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Last Updated: March 19, 2026

LAMISIL AT Drug Patent Profile


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When do Lamisil At patents expire, and when can generic versions of Lamisil At launch?

Lamisil At is a drug marketed by Karo Hlthcare and is included in two NDAs.

The generic ingredient in LAMISIL AT is terbinafine hydrochloride. There are twenty-seven drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the terbinafine hydrochloride profile page.

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Summary for LAMISIL AT
US Patents:0
Applicants:1
NDAs:2

US Patents and Regulatory Information for LAMISIL AT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Karo Hlthcare LAMISIL AT terbinafine GEL;TOPICAL 021958-001 Jul 24, 2006 OTC Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Karo Hlthcare LAMISIL AT terbinafine hydrochloride SOLUTION;TOPICAL 021124-001 Mar 17, 2000 OTC Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Karo Hlthcare LAMISIL AT terbinafine hydrochloride SPRAY;TOPICAL 021124-002 Mar 17, 2000 OTC 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

International Patents for LAMISIL AT

See the table below for patents covering LAMISIL AT around the world.

Country Patent Number Title Estimated Expiration
Germany 19975055 ⤷  Get Started Free
Austria 366660 ⤷  Get Started Free
Taiwan 252920 ⤷  Get Started Free
Philippines 22166 PROPENYLAMINES, METHOD OF USE, PHARMACEUTICAL COMPOSITION CONTAINING THEM ⤷  Get Started Free
Japan S63313753 PROPENYLAMINES, MANUFACTURE, DRUG COMPOSITION AND USE AS MEDICINE ⤷  Get Started Free
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for LAMISIL AT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0024587 93C0136 Belgium ⤷  Get Started Free PRODUCT NAME: TERBINAFINE (250 MG) SOUS FORME DE CHLORHYDRATE (281,25 MG); NAT. REG.: 616 S 201 F3 19911031; FIRST REG.: GB PL 0101/0304 19901003
0024587 SPC/GB93/096 United Kingdom ⤷  Get Started Free SPC/GB93/096, EXPIRES: 20050805
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Investment Scenario, Market Dynamics, and Financial Trajectory for LAMISIL AT

Last updated: February 3, 2026

Executive Summary

Lamisil AT (terbinafine hydrochloride) is an over-the-counter (OTC) topical antifungal medication approved primarily for the treatment of athlete’s foot, jock itch, and ringworm. As a well-established drug with a broad dermatological application, Lamisil AT occupies a significant position in the OTC antifungal segment. This report explores its current market landscape, growth potential, investment viability, and future financial trajectory, with detailed analysis of market drivers, competitive environment, regulatory factors, and projected revenues.


Table of Contents

  1. Market Overview and Historical Performance
  2. Current Market Dynamics for Lamisil AT
  3. Competitive Landscape and Key Players
  4. Regulatory and Patent Status
  5. Market Drivers and Restraints
  6. Financial Trajectory and Forecasts
  7. Investment Analysis
  8. Comparative Assessment with Competitors
  9. Future Outlook and Opportunities
  10. Key Takeaways
  11. FAQs

1. Market Overview and Historical Performance

Lamisil AT’s active component, terbinafine, is a fungicidal agent with efficacy against dermatophytes. Introduced as an OTC product in the early 1990s, it has maintained a leading market position globally, driven by high consumer recognition and robust distribution channels.

Year Global OTC Antifungal Market Size (USD billion) Lamisil AT Market Share (%) Estimated Revenue (USD million)
2018 1.2 30 360
2019 1.4 32 448
2020 1.5 34 510
2021 1.6 33 528
2022 1.8 35 630

Source: Market Research Future, 2023

The steady growth reflects increased awareness, self-treatment preferences, and expanding distribution channels.


2. Current Market Dynamics for Lamisil AT

Market Penetration and Consumer Preferences

  • Dominates OTC antifungal segment with approximately 35% market share globally.
  • Strong presence in North America, Europe, and emerging markets.
  • Consumer preference driven by efficacy, brand recognition, and OTC accessibility.

Distribution Channels

  • Pharmacies, online platforms, supermarkets, and direct OTC retail.
  • Digital channels gaining prominence, offering potential for increased sales.

Pricing Strategies

  • Premium but competitive pricing compared to generics.
  • Discounting in mature markets to maintain market share.

3. Competitive Landscape and Key Players

Company Product(s) Market Share (%) Key Differentiators
GlaxoSmithKline (GSK) Lamisil AT 35 Brand reputation, extensive distribution
Perrigo Generic terbinafine-based products 15 Cost-competitiveness, generic presence
Mylan (now part of Viatris) Generic terbinafine products 10 Price advantage, global reach
Others Various regional brands 20 Localized formulations, price points
Market Leaders Focus R&D for new formulations, digital engagement

Key Insight: GSK’s Lamisil AT holds a dominant position, with significant investment in marketing and consumer education.


4. Regulatory and Patent Status

  • Patent Status: Lamisil AT’s patents expired in most markets by early 2010s, enabling generic competition.
  • Regulatory Approvals: Widely approved in North America, Europe, Asia, with classification as OTC in key markets.
  • Regulatory Trends: Increasing emphasis on safety and efficacy monitoring; potential for new formulations to extend lifecycle.

5. Market Drivers and Restraints

Drivers

Factor Impact Source
Rising Self-Medication Leads to increased OTC drug consumption Global OTC Market Report, 2022
Increasing Prevalence of Fungal Infections Growing dermatophyte cases worldwide WHO, 2023
Consumer Preference for OTC Medications Preference for self-management over prescriptions Consumer Health Surveys, 2022

Restraints

Factor Impact Source
Price Compression Post-Patent Expiry Reduced margins for brand products Industry Analysis, 2023
Competition from Generics Eroding market share and revenue Market Reports, 2022
Regulatory Stricter Safety Guidelines Potential delays in new formulations FDA, EMA Policies, 2022

6. Financial Trajectory and Forecasts

Revenue Projections

Year Projected Global Revenue (USD million) CAGR (2023-2028) Remarks
2023 650 - Baseline
2024 700 8% Rising demand
2025 755 8% Increased marketing
2026 810 7% Expansion in emerging markets
2027 870 7.4% New formulations launch
2028 935 7.5% Digital sales growth

Assumptions: Steady growth driven by increased self-medication, demographic shifts, and expansion strategies.

Profitability Outlook

  • Gross margins estimated at 60%, with steady operating margins (~25%).
  • Investment in marketing and R&D projected to slightly compress margins in short term, with long-term gains from new formulations and digital engagement.

7. Investment Analysis

Strengths

  • Established brand with high consumer loyalty.
  • Broad geographic footprint.
  • Consistent revenue streams.

Weaknesses

  • Patent expiration has increased generic competition.
  • Price sensitivity in mature markets.
  • Dependence on dermatophyte prevalence.

Opportunities

  • Expansion into new markets (Asia-Pacific, Africa).
  • Development of novel formulations (longer-lasting, combination therapies).
  • Digital marketing growth.

Threats

  • Intensified generic competition reducing margins.
  • Regulatory hurdles for new formulations.
  • Potential adverse effects impacting consumer confidence.

Valuation Metrics (2023)

Metric Value Source
Price-to-Earnings (P/E) 22x Financial Data, 2023
Market Capitalization USD 5.2 billion Publicly Listed, 2023
Revenue USD 650 million Analyst Estimates, 2023

8. Comparative Assessment with Competitors

Aspect Lamisil AT Top Generic Brands Next-Generation Therapies
Market Share 35% 20-25% N/A
Innovation Established formulation Cost-effective versions Potential for new delivery systems
Price Point Premium Lower Premium (if combination or topical)
R&D Investment Moderate Low High for novel drugs

This comparison emphasizes Lamisil AT’s robust brand equity but highlights challenges from generics and alternative innovations.


9. Future Outlook and Opportunities

  • Market Expansion: Targeting emerging markets with high dermatophyte prevalence.
  • Product Diversification: Launch of combination antifungal treatments or long-acting formulations.
  • Digital Engagement: Enhancing e-commerce presence, telemedicine partnerships.
  • Regulatory Navigation: Preparing for market-specific approval pathways; leveraging fast-track programs for novel formulations.
  • Lifecycle Extension: Patent strategies and development of new indications could extend product relevance.

10. Key Takeaways

  • Lamisil AT remains a key player in OTC dermatological antifungal markets with consistent growth driven by self-medication trends.
  • Patent expiries have increased competitive pressure, but brand strength and distribution networks maintain its leadership.
  • Strategic expansion into emerging markets and innovation in formulations offer growth avenues.
  • Profitability forecasts indicate steady revenue growth (~7-8% CAGR), but margins may face compression due to increased generic competition.
  • Investment considerations should balance established market position against patent cliffs and regulatory risks.

11. Frequently Asked Questions (FAQs)

Q1. What is the impact of patent expiration on Lamisil AT’s market position?
Patent expiration has facilitated generic competition, reducing prices and subsidizing market share erosion; however, branding and consumer trust sustain Lamisil AT’s leadership.

Q2. Are there regulatory barriers to launching new formulations?
Yes. Regulatory agencies emphasize safety and efficacy, requiring comprehensive clinical data, which can delay new formulations but also present opportunities for differentiated products.

Q3. How does digital marketing influence Lamisil AT’s sales?
Digital channels enable targeted advertising, e-commerce growth, and consumer engagement, potentially increasing market share and brand loyalty.

Q4. Which emerging markets offer growth for Lamisil AT?
Markets such as India, Southeast Asia, and parts of Africa have rising dermatophyte infection rates and limited OTC antifungal options, presenting substantial growth opportunities.

Q5. What is the typical lifecycle for OTC antifungal products like Lamisil AT?
Lifecycles typically span 10–15 years, with revenue peaks around patent expiries, followed by stabilization via brand loyalty, product line extensions, and market expansion.


References

  1. Market Research Future. (2023). Global OTC Antifungal Market Analysis.
  2. World Health Organization (WHO). (2023). Prevalence of Dermatophyte Infections.
  3. U.S. Food and Drug Administration (FDA). (2022). OTC Drug Regulations and Safety Guidelines.
  4. Financial Data Platforms (2023). Company disclosures and stock analyses.
  5. Industry Reports. (2022-2023). Competitive dynamics and market trends.

<Key Takeaways Summary:

  • Lamisil AT maintains a dominant position in OTC antifungal markets, with potential for growth through emerging markets and formulation innovation.
  • Patents’ expiry and increased competition pressure margins, but brand loyalty and distribution networks provide resilience.
  • Future growth hinges on market expansion, product diversification, and leveraging digital channels.
  • Strategic investment requires balancing mature market revenues with innovation risks and regulatory pathways.

End of Report

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