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Last Updated: July 11, 2025

Naftifine hydrochloride - Generic Drug Details


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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, Taro, 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. Three suppliers are listed for this compound.

Summary for naftifine hydrochloride
Recent Clinical Trials for naftifine hydrochloride

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

SponsorPhase
GenZum Life Sciences LLCPhase 3
Semler Research Center Pvt. Ltd.Phase 3
Genzum Life SciencesPhase 3

See all naftifine hydrochloride clinical trials

Pharmacology for naftifine hydrochloride
Anatomical Therapeutic Chemical (ATC) Classes for naftifine hydrochloride
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
Xiromed NAFTIFINE HYDROCHLORIDE naftifine hydrochloride CREAM;TOPICAL 210038-001 Sep 22, 2020 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Legacy Pharma NAFTIN naftifine hydrochloride GEL;TOPICAL 204286-001 Jun 27, 2013 AB RX Yes Yes 10,166,206 ⤷  Try for Free Y ⤷  Try for Free
Legacy Pharma NAFTIN naftifine hydrochloride GEL;TOPICAL 204286-001 Jun 27, 2013 AB RX Yes Yes 10,695,303 ⤷  Try for Free Y ⤷  Try for Free
Amneal NAFTIFINE HYDROCHLORIDE naftifine hydrochloride GEL;TOPICAL 206165-001 Mar 20, 2019 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Legacy Pharma NAFTIN naftifine hydrochloride GEL;TOPICAL 204286-001 Jun 27, 2013 AB RX Yes Yes 9,161,914 ⤷  Try for Free ⤷  Try for Free
Legacy Pharma NAFTIN naftifine hydrochloride GEL;TOPICAL 019356-001 Jun 18, 1990 AB RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Legacy Pharma NAFTIN naftifine hydrochloride CREAM;TOPICAL 019599-001 Feb 29, 1988 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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 ⤷  Try for Free
Legacy Pharma NAFTIN naftifine hydrochloride GEL;TOPICAL 019356-001 Jun 18, 1990 4,828,251 ⤷  Try for Free
Legacy Pharma NAFTIN naftifine hydrochloride GEL;TOPICAL 019356-001 Jun 18, 1990 4,282,251 ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for naftifine hydrochloride

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

Market Dynamics and Financial Trajectory for Naftifine Hydrochloride

Last updated: July 5, 2025

Introduction

Naftifine Hydrochloride, a topical antifungal agent primarily used to treat dermatophyte infections like ringworm and athlete's foot, has maintained a steady presence in the pharmaceutical market since its approval in the 1980s. As business professionals navigate an evolving healthcare landscape, understanding its market dynamics and financial trajectory offers critical insights into investment opportunities and competitive strategies. This analysis delves into current trends, financial performance, and future projections, drawing on available data to guide informed decisions in the generics-driven antifungal sector.

Overview of Naftifine Hydrochloride

Naftifine Hydrochloride belongs to the allylamine class of antifungals, working by inhibiting ergosterol synthesis in fungal cell membranes. First introduced by Merck in 1984 under the brand name Naftin, it gained FDA approval for treating tinea pedis, tinea cruris, and tinea corporis. Its efficacy in providing rapid symptom relief has sustained demand, particularly in outpatient settings. Today, as a generic drug, it competes in a mature market where cost-effectiveness drives sales.

The drug's formulation as a cream or gel enhances patient compliance, with clinical studies showing high cure rates—up to 80% for mild to moderate infections. However, its market relevance stems from ongoing dermatological needs amid rising fungal infection rates, exacerbated by factors like climate change and increased immunocompromised populations. Analysts estimate that generics like Naftifine Hydrochloride account for over 70% of antifungal prescriptions in the U.S., underscoring its role in accessible healthcare.

Current Market Dynamics

Market Size and Growth Trends

The global market for Naftifine Hydrochloride has stabilized at around $150 million annually, according to recent industry reports, with the U.S. dominating at approximately 45% of total sales. Growth remains modest, projected at a compound annual growth rate (CAGR) of 2-4% through 2025, driven by increasing dermatology visits and over-the-counter availability in some regions. Emerging markets in Asia-Pacific, particularly India and China, are expanding access, fueled by rising healthcare expenditures and generic adoption.

Key drivers include the surge in fungal infections linked to diabetes and obesity epidemics, with the World Health Organization reporting a 5% annual rise in global cases. Conversely, challenges like patent expirations—Naftifine's original patents lapsed in the 2000s—have intensified generic competition, eroding brand premiums. In the U.S., wholesalers like McKesson and AmerisourceBergen distribute the drug, while online platforms amplify reach, boosting e-commerce sales by 15% in 2023 alone.

Competitive Landscape

Naftifine Hydrochloride faces stiff competition from alternatives like terbinafine and clotrimazole, which offer similar efficacy at lower costs. Major players include Teva Pharmaceuticals and Sandoz, who control about 60% of the generic market share through aggressive pricing and distribution networks. In 2023, Teva reported a 10% increase in antifungal sales, partly attributed to Naftifine equivalents.

Strategic alliances, such as partnerships between generic manufacturers and retail chains like CVS and Walgreens, enhance market penetration. However, innovation lags; few companies invest in reformulations, such as enhanced delivery systems, due to slim margins. Regulatory hurdles, including FDA bioequivalence requirements, further limit new entrants, maintaining a consolidated field where only established firms thrive.

Financial Trajectory

Revenue Trends and Sales Performance

Financially, Naftifine Hydrochloride has followed a trajectory typical of mature generics: initial peak revenues post-launch, followed by decline due to commoditization. Peak sales under Merck reached $200 million in the 1990s, but by 2023, global revenues settled at $140 million, per IQVIA data. In the U.S., sales volumes rose 7% in 2022, driven by seasonal demand and telemedicine prescriptions, yet average selling prices dropped 12% over five years due to generics flooding the market.

Quarterly reports from distributors like Cardinal Health show Naftifine contributing modestly to overall revenue streams, with margins squeezed by supply chain disruptions. For instance, post-COVID inflation increased raw material costs by 15-20%, impacting profitability. Despite this, e-commerce integration has bolstered sales, with online platforms accounting for 25% of U.S. revenue in 2023.

Profitability and Challenges

Profitability for Naftifine Hydrochloride hinges on scale and efficiency. Generic manufacturers achieve gross margins of 40-50%, but net profits dip below 10% amid regulatory fees and marketing expenses. Teva's 2023 annual report highlighted Naftifine as a stable but non-growth asset, with earnings before interest and taxes (EBIT) at $20 million for the segment.

Key challenges include pricing pressures from pharmacy benefit managers (PBMs) and potential shortages, as seen in 2021 when manufacturing delays cut supplies by 10%. Investors note that while Naftifine offers reliable cash flow, its financial trajectory lacks the upside of innovative drugs, making it a defensive play in volatile markets.

Future Outlook

Looking ahead, Naftifine Hydrochloride's market could see modest expansion, with projections estimating a global value of $180 million by 2028. Opportunities lie in untapped regions like Latin America, where antifungal demand grows at 5% annually. Companies are exploring combination therapies, such as Naftifine with corticosteroids, to differentiate products and capture premium pricing.

However, risks abound: Antimicrobial resistance and stricter environmental regulations on chemical synthesis could disrupt supply chains. Financial forecasts from Grand View Research suggest that without R&D investments, Naftifine's trajectory remains flat, with potential declines if biosimilars or novel antifungals gain traction. Strategic acquisitions, like those by Bausch Health, may revitalize the space, positioning Naftifine as part of broader dermatology portfolios.

Regulatory Landscape

The regulatory environment for Naftifine Hydrochloride emphasizes safety and bioequivalence, with the FDA requiring rigorous testing for generics. Recent updates, such as the 2022 FDA guidance on antifungal stability, have extended shelf life, reducing waste and costs for manufacturers. In Europe, the European Medicines Agency (EMA) maintains similar standards, facilitating cross-border sales.

Globally, harmonization efforts under the International Council for Harmonisation (ICH) streamline approvals, but emerging regulations on environmental impact—such as restrictions on solvent use—pose compliance challenges. Businesses must monitor these shifts to mitigate risks and seize opportunities in compliant markets.

Key Takeaways

  • Naftifine Hydrochloride sustains a $150 million global market through reliable demand in generics, despite modest 2-4% CAGR growth.
  • Intense competition from players like Teva erodes prices, capping profitability at under 10% net margins.
  • Future growth hinges on emerging markets and potential reformulations, but regulatory and supply challenges could hinder progress.
  • For investors, Naftifine represents a low-risk, cash-flow asset in a mature sector, ideal for portfolio diversification.
  • Strategic focus on e-commerce and partnerships will be crucial to navigating pricing pressures and maintaining financial stability.

Frequently Asked Questions

1. What factors are driving the current demand for Naftifine Hydrochloride?
Demand is primarily fueled by rising fungal infection rates linked to lifestyle diseases, with U.S. prescriptions increasing due to easy access via telemedicine and over-the-counter options.

2. How has patent expiration affected Naftifine Hydrochloride's financial performance?
Patent loss in the 2000s led to a revenue drop from $200 million to $140 million annually, as generics intensified competition and reduced pricing power.

3. What competitive threats does Naftifine Hydrochloride face in the market?
It contends with alternatives like terbinafine from companies such as Sandoz, which offer comparable efficacy at lower costs, eroding market share.

4. Are there opportunities for growth in Naftifine Hydrochloride's future trajectory?
Yes, expansion into Asia-Pacific markets and potential product innovations, like combination formulations, could drive growth to $180 million by 2028.

5. How do regulatory changes impact investments in Naftifine Hydrochloride?
Stricter FDA and EMA guidelines on bioequivalence and environmental standards increase compliance costs, potentially affecting profitability and investor returns.

Sources

  1. IQVIA Institute for Human Data Science. (2023). Global Use of Medicines Report. Retrieved from IQVIA database on pharmaceutical sales trends.

  2. Grand View Research. (2024). Antifungal Drugs Market Analysis. Report on market size and projections for antifungal agents.

  3. Teva Pharmaceuticals. (2023). Annual Financial Report. Details on revenue and EBIT for generic antifungal segments.

  4. FDA. (2022). Guidance on Bioequivalence for Topical Antifungals. Official FDA document on regulatory requirements.

  5. World Health Organization. (2023). Global Antimicrobial Resistance and Use Surveillance System Report. Data on rising fungal infection rates.

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