LAMISIL AT Drug Patent Profile

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

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-one suppliers are listed for this compound. Additional details are available on the terbinafine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Lamisil At

A generic version of LAMISIL AT was approved as terbinafine hydrochloride by SUN PHARMA CANADA on July 2^nd, 2007.

Summary for LAMISIL AT

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	95
Clinical Trials:	20
Patent Applications:	3,462
Drug Prices:	Drug price information for LAMISIL AT
DailyMed Link:	LAMISIL AT at DailyMed

See drug prices for LAMISIL AT

Recent Clinical Trials for LAMISIL AT

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

Sponsor	Phase
Assiut University	PHASE1
The Malassezia Foundation	Early Phase 1
Oregon Health and Science University	Early Phase 1

See all LAMISIL AT clinical trials

Pharmacology for LAMISIL AT

Drug Class

Allylamine Antifungal

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
Karo Hlthcare	LAMISIL AT	terbinafine hydrochloride	SOLUTION;TOPICAL	021124-001	Mar 17, 2000		OTC	Yes	Yes
Karo Hlthcare	LAMISIL AT	terbinafine hydrochloride	SPRAY;TOPICAL	021124-002	Mar 17, 2000		OTC	Yes	Yes

Expired US Patents for LAMISIL AT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Karo Hlthcare	LAMISIL AT	terbinafine hydrochloride	SPRAY;TOPICAL	021124-002	Mar 17, 2000	4,680,291
Karo Hlthcare	LAMISIL AT	terbinafine hydrochloride	SPRAY;TOPICAL	021124-002	Mar 17, 2000	5,681,849*PED
Karo Hlthcare	LAMISIL AT	terbinafine	GEL;TOPICAL	021958-001	Jul 24, 2006	5,681,849*PED
Karo Hlthcare	LAMISIL AT	terbinafine hydrochloride	SOLUTION;TOPICAL	021124-001	Mar 17, 2000	4,755,534*PED
Karo Hlthcare	LAMISIL AT	terbinafine hydrochloride	SOLUTION;TOPICAL	021124-001	Mar 17, 2000	4,680,291
Karo Hlthcare	LAMISIL AT	terbinafine	GEL;TOPICAL	021958-001	Jul 24, 2006	5,856,355*PED
Karo Hlthcare	LAMISIL AT	terbinafine hydrochloride	SPRAY;TOPICAL	021124-002	Mar 17, 2000	4,755,534*PED

International Patents for LAMISIL AT

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

Country	Patent Number	Title	Estimated Expiration
Finland	922252
Canada	1111852	PROCEDES D'OBTENTION DE PROPENYL-AMINES ET PRODUITS PHARMACEUTIQUES QUI EN CONTIENNENT (PROPENYL-AMINES, PROCESSES FOR THEIR PRODUCTION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM)
Mexico	9202328	COMPOSICION FARMACEUTICA LOCAL QUE CONTIENE UN COMPUESTO ALILAMINA COMO EL AGENTE ACTIVO.
Finland	102458
Ireland	50878	PROPENYLAMINES,PROCESSES FOR THEIR PRODUCTION,PHARMACEUTICAL COMPOSITIONS CONTAINING THEM AND THEIR USE AS PHARMACEUTICALS
Italy	RM920361
Spain	2186668

Supplementary Protection Certificates for LAMISIL AT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0024587	93C0136	Belgium		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		SPC/GB93/096, EXPIRES: 20050805

Market Dynamics and Financial Trajectory for LAMISIL AT (Terbinafine Hydrochloride)

Last updated: July 30, 2025

Introduction

Lamisil AT, a topical formulation of terbinafine hydrochloride, is a leading over-the-counter (OTC) treatment for fungal skin infections, notably athlete’s foot, ringworm, and jock itch. Its established efficacy and broad consumer acceptance have positioned it as a significant player within the global antifungal market. Understanding its market dynamics and projected financial trajectory involves analyzing market drivers, competitive landscape, regulatory environment, consumer trends, and potential growth avenues.

Market Overview and Industry Context

The global antifungal market was valued at approximately USD 13.5 billion in 2022, with a compound annual growth rate (CAGR) of around 4.2% projected through 2030 [1]. Lamisil AT, as a prominent OTC brand in this space, benefits from its strong brand recognition and clinical efficacy. Its segment includes both prescription and OTC formulations, with the topical variants accounting for a significant share due to ease of access and minimal systemic side effects.

The antifungal segment's growth is fueled by rising prevalence of dermatophyte infections, increased awareness of fungal treatments, and expanding healthcare access, especially in emerging markets. Coupled with an aging population and a rising trend of lifestyle-related fungal infections, the product's demand outlook remains positive.

Market Dynamics

Key Drivers

• Increasing Prevalence of Fungal Infections: The global burden of dermatophyte infections exceeds 20-25% of the population at any given time, creating sustained demand for antifungal agents such as terbinafine [2]. The rise in diabetes and immunocompromised conditions further exacerbates susceptibility.

• Consumer Preference for OTC Solutions: Consumers favor OTC options like Lamisil AT for their convenience, cost-effectiveness, and immediate availability. The shift from prescription to OTC sales has expanded the product’s reach, especially in developed markets.

• Brand Recognition and Efficacy: Lamisil AT’s proven efficacy and safety profile reinforce consumer loyalty and physician recommendations. Its reputation as a trusted brand supports sustained sales.

• E-commerce Growth: The online pharmacy sector accelerates access to antifungal products in a contactless environment, especially post-pandemic, facilitating broader distribution channels.

Market Challenges

• Competitive Alternatives: Generic terbinafine products and other antifungal classes (azoles, butenafine) pose significant competition, often at lower price points. Generic penetration pressures Lamisil’s premium pricing strategy and margins.

• Regulatory Landscape: Regulatory variations across markets influence product positioning. In some regions, stricter guidelines for OTC sales may restrict distribution channels or require reformulation.

• Consumer Education: Misinformation about fungal treatment duration and misuse can impact market growth. Accordingly, marketing strategies must emphasize proper use and compliance.

• Price Sensitivity: Economic downturns or market saturation in certain regions prompt price competition, affecting profitability.

Market Opportunities

• Emerging Markets Expansion: Rapid urbanization, increasing healthcare awareness, and rising income levels in regions such as Asia-Pacific and Latin America open substantial growth prospects for Lamisil AT.

• New Formulations and Indications: Development of longer-lasting formulations, combination therapies, or treatments targeting resistant strains could diversify offerings.

• Vertical Integration: Partnerships with healthcare providers and pharmacies strengthen distribution and brand visibility.

• Educational Campaigns: Investing in consumer education enhances treatment compliance, leading to higher repeat purchases and brand loyalty.

Financial Trajectory Analysis

Historical Performance

Lamisil AT’s parent company, Novartis (prior to sale to Sanofi in 2017), reported strong OTC sales, with terbinafine sales constituting a significant revenue stream. Post-acquisition, the product has maintained its position due to consistent demand and strategic marketing.

Projected Revenue Growth

Based on market growth estimates, Lamisil AT’s sales are anticipated to expand at a CAGR of approximately 4-5% over the next five years, aligning closely with overall antifungal market trends. Factors contributing include:

• Continued widespread use for dermatophyte infections.
• Market expansion into underserved regions.
• Consumer shift toward OTC antifungal treatments.

Profitability Outlook

With high brand recognition, minimal manufacturing costs for topical formulations, and growth in emerging markets, profit margins are expected to remain stable or improve marginally. However, increased competitive pressures and price reductions from generics may temper short-term profitability.

Investment and Innovation Impact

Innovation in formulation or new indications could significantly boost financial trajectory, providing competitive differentiation. Additionally, strategic acquisitions or partnerships could enhance market share and revenue streams.

Risks to Financial Outlook

• Patent expirations and generic entries threaten revenue stability.
• Regulatory hurdles or adverse market shifts can impact growth.
• Consumer misinformation leading to improper use may reduce repeat purchasing.

Regulatory and Market Access Considerations

Regulatory approvals are paramount; while Lamisil AT is sold OTC in many jurisdictions, some regions require prescriptions or have differing safety standards. Adapting to local regulations and maintaining compliance ensures market continuity.

Market access is influenced by pricing policies, reimbursement frameworks, and healthcare policies. In regions with robust healthcare systems, positioning Lamisil AT as a cost-effective OTC alternative enhances adoption.

Conclusion and Strategic Outlook

Lamisil AT’s market resilience hinges on its efficacy, consumer trust, and strategic market penetration. Its growth prospects remain favorable amid increasing dermatophyte infection prevalence and expanding OTC consumption globally.

To capitalize on emerging opportunities, the manufacturer should prioritize product innovation, geographic expansion, and consumer education campaigns. Active engagement with regulatory bodies and deployment of effective pricing strategies are essential to navigate competitive and regulatory challenges.

Key Takeaways

• The global antifungal market is projected to grow at approximately 4.2% CAGR through 2030, underpinning Lamisil AT’s sustained demand.

• Increasing dermatophyte infection prevalence, coupled with consumer preference for OTC treatments, drives continuous market expansion for Lamisil AT.

• Competition from generics and other antifungal classes requires proactive differentiation, including formulation innovation and branding strategies.

• Emerging markets present significant growth opportunities due to rising healthcare awareness and economic development.

• Ensuring compliance with regional regulatory standards and investing in consumer education are vital for maximizing market penetration and financial returns.

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FAQs

1. How does the patent status of Lamisil AT affect its market trajectory?
The original patent on terbinafine hydrochloride expired in many regions years ago, facilitating generic competition. However, Lamisil AT maintains brand recognition through proprietary formulations, marketing, and packaging, which sustain its market position despite patent expirations.

2. What are the key competitive threats to Lamisil AT?
Generic terbinafine products, azole-based antifungals, and emerging topical formulations pose significant threats. Price competition and marketing strategies of competitors are critical factors influencing Lamisil AT’s market share.

3. How does consumer behavior impact the growth of Lamisil AT?
A preference for OTC medications, quick symptom relief, and brand loyalty drive sales. Conversely, improper use or discontinuation of treatment can reduce effectiveness and repeat purchase rates.

4. What role do regulatory agencies play in the product’s market expansion?
Regulatory approvals determine the permissible formulations and indications in each jurisdiction. Stringent regulations can slow entry into new markets but ensure product safety and efficacy, fostering consumer confidence.

5. What strategic initiatives could enhance Lamisil AT’s financial future?
Investing in formulation innovations, expanding into emerging markets, reinforcing brand loyalty through marketing, and establishing strategic partnerships will bolster growth and profitability.

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References

[1] Grand View Research. (2022). Antifungal Drugs Market Size, Share & Trends Analysis Report.
[2] World Health Organization (WHO). (2020). Epidemiology of dermatophyte infections.