Terbinafine hydrochloride - Generic Drug Details

What are the generic drug sources for terbinafine hydrochloride and what is the scope of patent protection?

Terbinafine hydrochloride is the generic ingredient in three branded drugs marketed by Karo Hlthcare, Novartis, Taro, Aurobindo Pharma, Breckenridge Pharm, Chartwell, Cipla, Dr Reddys Labs Inc, Emed Medcl, Gedeon Richter Usa, Glenmark Pharms Ltd, Heritage Pharma Avet, Invagen Pharms, Mylan, Natco Pharma, Orbion Pharms, Roxane, and Wockhardt, and is included in twenty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-five drug master file entries for terbinafine hydrochloride. Forty-six suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for terbinafine hydrochloride

US Patents:	0
Tradenames:	3
Applicants:	18
NDAs:	22
Drug Master File Entries:	25
Finished Product Suppliers / Packagers:	46
Raw Ingredient (Bulk) Api Vendors:	115
Clinical Trials:	45
Patent Applications:	2,639
What excipients (inactive ingredients) are in terbinafine hydrochloride?	terbinafine hydrochloride excipients list
DailyMed Link:	terbinafine hydrochloride at DailyMed

Recent Clinical Trials for terbinafine hydrochloride

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

Sponsor	Phase
Dhaka Medical College	Phase 2/Phase 3
IQVIA Biotech	Phase 3
Moberg Pharma AB	Phase 3

See all terbinafine hydrochloride clinical trials

Generic filers with tentative approvals for TERBINAFINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		EQ 250MG BASE	TABLET; ORAL
		EQ 250MG BASE	TABLET;ORAL
		EQ 250MG BASE	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for terbinafine hydrochloride

Drug Class

Allylamine Antifungal

Anatomical Therapeutic Chemical (ATC) Classes for terbinafine hydrochloride

D01AE	Other antifungals for topical use
D01A	ANTIFUNGALS FOR TOPICAL USE
D01	ANTIFUNGALS FOR DERMATOLOGICAL USE
D	Dermatologicals

D01BA	Antifungals for systemic use
D01B	ANTIFUNGALS FOR SYSTEMIC USE
D01	ANTIFUNGALS FOR DERMATOLOGICAL USE
D	Dermatologicals

US Patents and Regulatory Information for terbinafine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Emed Medcl	TERBINAFINE HYDROCHLORIDE	terbinafine hydrochloride	TABLET;ORAL	077919-001	Jul 2, 2007	AB	RX	No	No
Dr Reddys Labs Inc	TERBINAFINE HYDROCHLORIDE	terbinafine hydrochloride	TABLET;ORAL	076390-001	Jul 2, 2007	AB	RX	No	No
Novartis	LAMISIL	terbinafine hydrochloride	GRANULE;ORAL	022071-001	Sep 28, 2007		DISCN	Yes	No

Expired US Patents for terbinafine hydrochloride

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
Novartis	LAMISIL	terbinafine hydrochloride	TABLET;ORAL	020539-001	May 10, 1996
Karo Hlthcare	LAMISIL	terbinafine hydrochloride	SOLUTION;TOPICAL	020749-001	Oct 17, 1997

Terbinafine hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Terbinafine Hydrochloride

Introduction

Terbinafine hydrochloride, an antifungal drug used primarily to treat fungal infections such as those affecting the fingernails and toenails, is a significant player in the global pharmaceutical market. This article delves into the market dynamics and financial trajectory of terbinafine hydrochloride, highlighting key trends, drivers, and challenges.

Global Market Size and Forecast

The global market for terbinafine hydrochloride was valued at US$ 614 million in 2023 and is projected to grow to US$ 912.6 million by 2030, with a compound annual growth rate (CAGR) of 6.4% during the forecast period of 2024-2030[1][2].

Market Segmentation

The terbinafine hydrochloride market is segmented by type and application. The types include topical and oral formulations, each catering to different needs and preferences of patients. The applications primarily cover fingernail infections, toenail infections, and other fungal infections[1][2].

Key Players

The market is dominated by several major pharmaceutical companies, including Novartis, GSK, TEVA, Dr. Reddy's Laboratories, CIPLA LTD, TARO, InvaGen Pharmaceuticals, Breckenridge Pharmaceutical, and others. These companies play a crucial role in driving innovation, production, and distribution of terbinafine hydrochloride[1].

Drivers of Market Growth

Several factors drive the growth of the terbinafine hydrochloride market:

Increasing Demand

The demand for terbinafine hydrochloride is driven by the rising incidence of fungal infections, particularly during warmer and more humid weather conditions. For instance, April's warmer weather fosters fungal growth, leading to a surge in demand for the drug[3].

Technological Adoption

The continued adoption of virtual technologies and the expansion of online channels are expected to drive market growth by providing new avenues for revenue generation and improving patient access to the drug[2].

Emerging Markets

Developing economies in Asia and Latin America present substantial growth opportunities due to rising client spending and favorable demographics. These regions are expected to contribute significantly to the market's expansion[2].

Challenges and Restraints

Despite the growth potential, the terbinafine hydrochloride market faces several challenges:

Seasonal Demand

The demand for terbinafine hydrochloride is seasonal, with higher demand during humid and warm weather conditions and lower demand during drier seasons. This fluctuation can lead to price volatility and supply chain disruptions[5].

Supply Chain Constraints

Constrained supply among market players, coupled with heightened demand, can lead to upward pressure on prices. Additionally, stabilization of supply chains from countries like China can result in a steady influx of raw materials and APIs, affecting market prices[3][5].

Competitive Landscape

The market is highly competitive, with aggressive pricing and dumping practices by Chinese suppliers exerting downward pressure on prices. Indian manufacturers are forced to lower their rates to remain competitive, which can impact profit margins[5].

Price Trends

The prices of terbinafine hydrochloride have shown significant fluctuations:

Price Increase

In the second quarter of 2024, prices rose due to heightened demand from the healthcare and pharmaceutical sectors, coupled with constrained supply. This upward trend was driven by strong sales in key therapeutic areas, including dermatology[3].

Price Decline

By the end of October 2024, prices are expected to decline due to weakening demand from end-consumers and ample supply in the market. The decline is also attributed to factors such as aggressive pricing by Chinese suppliers, stabilization of supply chains, and India’s production-linked incentive (PLI) scheme[5].

Regional Analysis

The global terbinafine hydrochloride market is analyzed across various regions, including the United States, European Union, China, India, and others. India, in particular, plays a significant role as a leading exporter of APIs, and trends in the Indian market often influence Western markets[2][5].

Strategic Imperatives for Market Players

To navigate the market effectively, players should focus on:

Innovation and R&D

Investing in research and development to create modern products that meet evolving customer needs and stay ahead of the competition[2].

Customer-Centric Strategies

Focusing on customer experience and engagement through personalized services, enhanced service, and effective use of digital platforms[2].

Sustainability Initiatives

Integrating sustainability into core strategies to gain from regulatory support, customer goodwill, and long-term viability. Developing and selling eco-friendly products can cater to the growing segment of environmentally conscious customers[2].

Financial Outlook

The financial trajectory of the terbinafine hydrochloride market is positive, with a projected CAGR of 6.4% from 2024 to 2030. The market's growth is driven by increasing demand, technological adoption, and expansion into emerging markets. However, the market must navigate challenges such as seasonal demand fluctuations, supply chain constraints, and competitive pricing pressures.

Key Takeaways

• The global terbinafine hydrochloride market is expected to grow to US$ 912.6 million by 2030.
• The market is driven by increasing demand for antifungal treatments, technological adoption, and growth in emerging markets.
• Key players include Novartis, GSK, TEVA, and others.
• Seasonal demand and supply chain constraints are significant challenges.
• Prices are expected to fluctuate based on demand and supply dynamics.
• Sustainability and customer-centric strategies are crucial for market success.

FAQs

What is the projected market size of terbinafine hydrochloride by 2030?

The global market for terbinafine hydrochloride is forecast to reach US$ 912.6 million by 2030[1].

What is the CAGR of the terbinafine hydrochloride market from 2024 to 2030?

The CAGR of the terbinafine hydrochloride market is 6.4% from 2024 to 2030[1].

Which regions are covered in the global terbinafine hydrochloride market analysis?

The analysis covers regions including the United States, European Union, China, India, Southeast Asia, Japan, Middle East, and Africa[2].

What are the main types of terbinafine hydrochloride products?

The main types are topical and oral formulations[1].

How does seasonal demand affect the terbinafine hydrochloride market?

Seasonal demand fluctuations, with higher demand during warm and humid weather and lower demand during drier seasons, can lead to price volatility and supply chain disruptions[5].

Sources

1. Valuates Reports: Global Terbinafine Hydrochloride Drug Market Report[1].
2. Market Reports World: Terbinafine Hydrochloride Drug Market Size 2024 Trends Analysis[2].
3. ChemAnalyst: Skyrocketing Demand Sends Global Terbinafine Hydrochloride Prices Surging[3].
4. Cognitive Market Research: Global Terbinafine Hydrochloride Market Report 2024 Edition[4].
5. ChemAnalyst: Terbinafine Hydrochloride Prices Set for Global Decline by End of October[5].