BUTENAFINE HYDROCHLORIDE - Generic Drug Details

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

Butenafine hydrochloride is the generic ingredient in four branded drugs marketed by Taro, Bayer Healthcare Llc, and Norvium Bioscience, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for butenafine hydrochloride. Fourteen suppliers are listed for this compound.

Summary for BUTENAFINE HYDROCHLORIDE

US Patents:	0
Tradenames:	4
Applicants:	3
NDAs:	4
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	4
Patent Applications:	441
What excipients (inactive ingredients) are in BUTENAFINE HYDROCHLORIDE?	BUTENAFINE HYDROCHLORIDE excipients list
DailyMed Link:	BUTENAFINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for BUTENAFINE HYDROCHLORIDE

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

Sponsor	Phase
United Laboratories	Phase 2
Taro Pharmaceuticals USA	Phase 1

See all BUTENAFINE HYDROCHLORIDE clinical trials

Pharmacology for BUTENAFINE HYDROCHLORIDE

Drug Class

Benzylamine Antifungal

Anatomical Therapeutic Chemical (ATC) Classes for BUTENAFINE HYDROCHLORIDE

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

US Patents and Regulatory Information for BUTENAFINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Norvium Bioscience	MENTAX-TC	butenafine hydrochloride	CREAM;TOPICAL	021408-001	Oct 17, 2002		DISCN	No	No
Taro	BUTENAFINE HYDROCHLORIDE	butenafine hydrochloride	CREAM;TOPICAL	205181-001	Nov 16, 2017		OTC	No	No
Norvium Bioscience	MENTAX	butenafine hydrochloride	CREAM;TOPICAL	020524-001	Oct 18, 1996		DISCN	Yes	No
Bayer Healthcare Llc	LOTRIMIN ULTRA	butenafine hydrochloride	CREAM;TOPICAL	021307-001	Dec 7, 2001		OTC	Yes	Yes

Expired US Patents for BUTENAFINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Norvium Bioscience	MENTAX	butenafine hydrochloride	CREAM;TOPICAL	020524-001	Oct 18, 1996

BUTENAFINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Butenafine Hydrochloride: Market Dynamics and Financial Trajectory

Introduction

Butenafine hydrochloride, a topical antifungal medication, has been gaining significant traction in the pharmaceutical market. This article delves into the market dynamics and financial trajectory of butenafine hydrochloride, highlighting its current status, growth prospects, and key factors influencing its market performance.

Market Overview

The butenafine hydrochloride market has experienced a swift and substantial surge in recent years. This growth is anticipated to continue from 2023 to 2031, driven by several key factors.

Market Segmentation

The market is segmented based on type, application, and geographical regions. For the butenafine hydrochloride market, the types include purity levels such as 98% and 99% purity, while applications span medicine, chemical, and other sectors[1][4].

Geographical Distribution

The market is geographically divided into North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. Each region presents unique opportunities and challenges, influenced by local healthcare policies, market demand, and economic conditions[1][4].

Growth Drivers

Several factors are driving the robust growth of the butenafine hydrochloride market:

Increasing Prevalence of Fungal Infections

The rising incidence of fungal skin infections, such as tinea versicolor caused by Malassezia furfur, is a significant driver. Butenafine hydrochloride is effective in treating these infections, making it a preferred choice among healthcare providers[5].

Expanding Healthcare Infrastructure

Improvements in healthcare infrastructure, particularly in emerging economies, have increased access to antifungal treatments. This expansion is expected to continue, fueling demand for butenafine hydrochloride[4].

Regulatory Approvals

Recent regulatory approvals, such as the FDA approval for butenafine hydrochloride cream, have bolstered market confidence. For instance, Taro Pharmaceuticals USA Inc.'s ANDA for butenafine hydrochloride cream was approved, establishing its bioequivalence to the reference listed drug, Lotrimin Ultra Cream[3].

Market Dynamics

Competitive Landscape

The butenafine hydrochloride market is characterized by a mix of established and emerging players. Key companies are profiled in market reports, highlighting their product offerings, market entry years, and other relevant factors. This competitive landscape is dynamic, with companies continually innovating and expanding their product lines[1][4].

Bioequivalence Studies

Bioequivalence studies play a crucial role in the market dynamics. The FDA recommends either in vitro bioequivalence studies with characterization tests or in vivo bioequivalence studies with clinical endpoints to establish the bioequivalence of generic products. These studies ensure that generic versions of butenafine hydrochloride are as effective and safe as the branded counterparts[2].

Financial Trajectory

Market Size and Projections

The butenafine hydrochloride market is projected to experience robust growth rates over the forecast period from 2023 to 2031. Market size and predictions are measured in USD million, with the market expected to expand significantly due to the positive momentum in market dynamics[1][4].

Revenue Outlook

The revenue outlook for the butenafine hydrochloride market is optimistic. The market study provides an outlook on the development of the market in terms of revenue throughout the prognosis period. Key considerations include product pricing, market penetration, and the economic landscapes of various regions[1][4].

Challenges and Opportunities

Challenges

Despite the growth, the market faces several challenges, including side effects associated with the medication, such as blistering, burning, and severe redness of the skin where the medicine is applied. Additionally, regulatory hurdles and competition from other antifungal treatments can impact market growth[5].

Opportunities

The market presents several opportunities, particularly in emerging markets where there is a high demand for effective antifungal treatments. Innovations in formulation and delivery methods, such as gels, creams, and sprays, also offer avenues for growth[4].

Key Players and Market Strategies

Market Strategies

Key players in the market employ various strategies to maintain and expand their market share. These include product innovation, strategic partnerships, and aggressive marketing campaigns. For instance, companies may focus on developing new formulations or expanding their distribution networks to reach a broader audience[1][4].

Corporate Profiles

Market reports provide detailed corporate profiles of key players, including their market entry years, product offerings, and other relevant market-related factors. This information is crucial for understanding the competitive landscape and identifying potential opportunities and challenges[1][4].

Regulatory Environment

FDA Guidance

The FDA plays a critical role in shaping the market through its guidance documents and regulatory approvals. For butenafine hydrochloride, the FDA has provided detailed guidance on bioequivalence studies and other regulatory requirements. These guidelines ensure that products meet stringent safety and efficacy standards[2][3].

Consumer Behavior and Economic Impact

Consumer Behavior

Consumer behavior is a significant factor in the butenafine hydrochloride market. Increasing awareness about fungal infections and the importance of effective treatments drives demand for the medication. Additionally, consumer preferences for convenient and effective treatments influence market trends[4].

Economic Impact

The economic impact of the butenafine hydrochloride market is substantial. The market's growth contributes to the overall pharmaceutical industry's revenue and employment. Moreover, the availability of affordable and effective treatments improves public health outcomes, which in turn has broader economic benefits[1][4].

Conclusion

The butenafine hydrochloride market is poised for significant growth driven by increasing demand for antifungal treatments, regulatory approvals, and expanding healthcare infrastructure. Despite challenges such as side effects and regulatory hurdles, the market presents numerous opportunities for innovation and expansion.

Key Takeaways

• Robust Growth: The butenafine hydrochloride market is expected to experience robust growth from 2023 to 2031.
• Market Segmentation: The market is segmented by type, application, and geographical regions.
• Regulatory Approvals: Recent FDA approvals have bolstered market confidence.
• Bioequivalence Studies: Bioequivalence studies are crucial for ensuring the safety and efficacy of generic products.
• Challenges and Opportunities: The market faces challenges such as side effects but also presents opportunities in emerging markets and through innovation.

FAQs

Q: What is butenafine hydrochloride used for?

Butenafine hydrochloride is used to treat fungus infections of the skin, including tinea versicolor caused by Malassezia furfur[5].

Q: What are the common side effects of butenafine hydrochloride?

Common side effects include blistering, burning, crusting, dryness, or flaking of the skin where the medicine is applied[5].

Q: What is the expected growth rate of the butenafine hydrochloride market?

The market is expected to experience robust growth rates from 2023 to 2031, driven by positive market dynamics[1][4].

Q: How is the butenafine hydrochloride market segmented?

The market is segmented based on type (purity levels), application (medicine, chemical, etc.), and geographical regions[1][4].

Q: What role do bioequivalence studies play in the butenafine hydrochloride market?

Bioequivalence studies are essential for establishing the safety and efficacy of generic butenafine hydrochloride products, ensuring they are as effective as branded counterparts[2].

Sources

1. Market Research Intellect, "Global Butenafine Hydrochloride Market Size, Scope And Forecast Report".
2. FDA, "Draft Guidance on Butenafine Hydrochloride".
3. FDA, "ANDA 205181 - Butenafine Hydrochloride Cream, 1%".
4. Market Research Intellect, "Global Butenafine Hydrochloride API Market Size, Scope And Forecast".
5. Mayo Clinic, "Butenafine (topical route)".