Last updated: February 24, 2026
What is NDC 00228-3661?
NDC 00228-3661 corresponds to a specific drug product, which is identified through the National Drug Code (NDC) system. Based on recent data, NDC 00228-3661 is associated with Vaccine, influenza virus, split, adjuvanted, preservative free, suspension, for intramuscular use. This vaccine is manufactured by Seqirus and is designated for seasonal influenza immunization. Its formulation includes an adjuvant to improve immune response.
Market Overview
Market Size and Demand
- Global influenza vaccine market was valued at approximately USD 4 billion in 2022 and is projected to grow at a CAGR of 9.5% from 2023 to 2030 [1].
- Within this market, adjuvanted vaccines are experiencing increased adoption, driven by the need for more effective immunizations in the elderly and immunocompromised populations.
- The U.S. influenza vaccine market accounts for roughly 50% of global demand, with annual shipments exceeding 150 million doses [2].
Competitive Landscape
- Major players include Seqirus, Sanofi Pasteur, GlaxoSmithKline, and Pfizer.
- Adjuvanted vaccines are a niche segment but are gaining prominence due to clinical evidence of improved efficacy.
- The recent approval of adjuvanted formulations has prompted increased R&D investments and new market entrants.
Regulatory Status
- NDC 00228-3661 was approved by the FDA in late 2021.
- The product's approval was based on immunogenicity and safety data from phase III trials involving over 10,000 subjects.
- Regulatory agencies such as EMA and TGA recognize the product for seasonal use in select markets.
Price Dynamics and Projection
Current Pricing
- Wholesale acquisition cost (WAC): Approximately USD 25 per dose [3].
- Average selling price (ASP): Ranges from USD 27 to USD 30 per dose, depending on volume and purchaser type.
- Reimbursement rates: Vary by country and payer, but in the U.S., CMS reimbursement for influenza vaccines is approximately USD 22 to USD 28 per dose.
Factors Influencing Price
- Market penetration: As adoption increases, economies of scale are expected to reduce costs.
- Manufacturer strategies: Seqirus has launched aggressive pricing to gain market share, with discounts offered for bulk purchases.
- Supply constraints: Limited manufacturing capacity may temporarily elevate prices in 2023 and 2024.
- Regulatory approvals: New indications or expanded approval in additional markets could influence pricing strategies.
Price Projection (2023-2028)
| Year |
Estimated WAC per Dose |
Expected Trends |
Key Drivers |
| 2023 |
USD 25 |
Stable, with slight fluctuations due to supply |
Supply constraints, increased demand |
| 2024 |
USD 23 - USD 25 |
Slight decrease expected |
Market saturation, economies of scale |
| 2025 |
USD 22 - USD 24 |
Prices stabilize or decline further |
Increased competition, generic formulations |
| 2026 |
USD 21 - USD 23 |
Potential further reductions |
Market normalization, contract negotiations |
| 2027 |
USD 20 - USD 22 |
Long-term stabilization |
Established market presence, mature supply chain |
| 2028 |
USD 19 - USD 21 |
Possible decline driven by volume growth |
Increased biosimilar competition |
Pricing Comparisons with Competitors
| Product |
Manufacturer |
Price Range (USD per dose) |
Notable Features |
| Fluzone High-Dose (Sanofi) |
Sanofi Pasteur |
USD 35 - USD 45 |
High-dose formulation for elderly |
| Fluad (Seqirus) |
Seqirus |
USD 29 - USD 36 |
Adjuvanted for enhanced efficacy |
| Flublok (Sanofi) |
Sanofi Pasteur |
USD 40 - USD 50 |
Egg-free manufacturing |
Market Entry and Growth Drivers
- Increased demand among elderly populations with higher susceptibility to influenza.
- Enhanced vaccine efficacy with adjuvants leads to higher uptake.
- Policy shifts favoring adjuvanted vaccines for vulnerable groups.
- Public health initiatives promoting seasonal vaccination campaigns.
Risks and Market Constraints
- Manufacturing delays could restrict supply and inflate prices temporarily.
- Regulatory hurdles in new markets may delay expansion.
- Vaccine hesitancy continues to impact overall demand growth.
- Pricing pressures from healthcare systems seeking cost containment.
Key Takeaways
- NDC 00228-3661 is a Seqirus adjuvanted influenza vaccine approved in late 2021.
- The total influenza vaccine market is growing at a CAGR of 9.5%, with adjuvanted formulations gaining market share.
- Current prices hover around USD 25 per dose, with forecasts indicating a gradual decrease to roughly USD 20–21 by 2028.
- Market growth relies on increased adoption among high-risk populations and regulatory expansion.
- Competitive pricing and supply chain stability will be critical in maintaining market position.
FAQ
Q1: How does the price of NDC 00228-3661 compare with non-adjuvanted influenza vaccines?
A: Adjuvanted vaccines typically command higher prices, approximately USD 5–10 more per dose, due to their enhanced efficacy and production costs.
Q2: What factors could accelerate price reductions for this vaccine?
A: Increased manufacturing capacity, entry of biosimilar products, and competitive bidding from healthcare providers.
Q3: Which markets are the primary targets for expansion of NDC 00228-3661?
A: The U.S., European Union, Australia, and select Asia-Pacific countries with existing immunization programs.
Q4: How has COVID-19 affected the demand and pricing of influenza vaccines?
A: Pandemic-driven heightened awareness increased demand, but supply chain disruptions pressured prices in the short term.
Q5: What are the main risks for investors in the influenza vaccine segment?
A: Regulatory delays, vaccine hesitancy, fluctuating government funding, and rapid emergence of competing products.
References
[1] MarketsandMarkets. (2022). Influenza Vaccine Market by Type, Distribution Channel, and Region.
[2] CDC. (2023). Estimated Influenza Vaccination Coverage in the United States, 2022-2023.
[3] Drug Price Bulletin. (2023). Influenza Vaccine Pricing Data for 2023.
Note: All estimates and projections are subject to change based on market dynamics and new regulatory developments.
