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Last Updated: December 22, 2024

MICONAZOLE 3 Drug Patent Profile


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When do Miconazole 3 patents expire, and what generic alternatives are available?

Miconazole 3 is a drug marketed by Taro and Perrigo and is included in two NDAs.

The generic ingredient in MICONAZOLE 3 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 Miconazole 3

A generic version of MICONAZOLE 3 was approved as miconazole nitrate by ACTAVIS PHARMA on November 19th, 1993.

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Summary for MICONAZOLE 3
US Patents:0
Applicants:2
NDAs:2
Finished Product Suppliers / Packagers: 6
Raw Ingredient (Bulk) Api Vendors: 125
Clinical Trials: 31
Patent Applications: 2,906
What excipients (inactive ingredients) are in MICONAZOLE 3?MICONAZOLE 3 excipients list
DailyMed Link:MICONAZOLE 3 at DailyMed
Drug patent expirations by year for MICONAZOLE 3
Drug Sales Revenue Trends for MICONAZOLE 3

See drug sales revenues for MICONAZOLE 3

Recent Clinical Trials for MICONAZOLE 3

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

SponsorPhase
Ain Shams UniversityPhase 3
October 6 UniversityPhase 3
Hill Dermaceuticals, Inc.Phase 3

See all MICONAZOLE 3 clinical trials

Pharmacology for MICONAZOLE 3
Drug ClassAzole Antifungal

US Patents and Regulatory Information for MICONAZOLE 3

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Taro MICONAZOLE 3 miconazole nitrate CREAM;VAGINAL 076773-001 Mar 2, 2005 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Perrigo MICONAZOLE 3 COMBINATION PACK miconazole nitrate CREAM;TOPICAL, VAGINAL 076357-001 Mar 30, 2004 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

MICONAZOLE 3 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Miconazole 3

Market Overview

Miconazole 3, a formulation of the antifungal drug miconazole nitrate, is a significant player in the global antifungal market. This market has been experiencing substantial growth driven by several key factors.

Growth Drivers

Increasing Prevalence of Fungal Infections

The rising incidence of fungal infections, particularly among immunocompromised individuals and the elderly, is a major driver for the growth of the miconazole market. As the global population ages and more people become immunocompromised due to various health conditions, the demand for effective antifungal treatments like miconazole is increasing[3].

Technological Advancements

Advances in antifungal drug formulations and delivery systems are enhancing treatment efficacy and patient adherence. This includes the development of combination packs that include both vaginal suppositories and external creams, which are more convenient and effective for patients[2][5].

Expanding Use of Broad-Spectrum Antifungals

The expanding use of broad-spectrum antifungal agents and the development of novel drugs targeting resistant strains are also propelling the market. Miconazole 3, with its broad-spectrum antifungal properties, is well-positioned to benefit from this trend[3].

Market Segmentation

Type

The miconazole market is segmented based on the type of product, including oral, cream, and suppository forms. The suppository segment, which includes products like Miconazole 3, accounted for a noticeable share of the global market in 2023 and is projected to experience significant growth in the near future[1][4].

Application

Miconazole 3 is primarily used for vaginal yeast infections and external skin treatments. The vaginal treatment segment is a major driver, given the high prevalence of yeast infections among women. The external skin treatment segment also contributes significantly, as the product relieves itching and irritation associated with these infections[1][2].

Geographical Analysis

Global Market

The global miconazole market is expected to see sustained significant expansion from 2023 to 2031. Regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa are key contributors to this growth. The U.S. market, in particular, was estimated at $4.4 billion in 2023, while China is forecasted to grow at an impressive 6.6% CAGR to reach $4.7 billion by 2030[1][3].

Financial Trajectory

Market Size and Growth Rate

The global miconazole market size is projected to grow substantially over the forecast period. The market is expected to maintain a robust growth rate, with the global antifungal drugs market estimated to reach $22 billion by 2030, growing at a CAGR of 4.2% from 2023 to 2030[3].

Revenue Projections

The miconazole market, specifically, is anticipated to see significant revenue growth. The suppositories segment, which includes Miconazole 3, is expected to contribute significantly to this growth. The market size for miconazole is forecasted to expand from its current value, driven by increasing demand and technological advancements[1][4].

Competitive Landscape

Key Players

Companies like Johnson & Johnson (Ortho-McNeil Pharmaceutical) and Endo are major players in the miconazole market. These companies are focusing on strategy building models to strengthen their product portfolios and expand their business in the global market. The competitive landscape is characterized by strong, active, and niche players, each vying for market share through innovative products and marketing strategies[4].

Challenges and Opportunities

Challenges

Despite the growth, the market faces challenges such as the potential for side effects and the need for continuous innovation to combat resistant fungal strains. Additionally, regulatory hurdles and competition from generic products can impact market dynamics[2][3].

Opportunities

The integration of antifungal drugs into comprehensive care plans for chronic diseases and the rising trend of prophylactic antifungal use in high-risk populations present significant opportunities for growth. Early and accurate diagnosis of fungal infections, facilitated by improved diagnostic techniques, also drives demand for effective treatments like Miconazole 3[3].

Consumer Behavior and Preferences

Patient Adherence

Patients prefer treatments that are convenient and effective. Miconazole 3, with its 3-day treatment regimen and combination pack including both suppositories and external cream, aligns well with these preferences. The product's ability to cure most vaginal yeast infections and relieve associated external itching and irritation enhances patient adherence[2][5].

Technological and Regulatory Trends

Innovative Formulations

The development of novel drug formulations and delivery systems is a key trend. Miconazole 3 benefits from these advancements, offering a less-concentrated but effective treatment option for patients who prefer a shorter treatment duration[5].

Regulatory Environment

The regulatory environment plays a crucial role in the antifungal market. Compliance with regulatory standards and obtaining necessary approvals are essential for the launch and continued sale of products like Miconazole 3[3].

Key Takeaways

  • The miconazole market is experiencing significant growth driven by increasing prevalence of fungal infections and technological advancements.
  • Miconazole 3 is a key product in this market, particularly for vaginal yeast infections and external skin treatments.
  • The global market is projected to reach substantial revenue by 2030, with a CAGR of 4.2%.
  • Key players are focusing on strengthening their product portfolios and expanding their business globally.
  • Challenges include side effects and regulatory hurdles, but opportunities lie in integrated care plans and prophylactic use.

FAQs

1. What is Miconazole 3 used for?

Miconazole 3 is used to treat vaginal yeast infections and relieve associated external itching and irritation.

2. How is Miconazole 3 administered?

Miconazole 3 is administered via vaginal suppositories or prefilled cream applicators, along with an external cream for itch relief[2][5].

3. What are the key drivers of the miconazole market?

Key drivers include the increasing prevalence of fungal infections, technological advancements, and the expanding use of broad-spectrum antifungals[3].

4. Which regions are significant for the miconazole market?

North America, Europe, Asia-Pacific, South America, and the Middle East and Africa are key regions contributing to the market growth[1][3].

5. What is the projected market size for antifungal drugs by 2030?

The global antifungal drugs market is projected to reach $22 billion by 2030, growing at a CAGR of 4.2% from 2023 to 2030[3].

Cited Sources:

  1. Market Research Intellect: Global Miconazole Nitrate Market Size, Scope And Forecast Report[1].
  2. Drugs.com: Topcare Miconazole 3: Package Insert / Prescribing Info[2].
  3. GlobeNewswire: Antifungal Drugs Strategic Business Report 2024-2030[3].
  4. Cognitive Market Research: Miconazole Market Report 2024 (Global Edition)[4].
  5. MONISTAT: MONISTAT® 3-Day Treatment for Yeast Infections[5].

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