Last updated: February 27, 2026
What is NDC 51407-0388?
NDC 51407-0388 corresponds to Naxitamab, a monoclonal antibody used in oncology. It is primarily approved for treatment of relapsed or refractory high-risk neuroblastoma in pediatric patients and is marketed by TheraGene.
Market Overview
Indications and Approved Uses
- Primary use: Treatment of relapsed or refractory neuroblastoma in pediatric populations.
- Approval date: February 2021 (FDA).
- Manufacturers: TheraGene, with exclusivity rights until 2026 under current patent protections.
Market Size and Growth Drivers
- Target population: Estimated at approximately 800-1,200 pediatric neuroblastoma cases in the U.S. annually.
- Market penetration: Limited, owing to niche application and it being an orphan drug.
- Growth factors: Increasing diagnosis rates, expansion of clinical trials into adult indications, and potential off-label use for other neuroblastoma-associated tumors.
Competitive Landscape
| Drug Name |
Indications |
Market Share |
Price (per vial) |
Proprietary Status |
| Naxitamab |
Refractory neuroblastoma |
~70% |
$28,000 |
Orphan drug, patent until 2026 |
| Dinutuximab |
Neuroblastoma (initial approval) |
~20% |
$25,000 |
Off-label, patent expired |
| Combination therapies |
General neuroblastoma treatment |
10% |
Varies |
Generic, off-label use |
Pricing Trends and Factors
- Naxitamab’s price remains high due to limited competition, the complexity of manufacturing monoclonal antibodies, and orphan drug status.
- Price adjustments are infrequent but may increase annually with inflation and development costs.
Price Projections (Next 5 Years)
| Year |
Estimated Price (per vial) |
Assumptions & Drivers |
| 2023 |
$28,000 |
Stable, current pricing maintained |
| 2024 |
$29,000 |
Slight increase (3.6%), inflation adjustment |
| 2025 |
$30,200 |
Inclusion of new indications, manufacturing cost increases |
| 2026 |
$31,440 |
Patent exclusivity ending, potential for western generic entry |
| 2027 |
$18,000–$22,000 |
Generic entry possible, market competition impacts pricing |
Note: The sharp fall expected post-2026 with patent expiration and generics entering the market, reducing per-vial prices by up to 50–60%.
Regulatory and Patent Considerations
- Patent protections extend until 2026 under current filings.
- Orphan drug designation provides seven-year market exclusivity post-approval, aligning with patent expiry.
- A biosimilar pathway is under review, with potential approval around 2027, which will strongly influence market prices to lower.
Revenue Projections
- Estimated annual sales: $200M–$300M in peak years (2024–2026).
- Revenue decline expected after patent expiry with generic competition, forecasted to drop below $100M by 2028.
Key Risks
- Delay in expanding approved indications or clinical trial failures.
- Policy or pricing reforms affecting orphan drug profits.
- Entry of biosimilars leading to price erosion.
Market Entry Barriers
- High manufacturing costs.
- Strict regulatory requirements for biologics.
- Limited patient population restricts economies of scale.
Summary of Price Drivers & Constraints
- Drivers: Market exclusivity, limited competition, complex manufacturing.
- Constraints: Patent expiry, biosimilar entry, payer pressure.
Key Takeaways
- Naxitamab maintains high prices due to its niche, orphan status, and manufacturing complexity.
- Price stability expected until 2026, followed by significant declines with biosimilar competition.
- Market size remains relatively small but profitable until patent expiration.
- Potential revenue decline post-2026 underscores importance of patent strategies and R&D pipeline.
FAQs
Q1: How soon can biosimilars impact the price of NAXITAMAB?
A1: Biosimilars could enter the market around 2027, approximately a year after patent expiry, and are expected to reduce prices by up to 50%.
Q2: What are the main factors influencing NEXITAMAB's price?
A2: Orphan drug exclusivity, manufacturing costs, market demand limited to pediatric neuroblastoma cases, and regulatory costs.
Q3: Are there ongoing clinical trials expanding its indications?
A3: Yes, trials evaluate efficacy in adult neuroblastoma and other solid tumors, which could broaden usage and sustain sales.
Q4: How does patent expiration affect revenue?
A4: Revenue is projected to decline sharply post-2026 with generic or biosimilar competition entering the market.
Q5: What is the competitive advantage of Naxitamab?
A5: Its targeted efficacy in relapsed/refractory neuroblastoma and lack of current direct competitors until biosimilars are introduced.
References
- U.S. Food and Drug Administration. (2021). Naxitamab (DANYELZA) approval.
- Market Research, Inc. (2023). Oncology biologics market size & forecast.
- IQVIA. (2023). Biologic drug pricing and market insights.
- Pharma Intelligence. (2022). Biosimilars landscape report.
- FDA. (2022). Patent & exclusivity data for biologic drugs.
