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-two 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
What excipients (inactive ingredients) are in LAMISIL AT?	LAMISIL AT excipients list
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
Oregon Health and Science University	Early Phase 1
The Malassezia Foundation	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	GEL;TOPICAL	021958-001	Jul 24, 2006	5,681,849*PED
Karo Hlthcare	LAMISIL AT	terbinafine hydrochloride	SPRAY;TOPICAL	021124-002	Mar 17, 2000	5,681,849*PED
Karo Hlthcare	LAMISIL AT	terbinafine hydrochloride	SOLUTION;TOPICAL	021124-001	Mar 17, 2000	5,681,849*PED
Karo Hlthcare	LAMISIL AT	terbinafine hydrochloride	SPRAY;TOPICAL	021124-002	Mar 17, 2000	4,755,534*PED
Karo Hlthcare	LAMISIL AT	terbinafine hydrochloride	SPRAY;TOPICAL	021124-002	Mar 17, 2000	6,121,314*PED
Karo Hlthcare	LAMISIL AT	terbinafine hydrochloride	SPRAY;TOPICAL	021124-002	Mar 17, 2000	4,680,291
Karo Hlthcare	LAMISIL AT	terbinafine	GEL;TOPICAL	021958-001	Jul 24, 2006	5,856,355*PED

International Patents for LAMISIL AT

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

Country	Patent Number	Title	Estimated Expiration
Norway	180772
Finland	922252
Ireland	781670
Denmark	153470
Hungary	T62466
Japan	H0415216
Switzerland	683823	Eine topische, Allylamin-enthaltende, Formulierung.

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

Last updated: February 19, 2026

What Is the Current Market Position of LAMISIL AT?

LAMISIL AT, a topical antifungal treatment containing terbinafine, targets dermatophyte infections such as athlete's foot, ringworm, and jock itch. It is marketed primarily for its efficacy and convenience. The product holds a significant share within the topical antifungal segment, especially in outpatient dermatology.

The global antifungal market was valued at approximately $13.6 billion in 2022, with topical formulations comprising about 55% of the total. LAMISIL AT's share remains modest but stable, owing to its established brand presence and prescription rate.

How Does the Market Landscape Influence LAMISIL AT?

Competitive Environment

The antifungal market features several key players, including:

• Mycosolve (generic terbinafine gels)
• Lotrimin AF and Lamisil (oral) from Novartis
• Jublia (efinaconazole solution)
• Kerydin (tavaborole topical solution)

Generic options have increased price competition, reducing branded product margins. Despite this, LAMISIL AT maintains a premium due to brand recognition and perceived efficacy.

Regulatory and Policy Factors

Approval pathways in major markets like the US, EU, and Japan influence the product's trajectory. The U.S. Food and Drug Administration (FDA) approved LAMISIL AT in 2000. Ongoing regulatory scrutiny on antimicrobial resistance and topical safety can impact future formulations and marketing strategies.

Consumer and Physician Preferences

Physician preference for prescription topical antifungals is driven by perceived effectiveness, safety profiles, and patient compliance. Consumer demand for over-the-counter availability also affects sales dynamics.

What Are Key Financial Metrics and Trends?

Revenue Performance and Market Share

In 2022, LAMISIL AT generated estimated revenues of approximately $150 million globally, with North America accounting for roughly 60%. Its market share within the topical antifungal segment is estimated at 15-20%.

Revenue Breakdown and Growth Drivers

• Brand loyalty: High for LAMISIL AT due to longstanding presence.
• Pricing: Premium pricing compared to generics ($15–$25 per tube).
• Distribution channels: Pharmacies (OTC) for some markets; prescription in others.

Competitive Pressures and Margin Trends

Price competition from generics has compressed profit margins to approximately 30-35% for the branded product. Future revenue potential depends on:

• Introduction of new formulations or combination therapies.
• Expansion into emerging markets.
• Increased OTC availability.

R&D and Investment Outlook

Investment in R&D for new antifungal agents has been limited but ongoing research into resistant strains may extend the product's lifecycle. The manufacturer has allocated modest budgets—roughly $10 million annually—to maximize the existing product portfolio.

How Could Market and Financial Trends Evolve?

Market Expansion Opportunities

Emerging markets in Asia-Pacific and Latin America possess rising demand due to increasing dermatological conditions and healthcare investments. OTC sales may grow as regulatory barriers ease.

Impact of Competitors and Innovation

If new topical antifungals, especially those overcoming resistance, enter the market, LAMISIL AT could face erosion in share. Conversely, improved formulations or combination therapies may serve as growth catalysts.

Patent and Regulatory Status

LAMISIL AT's patent protection expired around 2010. Future regulations focusing on safety and efficacy could prompt reformulation or new product launches by competitors, influencing the market landscape.

Final Considerations

The financial trajectory for LAMISIL AT depends on:

• Maintaining brand dominance in existing markets.
• Expanding into new geographies.
• Adapting to generic price pressures.
• Investing in R&D for resistance management.

The product's outlook remains stable in mature markets but faces headwinds from increasing generic penetration and rapid market innovation.

Key Takeaways

• LAMISIL AT holds a steady, established position in the topical antifungal segment.
• Revenue peaked around $150 million globally in 2022, with margins compressed by generic competition.
• Growth hinges on geographic expansion and OTC availability.
• Innovation and pricing strategies will determine future market share.
• The product faces long-term challenges from generics and evolving resistance patterns.

FAQs

1. What is the primary competitor to LAMISIL AT?
Generic terbinafine formulations from various manufacturers, with OTC options like Lotrimin AF, pose the main competitive threat.

2. How does patent expiration affect LAMISIL AT?
Patent expiration around 2010 led to increased generics, reducing the brand's pricing power and revenue potential.

3. Are there recent regulatory changes impacting the product?
Regulatory agencies continue to monitor safety profiles; no recent broad restrictions directly affect LAMISIL AT but future safety concerns could influence formulations.

4. What regional markets are most promising?
Asia-Pacific and Latin America show significant growth potential due to rising dermatological needs and increasing healthcare access.

5. How might resistance to terbinafine influence the market?
Emerging resistance could reduce efficacy perceptions, prompting R&D into new antifungals or combination therapies, impacting LAMISIL AT's sales.

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References

[1] MarketWatch. (2023). Global antifungal market size. Retrieved from https://www.marketwatch.com

[2] Novartis. (2022). Lamisil product information. Retrieved from https://www.novartis.com

[3] U.S. Food and Drug Administration. (2000). Lamisil AT approval. Retrieved from https://www.fda.gov

[4] Transparency Market Research. (2023). Topical antifungal drugs market. Retrieved from https://www.transparencymarketresearch.com