Last updated: February 27, 2026
What is NDC 42291-0522?
NDC 42291-0522 refers to a specific pharmaceutical product listed in the National Drug Code (NDC) database. The details associated with this code include:
- Product Name: Synagis (palivizumab)
- Indication: Prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in high-risk pediatric populations
- Formulation: Injection
- Strength: 50 mg/vial
Market Size and Demand Drivers
Pediatric RSV Prevention Market
The primary market for palivizumab (Synagis) is pediatric patients at high risk of RSV. High-risk groups include preterm infants, those with congenital heart disease, or with chronic lung disease.
- Global RSV prophylaxis market value: Estimated at $1.2 billion in 2022, projected to reach $1.75 billion by 2028. Compound annual growth rate (CAGR): 6.4% (Research and Markets, 2023).
- U.S. market share: Approximately 60%. The U.S. accounts for around $720 million of the global market.
Market Constraints
- Pricing sensitivity: Payor restrictions limit access due to high per-dose costs.
- Shared decision-making: Increasing use of risk assessments to determine eligibility reduces overall volume.
- Patent status: The original patent expired in 2014, but some formulations may be protected under follow-on biologic regulations.
Competitive Landscape
-
Main competitors:
- Palivizumab (Synagis)
- Respivax (potential biosimilars: ongoing developments)
- Possible future biosimilars entering the market could impact price and market share
Price Projection Analysis
Current Pricing
- Average wholesale price (AWP): Approximately $1,200 per 50 mg vial (Micromedex, 2023).
- Reimbursement frameworks: Medicare and commercial payors typically reimburse 70-90% of AWP, resulting in net prices around $840 to $1,080.
Historical Price Trends
- 2019-2022: Slight increases (~3-4%) annually, driven by manufacturing costs and inflation.
- Post-patent expiration impact: No significant decrease observed, but biosimilar entry anticipated to exert downward pressure.
Future Price Trends
| Year |
Estimated AWP per vial |
Notes |
| 2023 |
$1,200 |
Current market price |
| 2024 |
$1,250 |
Adjusted for inflation and manufacturing costs |
| 2025 |
$1,200 - $1,230 |
Biosimilar entry possible, price pressure begins |
| 2026 |
$1,150 - $1,200 |
Increased biosimilar competition reduces prices |
Impact of Biosimilars
- Biosimilars are expected to enter the market within 2-3 years.
- Price reductions of 20-30% are projected based on biosimilar uptake patterns in similar biologics.
- Market share may shift from originator to biosimilars, impacting revenues and pricing strategies.
Regulatory Environment and Policy Impact
- Biosimilar approval pathway: 351(k) pathway under the Biologics Price Competition and Innovation Act (BPCI Act).
- Reimbursement adjustments: CMS and private insurers may implement tiered pricing and formulary restrictions to control costs.
- Potential legislative actions: Price caps or negotiation rights could further influence pricing and market access.
Summary of Key Factors Affecting Market and Price
- High prevalence of RSV in vulnerable pediatric populations sustains demand.
- Entry of biosimilars will exert pressure on pricing starting 2024-2026.
- Payor restrictions and risk-based patient selection limit total market volume.
- Wholesale and net prices are likely to decline 10-20% over the next three years due to biosimilar competition.
- Ongoing innovation, such as longer-acting monoclonal antibodies, may challenge traditional palivizumab pricing and usage patterns in the longer term.
Key Takeaways
- The market for NDC 42291-0522 (Synagis) is stable but faces competitive and regulatory pressures.
- Wholesale prices are around $1,200 per vial, with net reimbursements decreasing as biosimilars gain traction.
- Price declines of up to 30% are projected with biosimilar entry.
- Demand remains focused on high-risk pediatric groups, limiting volume growth.
- Regulatory and legislative changes may further influence future market dynamics.
FAQs
1. When will biosimilars for palivizumab likely enter the market?
Biosimilar approval is anticipated within the next 2-3 years, with some candidates already in late-stage development.
2. How will biosimilar competition affect the price of NDC 42291-0522?
Prices will likely decrease by 20-30%, driven by biosimilar uptake and payer cost containment strategies.
3. What are the key regulatory hurdles for biosimilars?
Biosimilar approval requires demonstrating biosimilarity in terms of safety, purity, and potency, along with manufacturing process validation.
4. Can the current pricing model be sustained amid biosimilar entry?
Prices are expected to decline; manufacturers may shift focus to value-added features or longer-acting formulations to maintain margins.
5. How does payer restriction influence overall market volume?
Restrictions limit the number of eligible patients, which constrains total revenue despite high per-vial prices.
References
[1] Research and Markets. (2023). Global RSV market report, 2022-2028.
[2] Micromedex. (2023). Drug pricing and reimbursement data.
[3] U.S. Food and Drug Administration. (2023). Guidance for biosimilar approval.
[4] Centers for Medicare & Medicaid Services (CMS). (2023). Policies on biologic reimbursement.
[5] Pharmaceutical Research and Manufacturers of America. (2022). Biological patent landscape.
