Terbinafine hydrochloride - Generic Drug Details

What are the generic sources for terbinafine hydrochloride and what is the scope of freedom to operate?

Terbinafine hydrochloride is the generic ingredient in three branded drugs marketed by Karo Hlthcare, Novartis, Sun Pharma Canada, Anda Repository, Aurobindo Pharma, Breckenridge Pharm, Chartwell, Cipla, 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-one 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:	41
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	51
Patent Applications:	6,205
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
Assiut University	NA
Muhammad Aamir Latif	NA
Assiut University	PHASE1

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
Chartwell	TERBINAFINE HYDROCHLORIDE	terbinafine hydrochloride	TABLET;ORAL	078199-001	Jul 2, 2007	AB	RX	No	No
Emed Medcl	TERBINAFINE HYDROCHLORIDE	terbinafine hydrochloride	TABLET;ORAL	077919-001	Jul 2, 2007	AB	RX	No	No
Wockhardt	TERBINAFINE HYDROCHLORIDE	terbinafine hydrochloride	TABLET;ORAL	078229-001	Jul 2, 2007		DISCN	No	No
Aurobindo Pharma	TERBINAFINE HYDROCHLORIDE	terbinafine hydrochloride	TABLET;ORAL	078297-001	Jul 2, 2007	AB	RX	No	Yes

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	4,680,291
Novartis	LAMISIL	terbinafine hydrochloride	TABLET;ORAL	020539-001	May 10, 1996	4,680,291
Karo Hlthcare	LAMISIL	terbinafine hydrochloride	SOLUTION;TOPICAL	020749-001	Oct 17, 1997	6,121,314*PED
Karo Hlthcare	LAMISIL AT	terbinafine hydrochloride	SOLUTION;TOPICAL	021124-001	Mar 17, 2000	6,121,314*PED

Market Dynamics and Financial Trajectory for Terbinafine Hydrochloride

Last updated: July 27, 2025

Introduction

Terbinafine Hydrochloride is a widely used antifungal agent primarily prescribed to treat superficial dermatophyte infections, including athlete’s foot, ringworm, and nail fungus. Since its introduction, the drug has experienced substantial growth driven by increasing dermatological conditions, evolving healthcare paradigms, and the expanding pharmaceutical landscape. This analysis explores the market dynamics and financial trajectory shaping Terbinafine Hydrochloride’s future within global pharmaceutical markets.

Market Overview

Global Market Size and Growth Trends

The global antifungal drugs market, with Terbinafine Hydrochloride as a significant component, was valued at approximately USD 4.2 billion in 2022, with projections estimating a compound annual growth rate (CAGR) of around 4–6% through 2030 [1]. The growth is attributable to rising dermatological infections, increased awareness of fungal diseases, and expanding aging populations susceptible to such conditions.

Terbinafine Hydrochloride accounts for a substantial share of topical antifungals, given its effectiveness and relatively favorable safety profile. Its potent fungicidal activity and once-daily dosing regimen support high patient compliance, further fueling demand dynamics globally.

Key Geographic Markets

• North America: Dominates the market due to high diagnosis rates, advanced healthcare infrastructure, and strong patent protection. The U.S. remains the largest individual market, supported by insurance coverage and consumer awareness.

• Europe: Rapid growth driven by rising dermatological conditions and stringent healthcare protocols. Countries like Germany, the UK, and France constitute major markets.

• Asia-Pacific: Exhibits the fastest growth owing to large populations, increasing healthcare expenditure, and prevalence of fungal infections. China, India, and Southeast Asian nations exhibit significant uptake.

• Latin America and Middle East & Africa: Moderate growth driven by improving healthcare infrastructure and rising awareness.

Market Drivers

1. Rising Prevalence of Dermatological Conditions: An increase in fungal infections due to climate, lifestyle changes, and immunosuppression contributes to consistent demand.

2. Evolving Prescribing Practices: Growing preference for long-term, effective antifungal therapies favoring products like Terbinafine.

3. Patent Expirations and Generic Entry: Patent expiry for various formulations has led to increased generic competition, boosting overall market volume and reducing prices, but also exerting downward pressure on revenues for branded products.

4. Technological Advancements: Development of formulations with enhanced bioavailability and improved patient compliance influences market growth.

Competitive Landscape

The market is fragmented, with multiple generic manufacturers and some branded formulations. Major players include Novartis, Sandoz, Mylan, and Sun Pharma. The entry of generics has driven down prices, making the drug more accessible but challenging for brand-specific revenue retention.

Financial Trajectory

Revenue Streams and Profitability

• Generic Competition: The launch of generics post-patent expiry has significantly affected revenue streams of original patent-holding companies. For instance, Novartis’s Lamisil (oral and topical formulations) faced generic competition, resulting in revenue erosion [2].

• Pricing Trends: Prices for branded formulations tend to decline following generic entries, though overall volume sales can compensate for revenue loss, maintaining profitability.

• Formulation Diversification: Introduction of novel formulations, such as topical sprays or solutions, can command premium pricing and expand revenue streams.

Research & Development and Investment Outlook

Pharmaceutical companies are focusing on developing enhanced formulations and combination therapies to extend patent life or differentiate their products. R&D investments aim to improve bioavailability, reduce adverse effects, and develop long-acting preparations, potentially increasing market share and margins in the future.

Regulatory and Patent Considerations

Patent protections are critical in safeguarding revenue streams. However, patent cliffs occur typically 10–12 years post-launch, compelling companies to innovate continuously or rely on generics. Regulatory landscapes vary, impacting market access and pricing strategies.

Emerging Markets and Growth Opportunities

Encouraging growth in emerging markets presents a significant financial opportunity, driven by increasing healthcare access and rising incidence of fungal infections. Investments in local manufacturing and partnerships can facilitate market entry and expansion.

Market Challenges

• Price Competition: The surge of generics leads to compressed margins.
• Regulatory Barriers: Stringent regulatory approvals and patent litigations can delay product launches.
• Side Effect Profile: While generally safe, adverse effects in certain populations may restrict usage, influencing sales.
• Market Saturation: Mature markets show signs of saturation, curbing growth potential.

Future Outlook

The financial trajectory for Terbinafine Hydrochloride hinges upon strategic patent management, formulation innovation, and geographic expansion. While generic competition will persist, niche markets and specialized formulations can sustain higher margins. Digitization and pharmacovigilance will support compliance and brand differentiation, altering the revenue landscape advantageously.

Key Factors Influencing Financial Outcomes

• Patent Extensions & Cradle-to-Grave Lifecycle Management: Proper patent strategies can sustain revenues beyond initial expiry.
• Formulation Innovation: Advancing delivery systems can command premium pricing and capture niche segments.
• Market Penetration in Emerging Economies: Local manufacturing and strategic alliances will be vital.
• Regulatory Navigation: Streamlined approval pathways and compliance reduce costs and time-to-market.

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Key Takeaways

• The global Terbinafine Hydrochloride market maintains steady growth driven by increasing dermatological infections.
• Patent expiries and generic competition have led to pricing pressures but also expanded market access.
• Emerging markets offer high-growth opportunities, especially with local manufacturing and strategic positioning.
• Innovation in formulations and delivery methods could unlock premium markets and extend product lifecycle.
• Companies must balance patent protections, regulatory strategies, and cost management to optimize financial performance.

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FAQs

1. How does patent expiration impact the financial trajectory of Terbinafine Hydrochloride?
Patent expiration typically leads to generic entry, increasing competition, driving down prices, and eroding revenues for original patent holders. However, strategic formulation innovations and patent extensions can mitigate these impacts and sustain profitability.

2. What are the primary challenges in expanding Terbinafine Hydrochloride markets internationally?
Regulatory hurdles, differing healthcare infrastructure, patent laws, and price competition pose significant barriers. Tailoring formulations and local partnerships are essential to overcoming these challenges.

3. How does the rise of antifungal resistance affect the market outlook?
While resistance is currently limited for Terbinafine, emerging resistance could reduce efficacy, prompting the need for novel formulations or combination therapies, impacting future revenues.

4. What role do emerging markets play in the future financial growth of Terbinafine Hydrochloride?
Emerging markets represent high-growth zones due to increasing disease prevalence and expanding healthcare access. Local manufacturing and strategic pricing will be key to capturing these opportunities.

5. Will formulation innovations sustain the drug’s market share amid generic competition?
Yes; advanced formulations offering improved efficacy, safety, or convenience can command higher prices and differentiate products, helping sustain market share despite generic competition.

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References

[1] MarketsandMarkets. “Antifungal Drugs Market.” 2022.
[2] Novartis Annual Report 2022.
[3] EvaluatePharma. “Pharmaceutical Market Data: Antifungal Agents.” 2022.