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:	33
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
Cairo University	PHASE3
Ain Shams University	Phase 3
Assistance Publique - Hôpitaux de Paris	PHASE2

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
Teva	MICONAZOLE NITRATE	miconazole nitrate	CREAM;VAGINAL	074136-001	Jan 4, 1995		DISCN	No	No
Cosette	MICONAZOLE NITRATE	miconazole nitrate	CREAM;VAGINAL	074366-001	Feb 22, 1996		DISCN	No	No
Mylan	VUSION	miconazole nitrate; white petrolatum; zinc oxide	OINTMENT;TOPICAL	021026-001	Feb 16, 2006		RX	Yes	Yes
L Perrigo Co	MICONAZOLE NITRATE COMBINATION PACK	miconazole nitrate	CREAM, SUPPOSITORY;TOPICAL, VAGINAL	075329-001	Apr 20, 1999		OTC	No	No
Janssen Pharma	MONISTAT	miconazole	INJECTABLE;INJECTION	018040-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Cosette	MICONAZOLE NITRATE	miconazole nitrate	SUPPOSITORY;VAGINAL	073507-001	Nov 19, 1993		OTC	No	No

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
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

Market Dynamics and Financial Trajectory for Miconazole

Last updated: February 13, 2026

How Large Is the Miconazole Market?

The global pharmaceutical market for antifungal agents, which includes miconazole, was valued at approximately $3.2 billion in 2022. Miconazole accounts for roughly 12% of this segment, equating to an estimated market size of $384 million. The compound is prescribed primarily for fungal infections such as athlete's foot, ringworm, and candidiasis.

What Are the Key Drivers of Market Growth?

1. Prevalence of Fungal Infections: The increasing incidence of superficial fungal infections worldwide supports steady demand for miconazole. According to the WHO, fungal infections affect over 1.5 billion people annually.

2. Expanding Use in Dermatology: Miconazole's efficacy in topical formulations (creams, powders, sprays) makes it a preferred choice in dermatology, especially in regions with rising dermatophytosis rates.

3. Consumer Preference for Over-the-Counter Sales: Miconazole products are available OTC in many countries, expanding market reach and volume.

4. Rising Healthcare Access: Better healthcare infrastructure in emerging markets increases prescription and OTC sales of antifungal drugs.

What Are the Market Constraints?

1. Generic Competition: Miconazole has been off patent for several decades, leading to numerous generic versions. The resulting price pressures diminish profit margins for branded formulations.

2. Regulatory Challenges: Approval processes and regulatory standards vary globally. Some markets impose restrictions that slow market expansion.

3. Limited Innovation: Current formulations are well-established. There is limited pipeline development, leading to slow growth in novel indications.

How Is the Financial Trajectory Evolving?

Revenue Trends

• Historical Growth: Between 2018 and 2022, annual sales CAGR hovered around 3%. This slow but steady growth is driven by increasing global infection prevalence and OTC availability.

• Projected Growth: The market is expected to grow at approximately 3-4% CAGR through 2027, reaching around $440 million in annual revenue.

Cost and Pricing Considerations

• Pricing: Average retail prices for miconazole topical creams range from $5 to $15 per tube, varying with formulation and market.

• Margins: Branded formulations have margins around 30-40%, but generic competition reduces these margins to 10-15%.

Investment in R&D

• Limited investment exists in new formulations or indications; most revenue derives from existing products.

• Small biotech firms and generics companies dominate the market, with a focus on price competition rather than innovation.

How Do Regional Markets Differ?

Region	Market Size (2022)	Growth Rate (2022-2027)	Key Factors
North America	$180 million	2.5%	High OTC sales, mature market
Europe	$100 million	3%	Robust healthcare infrastructure
Asia-Pacific	$60 million	5%	Rising infection rates, budget use
Latin America	$30 million	4%	Growing access, OTC sales

What Are the Competitive Dynamics?

• Multiple generics compete on price.

• Top players include pharmaceutical companies like Pfizer, Teva, and Mylan.

• Limited new entrants due to the low growth potential and patent expiration.

What Are the Impactful Regulatory Trends?

• Increasing approval for combination products involving miconazole.

• Moves towards simplified OTC regulations in select markets bolster sales volume.

Can Miconazole Market Expand Into New Indications?

Currently, the focus remains on superficial fungal infections. There is minimal development aimed at systemic fungal infections or resistant strains, constraining potential growth.

Final Market Outlook

The miconazole market remains stable. Its steady demand is driven by uncomplicated treatment needs and broad OTC accessibility. Future growth hinges on regional healthcare access expansion and potential new formulations. Price competition continues to suppress revenue growth.

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Key Takeaways

• The global antifungal market was valued at approximately $3.2 billion in 2022, with miconazole representing roughly $384 million.

• Market growth is steady at 3-4% CAGR, supported by rising superficial fungal infections and OTC availability.

• Generic competition heavily influences pricing and profit margins.

• Regional differences exist, with Asia-Pacific showing higher growth due to rising infection rates and increasing healthcare access.

• Innovation in formulations or indications remains limited; growth primarily relies on existing demand.

FAQs

1. Is there potential for branded miconazole formulations to increase margins?
Limited. Due to widespread generic competition and price-based market strategies, branded products face pressure to maintain competitiveness.

2. Are new formulations of miconazole being developed?
Few pipelines exist for reformulation or new indications, as most companies focus on existing markets.

3. How affected is the market by regulatory changes?
Regulatory trends favor OTC sales in some regions, which can boost sales volume but may increase market saturation.

4. What is the outlook for emerging markets?
Growing healthcare infrastructure and infection prevalence in emerging economies present growth opportunities, especially if regulation eases.

5. Will resistance impact future sales of miconazole?
Resistance development could limit efficacy in some cases, but widespread resistance remains limited, maintaining current demand levels.

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References:

[1] MarketWatch. "Antifungal Drugs Market Size, Share & Trends Analysis 2022."
[2] WHO. "Global fungal infections statistics."
[3] IQVIA. "Pharmaceutical Market Data 2022."