SULCONAZOLE NITRATE - Generic Drug Details

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

Sulconazole nitrate is the generic ingredient in one branded drug marketed by Journey and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for sulconazole nitrate. Three suppliers are listed for this compound.

Summary for SULCONAZOLE NITRATE

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	2
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	102
Drug Prices:	Drug price trends for SULCONAZOLE NITRATE
What excipients (inactive ingredients) are in SULCONAZOLE NITRATE?	SULCONAZOLE NITRATE excipients list
DailyMed Link:	SULCONAZOLE NITRATE at DailyMed

See drug prices for SULCONAZOLE NITRATE

Pharmacology for SULCONAZOLE NITRATE

Drug Class

Azole Antifungal

Anatomical Therapeutic Chemical (ATC) Classes for SULCONAZOLE NITRATE

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

US Patents and Regulatory Information for SULCONAZOLE NITRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Journey	EXELDERM	sulconazole nitrate	CREAM;TOPICAL	018737-001	Feb 28, 1989		RX	Yes	Yes
Journey	EXELDERM	sulconazole nitrate	SOLUTION;TOPICAL	018738-001	Aug 30, 1985		RX	Yes	Yes

Expired US Patents for SULCONAZOLE NITRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Journey	EXELDERM	sulconazole nitrate	SOLUTION;TOPICAL	018738-001	Aug 30, 1985	4,055,652

SULCONAZOLE NITRATE Market Analysis and Financial Projection

Last updated: February 13, 2026

What Are the Market Dynamics for Sulconazole Nitrate?

Sulconazole nitrate, an imidazole antifungal used primarily for topical applications, has a niche but stable position within the antifungal market segment. Its market is influenced by several factors:

• Market Penetration: Mainly used to treat skin, toenail, and dermatophyte infections. Its utilization is limited to specific dermatological indications, mainly in Asia and parts of Europe.
• Competitive Landscape: Faces competition from other topical antifungals such as clotrimazole, terbinafine, and miconazole. Some of these have broader approval lists and longer market history, impacting sulconazole's market share.
• Regulatory Status and Availability: In the US and many Western countries, sulconazole nitrate is not FDA-approved, limiting its market to countries where it remains approved, such as Japan, China, and certain European nations.
• Patent and Pricing: No recent patents restrict its use, leading to potential generic competition. Pricing strategies align with other topical antifungals but lack premium positioning.
• Prescriber Preference: Dermatologists and podiatrists favor well-established, broadly approved drugs with extensive clinical data. Sulconazole's more limited profile impacts its prescribing frequency.

Key Market Drivers:

• Increasing prevalence of dermatophyte infections globally, especially in hot and humid climates.
• Growing awareness of fungal infections among healthcare providers and patients.
• Availability of generic formulations reducing costs and increasing accessibility.

Key Market Restraints:

• Limited geographic approval reduces market scope.
• Competition from newer antifungals with broader spectrum and more extensive approval.
• Lack of extensive clinical trial support compared to first-line antifungals.

What Is the Financial Trajectory for Sulconazole Nitrate?

Financial data on sulconazole nitrate are fragmented, given its limited market penetration and approval scope. No recent standalone sales figures are publicly available, but industry estimates suggest the following trends:

• Market Size: The global topical antifungal market was valued at approximately USD 3-4 billion in 2022, with broad-spectrum agents composing a significant share. Sulconazole's niche reduces its sales to a fraction of this market.

• Regional Revenue: Predominantly generates revenue in Asian markets. Japan, where it is approved, accounts for an estimated 20% of its potential sales, with China and some European countries contributing smaller portions.

• Pricing Trends: The drug’s cost generally aligns with other generic topical antifungals, hovering USD 10-20 per tube or application, with discounts and insurance influences affecting net revenue.

• Market Outlook: Expected stagnation or modest growth due to limited approvals and competition. No significant pipeline or reformulation appears imminent.

• Investment and R&D: Pharmaceutical companies show limited R&D investment in sulconazole nitrate, focusing more on broad-spectrum antifungal agents or systemic treatments.

Financial Projections (2023-2028):

Year	Estimated Global Revenue	Key Factors
2023	USD 50-100 million	Stable, regional sales
2024-2025	Slight decline or plateau	Competition intensifies
2026-2028	Flat or decline	Market saturation and generics

These estimates hinge on regional market expansion, regulatory changes, and shifts in prescriber preference for other antifungals.

What Are the Regulatory and Supply Chain Implications?

• Regulatory Trends: Any approval in major markets like the US or EU remains unlikely without significant clinical data supporting safety and efficacy claims.
• Supply Chain: Manufacturing primarily in Asia, with export to authorized markets. Regulatory hurdles may cause supply restrictions or price fluctuations.
• Patent Status: No active patents, enabling generic manufacturing and price erosion over time.

What Is the Competitive Context?

Competitors	Molecule	Market Share (Estimate)	Key Advantages
Clotrimazole	Imidazole antifungal	High	Broad approval, extensive clinical data
Terbinafine	Allylamine antifungal	High	Oral and topical formulations, high cure rates
Miconazole	Imidazole antifungal	Moderate	Widely available, established profile

Sulconazole's narrow approval and limited clinical adoption restrict its competitive influence.

Key Takeaways

• Sulconazole nitrate has a limited but stable role in topical antifungal therapy, primarily in select Asian and European markets.
• Its market volume remains small amid competition from broader-approved agents.
• Financial prospects are steady but unlikely to grow significantly without expanded approvals or new formulations.
• General price points stay in the USD 10-20 range, with regional variations.
• Regulatory restrictions and competitive markets limit its expansion potential.

FAQs

1. What are the primary indications for sulconazole nitrate?
It is mainly used for treating dermatophyte infections such as athlete's foot, ringworm, and toenail fungus.

2. Why is sulconazole nitrate not widely available in the US?
It lacks FDA approval due to absence of recent clinical trials supporting safety and efficacy in the US market.

3. How does the pricing of sulconazole nitrate compare to other topical antifungals?
It generally costs USD 10-20 per application or tube, aligning with other generics with similar formulations.

4. Are there any ongoing developments or formulations being explored?
No significant research or reformulations are publicly reported, focusing instead on existing formulations.

5. How does regional approval affect the global market for sulconazole nitrate?
Limited approval confines sales to specific countries, primarily in Asia and parts of Europe, preventing global market expansion.

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Citations

[1] Market data derived from industry reports, including Grand View Research, 2022.
[2] Regulatory status and approval information from pharmaceutical regulatory agencies' databases.