You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 28, 2025

NAFTIN Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Naftin patents expire, and what generic alternatives are available?

Naftin is a drug marketed by Legacy Pharma and is included in three NDAs. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has three patent family members in three countries.

The generic ingredient in NAFTIN is naftifine hydrochloride. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the naftifine hydrochloride profile page.

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for NAFTIN?
  • What are the global sales for NAFTIN?
  • What is Average Wholesale Price for NAFTIN?
Drug patent expirations by year for NAFTIN
Drug Prices for NAFTIN

See drug prices for NAFTIN

Recent Clinical Trials for NAFTIN

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

SponsorPhase
Therapeutics, Inc.Phase 1
GenZum Life Sciences LLCPhase 3
Semler Research Center Pvt. Ltd.Phase 3

See all NAFTIN clinical trials

Pharmacology for NAFTIN
Paragraph IV (Patent) Challenges for NAFTIN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
NAFTIN Gel naftifine hydrochloride 2% 204286 1 2015-02-04

US Patents and Regulatory Information for NAFTIN

NAFTIN is protected by six US patents.

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 CREAM;TOPICAL 019599-001 Feb 29, 1988 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Legacy Pharma NAFTIN naftifine hydrochloride GEL;TOPICAL 204286-001 Jun 27, 2013 AB RX Yes Yes 10,695,303 ⤷  Get Started Free Y ⤷  Get Started Free
Legacy Pharma NAFTIN naftifine hydrochloride GEL;TOPICAL 204286-001 Jun 27, 2013 AB RX Yes Yes 9,161,914 ⤷  Get Started Free ⤷  Get Started Free
Legacy Pharma NAFTIN naftifine hydrochloride GEL;TOPICAL 204286-001 Jun 27, 2013 AB RX Yes Yes 10,166,206 ⤷  Get Started Free Y ⤷  Get Started Free
Legacy Pharma NAFTIN naftifine hydrochloride CREAM;TOPICAL 019599-002 Jan 13, 2012 AB RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Legacy Pharma NAFTIN naftifine hydrochloride GEL;TOPICAL 019356-001 Jun 18, 1990 AB RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started 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 NAFTIN

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

International Patents for NAFTIN

See the table below for patents covering NAFTIN around the world.

Country Patent Number Title Estimated Expiration
Australia 513249 ⤷  Get Started Free
Japan S6149297 ⤷  Get Started Free
Australia 2014212201 ⤷  Get Started Free
Denmark 147068 ⤷  Get Started Free
Kenya 3385 CINNAMYL NAPHTHALENE DERIVATIVE ⤷  Get Started Free
South Africa 7702564 ⤷  Get Started Free
>Country >Patent Number >Title >Estimated Expiration

Market Dynamics and Financial Trajectory for NAFTIN (Nifurate)

Last updated: July 27, 2025

Introduction

Naftin, the brand name for nifurate, is a topical antifungal medication primarily used to treat superficial fungal skin infections, including athlete’s foot, ringworm, and jock itch. Since its market introduction, Naftin has maintained a consistent presence within dermatology and anti-infective portfolios. Analyzing its current market dynamics and financial trajectory necessitates an understanding of its historical performance, competitive landscape, regulatory environment, and emerging trends influencing its future.

Market Overview and Current Position

Naftin holds a moderate but stable share within the dermatological antifungal segment. The global antifungal market is projected to grow at a compound annual growth rate (CAGR) of approximately 4% from 2022 to 2028, driven by rising incidence of fungal infections, expanding dermatological healthcare awareness, and increased prescription rates [1]. Naftin's niche focuses primarily on topical formulations, which constitute a significant segment of the antifungal market due to their favorable safety profile and ease of use.

Segment Performance and Regional Trends

North America and Europe dominate the antifungal topical market, attributed to high healthcare expenditures, rigorous diagnostic protocols, and widespread consumer awareness. Emerging economies, particularly in Asia-Pacific, demonstrate rapid growth fueled by increasing urbanization, changing lifestyles, and expanding pharmaceutical infrastructure.

Naftin's revenues are predominantly derived from these mature markets, with potential headroom in emerging economies. Its performance in these regions remains contingent on regulatory approval, local manufacturing partnerships, and market penetration strategies.

Competitive Landscape

Naftin faces competition from several antifungal agents, both topical and systemic. Key competitors include:

  • Clotrimazole and miconazole: Over-the-counter and prescription antifungals with wider availability and lower costs.
  • Terbinafine: A systemic and topical antifungal with a broader spectrum and strong efficacy profile.
  • Efinaconazole and tavaborole: Newer topical agents with advanced formulations targeting resistant strains.

Despite competitive pressure, Naftin maintains a distinctive position owing to its proven efficacy, tolerability, and brand recognition established over decades.

Differentiators and Market Positioning

Naftin’s differentiators include:

  • Proven safety profile with minimal adverse effects.
  • Clinical data supporting efficacy in various superficial fungal infections.
  • Established physician trust and familiarity.

However, the trend toward OTC availability for certain antifungals and the rising preference for combination therapies challenge Naftin’s exclusivity.

Regulatory Landscape and Patent Considerations

Naftin’s patent expirations vary by jurisdiction but generally occurred several years ago, leading to increased generic competition. This has pressed down prices and margins in several markets. Regulatory bodies like the FDA and EMA continue to oversee manufacturing standards, while regional approvals influence geographic market access.

As patent protections decline, manufacturers often adopt strategies such as formulation improvements or combination products to extend exclusivity, though such interventions are less prevalent for older drugs like Naftin.

Innovation and Future Opportunities

To sustain growth, stakeholders are exploring several avenues:

  • Formulation enhancements: Developing novel delivery systems (e.g., liposomal or nanoemulsion formulations) to improve penetration and efficacy.
  • Therapeutic expansions: Investigating off-label uses or broader indications, such as resistant fungal infections or dermatophytic conditions.
  • Combination therapies: Pairing Naftin with anti-inflammatory agents or other antifungals to enhance outcomes.
  • Digital health integration: Leveraging telemedicine for prescription and adherence monitoring.

Investments in research and development (R&D) may bring incremental innovations, but the core product faces intrinsic limitations due to its age and the commoditization trend in topical antifungals.

Market Dynamics Influencing Financial Trajectory

Pricing and Reimbursement

Prices for topical antifungals like Naftin are sensitive to generic entry, insurance coverage policies, and healthcare payer negotiations. With increased generic competition, profit margins have declined, emphasizing the importance of cost management and strategic market positioning.

Demand Drivers

Rising prevalence of fungal skin infections (approximately 20-25% globally) correlates directly with Naftin’s revenue potential. Demographic shifts, particularly aging populations and increased immunosuppression, may further elevate demand, provided the product remains competitive.

Market Penetration and Expansion Strategies

Pharmaceutical companies focus on expanding access in emerging markets through licensing, partnerships, and local manufacturing. Differentiated branding initiatives aimed at clinicians also influence prescribing patterns.

Regulatory and Patent Risks

Patent expirations and regulatory hurdles introduce revenue volatility. Intellectual property protections that previously secured long-term market exclusivity are weakening, requiring ongoing adaptation and innovation.

Impact of Digital and Prescriptive Trends

The modernization of healthcare delivery—through teledermatology and electronic prescriptions—enhances the reach for topical therapies like Naftin. Conversely, the proliferation of OTC options and transfer of some antifungal sales outside prescription channels restrain growth.

Financial Outlook and Earnings Trajectory

The financial trajectory for Naftin hinges on multiple factors:

  • Revenue projections suggest plateauing or marginal declines in mature markets due to generic competition.
  • Cost optimization and manufacturing efficiencies may mitigate margins erosion.
  • Potential expansion in emerging markets can generate incremental revenue streams, though margins may be somewhat thinner.
  • R&D expenditures on formulation innovation are small relative to overall sales but could yield moderate long-term benefits.

Overall, Naftin’s financial growth is expected to be modest, aligning with the broader trend of mature dermatological products—that is, slow but resilient performance informed by market penetration management and incremental innovation.

Strategic Considerations for Stakeholders

  • Manufacturers should prioritize differentiated formulations or combination therapies to maintain market share.
  • Investors and licensees need to monitor patent landscapes and regulatory changes closely to manage revenue risks.
  • Market analysts should consider regional growth potential, especially in underserved geographies, to project future revenue streams.

Key Challenges and Opportunities

Challenges:

  • Declining patent protections leading to intense price competition.
  • Increased OTC availability reducing prescription-driven sales.
  • Regulatory barriers in emerging markets delaying growth.

Opportunities:

  • Innovating formulations for better efficacy and patient adherence.
  • Expanding into new indications with clinical trial support.
  • Strengthening presence in emerging regions through strategic partnerships.

Conclusion

Naftin’s market dynamics reveal a product navigating mature phase attributes—marked by competition, price pressures, and patent expirations. Its financial trajectory is anticipated to stabilize with slow growth, contingent upon innovation, regional expansion, and strategic repositioning. Stakeholders who effectively harness these levers may preserve or enhance Naftin’s value amid evolving dermatological therapy landscapes.


Key Takeaways

  • Naftin maintains a stable yet competitive position within the topical antifungal market, with growth driven chiefly by regional expansion and incremental innovation.
  • Patent expirations and generic entry have pressured margins but also spurred differentiation through formulation improvements.
  • Emerging markets offer significant growth potential, contingent on regulatory approval and local manufacturing collaborations.
  • Ongoing innovations such as advanced delivery systems and combination therapies are vital strategies for prolonging product lifecycle.
  • The shifting landscape toward OTC options and digital health solutions necessitates adaptable marketing and distribution approaches.

FAQs

  1. What is the primary use of Naftin?
    Naftin (nifurate) is primarily used to treat superficial fungal infections like athlete's foot, ringworm, and jock itch through topical application.

  2. How has patent expiration affected Naftin’s market?
    Patent expirations have led to increased generic competition, reducing prices and profit margins, and emphasizing the need for product differentiation.

  3. Are there significant growth opportunities for Naftin in emerging markets?
    Yes. Rising demand for dermatological treatments, improving healthcare infrastructure, and increasing awareness make emerging markets promising for Naftin’s expansion.

  4. What strategies can extend Naftin’s market life cycle?
    Formulation improvements, exploring new indications, combination therapies, and leveraging digital health tools can help prolong its relevance.

  5. What are the main challenges facing Naftin’s future?
    Major challenges include generic price competition, OTC market shifts, regulatory barriers, and the need for continual innovation.


References
[1] MarketWatch. "Global Antifungal Market Size, Share & Trends Analysis," 2022–2028.

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.