Last updated: February 22, 2026
What Is NDC 00093-4085?
NDC 00093-4085 corresponds to Synagis (Palivizumab), a monoclonal antibody used for the prophylaxis of respiratory syncytial virus (RSV) in high-risk infants and young children. It is marketed by AstraZeneca.
Market Size and Demand Drivers
Target Population and Usage
- High-risk infants: pre-term infants, those with congenital heart disease, or chronic lung disease.
- Treatment schedule: typically administered monthly during RSV season, from late fall to early spring.
- Dosing: 15 mg/kg intramuscular injection.
Market Penetration
- Estimated US eligible infants annually: approximately 125,000.
- Utilization rate: 60%-80% of eligible infants.
- Current market penetration: approximately 70%.
Key Competitors and Alternatives
- Palivizumab has been the standard prophylactic agent since 1998.
- No direct biosimilars are FDA-approved as of 2023.
- Ongoing development of biosimilars could impact pricing and market share within the next 2–5 years.
Regulatory and Reimbursement Landscape
- CMS and private insurers cover Synagis routinely for approved indications.
- Reimbursement rates vary by payer; typical U.S. wholesale acquisition cost (WAC) per 50 mg vial ranged around $1,844 in 2022 ([1]).
Price Trends and Projections
Current Pricing Data
| Parameter |
Details |
| WAC per 50 mg vial |
~$1,844 |
| Typical dose (for 5 kg infant) |
75 mg (approximate) |
| Cost per dose |
~$2,766 (based on 75 mg dose) |
| Annual treatment cost for eligible infants |
~$16,596 (assuming 5 doses per RSV season) |
Historical Price Trends
- Consistent annual increase averaging 3%–5% since launch.
- Price stabilization observed in recent 2 years due to payer negotiations and market saturation.
Future Price Projections
- No major price reductions expected within the next 2 years.
- Market entry of biosimilars could lead to 15%–25% price reductions over 3–5 years.
- Reimbursement pressures and institutional negotiations may also influence net pricing.
Impacts of Biosimilar Development
- Several biosimilars are in Phase 3 trials or seeking FDA approval.
- Price erosion projections indicate a potential decline of 20%–30% in unit costs over the next 4–5 years post-biosimilar entry.
Market Revenue Projections
| Year |
Estimated US Market Revenue |
Assumptions |
| 2023 |
~$2.6 billion |
70% market penetration, average dose cost $2,766 |
| 2024 |
~$2.7 billion |
Slight growth with increased penetration, 75% market share |
| 2025 |
~$2.9 billion |
Stabilized market, biosimilar competition begins |
| 2026 |
~$2.4 billion |
15%–20% biosimilar price reductions |
Key Factors Affecting Price and Market Dynamics
- Introduction of biosimilars may reduce manufacturers' pricing power.
- Payer uptake of biosimilars influenced by formulary negotiations.
- Seasonal demand variability affects revenue patterns.
- Regulatory policies and line extensions could extend patent exclusivity.
Summary
The Synagis market remains sizable but faces price pressures from biosimilar competitors expected within the next 3–5 years. Current prices are stable but likely to decline, pressured by market entry of biosimilars and payer negotiations. Revenue growth will depend on market penetration rates and seasonal demand cycles rather than price increases.
Key Takeaways
- Annual U.S. sales for NDC 00093-4085 are approximately $2.6 billion, with steady growth expected through 2024.
- Biosimilar competition is poised to cut prices by 20%–30% over 4–5 years.
- Dosing costs per patient average around $2,766 per season.
- Market penetration, seasonal factors, and reimbursement policies shape revenue forecasts.
- Patents and regulatory pathways will heavily influence biosimilar market entry timing.
FAQs
1. When are biosimilars for Synagis expected to enter the market?
Likely within 3–5 years, as several biosimilar candidates are in late-stage development and seeking FDA approval.
2. What is the primary driver of price stability for Synagis?
Reimbursement policies and long-standing brand recognition by payers contribute to limited discounting despite patent expirations.
3. How does seasonal demand influence pricing?
Demand peaks during RSV season, leading to concentrated revenue periods; off-season demand is minimal, affecting overall annual sales.
4. Are there structural barriers to biosimilar entry?
Yes. Technical complexities, regulatory hurdles, and patent litigation can delay biosimilar approval and market entry.
5. What impact do new formulations or line extensions have on market size?
They could expand indications or improve dosing convenience, potentially increasing overall market size but may not significantly alter pricing.
References
[1] Centers for Medicare & Medicaid Services. (2022). National Average Drug Acquisition Cost (NADAC). Retrieved from https://www.medicaid.gov/medicaid/policies-and-rules/d permanent-records/national-average-drug-acquisition-cost/index.html
