Last updated: July 28, 2025
Introduction
The drug associated with NDC 28105-0421 is a pharmaceutical product marketed in the United States. This analysis evaluates the current market landscape, competitive environment, regulatory considerations, and price trends for this drug. The goal is to assist stakeholders—including manufacturers, investors, and healthcare providers—in understanding market dynamics and making informed strategic decisions.
Product Overview
NDC 28105-0421 corresponds to Palivizumab (Synagis), a monoclonal antibody indicated for the prevention of serious lower respiratory tract disease caused by Respiratory Syncytial Virus (RSV) in high-risk infants and young children. Approved by the FDA, Palivizumab has been a critical component in pediatric infectious disease management since 1998.
Key features:
- Administration: Monthly intramuscular injection during RSV season.
- Indications: Premature infants, children with congenital heart disease, and those with certain immunodeficiencies.
- Market exclusivity: Patent protection and orphan drug status (for some indications) have provided periods of market exclusivity, affecting pricing and competition.
Market Dynamics
Market Size and Demand
The pediatric RSV prophylaxis market has traditionally been stable, driven by epidemiological data indicating high RSV morbidity among high-risk infants. The Centers for Disease Control and Prevention (CDC) estimates that annual RSV hospitalizations in infants under 1 year exceed 50,000 cases with significant medico-economic implications.
Approximately 20,000–25,000 infants per year qualify for Palivizumab prophylaxis in the U.S., according to CDC data and CDC/ACIP guidelines. The demand is seasonal, peaking during the fall and winter months.
Competitive Landscape
Since the introduction of Palivizumab, alternative prophylactic agents have entered the pipeline, but none have yet replaced it due to regulatory and clinical data requirements.
- Main Competitors:
- Battery of biosimilar or generic antibodies (limited, as of now).
- Emerging alternatives: Small molecule or vaccine-based preventative strategies are under clinical development but are not yet commercially viable or approved.
Market share is predominantly held by Palivizumab, with Novartis (later acquired by AstraZeneca) as the primary manufacturer.
Regulatory Factors
Regulatory scrutiny remains high, given the high expenditure associated with Palivizumab prophylaxis, and recent guidelines from ACIP have refined indications, influencing prescribing patterns and volume.
In 2014, the FDA extended the patent life through additional patents and exclusivity agreements, delaying generic entry. However, patent cliffs are projected around 2024–2027, opening potential for biosimilar competition.
Pricing Trends and Projections
Historical Price Data
- Per-dose price: Historically, each 50 mg vial has been priced approximately $1,200–$1,600.
- Annual treatment cost: Varies based on weight and dose frequency, generally ranging from $4,000 to over $6,000 per patient annually.
Due to pricing transparency initiatives and healthcare reforms, there's downward pressure on prices, although discounts and rebates often obscure actual net price paid by payers.
Current Market Pricing
In 2022, the average wholesale price (AWP) for Palivizumab was approximately $1,500 per 50 mg vial, with hospitals and insurers negotiating discounts, resulting in net prices estimated between $1,200 and $1,400.
Future Price Projections (2023–2028)
- Short-term (1–2 years): Prices are expected to remain stable, driven by fixed manufacturing costs and existing patent protections. Slight adjustments for inflation or supply chain factors are possible.
- Medium-term (3–5 years): The entry of biosimilars, projected around 2024–2025, could precipitate price declines of 15–30%. Competitive pressure may also incentivize manufacturers to offer discounts or value-based contracting.
- Long-term (beyond 2028): Biosimilar proliferation, combined with potential vaccine-based RSV prophylactics, could reshape the market significantly, leading to further price reductions or substitution.
Factors Influencing Price Trajectory
- Patent expirations and increased biosimilar competition.
- Regulatory approvals of new RSV vaccines and monoclonal antibodies.
- Reimbursement policies and value-based payment models.
- Manufacturing costs and supply chain stability.
Market Outlook and Revenue Potential
The global RSV vaccine and therapeutic market is projected to grow at a compound annual growth rate (CAGR) of 7-9% through 2030, driven by broader pediatric immunization initiatives and increasing awareness.
While Palivizumab remains the gold standard for prophylaxis, its high cost and limited scope for expanding indications constrict revenue growth in the long term. The upcoming biosimilars and alternative therapies could erode market share sharply, reducing revenue potential for incumbent producers.
Strategic Considerations for Stakeholders
- Manufacturers should prepare for biosimilar entry by investing in process efficiencies and navigating patent litigations.
- Investors should monitor pipeline developments and regulatory milestones.
- Healthcare payers will seek value-based agreements to optimize expenditures.
- Regulatory agencies expect ongoing data submission to facilitate approval pathways for biosimilars and vaccines.
Key Takeaways
- Market Stability: The high-risk infant population requiring RSV prophylaxis sustains steady demand for Palivizumab.
- Pricing Trends: Current prices are relatively stable but face downward pressure from impending biosimilar competition and policy reforms.
- Patent Landscape: Patent expiration around 2024–2027 may trigger biosimilar market entry and price declines.
- Future Competition: Enhanced vaccine research and new biologics are expected to challenge Palivizumab's market dominance.
- Investment Implication: Stakeholders should strategize around patent timelines, biosimilar integration, and vaccine developments.
FAQs
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When are biosimilars for Palivizumab expected to enter the market?
Biosimilar development is underway, with anticipated approval around 2024–2025, contingent upon regulatory review and patent litigation outcomes.
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How does the price of Palivizumab compare globally?
Pricing varies internationally, with lower prices generally observed in countries with government-negotiated healthcare systems; the U.S. sees higher list prices due to market dynamics.
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What are the regulatory challenges facing new RSV prophylactic therapies?
New entrants must demonstrate non-inferiority or superiority to existing treatments through comprehensive clinical trials, and navigate biosimilar approval pathways.
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Will a vaccine replace Palivizumab in the future?
Potentially. Several RSV vaccine candidates are in late-stage development, aiming to provide broader and more cost-effective protection, possibly diminishing Palivizumab’s market share.
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How are healthcare payers responding to Palivizumab's high costs?
Payers are increasingly adopting prior authorization, risk-based contracting, and negotiating discounts to manage expenses, especially as alternative options emerge.
Sources
[1] CDC. Respiratory Syncytial Virus (RSV) Year-round. https://www.cdc.gov/rsv/about/seasonality.html
[2] FDA. Palivizumab (Synagis) Prescribing Information. 2022.
[3] IQVIA. US Market Analysis for Pediatric Immunoglobulins. 2022.
[4] EvaluatePharma. RSV Therapeutics Market Report. 2022.
[5] American Academy of Pediatrics. Clinical Practice Guidelines on RSV. 2014.
