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Last Updated: December 22, 2024

BUTENAFINE HYDROCHLORIDE Drug Patent Profile


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When do Butenafine Hydrochloride patents expire, and what generic alternatives are available?

Butenafine Hydrochloride is a drug marketed by Taro and is included in one NDA.

The generic ingredient in BUTENAFINE HYDROCHLORIDE is butenafine hydrochloride. There are two drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the butenafine hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Butenafine Hydrochloride

A generic version of BUTENAFINE HYDROCHLORIDE was approved as butenafine hydrochloride by TARO on November 16th, 2017.

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Drug patent expirations by year for BUTENAFINE HYDROCHLORIDE
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SponsorPhase
United LaboratoriesPhase 2
Taro Pharmaceuticals USAPhase 1

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Pharmacology for BUTENAFINE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for BUTENAFINE HYDROCHLORIDE

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
Taro BUTENAFINE HYDROCHLORIDE butenafine hydrochloride CREAM;TOPICAL 205181-001 Nov 16, 2017 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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)".

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