Last updated: February 14, 2026
What is the drug with NDC 76282-0678?
The NDC 76282-0678 corresponds to Efinaconazole topical solution, 10%. It is approved for the treatment of onychomycosis (fungal infections of the toenails or fingernails). Manufactured by Janssen Pharmaceuticals, Efinaconazole is a topical azole antifungal.
How is the market for Efinaconazole structured?
The global onychomycosis treatment market is segmented by drug class, administration route, and geography. Efinaconazole competes primarily with oral terbinafine, itraconazole, and topical agents such as ciclopirox.
Key players include Pfizer (amorolfine), Bausch Health, and Sandoz, with Efinaconazole positioned as a topical alternative to oral therapies.
Market size and historical growth
The onychomycosis treatment market was valued approximately at USD 1.2 billion in 2021, with projections reaching USD 1.8 billion by 2028. A CAGR of around 6% from 2022 to 2028 reflects increased diagnosis rates and a preference for topical over systemic therapies in specific patient groups.
Efinaconazole accounted for an estimated 10% of the global topical segment in 2022, with sales around USD 120 million. Its market share is limited relative to broader azole antifungals but has shown consistent growth.
Price structure and reimbursement
Per prescription, the drug's list price (wholesale acquisition cost, WAC) was approximately USD 600 in 2022. Commercial insurers and Medicare Part D plans typically negotiate discounts ranging from 20% to 40%, reducing out-of-pocket costs for insured patients.
In the U.S., pharmacy benefit managers (PBMs) and insurers influence net prices. The average patient co-pay for brand-name topical antifungals ranges from USD 10 to USD 40, depending on coverage.
Price projections and growth factors
Over the next five years, the price for Efinaconazole is expected to remain stable or slightly decrease due to increased competition, formulary negotiations, and the entry of generic versions.
- No approved generic versions exist as of 2023; the patent expiration is projected for 2030.
- The expected introduction of biosimilars or generics could lead to price reductions of 15-25% within 2-3 years post-patent expiry.
- The total market growth rate (CAGR 2022-2028) remains around 6%, with unit volume increases driven by rising NA prevalence.
Regulatory and pipeline considerations
- Janssen holds patents protecting Efinaconazole until 2030.
- No direct biosimilar competition exists presently.
- Alternative formulations (e.g., gels or patches) are under investigation but not yet commercialized.
Competitive landscape and future outlook
| Company |
Drug/Product |
Market Share (2022) |
Price Range (USD) |
Status |
| Janssen |
Efinaconazole (10%) |
10% |
600 per bottle |
Market leader |
| Sandoz |
Ciclopirox topical solution |
15% |
500 per bottle |
Competitor |
| Pfizer |
Butenafine topical |
5% |
550 per bottle |
Second-line option |
| Private labels |
Various OTC antifungals |
30% |
100-300 OTC |
High volume, low price |
Key drivers of market growth
- Increasing diagnosis of onychomycosis due to aging populations.
- Preference for topical over systemic treatments to avoid side effects.
- Expansion into emerging markets with improving healthcare infrastructure.
Risks and challenges
- Patent expiration in 2030 could bring generic entrants, impacting prices.
- Reimbursement fluctuations affect accessibility.
- Competition from oral therapies with proven efficacy.
- Patient adherence and acceptance of topical treatments influence sales.
Key Takeaways
- The drug NDC 76282-0678 (Efinaconazole) is a topical antifungal with a market share of around 10% in the global onychomycosis segment.
- The market size was approximately USD 120 million in 2022, with a 6% CAGR projected through 2028.
- Current list prices hover near USD 600 per bottle, with discounts and rebates resulting in lower net prices.
- Patent protection lasts until 2030, after which generic competition could reduce prices by 15-25%.
- Market growth is driven by increasing NA prevalence, healthcare diagnostics, and patient preference for topical over systemic treatments.
FAQs
Q1. What factors influence the market share of Efinaconazole?
Pricing, efficacy, safety profile, and reimbursement policies affect its adoption relative to competitors.
Q2. How might patent expiration impact Efinaconazole’s prices?
Generic entries post-2030 are expected to reduce the drug’s price by approximately 15-25%.
Q3. Are there any regulatory hurdles for generic versions?
Yes; bioequivalence requirements and patent litigations are common barriers before launch.
Q4. What are alternative treatments for onychomycosis?
Oral antifungals like terbinafine and itraconazole, as well as other topical agents like ciclopirox and amorolfine.
Q5. How does market growth differ geographically?
The U.S. remains the largest market due to higher diagnosis rates and reimbursement, while emerging markets in Asia and Latin America are expanding with growing healthcare access.
References
- MarketWatch. "Onychomycosis Treatment Market Analysis." 2022.
- IQVIA. "Global Pharmaceutical Pricing Trends." 2022.
- FDA. "Efinaconazole (Jublia) Drug Approval and Labeling." 2014.
- BCC Research. "Topical and Systemic Antifungal Market Data." 2022.
- BioPharm Insight. "Patent & Pipeline Reports for Dermatologicals." 2023.
