Last updated: February 13, 2026
What is the drug identified by NDC 00131-2479?
The National Drug Code (NDC) 00131-2479 corresponds to Afluria Quadrivalent, a flu vaccine manufactured by Seqirus. It is designed for intramuscular administration to prevent seasonal influenza.
What is the current market status of Afluria Quadrivalent?
Market presence:
- Approved for use in adults and children aged 3 years and older.
- Widely distributed via government vaccination programs and private pharmacies.
- Competes primarily with vaccines such as Fluarix, Fluzone, and Flucelvax.
Market size:
- U.S. flu vaccine sales reach approximately $4 billion annually.
- Afluria's market share fluctuates around 15-20% within this segment, translating to annual revenue estimates between $600 million and $800 million.
Distribution channels:
- Hospitals and clinics.
- Pharmacies (retail and mail-order).
- Government immunization programs.
Regulatory status:
- FDA approval granted on August 11, 2014.
- Listed in CDC's annually recommended influenza vaccines.
What are the factors impacting the market for Afluria Quadrivalent?
Seasonal flu trends:
- Variability in flu activity affects vaccine demand.
- Severe seasons can elevate vaccination rates.
Vaccine supply and production:
- Seqirus produces the vaccine domestically, with manufacturing capacity increasing capacity over recent years.
- Supply chain disruptions can impact availability.
Pricing and reimbursement environment:
- Average wholesale prices (AWP): Approximately $20-$40 per dose.
- Reimbursement varies across payers, with Medicare and private insurers covering most costs.
Competitive landscape:
- Major competitors include Sanofi's Fluzone, GlaxoSmithKline's Fluarix and Flulaval, and Seqirus's Flucelvax.
- No dominant market share held by any single vaccine; market is segmented.
What are the current price projections and future trends?
Historical pricing trends:
- Afluria's per-dose prices have remained relatively stable over recent years.
- Slight downward pressure exists due to increased vaccine supply and competitive pricing.
Projections (2023-2028):
- Prices are projected to decline marginally, averaging $18-$35 per dose.
- Volume increases are expected to offset price reductions, maintaining or elevating overall revenue.
Impact of pricing policies:
- CMS and private insurers' reimbursement policies could influence net prices.
- Potential for price erosion due to generic or biosimilar entries is currently low for vaccines.
| Analysis and forecast: |
Year |
Average Price (Per Dose) |
Estimated Market Volume (Millions of Doses) |
Estimated Revenue (Millions USD) |
| 2023 |
$20 |
25 |
$500 |
| 2024 |
$19.50 |
26 |
$507 |
| 2025 |
$19 |
27 |
$513 |
| 2026 |
$18.50 |
28 |
$518 |
| 2027 |
$18 |
29 |
$522 |
| 2028 |
$17.50 |
30 |
$525 |
Note: These projections assume stable production, no major regulatory changes, and consistent demand.
What are key regulatory and market risks?
- Potential for new flu vaccines or alternative immunization strategies to reduce demand.
- Changes in reimbursement policies that could compress margins.
- Manufacturing delays or supply chain disruptions.
- Emergence of biosimilars or next-generation vaccines.
What are potential opportunities?
- Expansion into pediatric markets (ages 6 months and above).
- Increased vaccination rates driven by public health initiatives.
- Concurrent development of improved formulations (adjuvants, higher-dose variants).
Key Takeaways
- The vaccine has a stable market with annual revenues around $600 million.
- Moderate pricing pressure is projected but supported by consistent demand.
- Competition and seasonal variability pose market risks.
- Pricing per dose is expected to decline slightly over the next five years, but total revenue may stabilize or increase due to volume growth.
FAQs
1. How does Afluria Quadrivalent compare with other flu vaccines in market share?
It holds approximately 15-20% of the U.S. flu vaccine market, competing with other brands like Fluarix and Fluzone.
2. Are there upcoming regulatory changes that could impact pricing or sales?
No significant regulatory changes are currently expected, but modifications in CDC recommendations or reimbursement policies could influence sales.
3. What factors could significantly alter future prices?
Introduction of generic or biosimilar vaccines, supply chain disruptions, or shifts in public health policy.
4. How does vaccine efficacy influence market demand?
In years with higher flu activity or better vaccine efficacy, demand increases. Conversely, vaccines with lower efficacy may see reduced uptake.
5. What role does government procurement play in the vaccine market?
Large government orders during flu season ensure steady demand, often at negotiated lower prices, influencing overall market dynamics.
References
- CDC. Recommended adult immunization schedule — United States, 2023.
- IQVIA. U.S. pharmaceutical market data, 2022.
- Seqirus. Afluria Quadrivalent product information.
- CMS. Reimbursement policies for influenza vaccines, 2023.
- Bloomberg Industry Reports, 2023.
