LAMISIL Drug Patent Profile

Which patents cover Lamisil, and what generic alternatives are available?

Lamisil is a drug marketed by Karo Hlthcare and Novartis and is included in eight NDAs.

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

Summary for LAMISIL

US Patents:	0
Applicants:	2
NDAs:	8
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	91
Clinical Trials:	19
Patent Applications:	3,852
Drug Prices:	Drug price information for LAMISIL
What excipients (inactive ingredients) are in LAMISIL?	LAMISIL excipients list
DailyMed Link:	LAMISIL at DailyMed

See drug prices for LAMISIL

See drug sales revenues for LAMISIL

Recent Clinical Trials for LAMISIL

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

Sponsor	Phase
The Malassezia Foundation	Early Phase 1
Oregon Health and Science University	Early Phase 1
Pak Emirates Military Hospital	Phase 3

See all LAMISIL clinical trials

Pharmacology for LAMISIL

Drug Class

Allylamine Antifungal

US Patents and Regulatory Information for LAMISIL

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	terbinafine hydrochloride	CREAM;TOPICAL	020980-001	Mar 9, 1999		OTC	Yes	Yes
Novartis	LAMISIL	terbinafine hydrochloride	TABLET;ORAL	020539-001	May 10, 1996		DISCN	Yes	No
Novartis	LAMISIL	terbinafine hydrochloride	GRANULE;ORAL	022071-001	Sep 28, 2007		DISCN	Yes	No
Karo Hlthcare	LAMISIL AT	terbinafine	GEL;TOPICAL	021958-001	Jul 24, 2006		OTC	Yes	Yes

Expired US Patents for LAMISIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Karo Hlthcare	LAMISIL	terbinafine hydrochloride	SOLUTION;TOPICAL	020749-001	Oct 17, 1997
Karo Hlthcare	LAMISIL	terbinafine	GEL;TOPICAL	020846-001	Apr 29, 1998
Karo Hlthcare	LAMISIL	terbinafine	GEL;TOPICAL	020846-001	Apr 29, 1998
Karo Hlthcare	LAMISIL	terbinafine hydrochloride	CREAM;TOPICAL	020980-001	Mar 9, 1999

International Patents for LAMISIL

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

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2093152	ANTIMYCOTIC PHARMACEUTICAL COMPOSITION (VARIANTS)
United Kingdom	9111477
Singapore	89287
Netherlands	930136

Supplementary Protection Certificates for LAMISIL

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

LAMISIL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Lamisil

Introduction

Lamisil, a brand name for the antifungal drug terbinafine, has been a significant player in the pharmaceutical market, particularly in the treatment of fungal infections. Here, we delve into the market dynamics and financial trajectory of Lamisil, highlighting key trends, drivers, and challenges.

Market Size and Growth Projections

The global Lamisil market has experienced substantial growth in recent years and is projected to continue this trend. According to market research, the Terbinafine (Lamisil) market is expected to see sustained and significant expansion from 2023 to 2031, driven by robust growth rates across various segments[1][4].

Segmentation and Applications

The Lamisil market is segmented based on type (oral and external use) and application (fungal infections of the skin and mucous membrane, onychomycosis, bronchial asthma, gynecological anti-infection preparations, and others). These segments are crucial in understanding the diverse demand and growth potential of Lamisil across different therapeutic areas[1][4].

Geographical Analysis

The market is geographically segmented into North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. Each region presents unique market dynamics, with Asia-Pacific showing significant growth due to increasing healthcare demands and a large patient population[1][4].

Drivers of Growth

Several factors drive the growth of the Lamisil market:

• Increasing Prevalence of Fungal Infections: The rise in fungal infections, particularly during warmer months, drives up demand for antifungal medications like Lamisil[3].
• Strong Sales in Key Therapeutic Areas: The Indian pharmaceutical sector, for example, has seen strong sales in dermatology, which includes Terbinafine Hydrochloride, contributing to overall market growth[3].
• Product Innovation and Penetration: Continuous innovation and effective market execution by key players enhance the market share and growth of Lamisil[2].

Restraints and Challenges

Despite the positive growth trajectory, the Lamisil market faces several challenges:

• Supply Chain Constraints: Constrained supply among market players, especially during periods of high demand, can lead to price increases and market volatility[3].
• Competition: The antifungal market is competitive, with various other treatments available, which can impact the market share of Lamisil[4].
• Regulatory and Economic Factors: Economic uncertainties, foreign exchange fluctuations, and regulatory changes can affect the financial performance of companies involved in the Lamisil market[2][5].

Financial Performance and Recent Developments

Haleon, a major player in the consumer health sector, recently completed the sale of Lamisil to Karo Healthcare AB in October 2023. This disposal is expected to be slightly dilutive to adjusted operating profit growth in the short term but will be offset by the company's productivity program[2][5].

• Revenue and Profit Growth: Despite the disposal, Haleon reported strong organic revenue growth and adjusted operating profit growth in 2023. The company expects continued strong growth in 2024, with organic revenue growth projected at 4-6% and organic operating profit growth ahead of revenue growth[2][5].
• Cash Flow and Debt Management: Haleon has demonstrated strong cash flow management, reducing net debt significantly and maintaining a healthy net debt/adjusted EBITDA ratio. This financial discipline supports increased dividend payouts and share buybacks[5].

Price Trends

The prices of Terbinafine Hydrochloride have seen an upward trend, particularly in the second quarter of 2024, due to heightened demand and constrained supply. This trend is expected to continue as market participants prioritize bolstering their stocks in anticipation of further demand surges[3].

Consumer Behavior and Market Sentiment

Consumer behavior plays a crucial role in the demand for Lamisil. The resurgence in the Indian pharmaceutical sector, driven by strong sales in key therapeutic areas, reflects positive market sentiment. This sentiment is further supported by the introduction of new products and effective pricing strategies[3].

Competitive Landscape

The Lamisil market is characterized by a competitive landscape with several key players. The market analysis includes competitor analysis, regional analysis, and segment analysis to provide a comprehensive understanding of the industry dynamics[4].

Future Outlook

The future outlook for the Lamisil market is promising, with sustained growth projected across various segments. Key factors such as increasing demand for antifungal treatments, product innovation, and effective market execution will drive this growth. However, the market must navigate challenges such as supply chain constraints and economic uncertainties to maintain its momentum[1][4].

Key Takeaways

• The Lamisil market is expected to experience significant growth from 2023 to 2031.
• The market is driven by increasing prevalence of fungal infections, strong sales in key therapeutic areas, and product innovation.
• Supply chain constraints and economic uncertainties are key challenges.
• Haleon’s financial performance remains strong despite the disposal of Lamisil.
• Price trends are expected to remain upward due to sustained demand.

FAQs

Q: What are the primary applications of Lamisil? A: Lamisil is primarily used for treating fungal infections of the skin and mucous membrane, onychomycosis, and other related conditions[1][4].

Q: Who are the key players in the Lamisil market? A: Key players include Haleon (previously the owner of the Lamisil brand) and Karo Healthcare AB, which recently acquired the Lamisil brand[2][5].

Q: What are the main drivers of growth for the Lamisil market? A: The main drivers include increasing prevalence of fungal infections, strong sales in key therapeutic areas, and product innovation[1][3].

Q: How has the recent sale of Lamisil affected Haleon’s financial performance? A: The sale of Lamisil is expected to be slightly dilutive to adjusted operating profit growth in the short term but will be offset by Haleon’s productivity program[2][5].

Q: What is the projected growth rate for the Lamisil market from 2023 to 2031? A: The market is projected to see sustained and significant expansion, with robust growth rates across various segments[1][4].

Sources

1. Market Research Intellect - Global Terbinafine (Lamisil) Market Size, Trends and Projections
2. Haleon - 2023 Q3 Trading Statement
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