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Last Updated: March 16, 2025

LAMISIL AT Drug Patent Profile


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

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Drug patent expirations by year for LAMISIL AT
Drug Prices for LAMISIL AT

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Recent Clinical Trials for LAMISIL AT

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

SponsorPhase
Oregon Health and Science UniversityEarly Phase 1
The Malassezia FoundationEarly Phase 1
Pak Emirates Military HospitalPhase 3

See all LAMISIL AT clinical trials

US Patents and Regulatory Information for LAMISIL AT

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Karo Hlthcare LAMISIL AT terbinafine hydrochloride SOLUTION;TOPICAL 021124-001 Mar 17, 2000 OTC Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Karo Hlthcare LAMISIL AT terbinafine hydrochloride SPRAY;TOPICAL 021124-002 Mar 17, 2000 OTC Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Karo Hlthcare LAMISIL AT terbinafine GEL;TOPICAL 021958-001 Jul 24, 2006 OTC Yes Yes ⤷  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
Showing 1 to 3 of 3 entries

Expired US Patents for LAMISIL AT

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Karo Hlthcare LAMISIL AT terbinafine hydrochloride SPRAY;TOPICAL 021124-002 Mar 17, 2000 ⤷  Try for Free ⤷  Try for Free
Karo Hlthcare LAMISIL AT terbinafine hydrochloride SPRAY;TOPICAL 021124-002 Mar 17, 2000 ⤷  Try for Free ⤷  Try for Free
Karo Hlthcare LAMISIL AT terbinafine GEL;TOPICAL 021958-001 Jul 24, 2006 ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 3 of 3 entries

International Patents for LAMISIL AT

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

CountryPatent NumberTitleEstimated Expiration
Canada 2068957 COMPOSITION PHARMACEUTIQUE (PHARMACEUTICAL COMPOSITION) ⤷  Try for Free
Hong Kong 148896 Topical composition containing terbinafine ⤷  Try for Free
Hungary 9201518 ⤷  Try for Free
>Country>Patent Number>Title>Estimated Expiration
Showing 1 to 3 of 3 entries

Supplementary Protection Certificates for LAMISIL AT

Patent NumberSupplementary Protection CertificateSPC CountrySPC ExpirationSPC Description
0024587 93C0136 Belgium ⤷  Try for 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 ⤷  Try for Free SPC/GB93/096, EXPIRES: 20050805
>Patent Number>Supplementary Protection Certificate>SPC Country>SPC Expiration>SPC Description
Showing 1 to 2 of 2 entries

Market Dynamics and Financial Trajectory for Lamisil (Terbinafine)

Market Overview

Lamisil, known generically as Terbinafine, is a widely used antifungal medication that has seen significant growth in recent years. Here’s a detailed look at the market dynamics and financial trajectory of this drug.

Market Size and Growth Projections

The Terbinafine (Lamisil) market has experienced a rapid and substantial surge, with projections indicating sustained and significant expansion from 2023 to 2031. The market size is expected to grow substantially, driven by increasing demand for antifungal treatments, particularly for skin and mucous membrane infections, onychomycosis, and other fungal infections[1][4].

Segmentation and Applications

The market is segmented based on type (oral and external use) and application (fungal infection of the skin and mucous membrane, onychomycosis, bronchial asthma, gynecological anti-infection preparations, and others). Geographically, the market is divided into North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. Each segment is expected to contribute to the overall growth, with onychomycosis and skin infections being key drivers[1].

Drivers of Growth

Several factors are driving the growth of the Terbinafine market:

  • Increasing Demand: The rise in fungal infections, particularly during warmer months, is a significant driver. For instance, April's warmer weather has been associated with a surge in fungal infections, leading to higher demand for Terbinafine Hydrochloride[3].
  • Expanding Healthcare Sector: The growth of the healthcare and pharmaceutical sectors, especially in regions like India, is contributing to the increased demand for antifungal medications[3].
  • Product Penetration: The extent of product penetration at national and regional levels, along with the introduction of new products, is also boosting market growth[3].

Challenges and Restraints

Despite the positive growth trajectory, there are several challenges and restraints to consider:

  • Supply Chain Constraints: Constrained supply among market players has led to upward pressure on prices. This strain on the supply chain is a significant challenge, particularly during periods of high demand[3].
  • Market Competition: The antifungal market is competitive, and other treatments could pose a challenge to Lamisil's market share. However, Lamisil's strong brand presence and efficacy help it maintain a competitive edge[4].

Financial Performance

Haleon's Financials

Haleon, the company behind Lamisil, has reported strong financial performance in recent years. Here are some key financial highlights:

  • Revenue Growth: Haleon reported an 8% organic revenue growth in 2023, with positive volume/mix contributions. The company expects organic revenue growth of 4-6% in the medium term[5].
  • Operating Profit: Adjusted operating profit increased by 10.4% in constant currency, driven by positive operational leverage. However, the disposals of Lamisil and ChapStick are expected to dilute FY 2024 revenue and adjusted operating profit by around 1% and 3%, respectively[5].
  • Cash Flow and Debt: Haleon has strong cash flow, with £2,100m in net cash flow from operating activities and £1,575m in free cash flow in 2023. The company has reduced its net debt significantly, bringing the net debt/adjusted EBITDA ratio down from around 4x to 3x[5].

Impact of Lamisil Disposal

Haleon completed the sale of Lamisil in October 2023, which included a cash consideration of £235m and a working capital release of around £15m. This disposal is part of Haleon's portfolio optimization strategy, aiming to focus on other growth areas such as oral health and vitamins, minerals, and supplements (VMS)[2][5].

Regional Performance

The Terbinafine market performs differently across various regions:

  • Asia-Pacific: This region is expected to see significant growth due to increasing healthcare spending and a rising incidence of fungal infections[1].
  • India: The Indian pharmaceutical sector has shown strong growth, particularly in therapeutic areas such as dermatology, which includes Terbinafine Hydrochloride. This growth is driven by both pricing strategies and the introduction of new products[3].

Consumer Behavior and Market Sentiment

Consumer behavior plays a crucial role in the demand for Lamisil. Here are some key points:

  • Increased Awareness: Growing awareness about fungal infections and the importance of antifungal treatments has led to increased demand for Lamisil[3].
  • Positive Market Sentiment: Despite modest volume growth, the overall market sentiment remains positive, driven by strong sales in key therapeutic areas and the introduction of new products[3].

Key Players and Competitive Landscape

The competitive landscape of the antifungal market is dynamic, with several key players:

  • Haleon: Although Haleon has disposed of Lamisil, the brand remains a significant player in the market due to its established presence and efficacy[2][5].
  • Other Market Players: Other pharmaceutical companies are also active in the antifungal segment, offering a range of treatments that compete with Lamisil[4].

Technological and Regulatory Trends

Technological advancements and regulatory changes can impact the market:

  • Regulatory Environment: Changes in regulatory policies can affect the approval and marketing of antifungal medications. Companies must navigate these changes to maintain market presence[4].
  • Technological Advancements: Innovations in drug delivery systems and formulations can enhance the efficacy and convenience of antifungal treatments, potentially influencing market dynamics[4].

Future Outlook

The future outlook for the Terbinafine market is positive, driven by several factors:

  • Sustained Demand: The ongoing demand for antifungal treatments, particularly in regions with high incidence rates of fungal infections, will continue to drive market growth[1][3].
  • Market Expansion: The market is expected to expand significantly from 2023 to 2031, with a focus on emerging markets and new product introductions[1][4].
"Within 18 months of our demerger, we reduced net debt by over £2 billion, bringing net debt/adjusted EBITDA down from c.4x to 3x, reflecting both strong cash conversion and financial discipline, underpinning an increased dividend payout and share buyback." - Brian McNamara, Chief Executive Officer, Haleon[5].

Key Takeaways

  • Market Growth: The Terbinafine market is expected to experience significant growth from 2023 to 2031.
  • Segmentation: The market is segmented by type (oral and external use) and application (various fungal infections).
  • Drivers: Increasing demand, expanding healthcare sector, and product penetration are key drivers.
  • Challenges: Supply chain constraints and market competition are significant challenges.
  • Financial Performance: Haleon reported strong financials, but the disposal of Lamisil will impact future revenue.
  • Regional Performance: Asia-Pacific and India are expected to see significant growth.
  • Consumer Behavior: Growing awareness and positive market sentiment drive demand.

FAQs

What are the primary applications of Terbinafine (Lamisil)?

The primary applications of Terbinafine include treating fungal infections of the skin and mucous membrane, onychomycosis, and other fungal infections.

How is the Terbinafine market segmented?

The market is segmented based on type (oral and external use) and application (fungal infection of the skin and mucous membrane, onychomycosis, etc.), as well as geographically into regions like North America, Europe, Asia-Pacific, etc.[1].

What are the key drivers of the Terbinafine market growth?

Key drivers include increasing demand for antifungal treatments, expanding healthcare sectors, and product penetration in various regions[1][3].

How has Haleon's financial performance been impacted by the disposal of Lamisil?

The disposal of Lamisil is expected to dilute FY 2024 revenue and adjusted operating profit by around 1% and 3%, respectively, but Haleon has otherwise reported strong financial performance and reduced its net debt significantly[5].

What is the expected market size and growth rate of the Terbinafine market from 2023 to 2031?

The market is expected to experience significant growth, with detailed projections indicating sustained expansion throughout the forecast period[1][4].

How does the competitive landscape of the antifungal market affect Lamisil?

The competitive landscape is dynamic, with several key players. Despite competition, Lamisil's established presence and efficacy help it maintain a competitive edge[4].

Sources

  1. Market Research Intellect: Global Terbinafine (Lamisil) Market Size, Trends and Projections.
  2. Haleon: 2023 Full year results.
  3. ChemAnalyst: Skyrocketing Demand Sends Global Terbinafine Hydrochloride Prices Surging.
  4. Cognitive Market Research: Global Lamisil Market Report 2024 Edition.
  5. Haleon: 2023 Full year results - Haleon Press Release.

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