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Last Updated: December 22, 2024

M-ZOLE 7 DUAL PACK Drug Patent Profile


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When do M-zole 7 Dual Pack patents expire, and when can generic versions of M-zole 7 Dual Pack launch?

M-zole 7 Dual Pack is a drug marketed by Actavis Mid Atlantic and is included in one NDA.

The generic ingredient in M-ZOLE 7 DUAL PACK is miconazole nitrate. There are twenty-eight drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the miconazole nitrate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for M-zole 7 Dual Pack

A generic version of M-ZOLE 7 DUAL PACK was approved as miconazole nitrate by ACTAVIS PHARMA on November 19th, 1993.

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Summary for M-ZOLE 7 DUAL PACK
Drug patent expirations by year for M-ZOLE 7 DUAL PACK

US Patents and Regulatory Information for M-ZOLE 7 DUAL PACK

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actavis Mid Atlantic M-ZOLE 7 DUAL PACK miconazole nitrate CREAM, SUPPOSITORY;TOPICAL, VAGINAL 074586-001 Jul 17, 1997 DISCN 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

M-ZOLE 7 DUAL PACK Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for M-ZOLE 7 DUAL PACK

Introduction

M-ZOLE 7 DUAL PACK, a product containing the antifungal agent miconazole, is widely used to treat various fungal infections. Understanding the market dynamics and financial trajectory of this product is crucial for stakeholders, including pharmaceutical companies, investors, and healthcare providers.

Market Overview

Antifungal Market

The antifungal market is a segment of the broader pharmaceutical industry, driven by the increasing incidence of fungal infections and the growing resistance to existing antifungal drugs. Miconazole, an azole antifungal, is a key player in this market due to its broad-spectrum activity against various fungal infections, including candidiasis, dermatophytosis, and diaper dermatitis[4].

Competitive Landscape

The antifungal market is competitive, with several products available, including clotrimazole and other azole antifungals. Miconazole, however, holds a significant market share due to its efficacy and the variety of formulations available, such as creams, ointments, and vaginal suppositories[4].

Product Specifics: M-ZOLE 7 DUAL PACK

Indications and Usage

M-ZOLE 7 DUAL PACK is specifically designed to treat vaginal yeast infections and other fungal infections. It is available in a dual-pack format, which includes both an internal cream and external cream, making it a comprehensive treatment solution[4].

Pharmacokinetics and Safety

Miconazole is characterized by poor absorption into the systemic circulation when applied topically, which reduces the risk of systemic side effects. This makes it a safe option for treating localized fungal infections[4].

Market Dynamics

Demand Drivers

  • Increasing Incidence of Fungal Infections: The rise in fungal infections, particularly among immunocompromised patients, drives the demand for antifungal medications like miconazole.
  • Antimicrobial Resistance: The growing concern over antimicrobial resistance highlights the need for effective antifungal treatments, boosting the demand for established products like M-ZOLE 7 DUAL PACK[3].

Market Barriers

  • Generic Competition: The availability of generic versions of miconazole can reduce the market share of branded products like M-ZOLE 7 DUAL PACK.
  • Regulatory Environment: Strict regulatory requirements and the need for continuous compliance can impact the financial trajectory of pharmaceutical products[3].

Financial Trajectory

Revenue Streams

  • Prescription Sales: M-ZOLE 7 DUAL PACK generates revenue primarily through prescription sales. The product's efficacy and brand recognition contribute to its market share.
  • Over-the-Counter (OTC) Sales: In some regions, miconazole products are available OTC, which can provide an additional revenue stream.

Cost Structure

  • Research and Development: Although miconazole is an established drug, ongoing R&D is necessary to maintain market position and comply with regulatory standards.
  • Manufacturing and Distribution: The cost of manufacturing and distributing the product, including the dual-pack format, is a significant expense.
  • Marketing and Advertising: Continuous marketing efforts are required to maintain brand visibility and compete with generic alternatives.

Pricing Strategies

  • Competitive Pricing: The pricing of M-ZOLE 7 DUAL PACK is influenced by the competitive landscape, with prices often set to remain competitive with other antifungal products.
  • Value-Based Pricing: The product's value in treating fungal infections effectively can justify premium pricing in some markets.

Financial Performance Indicators

Sales Growth

The sales growth of M-ZOLE 7 DUAL PACK can be measured by tracking year-over-year sales figures. A steady or increasing sales trend indicates a strong market position.

Profit Margins

Profit margins are influenced by the cost structure and pricing strategies. Maintaining high profit margins is crucial for the financial health of the product.

Market Share

Monitoring market share relative to competitors is essential. A stable or increasing market share suggests strong market dynamics.

Regulatory and Compliance Aspects

FDA Approvals and Compliance

M-ZOLE 7 DUAL PACK must comply with FDA regulations and guidelines. Any changes in regulatory requirements can impact the product's financial trajectory[4].

Patent and Intellectual Property

The patent status of miconazole and the dual-pack formulation can affect the product's market exclusivity and revenue potential. Generic competition increases once patents expire.

Future Outlook

Emerging Trends

  • Increased Focus on Antimicrobial Stewardship: Efforts to combat antimicrobial resistance may lead to increased demand for targeted antifungal treatments like miconazole.
  • Advancements in Formulations: Innovations in formulation and delivery methods can enhance the product's efficacy and user compliance.

Challenges and Opportunities

  • Generic Competition: The entry of generic versions poses a significant challenge but also presents opportunities for the manufacturer to differentiate the branded product through marketing and customer service.
  • Expanding into New Markets: Entering new geographic markets or expanding into new indications can provide growth opportunities.

Key Takeaways

  • Strong Market Position: M-ZOLE 7 DUAL PACK holds a strong position in the antifungal market due to its efficacy and comprehensive treatment approach.
  • Competitive Landscape: The product faces competition from other antifungal agents, including generics.
  • Regulatory Compliance: Continuous compliance with regulatory requirements is crucial for maintaining market presence.
  • Financial Health: The product's financial health is influenced by sales growth, profit margins, and market share.

FAQs

What is M-ZOLE 7 DUAL PACK used for?

M-ZOLE 7 DUAL PACK is used to treat vaginal yeast infections and other fungal infections, offering both internal and external creams for comprehensive treatment.

How does miconazole work?

Miconazole is an azole antifungal that works by inhibiting the synthesis of ergosterol, a critical component of fungal cell membranes, thereby killing the fungal cells.

Is M-ZOLE 7 DUAL PACK available over-the-counter?

In some regions, miconazole products, including M-ZOLE 7 DUAL PACK, may be available over-the-counter, but this varies by country and region.

What are the common side effects of miconazole?

Common side effects of miconazole include local irritation, itching, and burning at the application site. Systemic side effects are rare due to poor absorption.

How does the regulatory environment impact M-ZOLE 7 DUAL PACK?

The regulatory environment, including FDA approvals and compliance, significantly impacts the market presence and financial trajectory of M-ZOLE 7 DUAL PACK. Continuous compliance is essential to maintain market share.

Sources

  1. Wikipedia - Clotrimazole
  2. HCA Washington - Uniform Medical Plan | Prescription drug preauthorization criteria
  3. Access to Medicine Foundation - Antimicrobial Resistance Benchmark 2018
  4. DrugBank - Miconazole: Uses, Interactions, Mechanism of Action

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