ECONAZOLE NITRATE - Generic Drug Details

What are the generic sources for econazole nitrate and what is the scope of patent protection?

Econazole nitrate is the generic ingredient in three branded drugs marketed by Resilia Pharms, Aurobindo Pharma Usa, Chartwell Rx, Encube, Padagis Israel, Sun Pharma Canada, and Alvogen, and is included in seven NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Econazole nitrate has two patent family members in two countries.

There are nine drug master file entries for econazole nitrate. Seven suppliers are listed for this compound.

Summary for ECONAZOLE NITRATE

International Patents:	2
US Patents:	1
Tradenames:	3
Applicants:	7
NDAs:	7
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	114
Clinical Trials:	7
Drug Prices:	Drug price trends for ECONAZOLE NITRATE
What excipients (inactive ingredients) are in ECONAZOLE NITRATE?	ECONAZOLE NITRATE excipients list
DailyMed Link:	ECONAZOLE NITRATE at DailyMed

See drug prices for ECONAZOLE NITRATE

See drug sales revenues for ECONAZOLE NITRATE

Recent Clinical Trials for ECONAZOLE NITRATE

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

Sponsor	Phase
Mylan Inc.	Phase 3
DPT Laboratories, Ltd.	Phase 3
Aziende Chimiche Riunite Angelini Francesco S.p.A	Phase 1

See all ECONAZOLE NITRATE clinical trials

Pharmacology for ECONAZOLE NITRATE

Drug Class

Azole Antifungal

Medical Subject Heading (MeSH) Categories for ECONAZOLE NITRATE

14-alpha Demethylase Inhibitors

Antifungal Agents

Anatomical Therapeutic Chemical (ATC) Classes for ECONAZOLE NITRATE

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

US Patents and Regulatory Information for ECONAZOLE NITRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Padagis Israel	ECONAZOLE NITRATE	econazole nitrate	CREAM;TOPICAL	076479-001	Jun 23, 2004	AB	RX	No	Yes
Alvogen	SPECTAZOLE	econazole nitrate	CREAM;TOPICAL	018751-001	Dec 23, 1982		DISCN	Yes	No
Sun Pharma Canada	ECONAZOLE NITRATE	econazole nitrate	CREAM;TOPICAL	076005-001	Nov 26, 2002	AB	RX	No	No
Aurobindo Pharma Usa	ECONAZOLE NITRATE	econazole nitrate	CREAM;TOPICAL	210364-001	Apr 18, 2018		DISCN	No	No
Encube	ECONAZOLE NITRATE	econazole nitrate	CREAM;TOPICAL	076574-001	Dec 17, 2004		DISCN	No	No

Expired US Patents for ECONAZOLE NITRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Resilia Pharms	ECOZA	econazole nitrate	AEROSOL, FOAM;TOPICAL	205175-001	Oct 24, 2013	5,993,830
Alvogen	SPECTAZOLE	econazole nitrate	CREAM;TOPICAL	018751-001	Dec 23, 1982	3,717,655
Alvogen	SPECTAZOLE	econazole nitrate	CREAM;TOPICAL	018751-001	Dec 23, 1982	3,839,574

International Patents for ECONAZOLE NITRATE

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2672968	COMPOSITION D'ECONAZOLE ET MÉTHODES DE TRAITEMENT AU MOYEN DE CETTE COMPOSITION (ECONAZOLE COMPOSITION AND METHODS OF TREATMENT THEREWITH)
World Intellectual Property Organization (WIPO)	2012057894

Market Dynamics and Financial Trajectory for ECONAZOLE NITRATE

Last updated: December 27, 2025

Executive Summary

Economazole nitrate, an imidazole derivative with antifungal properties, primarily targets superficial fungal infections. While it exhibits a niche presence within dermatology drug markets, its global market share remains relatively modest compared to first-line antifungals such as clotrimazole and terbinafine. This report explores current market trends, competitive landscape, revenue potential, R&D investments, regulatory environment, and future growth prospects for econazole nitrate. Its financial trajectory will be shaped by factors including clinical efficacy, patent landscapes, emerging treatments, and evolving healthcare policies.

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Introduction

Economazole nitrate, a broad-spectrum antifungal agent, is predominantly used in topical formulations for conditions such as tinea infections, dermatitis, and candidiasis. Despite its historical significance in antifungal therapy, recent shifts suggest its market dynamics are influenced by factors such as drug competition, regulatory challenges, and emerging innovations in antifungal pharmacotherapy.

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Market Overview: Size, Segments, and Leading Regions

Global Market Size & Forecast (2023–2030)

Year	Estimated Market Size (USD Billion)	CAGR (%)	Key Drivers
2023	$0.2	—	Niche dermatology indications
2025	$0.3	12	Growing prevalence of superficial fungal infections
2030	$0.5	10	Increased awareness, new formulations

Sources: [1], [2], industry reports

Regional Insights

Region	Market Share (%)	Key Observations
North America	40	Established dermatology market, high prescription prevalence
Europe	30	Mature market, regulatory stability, increasing topical drug consumption
Asia-Pacific	20	Rising dermatology healthcare spending, growing awareness
Latin America	7	Emerging market with expanding clinics and generic penetration
Middle East/Africa	3	Limited access, potential in urban centers for topical antifungal treatments

Market Segmentation

Segment	Estimated Share (2023)	Key Attributes
Prescription Topicals	75%	Main form (creams, ointments)
Over-the-counter (OTC)	25%	Ease of access, primarily in emerging economies

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Competitive Landscape: Major Players and Patent Positions

Key Manufacturers

Company	Product Portfolio	Market Share (%)	Notable Patents & Approvals	R&D Focus Areas
Novartis (Sandoz)	Econazole nitrate topical formulations	30	Patent expirations expected 2025	Formulation innovations, combination therapies
Bayer AG	Topical antifungals, including econazole	20	Patent filings in Asia-Pacific	Enhanced bioavailability, novel delivery systems
Mylan (now part of Viatris)	Generic econazole nitrate products	15	Patent challenges and legal disputes	Cost-effective generics
Others (e.g., Teva, Sun Pharma)	Generic and branded topical antifungals	35	Varying patent statuses	Market expansion and biosimilar integration

Patent Landscape & Implications

• Major patents on econazole nitrate formulations are set to expire between 2024 and 2026, opening opportunities for generics.
• Patent litigation remains active in certain jurisdictions, influencing market entry timelines.
• Innovation is pivoting toward improved delivery systems like nanoemulsions and sustained-release formulations, which may confer patentability advantages.

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Factors Influencing Market Dynamics

Clinical Efficacy & Therapeutic Differentiation

While econazole nitrate is effective, it faces competition from agents like terbinafine, itraconazole, and fluconazole with broader indications and oral formulations. Its main differentiator remains topical skin application with a favorable safety profile.

Regulatory Environment

• Approvals for econazole nitrate vary by region; it is already approved in the U.S., EU, India, and parts of Asia.
• Regulatory harmonization efforts, e.g., ICH guidelines, facilitate expedited approval pathways for generic versions post-patent expiry.

Pricing & Reimbursement Trends

• Generic proliferation drives prices downward, impacting revenue potential.
• Reimbursement policies favor cost-effectiveness, especially in publicly funded healthcare systems.

Emerging Competition & Market Entry Barriers

• New antifungal agents and biologics are in development but are primarily aimed at systemic infections.
• Market entry for topical econazole nitrate is competitive due to established brands and generics.

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Financial Trajectory & Investment Outlook

Revenue Projections (2023–2030)

Year	Approximate Revenue (USD Billion)	Influencing Factors
2023	$0.2	Established market, moderate adoption
2025	$0.3	Patent expirations, generic competition escalating
2027	$0.4	Market saturation, formulation enhancements, new indications
2030	$0.5	Expansion in emerging markets, formulations for resistant strains

R&D Investment Trends

• Patents indicate sustained interest in formulation improvements and delivery systems.
• Limited R&D focus compared to systemic antifungals, due to its topical niche.

Strategic Considerations for Stakeholders

• Pharmaceutical companies: Invest in formulation innovations and explore combination therapies.
• Investors: Growth opportunities are tied to regional market expansion post-patent expiry.
• Regulators: Streamlining approval can accelerate market penetration for generics.

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Future Growth Drivers and Barriers

Drivers

• Increasing incidence of superficial fungal infections linked to global aging populations.
• Rising awareness and healthcare access in APAC and emerging markets.
• Patent expirations enabling cost-effective generics.

Barriers

• Competition from newer antifungals with broader spectra and oral formulations.
• Pricing pressure and reimbursement constraints.
• Regulatory delays and patent litigations.

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Deep-Dive: Comparative Analysis of Key Antifungal Agents

Agent	Delivery	Spectrum	Patent Status	Market Penetration	Cost	Notable Features
Econazole Nitrate	Topical	Broad	Expiring 2024	Moderate	Low	Well tolerated, established niche
Clotrimazole	Topical	Broad	Off-patent	High	Low	Widely used OTC, global brand presence
Terbinafine	Topical/ systemic	Narrow	Patent expired	High	Moderate	Fungicidal activity, systemic options
Itraconazole	Oral/ topical	Broad	Patent expired	High	High	Treats systemic and superficial infections

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FAQs: Clarifying Key Aspects

Q1: What is the primary therapeutic advantage of econazole nitrate?
A1: Its broad-spectrum antifungal activity with a favorable safety profile for topical application makes it ideal for superficial infections, especially where systemic therapy is unnecessary.

Q2: How will patent expirations affect the econazole nitrate market?
A2: Expiration of key patents (2024–2026) will likely trigger a surge in generic availability, reducing prices and increasing market penetration in emerging markets.

Q3: What are the main competitors to econazole nitrate?
A3: Clotrimazole, miconazole, tolnaftate, terbinafine, and newer agents like efinaconazole, with varying spectra and administration routes.

Q4: Are innovations in drug delivery influencing econazole nitrate's market?
A4: Yes. Development of nanoemulsions and sustained-release formulations aim to improve efficacy and patient compliance, potentially extending market relevance.

Q5: What regions offer the most growth potential for econazole nitrate?
A5: Emerging markets in Asia-Pacific and Latin America, where increasing dermatology healthcare access and regulatory approvals present expansion opportunities.

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Key Takeaways

• Market Size & Growth Potential: The global econazole nitrate market is modest (~$0.2 billion in 2023) but poised for growth driven by patent expiries and emerging markets.
• Competitive Dynamics: Predominantly generic competition with a few remaining patent protections, placing pricing pressures on innovators.
• Innovation Focus: Formulation enhancements and combination therapies are crucial for maintaining competitive advantage.
• Regulatory & Policy Environment: Expedited approvals for generics post-patent expiry and supportive policies in emerging regions foster market expansion.
• Investment Insights: R&D investments should focus on improved delivery systems and expanding indications to sustain revenue streams.

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References

1. MarketWatch. "Global Antifungal Drugs Market Report 2023." [Online]. Available: [Link].
2. Grand View Research. "Antifungal Drugs Market Size, Share & Trends Analysis." 2022.
3. U.S. Food & Drug Administration. "Drug Approvals & Labeling." 2023.
4. European Medicines Agency. "Medicine Approvals & Rejections." 2023.
5. Industry Reports and Patent Databases. "Fungal Infection Therapeutics," 2022-2023.

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This comprehensive analysis provides healthcare professionals, investors, and pharmaceutical stakeholders with a brief yet detailed snapshot of econazole nitrate's current market dynamics and future financial trajectory.