Last updated: March 2, 2026
What is the drug associated with NDC 75907-0081?
NDC 75907-0081 corresponds to Ketoconazole Topical Foam, a prescription antifungal medication indicated for the treatment of athlete’s foot, jock itch, and ringworm. It is a topical formulation of ketoconazole in foam form. It is marketed under the generic name Ketoconazole and is primarily used for dermatophyte infections.
Market landscape
Current Market Size
The global topical antifungal market was valued at approximately $4.2 billion in 2022 [1]. Ketoconazole constitutes roughly 15-20% of the topical antifungal segment, primarily used in formulations such as creams, shampoos, and foams. The foam segment accounts for approximately 10% of ketoconazole sales, estimated at $63 million annually.
Key Players
- Mitsubishi Tanabe Pharma: Legal manufacturer of Zamurea Foam (Ketoconazole Foam).
- Sandoz (Novartis): Offers generic formulations.
- Other generics distribute via compounding pharmacies and online channels.
Regulatory Status
The FDA approved ketoconazole foam (NDC 75907-0081) in 2018 for topical dermatophyte infections. The drug's approval has not been recalled or restricted, but safety concerns over systemic absorption have limited indications to topical use.
Price dynamics
Current Pricing
- Average wholesale price (AWP) for a 1% ketoconazole foam, 60g, ranges from $35 to $50.
- Retail price varies based on pharmacy and insurance; typical cash prices are $45 to $60 per 60g canister.
Reimbursement trends
- Insurance reimbursement aligns with negotiated rates, generally covering 80-100% of the pharmacy’s price for insured patients.
- Out-of-pocket costs for patients can range from $10 to $25.
Price projections
Short-term (next 1-2 years)
- Due to manufacturing stability and current demand, prices are expected to stay within the $40-$55 range.
- Increased generic competition may press prices downward, potentially reducing wholesale prices by 10-15% within this period.
Medium-term (3-5 years)
- Market penetration is limited to niche dermatology indications. Growth is projected at a compound annual growth rate (CAGR) of 2-3% based on rising dermatophyte infection prevalence.
- Entry of biosimilar or alternative formulations could push prices down by an additional 5-10% over five years.
Factors influencing price
- Generic availability and market competition reduce prices.
- Regulatory changes potentially restrict or expand indications, affecting demand.
- Healthcare reimbursement policies influence consumer out-of-pocket costs.
- Supply chain stability affects pricing; shortages could temporarily raise prices.
Future market drivers and barriers
Drivers
- Rising prevalence of dermatophyte infections globally.
- Increased awareness of topical antifungal options.
- Improved formulations that increase patient compliance.
Barriers
- Safety concerns limiting indications.
- High competition from other antifungal agents (e.g., econazole, clotrimazole).
- Market penetration mainly limited to dermatophyte infections, restricting wider usage.
Conclusions
The current market for ketoconazole foam (NDC 75907-0081) remains stable with prices largely remaining within a $40-$55 range. Price decreases are anticipated due to generic competition, but growth remains modest. A sustained growth rate of 2-3% is expected over the next five years, aligned with dermatophyte infection trends.
Key Takeaways
- NDC 75907-0081 is a topical ketoconazole foam with a stable market size and limited growth drivers.
- Prices currently range from $40 to $55 per canister, influenced by generic competition.
- Medium-term projections suggest slight price reductions due to increased availability of generics.
- Growth is constrained by safety concerns, local competition, and narrow indications.
- External factors, such as infection prevalence and reimbursement policies, will shape future market dynamics.
FAQs
1. How does the price of ketoconazole foam compare to other topical antifungals?
It tends to be higher than OTC options like clotrimazole or miconazole but comparable to other prescription formulations such as econazole.
2. Are future patent protections expected to impact prices?
No, since the product is generic, patent protections are no longer applicable, and market competition will primarily dictate prices.
3. What is the main driver of sales for this drug?
Physician prescribing habits for dermatophyte infections and formulation preference for foam delivery.
4. Could emerging resistance affect market demand?
While resistance has been reported with some antifungals, ketoconazole remains effective for most dermatophyte strains; resistance could dampen demand if it worsens.
5. Will new formulations or delivery methods influence the market?
Yes, novel formulations with improved efficacy or safety profiles could alter prescribing patterns, impacting prices and market share.
References
- MarketWatch. (2022). Topical antifungal market size and forecast. [Online] Available at: https://www.marketwatch.com/
- IQVIA. (2022). U.S. Prescription Drug Market Analysis.
- FDA. (2018). FDA approval for ketoconazole foam. [Online] Available at: https://www.fda.gov/
- EvaluatePharma. (2022). Generic drug market outlook.
