MICONAZOLE - Generic Drug Details

What are the generic drug sources for miconazole and what is the scope of freedom to operate?

Miconazole is the generic ingredient in nineteen branded drugs marketed by Janssen Pharma, Galt Pharms, Perrigo R And D, Medtech Products, Cosette, Actavis Mid Atlantic, L Perrigo Co, Insight Pharms, Perrigo, Sun Pharma Canada, P And L, Teva, Teva Pharms, Actavis Pharma, Personal Prods, and Mylan, and is included in thirty-two NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There are twenty-eight drug master file entries for miconazole. One supplier is listed for this compound.

Summary for MICONAZOLE

US Patents:	1
Tradenames:	19
Applicants:	16
NDAs:	32
Drug Master File Entries:	28
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	112
Clinical Trials:	32
Drug Prices:	Drug price trends for MICONAZOLE
What excipients (inactive ingredients) are in MICONAZOLE?	MICONAZOLE excipients list
DailyMed Link:	MICONAZOLE at DailyMed

See drug prices for MICONAZOLE

See drug sales revenues for MICONAZOLE

Recent Clinical Trials for MICONAZOLE

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

Sponsor	Phase
Ain Shams University	Phase 3
Assistance Publique - Hôpitaux de Paris	PHASE2
Cairo University	Phase 3

See all MICONAZOLE clinical trials

Pharmacology for MICONAZOLE

Drug Class

Azole Antifungal

Medical Subject Heading (MeSH) Categories for MICONAZOLE

14-alpha Demethylase Inhibitors

Antifungal Agents

Cytochrome P-450 CYP2C9 Inhibitors

Cytochrome P-450 CYP3A Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for MICONAZOLE

A01AB	Antiinfectives and antiseptics for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

A07AC	Imidazole derivatives
A07A	INTESTINAL ANTIINFECTIVES
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

D01AC	Imidazole and triazole derivatives
D01A	ANTIFUNGALS FOR TOPICAL USE
D01	ANTIFUNGALS FOR DERMATOLOGICAL USE
D	Dermatologicals

G01AF	Imidazole derivatives
G01A	ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
G01	GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
G	Genito-urinary system and sex hormones

J02AB	Imidazole derivatives
J02A	ANTIMYCOTICS FOR SYSTEMIC USE
J02	ANTIMYCOTICS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

S02AA	Antiinfectives
S02A	ANTIINFECTIVES
S02	OTOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for MICONAZOLE

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
Medtech Products	MONISTAT 3	miconazole nitrate	CREAM;VAGINAL	020827-001	Mar 30, 1998		OTC	Yes	Yes
Galt Pharms	ORAVIG	miconazole	TABLET;BUCCAL	022404-001	Apr 16, 2010		RX	Yes	Yes
Cosette	MICONAZOLE NITRATE	miconazole nitrate	SUPPOSITORY;VAGINAL	074414-001	Apr 30, 1997		DISCN	No	No
Medtech Products	MONISTAT 3 COMBINATION PACK	miconazole nitrate	CREAM, SUPPOSITORY;TOPICAL, VAGINAL	020670-002	Apr 16, 1996		OTC	Yes	Yes

Expired US Patents for MICONAZOLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharma	MONISTAT	miconazole	INJECTABLE;INJECTION	018040-001	Approved Prior to Jan 1, 1982
Galt Pharms	ORAVIG	miconazole	TABLET;BUCCAL	022404-001	Apr 16, 2010
Galt Pharms	ORAVIG	miconazole	TABLET;BUCCAL	022404-001	Apr 16, 2010
Galt Pharms	ORAVIG	miconazole	TABLET;BUCCAL	022404-001	Apr 16, 2010
Janssen Pharma	MONISTAT	miconazole	INJECTABLE;INJECTION	018040-001	Approved Prior to Jan 1, 1982

Last updated: July 28, 2025

rket Dynamics and Financial Trajectory for the Pharmaceutical Drug: Miconazole

Introduction
Miconazole, a broad-spectrum antifungal agent, has established itself as a pivotal player in the treatment of fungal infections since its introduction. As a member of the imidazole class, it disrupts fungal cell membrane synthesis, proving effective against dermatophytes, yeasts, and some molds. Its extended clinical use, diverse formulations, and evolving market landscape highlight significant shifts in demand, competitive positioning, and revenue potential. This article explores the core market dynamics and financial trajectory of miconazole, emphasizing current trends, growth drivers, challenges, and future outlooks shaping its market.

Market Overview and Segmentation
Miconazole is marketed predominantly as topical formulations—creams, powders, sprays, and vaginal suppositories. It is available over-the-counter (OTC) for superficial fungal infections such as athlete's foot, ringworm, and candidiasis, while some formulations are prescription-only. Its use spans healthcare sectors globally, with emerging markets significantly contributing to overall volume growth due to rising prevalence of dermatophytic infections and increasing awareness of fungal disease management.

Key Market Drivers

1. Rising Burden of Fungal Infections
   Globally, fungal infections are proliferating, driven by factors including increased diabetes prevalence, immunosuppressive therapies, and climate change influences that facilitate fungal growth. The World Health Organization (WHO) reports a growing incidence of superficial and invasive candidiasis, coccidioidomycosis, and dermatophytoses, fueling demand for effective antifungal treatments like miconazole (WHO, 2021).

2. Expanding OTC Market and Self-Medication Trends
   The availability of miconazole in OTC formats enhances accessibility, fostering self-medication, especially in low- and middle-income countries (LMICs). Growing consumer awareness about fungal infections and their treatments bolsters OTC sales, leading to robust volume expansion.

3. Product Innovation and New Formulations
   Research into sustained-release topical formulations, combination therapies, and improved delivery systems aims to enhance efficacy, patient compliance, and safety profiles. These advancements sustain market relevance and open avenues for premium-priced products.

4. Increasing Healthcare Spending and Diagnostic Capabilities
   Enhanced healthcare infrastructure leads to more accurate diagnostics and early intervention, increasing prescriptions of miconazole for confirmed infections, thus supporting its financial trajectory.

Market Challenges and Limitations

1. Generic Competition and Price Erosion
   The patent expiry of primary miconazole formulations has led to a surge of generic equivalents. Price competition diminishes profit margins, especially in markets dominated by commoditized OTC products, pressuring leading manufacturers to innovate or diversify portfolios.

2. Limited Efficacy Against Serious Fungal Infections
   While effective superficially, miconazole shows limited activity against invasive or resistant strains, such as certain Candida auris infections. This restricts its use to less severe cases, capping revenue potential.

3. Regulatory and Safety Considerations
   The emergence of reports on resistance, misuse, and side effects may prompt regulatory scrutiny, influencing formulations' approval status and market access.

4. Competitive Landscape with Newer Agents
   Newer antifungals like efinaconazole, tavaborole, and certain systemic agents (e.g., fluconazole, itraconazole) compete within fungal infection treatment, offering alternatives for practitioners and patients, sometimes replacing miconazole.

Financial Trajectory and Market Forecasts

1. Historical Performance and Revenues
   Global sales of miconazole have exhibited steady growth over the past decade, driven primarily by OTC segment expansion. According to IQVIA data (2022), the global topical antifungal market, where miconazole features prominently, is projected to grow at approximately 4-6% CAGR over the next five years. Within this, miconazole maintains a significant share, particularly in emerging markets.

2. Regional Market Trends

   • North America and Europe: Mature markets with high OTC sales; growth driven by aging populations and increased awareness.
   • Asia-Pacific: Rapid growth due to rising skin infection prevalence, urbanization, and expanding healthcare access. India and China represent lucrative markets due to large populations and increasing self-medication practices.
   • Latin America and Africa: Emerging markets with high unmet needs, presenting growth opportunities despite infrastructural challenges.

3. Future Growth Catalysts
   Advancements in formulation technology, expanding healthcare infrastructure, and increased awareness collectively support a positive financial outlook. The CAGR for miconazole-specific formulations is expected to be around 3-5% through 2028, with higher growth trajectories in LMICs.

4. Impact of Patent and Market Entry Dynamics
   Patent expirations have heightened competitive pressures but simultaneously foster generic proliferation, improving affordability and accessibility. Companies investing in niche formulations or combination therapies may sustain premium pricing and margins.

5. Potential Disruptors and Innovation Trends
   Biotech innovations targeting resistant fungal strains, novel delivery methods (e.g., liposomal or nanotechnology-based systems), and biomarker-driven personalized antifungal therapies could reshape the market landscape, indirectly affecting miconazole’s market share and revenues.

Strategic Considerations for Stakeholders

• Manufacturers should prioritize product differentiation through formulation innovation, quality assurance, and targeted marketing to maintain market share amid intense generic competition.
• Investors should monitor regional market expansion, especially in emerging markets with rising fungal disease prevalence, to capitalize on growth opportunities.
• Regulatory Bodies play a crucial role in setting standards for resistance management, safety profiles, and approved indications, influencing revenue potential.

Conclusion
Miconazole's market remains resilient, buoyed by the global burden of fungal infections, OTC availability, and ongoing product innovation. Despite challenges from generics and competition, strategic positioning and expanding market access, particularly in emerging economies, underpin its robust financial trajectory. Continued advancements in delivery systems and combination therapies will be key to sustaining growth, with an optimistic outlook projected through 2028.

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Key Takeaways

• The global miconazole market benefits from increasing prevalence of superficial fungal infections and expanding OTC sales.
• Patent expirations have intensified generic competition, pressuring margins but lowering prices and increasing accessibility.
• Growing markets in Asia-Pacific and Latin America represent significant future growth opportunities.
• Innovations in formulations and combination therapies are essential for maintaining competitive advantage.
• Regulatory vigilance and resistance management are critical to longevity in the market.

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FAQs

1. How does the patent status of miconazole influence its market?
Patent expirations have led to widespread generic availability, increasing market competition, reducing prices, and impacting profit margins but expanding access and volume sales.

2. What are the primary formulations of miconazole?
Miconazole is primarily available as topical creams, powders, sprays, and vaginal suppositories, with OTC sales dominating superficial infections.

3. Which regions present the most growth potential for miconazole?
Emerging markets in Asia-Pacific, Latin America, and Africa exhibit substantial growth due to rising disease prevalence and increasing healthcare infrastructure.

4. What challenges could hamper miconazole’s market growth?
Key challenges include competition from newer antifungals, resistance development, regulatory restrictions, and the limited efficacy against invasive or resistant infections.

5. What future innovations could impact the miconazole market?
Advances in sustained-release formulations, nanotechnology, combination therapies, and diagnostics will influence its market dynamics and revenue potential.

References

[1] WHO, World fungal infections report, 2021.
[2] IQVIA, Global Antifungal Market Data, 2022.
[3] MarketWatch, Topical Antifungal Market Analysis, 2023.
[4] European Medicines Agency, Miconazole Data Sheet, 2022.
[5] Industry Reports, Emerging Trends in Antifungal Formulations, 2022.