Last updated: March 12, 2026
What is NDC 00143-9634?
NDC 00143-9634 refers to a pharmaceutical product approved by the FDA. According to available databases, this code corresponds to Synagis (palivizumab), a monoclonal antibody used for RSV prophylaxis in high-risk infants and young children.
Market Overview
Indications and Target Population
Synagis is indicated for preventing serious lower respiratory tract disease caused by RSV in:
- Infants and children up to 24 months with specific risk factors, including prematurity (less than 35 weeks gestation).
- Infants with chronic lung disease of prematurity.
- Infants and children with certain congenital heart diseases.
Market Size
- The global RSV prophylaxis market was valued at approximately USD 900 million in 2022.
- The US accounts for roughly 70% of the market, driven by the high incidence of RSV and reimbursement policies.
- The target population in the US is estimated at 100,000-150,000 high-risk infants annually, with variability based on criteria.
Competitive Landscape
Major competitors include:
- Becasusimab (development stage, not yet marketed)
- Synergistic monoclonal antibodies designed for broader infant populations
- Traditional supportive care without pharmacological intervention
Synagis maintains dominant market share owing to its FDA approval since 1998 and established reimbursement pathways.
Regulatory and Reimbursement Environment
- CMS reimburses Synagis through specific ICD codes for high-risk infant populations.
- Payer policies restrict usage to high-risk groups, limiting broad commercial expansion.
Price Analysis
Historical Pricing Trends
- The list price of Synagis has historically ranged from USD 1,200 to USD 2,100 per vial.
- Vials are administered monthly during RSV season (typically 5 doses).
Pricing Breakdown
| Year |
List Price per Vial |
Doses per Season |
Estimated Season Cost (USD) |
| 2018 |
1,200 |
5 |
6,000 |
| 2020 |
1,500 |
5 |
7,500 |
| 2022 |
2,000 |
5 |
10,000 |
Costs Drivers
- Manufacturing complexity of monoclonal antibodies
- Regulatory compliance costs
- Market demand fluctuations during RSV seasons
- Payer negotiations leading to discounts and rebates
Current Price Dynamics
- List prices continue to rise driven by manufacturing costs, but net prices are often lower due to payer rebates.
- Manufacturer price hikes are limited by payer resistance and competitive pressures.
Price Projections
Short-Term (Next 1-2 Years)
- Likely stabilization around USD 2,000 to USD 2,200 per vial due to manufacturing costs and payer negotiations.
- Slight price increases of 3-5% annually remain probable to offset inflation and R&D expenditures.
Medium to Long-Term (3-5 Years)
- Potential introduction of biosimilars or alternative monoclonal antibodies could pressure prices downward by 10-15%.
- Market expansion to include broader infant populations or alternative RSV prophylaxis indications could increase sales volumes but not necessarily price per vial.
- Regulatory process for biosimilars is evolving; FDA approval expected in the next 2-4 years.
Impact of New Entrants
- Entry barriers remain high due to complex manufacturing and FDA approval requirements.
- Biosimilar competition could eventually reduce prices, but no immediate significant price erosion is expected within the next 2 years.
Revenue Projections
Assuming stable high-risk infant population (~150,000 annually) and an average vial price of USD 2,200:
| Year |
Estimated Vials Sold |
Gross Revenue (USD millions) |
| 2023 |
750,000 |
1,650 |
| 2025 |
800,000 |
1,760 |
| 2027 |
850,000 |
1,870 |
Rebates and insurance adjustments mean net revenue could be 20-30% lower.
Risks & Opportunities
- The emergence of biosimilars presents risk of price erosion.
- Improved diagnostics enabling targeted prophylaxis could increase market share.
- Expanded indications or formulations (e.g., longer-acting versions) could open new revenue streams.
Key Takeaways
- NDC 00143-9634 (Synagis) dominates the RSV prophylaxis market for high-risk infants.
- Market size is approximately USD 900 million globally, predominantly in the US.
- Prices per vial have increased over the past five years, with current list prices around USD 2,000.
- Short-term pricing is expected to stabilize; long-term prices may decline if biosimilars receive approval.
- Market expansion and better risk stratification could influence future revenues and pricing strategies.
FAQs
1. What factors most influence Synagis pricing?
Manufacturing costs, market demand, payer negotiations, and regulatory environment.
2. When might biosimilars enter the market?
Potential FDA approval within 2-4 years; actual market entry depends on regulatory approval and commercial readiness.
3. How does payer reimbursement impact net revenue?
Rebates and discounts reduce net revenue by 20-30% from list prices.
4. Are there ongoing efforts to expand the target patient population?
Yes, research aims at broader prophylactic use, but regulatory approvals are pending.
5. What are the major risks for market growth?
Biosimilar competition, changes in payer policies, and shifting clinical guidelines.
Citations
- National Library of Medicine. (2023). Palivizumab. https://pubmed.ncbi.nlm.nih.gov/
- IQVIA. (2022). Global RSV Market Report.
- Centers for Medicare & Medicaid Services. (2023). Reimbursement policies for RSV prophylaxis.
- U.S. Food and Drug Administration. (2022). Biosimilar approval pathway.
- MarketWatch. (2023). Pharmaceutical Price Trends.
