Last updated: March 1, 2026
What is NDC 49483-0080?
NDC 49483-0080 is the code assigned by the FDA for specific formulations of Dinutuximab (.brand name: Unituxin). It is an immunotherapy used primarily for high-risk neuroblastoma in pediatric patients.
Market Overview
Indications and Usage
Dinutuximab is approved by the FDA for first-line treatment of pediatric patients with high-risk neuroblastoma following induction chemotherapy and ifosfamide, carboplatin, etoposide (ICE) consolidation. It is used in combination with existing chemotherapeutic agents and supports maintenance therapy by targeting GD2-positive neuroblastoma cells.
Market Size and Trends
- Target Population: Approximately 1,000–1,400 pediatric neuroblastoma cases diagnosed annually in the United States.
- Market Penetration: Limited, due to the rarity of the disease and specialized administration procedures.
- Competitors: Sacituzumab govitecan, dinutuximab beta (used predominantly in Europe), and newer bi-specific antibodies in late-stage development.
Current Sales Data
- Estimated US Sales (2022): $150 million.
- Growth Rate: 5%-8% annually, driven by increased diagnosis rates and treatment adoption.
- Pricing: Wholesale acquisition cost (WAC) roughly $150,000–$200,000 per treatment course, depending on dosing and patient weight.
Price Projection assumptions
- Market penetration rate: Expected to grow modestly, reaching 70% of eligible patients by 2028.
- Pricing trends: Prices are projected to stabilize with minimal inflation due to biosimilar entry.
Price Projection Scenarios (2023–2028)
| Year |
Price per Treatment Course |
Approximate Annual Revenue |
Comments |
| 2023 |
$180,000 |
$135 million |
Current peak sales with limited biosimilar impact. |
| 2024 |
$180,000 |
$140 million |
Slight increase due to wider adoption. |
| 2025 |
$180,000 |
$145 million |
Market stabilization; conservative growth. |
| 2026 |
$175,000 |
$150 million |
Possible biosimilar entry; price pressure. |
| 2027 |
$170,000 |
$155 million |
Increased biosimilar competition, slight price decline. |
| 2028 |
$165,000 |
$160 million |
Biosimilar impact stabilizes; growth driven by expanded indications. |
Biosimilar Impact
Recent approvals for potential biosimilars could reduce prices by approximately 20% over the next 3-5 years, impacting revenue projections. The entry is expected around 2026–2027, influencing pricing and market share.
Policy and Reimbursement Dynamics
- Reimbursement Status: Reimbursed through Medicaid, Medicare, and private insurers, with coverage typically favorable for oncologic biologics.
- Pricing Pressures: Hospitals and payers are increasingly negotiating for biosimilars, influencing list prices.
- Orphan Drug Designation: Extends exclusivity, delaying biosimilar entry until at least 2026.
Competitive Landscape
| Product |
Indication |
Approval Year |
Market Share (Estimated) |
Pricing Strategy |
| Dinutuximab (Unituxin) |
Neuroblastoma |
2015 |
85% |
Premium due to orphan status and limited competition. |
| Dinutuximab beta |
Neuroblastoma |
2017 (Europe) |
Less than 10% in US |
Competitive pricing models. |
| Biosimilars (Upcoming) |
Various |
Expected 2026–2027 |
15%–30% over 5 years |
Price reduction focus. |
Key Risks and Opportunities
- Risks: Biosimilar market entry, healthcare policy shifts, limited patient population constraining growth.
- Opportunities: Expanded indications, combination therapy labeling, development of next-generation immunotherapies.
Summary
The market for NDC 49483-0080, dinutuximab, represents a high-cost, low-volume segment with steady revenue growth driven by demand in pediatric neuroblastoma treatment. Pricing is expected to remain stable until biosimilar competition materializes, which could lead to moderate price reductions. Market expansion depends on increased diagnosis and potential indication expansion.
Key Takeaways
- The current US market size is approximately $150 million annually.
- Prices are around $180,000 per treatment course, with minimal inflation.
- Biosimilar entry around 2026–2027 could cut prices by approximately 20–30%.
- Growth prospects hinge on increased adoption and potential label expansions.
- Competitive pressure from biosimilars and policy changes are primary risk factors.
FAQs
Q1: What factors influence the pricing of dinutuximab?
A1: Pricing is influenced by manufacturing costs, market exclusivity, competition from biosimilars, reimbursement negotiations, and orphan drug status.
Q2: When might biosimilars enter the US market?
A2: Biosimilars are expected to gain approval around 2026–2027, pending regulatory and development timelines.
Q3: How prevalent is neuroblastoma worldwide?
A3: Approximately 800–1,200 cases are diagnosed annually in the US; worldwide estimates range from 800–1,600 cases per year.
Q4: What are the major hurdles for market expansion?
A4: Limited patient population, high treatment costs, and competition from emerging therapies.
Q5: How does orphan drug designation impact pricing and market?
A5: It grants exclusivity lasting at least seven years in the US, preventing biosumislar implementation during this period, enabling premium pricing.
References
[1] Food and Drug Administration. (2015). FDA approval of dinutuximab. Retrieved from https://www.fda.gov
[2] IQVIA. (2022). Market estimates for pediatric oncology biologics.
[3] FDA. (2016). Orphan drug act and exclusivity.
[4] EvaluatePharma. (2022). Oncology market forecasts.
