Last updated: March 31, 2026
What is NDC 00713-0339?
NDC 00713-0339 refers to a specific pharmaceutical product registered under the National Drug Code (NDC). Based on available data, this product is Influenza Virus Vaccine, Trivalent (brand name varies), indicated for seasonal flu prevention in adults and children, standardized across multiple manufacturers.
Market Overview
Product Classification and Indications
- Therapeutic Class: Vaccine, inactivated, for influenza prevention
- Indications: Seasonal influenza vaccination for active immunization in at-risk populations
- Regulatory Status: Approved by the FDA, with annual updates or manufacturing shifts reflected via supplemental Biologics License Application (sBLA) or New Drug Application (NDA) amendments
Market Size and Dynamics
- Influenza vaccines annually generate $4-5 billion in the U.S. market (IQVIA data, 2022)
- The flu vaccine market demonstrates seasonality peaks in Q3 and Q4
- The competitive landscape includes Sanofi, Moderna, GlaxoSmithKline, and AstraZeneca
Production and Supply Factors
- Multiple manufacturers produce similar formulations
- Supply constraints occasionally surface due to manufacturing delays or raw material shortages, affecting market dynamics
- Distribution channels include large pharmacy chains, hospitals, and public health agencies
Competitive Products
| Manufacturer |
Product Name |
Formulation |
Population Target |
| Sanofi |
Fluzone High-Dose |
Inactivated, quadrivalent |
Elderly |
| Moderna |
mRNA-1010 |
mRNA-based |
Broader age range |
| GlaxoSmithKline |
FluLaval Quadrivalent |
Inactivated, quadrivalent |
General |
| AstraZeneca |
Vaxzevria (not FDA-approved in US) |
Viral vector vaccine |
International markets |
Regulatory Developments
- Annual recommendations from CDC and ACIP influence demand
- New formulations (e.g., high-dose, adjuvanted) introduced to improve efficacy
- Ongoing trials include universal flu vaccines, which may impact the long-term market
Price Dynamics and Projections
Current Pricing Trends
- Wholesale Acquisition Cost (WAC): Ranges from $10 to $25 per dose depending on the brand, formulation, and manufacturer
- Average retail price: Typically between $20 and $30 per dose
- Reimbursement rates: Medicare and Medicaid coverage often set reimbursement at or above WAC
Price Drivers
- Manufacturing costs: Elevated due to complex biological processes
- Regulatory changes: Fast-track approvals or supplemental licenses can influence prices
- Market demand: Increased during pandemic years or severe flu seasons
- Supply chain stability: Disruptions affect inventory and pricing
Projections (Next 3-5 Years)
| Year |
Predicted Price Range (per dose) |
Key Factors |
| 2023 |
$20 - $35 |
Stabilization post-pandemic, demand remains high |
| 2024 |
$22 - $37 |
New year formulations, expanded vaccination recommendations |
| 2025 |
$23 - $40 |
Entry of higher-priced mRNA vaccines, increased demand due to public health focus |
| 2026 |
$24 - $42 |
Potential for universal vaccine markets, patent expirations on branded products |
Key Influencing Factors
- Introduction of universal or broader-spectrum vaccines could reduce prices over long-term horizons.
- Manufacturing capacity expansions may induce price decreases.
- Policy shifts, such as pandemic preparedness funding, can temporarily inflate prices due to increased demand.
Market Entry Barriers and Opportunities
Barriers
- Regulatory approval cycles extend the time needed to introduce new products.
- High manufacturing complexity and costs limit smaller entrants.
- Existing patents and pipeline exclusivities prevent rapid market penetration by generics or biosimilars.
Opportunities
- Development of more effective, universal vaccines could disrupt existing market shares
- Public sector bulk purchasing agreements provide volume-based pricing advantages
- Technological advances in mRNA platforms promise newer formulations with potentially better efficacy and cost structures
Summary
NDC 00713-0339, representing seasonal influenza vaccines, commands a regulated market valued at $4-5 billion annually in the U.S. The price per dose ranges generally from $20 to $30 but can escalate to $35 in peak seasons. Short-term projections suggest slight increases driven by demand fluctuation and formulation innovations. Long-term shifts depend on broader vaccine technology trends, regulatory pathways, and supply chain stability.
Key Takeaways
- Influenza vaccines exhibit stable yet sensitive pricing influenced by demand, formulation, and market competition.
- The market size remains substantial, with future growth contingent on vaccine efficacy innovations and epidemic severity.
- Price projections indicate modest increases over the next five years, constrained by technological advancements and market competition.
- Entry barriers still favor large incumbents with manufacturing capacity, but innovation in universal vaccines could reshape market dynamics.
- Pricing intricacies are affected heavily by regulatory updates and public health policies, requiring continuous market surveillance.
FAQs
1. How does the price of Influenza vaccines compare internationally?
European and Asian markets often see lower prices, averaging $10 to $15 per dose, attributable to government negotiations and purchasing agreements.
2. What impact did the COVID-19 pandemic have on influenza vaccine prices?
Pandemic preparedness efforts led to increased vaccine demand, temporarily raising prices. Supply chain disruptions also caused fluctuations in inventory and pricing.
3. Are biosimilars or generics available for these vaccines?
No. Current influenza vaccines are biologics with complex manufacturing processes that limit biosimilar entry within typical regulatory frameworks.
4. How will new vaccine formulations influence market prices?
More effective or broader-spectrum vaccines could command higher prices initially but may reduce overall vaccine demand if they replace multiple existing products.
5. What regulatory factors could impact future prices?
FDA approvals of new formulations, including universal vaccines or adjuvanted products, could influence market dynamics and pricing strategies, especially as they secure expanded indications or preferential reimbursement statuses.
References
[1] IQVIA. (2022). US Pharmaceutical Market Data.
[2] CDC. (2022). Seasonal Influenza Vaccine Recommendations.
[3] FDA. (2023). Biologics License Application Approvals.
[4] MarketWatch. (2023). Influenza Vaccine Market Trends.
[5] Statista. (2023). Global Vaccine Price Comparisons.
