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Last Updated: April 24, 2025

OXICONAZOLE NITRATE Drug Patent Profile


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Which patents cover Oxiconazole Nitrate, and what generic alternatives are available?

Oxiconazole Nitrate is a drug marketed by Taro and is included in one NDA.

The generic ingredient in OXICONAZOLE NITRATE is oxiconazole nitrate. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the oxiconazole nitrate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Oxiconazole Nitrate

A generic version of OXICONAZOLE NITRATE was approved as oxiconazole nitrate by TARO on March 7th, 2016.

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Recent Clinical Trials for OXICONAZOLE NITRATE

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SponsorPhase
Minia UniversityPhase 1
Taro Pharmaceuticals USAPhase 1

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Pharmacology for OXICONAZOLE NITRATE
Drug ClassAzole Antifungal

US Patents and Regulatory Information for OXICONAZOLE NITRATE

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Taro OXICONAZOLE NITRATE oxiconazole nitrate CREAM;TOPICAL 205076-001 Mar 7, 2016 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 1 of 1 entries

Market Dynamics and Financial Trajectory of Oxiconazole Nitrate

Introduction

Oxiconazole nitrate, a broad-spectrum antifungal agent, has been a staple in the treatment of various fungal infections since its approval in the United States in December 1988. This article delves into the market dynamics and financial trajectory of oxiconazole nitrate, exploring its pharmacology, market trends, and future prospects.

Pharmacology and Efficacy

Oxiconazole nitrate is highly effective against many dermatophytes, including Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, and Epidermophyton floccosum[2]. It is rapidly absorbed into the stratum corneum and maintains fungicidal concentrations in the epidermis, upper corium, and deeper corium for several hours. This makes it an effective treatment for tinea pedis, tinea cruris, tinea corporis, and tinea versicolor.

Market Approval and Historical Use

Since its introduction in 1989, oxiconazole nitrate has been widely used as a 1% cream for the once-daily treatment of various fungal infections. Its efficacy and tolerability have been compared favorably to other antifungal creams such as miconazole, clotrimazole, and tolnaftate[2].

Market Trends

The antifungal market, including oxiconazole nitrate, has seen significant growth driven by increasing incidence of fungal infections and advancements in drug delivery systems.

Advancements in Drug Delivery Systems

Recent research has focused on enhancing the delivery of oxiconazole nitrate through novel formulations such as solid lipid nanoparticles (SLNs) and nanostructured lipid carriers (NLCs). These formulations aim to improve the drug's effectiveness and patient compliance[1][4].

Growing Demand for Antifungal Treatments

The global antifungal market is expanding due to the rising prevalence of fungal infections, particularly in immunocompromised patients. This demand is expected to drive the sales of oxiconazole nitrate and other antifungal agents.

Financial Trajectory

Historical Sales

Since its approval, oxiconazole nitrate has generated significant revenue as a widely prescribed antifungal agent. Its once-daily application and high efficacy rates have contributed to its market success.

Current Market Analysis

The market for oxiconazole nitrate continues to grow, albeit at a moderate pace. The development of new formulations and delivery systems is expected to boost sales. For instance, the use of SLNs and NLCs could enhance the drug's penetration and retention in the skin, potentially increasing its market share[1][4].

Future Prospects

The antifungal market is projected to continue growing, driven by increasing awareness of fungal infections and advancements in treatment options. Oxiconazole nitrate, with its established efficacy and new delivery systems, is well-positioned to benefit from this growth.

Competitive Landscape

Oxiconazole nitrate competes with other topical antifungal agents such as miconazole, clotrimazole, and tolnaftate. However, its unique pharmacological profile and new delivery systems give it a competitive edge.

Regulatory Environment

The regulatory environment for oxiconazole nitrate is stable, with the drug having been approved for over three decades. New formulations, however, must comply with regulatory standards, which can be a challenge but also an opportunity for innovation and market differentiation[4].

Challenges and Opportunities

Challenges

  • Competition: The antifungal market is competitive, with several established and new entrants.
  • Regulatory Compliance: New formulations must meet stringent regulatory requirements.
  • Resistance: The potential for antifungal resistance is a growing concern.

Opportunities

  • Innovative Delivery Systems: Advances in SLNs, NLCs, and other nanoparticle technologies offer opportunities to enhance the drug's effectiveness and patient compliance.
  • Expanding Market: The growing demand for antifungal treatments presents a significant market opportunity.
  • Repurposing: Research into repurposing oxiconazole nitrate for other conditions, such as colorectal cancer, could expand its market potential[1].

Key Takeaways

  • Oxiconazole nitrate is a well-established antifungal agent with a strong market presence.
  • Advances in drug delivery systems, such as SLNs and NLCs, are expected to enhance its effectiveness and market share.
  • The growing demand for antifungal treatments and potential repurposing of the drug for other conditions present significant opportunities for growth.
  • Regulatory compliance and competition are key challenges that need to be addressed.

FAQs

  1. What is oxiconazole nitrate used for? Oxiconazole nitrate is used for the treatment of various fungal infections, including tinea pedis, tinea cruris, tinea corporis, and tinea versicolor.

  2. How is oxiconazole nitrate administered? Oxiconazole nitrate is typically administered as a 1% cream applied once daily to the affected area.

  3. What are the advantages of using oxiconazole nitrate? Oxiconazole nitrate is highly effective against many dermatophytes, has a favorable tolerability profile, and maintains fungicidal concentrations in the skin for several hours.

  4. Are there new formulations of oxiconazole nitrate being developed? Yes, new formulations such as solid lipid nanoparticles (SLNs) and nanostructured lipid carriers (NLCs) are being developed to enhance the drug's effectiveness and patient compliance.

  5. Can oxiconazole nitrate be used for conditions other than fungal infections? Research is ongoing into the potential repurposing of oxiconazole nitrate for other conditions, such as colorectal cancer, but it is currently approved only for fungal infections.

Sources

  1. Unbound Medicine - Oxiconazole journal articles from PubMed
  2. PubMed - Oxiconazole nitrate: pharmacology, efficacy, and safety
  3. chemBlink - Market Analysis Reports - Oxiconazole nitrate
  4. ACS Publications - Lipid-Based Nanoparticles for Drug/Gene Delivery
  5. Patsnap - Exploring Oxiconazole Nitrate's Revolutionary R&D Successes and Market Trends

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