand indications. Proprietary combination products or sustained-release formulations could command premium pricing, impacting long-term revenue trajectories.

Emerging technologies, such as nanotechnology-based delivery systems and biofilm-targeted formulations, may revolutionize treatment modalities for resistant or recurrent infections. Early-stage investments in such R&D activities indicate potential future revenue growth pathways.

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Market Players and Competitive Landscape

The competitive environment predominantly comprises generic manufacturing companies, with a few regional pharmaceutical firms leading in marketing and distribution. Notable players include Dr. Reddy’s Laboratories, Aurobindo Pharma, and Sun Pharmaceutical Industries, among others.

Innovative startups and biotech firms are exploring formulations combining naftifine with other antifungal agents, aiming for synergistic effects and enhanced patient adherence.

The entry of new players into emerging markets, coupled with strategic licensing agreements, influences market share distribution and pricing strategies.

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Regulatory and Patent Considerations

Patents protecting specific formulations or delivery mechanisms of naftifine hydrochloride have limited expiry timelines, opening avenues for generics. Regulatory approval processes—especially in Asian and Latin American markets—are streamlined relative to stringent regions like the USA and EU, enabling faster market penetration.

Ongoing patent litigations and exclusivity periods significantly impact product launch timelines and revenue forecasts.

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Future Outlook and Growth Opportunities

The future of naftifine hydrochloride hinges on:

• Formulation innovations that improve patient compliance and efficacy.
• Expansion into new indications, such as onychomycosis or systemic infections, where topical agents currently have limited roles.
• Market expansion in untapped regions driven by improving healthcare infrastructure.
• Combination therapies that leverage synergistic effects and combat antifungal resistance challenges.

Given the rising burden of superficial fungal infections worldwide, compounded by increasing awareness and diagnosis, industry forecasts project a steady, moderate growth trajectory for naftifine hydrochloride-based products over the next decade.

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Key Takeaways

• Growing demand: The worldwide increase in dermatophyte infections, especially in developing countries, sustains demand for antifungal agents like naftifine hydrochloride.
• Competitive landscape: The market remains fragmented with high generic penetration, challenging differentiation but presenting opportunities for innovative formulations.
• Revenue outlook: The global topical antifungal market is forecasted to grow at a CAGR of around 4-6% through 2028, with naftifine hydrochloride maintaining a modest but stable share.
• Regulatory environment: Patent expiries enable generic proliferation, but newer formulations and combination therapies could offer premium opportunities.
• Strategic growth: Investment in R&D, regional market expansion, and formulation innovation are vital for capturing emerging growth opportunities.

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FAQs

1. What factors influence the pricing of naftifine hydrochloride products?
Pricing is affected by market maturity, regulatory policies, competition from generics, formulation technology, and reimbursement structures, with advanced formulations commanding higher margins.

2. How does patent expiration impact the market for naftifine hydrochloride?
Patent expiries lead to increased generic competition, reducing prices but expanding market access, especially in emerging markets. They also incentivize innovation to sustain premium offerings.

3. What is the revenue potential for naftifine hydrochloride in emerging markets?
Significant, driven by rising dermatological health awareness, increasing prevalence of infections, and relatively streamlined regulatory frameworks, enabling faster commercialization.

4. How are R&D efforts shaping the future of naftifine hydrochloride?
R&D is focused on improved formulations, combination drugs, and expanding indications—these efforts can generate higher-value products and address resistance issues.

5. What competitive strategies are employed by pharmaceutical companies in this segment?
Strategies include formulation innovation, geographic expansion, aggressive marketing, partnerships, and pursuing regulatory approvals for new indications to sustain revenue streams.

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References

1. Grand View Research. "Topical Antifungal Market Size, Share & Trends Analysis." 2022.
2. World Health Organization. "Fungal Infections: Epidemiology and Burden." 2020.
3. MarketWatch. "Antifungal Drugs Market Forecast." 2023.
4. US Patent and Trademark Office. "Patent Status and Expiry Timeline for Topical Antifungals." 2022.
5. PharmaTimes. "Innovations in Antifungal Formulations." 2022.