TERBINAFINE - Generic Drug Details

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

Terbinafine 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-four NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-seven drug master file entries for terbinafine. There are four tentative approvals for this compound.

Summary for TERBINAFINE

US Patents:	0
Tradenames:	3
Applicants:	18
NDAs:	24
Drug Master File Entries:	27
Raw Ingredient (Bulk) Api Vendors:	91
Clinical Trials:	45
Patent Applications:	7,520
Drug Prices:	Drug price trends for TERBINAFINE
Drug Sales Revenues:	Drug sales revenues for TERBINAFINE
What excipients (inactive ingredients) are in TERBINAFINE?	TERBINAFINE excipients list
DailyMed Link:	TERBINAFINE at DailyMed

See drug prices for TERBINAFINE

See drug sales revenues for TERBINAFINE

Recent Clinical Trials for TERBINAFINE

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 clinical trials

Generic filers with tentative approvals for TERBINAFINE

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.

Anatomical Therapeutic Chemical (ATC) Classes for TERBINAFINE

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cipla	TERBINAFINE HYDROCHLORIDE	terbinafine hydrochloride	TABLET;ORAL	077137-001	Jul 2, 2007		DISCN	No	No
Chartwell	TERBINAFINE HYDROCHLORIDE	terbinafine hydrochloride	TABLET;ORAL	078199-001	Jul 2, 2007	AB	RX	No	No
Novartis	LAMISIL	terbinafine hydrochloride	CREAM;TOPICAL	020192-001	Dec 30, 1992		DISCN	No	No
Invagen Pharms	TERBINAFINE HYDROCHLORIDE	terbinafine hydrochloride	TABLET;ORAL	077533-001	Jul 2, 2007	AB	RX	No	No

Expired US Patents for TERBINAFINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Karo Hlthcare	LAMISIL	terbinafine	GEL;TOPICAL	020846-001	Apr 29, 1998	6,005,001*PED
Karo Hlthcare	LAMISIL AT	terbinafine	GEL;TOPICAL	021958-001	Jul 24, 2006	6,121,314
Karo Hlthcare	LAMISIL	terbinafine	GEL;TOPICAL	020846-001	Apr 29, 1998	4,680,291
Karo Hlthcare	LAMISIL AT	terbinafine	GEL;TOPICAL	021958-001	Jul 24, 2006	5,681,849*PED

TERBINAFINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Terbinafine

Introduction to Terbinafine

Terbinafine, commonly known by its brand name Lamisil, is an antifungal medication used to treat various fungal infections, including onychomycosis (fungal nail infections). The drug has been a cornerstone in the treatment of these conditions due to its high efficacy and relatively low relapse rates compared to other antifungal medications[5].

Market Growth and Projections

The Terbinafine market has been experiencing a significant surge in recent years and is projected to continue this growth trajectory. From 2023 to 2031, the market is expected to see sustained and substantial expansion, driven by robust growth rates. This positive momentum is attributed to the increasing demand for effective antifungal treatments and the drug's proven long-term efficacy[1].

Market Size and Revenue

As of 2023, the global Terbinafine Hydrochloride market was estimated to be worth approximately US$ 614 million. Projections indicate that this figure will rise to US$ 912.6 million by 2030, with a Compound Annual Growth Rate (CAGR) of 6.4% during the forecast period of 2024-2030[4].

Drivers of Market Growth

Several factors are driving the growth of the Terbinafine market:

Increasing Demand for Antifungal Medications

The rise in fungal infections, particularly during seasonal changes like the transition from winter to spring, contributes to a surge in demand for antifungal medications. This increased demand is especially notable in regions such as India and the USA[2].

Efficacy and Long-Term Cure Rates

Terbinafine's superior long-term mycological and clinical cure rates compared to other antifungal drugs, such as itraconazole, make it a preferred choice among healthcare providers. This efficacy translates into higher demand and market growth[5].

Expanding Pharmaceutical Sector

The pharmaceutical sector, particularly in countries like India, has seen significant growth driven by strong sales in key therapeutic areas, including dermatology. This growth fuels the demand for Terbinafine and other antifungal medications[3].

Supply Chain and Pricing Dynamics

Supply Chain Disruptions

Global supply chain disruptions, such as those caused by the Lunar New Year in China and logistical issues in shipping routes like the Panama Canal, have led to scarcity and increased prices of Terbinafine Hydrochloride. These disruptions exacerbate the challenges in maintaining a steady supply, contributing to price hikes[2].

Price Increases

The combination of heightened demand and constrained supply has resulted in an upward trend in Terbinafine Hydrochloride prices. This trend is expected to continue into the second quarter of 2024, driven by sustained demand from end-user healthcare and pharmaceutical sectors[3].

Regional Market Dynamics

China and India

China and India are pivotal players in the global market for Active Pharmaceutical Ingredients (APIs), including Terbinafine Hydrochloride. Factory closures during the Lunar New Year in China and increased production efforts in India to meet domestic and international demands contribute to supply shortages and price increases[2][3].

USA and Eurozone

The USA and Eurozone, particularly Germany, are also experiencing increased demand for Terbinafine Hydrochloride. Economic recovery and improved consumer spending in these regions further drive the demand for this medication, leading to similar pricing trends[3].

Competitive Landscape

The Terbinafine market is competitive, with several key players including Novartis, GSK, TEVA, Dr. Reddy's Laboratories, CIPLA LTD, and others. These companies are involved in various strategies such as pricing adjustments, new product introductions, and stockpiling to manage the dynamic market conditions[4].

Challenges and Opportunities

Challenges

• Supply chain disruptions and logistical issues pose significant challenges to maintaining a stable supply of Terbinafine Hydrochloride.
• Increased production costs and domestic supply constraints in major producing countries can lead to price volatility.

Opportunities

• The growing demand for effective antifungal treatments presents opportunities for pharmaceutical companies to expand their market share.
• Innovations in manufacturing and logistics can help mitigate supply chain disruptions and reduce costs.

Key Takeaways

• The Terbinafine market is experiencing rapid growth driven by increasing demand and proven efficacy.
• Supply chain disruptions and constrained supply are leading to price increases.
• China and India play crucial roles in the global supply of Terbinafine Hydrochloride.
• The market is projected to reach US$ 912.6 million by 2030 with a CAGR of 6.4%.
• Pharmaceutical companies are adopting various strategies to manage market dynamics.

Frequently Asked Questions (FAQs)

1. What is the current market size of Terbinafine Hydrochloride? The global Terbinafine Hydrochloride market was estimated to be worth approximately US$ 614 million in 2023[4].

2. What is the projected growth rate of the Terbinafine market? The market is expected to grow at a CAGR of 6.4% from 2024 to 2030[4].

3. Why are Terbinafine Hydrochloride prices increasing? Prices are increasing due to a surge in demand, supply chain disruptions, and constrained supply, particularly during seasonal changes and factory closures in China[2][3].

4. Which regions are key players in the Terbinafine market? China and India are major producers and exporters of Terbinafine Hydrochloride, while the USA and Eurozone are significant consumers[2][3].

5. How does Terbinafine compare to other antifungal medications? Terbinafine achieves significantly higher long-term mycological and clinical cure rates compared to other antifungal drugs like itraconazole[5].

Cited Sources:

1. MarketResearchIntellect - Global Terbinafine (Lamisil) Market Size, Trends and Projections
2. ChemAnalyst - Global Upturn in Terbinafine Hydrochloride Costs Projected Amid Supply Chain Disruptions
3. ChemAnalyst - Skyrocketing Demand Sends Global Terbinafine Hydrochloride Prices Surging
4. Valuates Reports - Terbinafine Hydrochloride Drug - Market Size
5. JAMA Dermatology - Long-term Effectiveness of Treatment With Terbinafine vs Itraconazole for Onychomycosis