Last Updated: April 27, 2026

AFLURIA, AFLURIA QUADRIVALENT Drug Profile


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Summary for Tradename: AFLURIA, AFLURIA QUADRIVALENT
High Confidence Patents:15
Applicants:1
BLAs:1
Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

  1. Brand-side disclosures in response to biosimilar applications
  2. These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

  3. DrugPatentWatch analysis and company disclosures
  4. These patents were identified from searching various sources, including drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

  5. Patents from broad patent text search
  6. For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for AFLURIA, AFLURIA QUADRIVALENT Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for AFLURIA, AFLURIA QUADRIVALENT Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures
Applicant Tradename Biologic Ingredient Dosage Form BLA Patent No. Estimated Patent Expiration Source
Seqirus Pty Ltd. AFLURIA, AFLURIA QUADRIVALENT influenza vaccine Injection 125254 10,098,971 2036-12-05 DrugPatentWatch analysis and company disclosures
Seqirus Pty Ltd. AFLURIA, AFLURIA QUADRIVALENT influenza vaccine Injection 125254 10,124,067 2037-04-13 DrugPatentWatch analysis and company disclosures
Seqirus Pty Ltd. AFLURIA, AFLURIA QUADRIVALENT influenza vaccine Injection 125254 10,653,765 2039-08-09 DrugPatentWatch analysis and company disclosures
Seqirus Pty Ltd. AFLURIA, AFLURIA QUADRIVALENT influenza vaccine Injection 125254 10,682,405 2039-10-03 DrugPatentWatch analysis and company disclosures
Seqirus Pty Ltd. AFLURIA, AFLURIA QUADRIVALENT influenza vaccine Injection 125254 10,912,836 2038-11-05 DrugPatentWatch analysis and company disclosures
Seqirus Pty Ltd. AFLURIA, AFLURIA QUADRIVALENT influenza vaccine Injection 125254 11,179,469 2038-03-26 DrugPatentWatch analysis and company disclosures
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Patent No. >Estimated Patent Expiration >Source

3) Low Certainty: US Patents for AFLURIA, AFLURIA QUADRIVALENT Derived from Patent Text Search

These patents were obtained by searching patent claims

AFLURIA and AFLURIA QUADRIVALENT: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

This analysis examines the market dynamics and financial trajectory of AFLURIA and AFLURIA QUADRIVALENT, influenza vaccines. The market is characterized by seasonal demand, regulatory oversight, and competition from other vaccine manufacturers. Financial performance is influenced by sales volumes, pricing strategies, and manufacturing costs.

What is the Market Landscape for Influenza Vaccines?

The global influenza vaccine market is a significant segment of the broader vaccine industry. Demand is driven annually by public health recommendations and the recurring nature of influenza outbreaks. Key market drivers include government purchasing programs, rising healthcare awareness, and the need to mitigate the economic impact of seasonal flu.

The market is highly seasonal, with demand peaking prior to the influenza season, typically in the fall. Vaccine manufacturers must accurately forecast demand and production capacity to meet this cyclical requirement.

Key Market Participants

Major competitors in the influenza vaccine market include:

  • Sanofi Pasteur
  • GlaxoSmithKline (GSK)
  • CSL Seqirus (manufacturer of AFLURIA and AFLURIA QUADRIVALENT)
  • AstraZeneca
  • Emergent BioSolutions

These companies compete on factors such as vaccine efficacy, strain coverage, price, and distribution networks.

Regulatory Environment

Influenza vaccines are subject to rigorous regulatory approval processes by bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). These agencies review clinical trial data, manufacturing processes, and quality control measures to ensure vaccine safety and efficacy. Post-market surveillance is also a critical component of regulatory oversight.

The selection of influenza strains for inclusion in vaccines is a dynamic process, overseen by the World Health Organization (WHO). This annual selection process, based on epidemiological surveillance, influences the composition of available vaccines each season.

What are the Product Specifications for AFLURIA and AFLURIA QUADRIVALENT?

AFLURIA and AFLURIA QUADRIVALENT are inactivated influenza vaccines developed and manufactured by CSL Seqirus. They are designed to protect against influenza illness caused by specific strains of influenza viruses.

AFLURIA (Trivalent Influenza Vaccine)

  • Type: Inactivated influenza vaccine
  • Valency: Trivalent (protects against three influenza strains: two influenza A strains and one influenza B strain)
  • Formulation: Intramuscular injection
  • Target Population: Approved for individuals aged 6 months and older.
  • Manufacturing: Produced using egg-based manufacturing processes.

AFLURIA QUADRIVALENT (Quadrivalent Influenza Vaccine)

  • Type: Inactivated influenza vaccine
  • Valency: Quadrivalent (protects against four influenza strains: two influenza A strains and two influenza B strains)
  • Formulation: Intramuscular injection
  • Target Population: Approved for individuals aged 6 months and older.
  • Manufacturing: Produced using egg-based manufacturing processes.

The addition of a second influenza B strain in AFLURIA QUADRIVALENT aims to provide broader protection against circulating influenza B lineages, which can vary in prevalence between seasons.

What is the Commercialization and Distribution Strategy?

CSL Seqirus employs a multi-faceted strategy for the commercialization and distribution of AFLURIA and AFLURIA QUADRIVALENT. The company targets both public and private sectors, including government health agencies, healthcare providers, and pharmacies.

Distribution Channels

  • Government Contracts: Significant sales volumes are generated through contracts with national health programs, such as those managed by the Centers for Disease Control and Prevention (CDC) in the United States. These contracts often involve large-scale procurement and distribution.
  • Wholesalers and Distributors: Vaccines are supplied to pharmaceutical wholesalers who then distribute them to healthcare facilities, pharmacies, and physician offices.
  • Direct Sales: CSL Seqirus may engage in direct sales efforts to large healthcare systems or government entities.

Marketing and Promotion

Marketing efforts focus on highlighting the vaccines' efficacy, safety profiles, and the benefits of annual vaccination. The company’s messaging often emphasizes public health imperatives and the role of influenza vaccination in preventing illness and reducing healthcare burdens.

What are the Financial Performance Indicators?

The financial performance of AFLURIA and AFLURIA QUADRIVALENT is directly tied to influenza season demand, market share, and pricing. CSL Seqirus, as a subsidiary of CSL Limited, reports its financial results within the broader group.

Sales Trends

CSL Seqirus has reported consistent sales for its influenza vaccine portfolio. For instance, in fiscal year 2023, CSL Seqirus’s influenza vaccine sales were A$2.3 billion, representing a 7% increase on a constant currency basis compared to the prior year. This figure includes sales of various influenza vaccine products, including AFLURIA and AFLURIA QUADRIVALENT, as well as other offerings. [1]

The demand for quadrivalent vaccines has grown over time as they offer broader protection. AFLURIA QUADRIVALENT's market penetration is influenced by its competitive positioning against other quadrivalent vaccines.

Pricing and Reimbursement

Pricing for influenza vaccines is influenced by several factors, including manufacturing costs, competitive pricing, and the perceived value of the vaccine in public health. Reimbursement policies vary by country and region, with many national health systems covering the cost of influenza vaccination. In the U.S., the CDC's Vaccines for Children (VFC) program and Medicare Part D are significant reimbursement pathways. [2]

CSL Seqirus aims to maintain competitive pricing while ensuring the economic viability of its manufacturing operations.

Manufacturing Costs and Profitability

The production of influenza vaccines, particularly those manufactured using egg-based methods, involves significant costs related to antigen sourcing, cell culture, purification, and quality control. Fluctuations in raw material costs and manufacturing yields can impact profitability. CSL Seqirus continuously invests in manufacturing technologies and capacity to optimize cost-efficiency and supply reliability.

What are the Competitive Advantages and Challenges?

CSL Seqirus faces both advantages and challenges in the influenza vaccine market.

Competitive Advantages

  • Established Market Position: CSL Seqirus has a well-established presence in the influenza vaccine market with a history of reliable supply.
  • Product Portfolio: The availability of both trivalent (AFLURIA) and quadrivalent (AFLURIA QUADRIVALENT) vaccines allows the company to cater to different market segments and public health recommendations.
  • Manufacturing Scale: CSL Seqirus operates large-scale manufacturing facilities, enabling it to meet substantial demand, especially during peak flu seasons.
  • Global Reach: The company has a global distribution network, facilitating access to its vaccines in numerous countries.

Market Challenges

  • Intense Competition: The influenza vaccine market is crowded with multiple global manufacturers offering a range of products, leading to pricing pressures and competition for market share.
  • Seasonal Demand Volatility: Demand can fluctuate based on the severity of the influenza season and public vaccination uptake, impacting sales forecasts and inventory management.
  • Strain Selection Uncertainty: The annual need to adapt vaccine composition to circulating strains requires ongoing research and development and can sometimes lead to mismatches between vaccine strains and circulating strains, potentially affecting vaccine effectiveness.
  • Emergence of Alternative Technologies: While egg-based vaccines remain dominant, the development of cell-culture-based and recombinant influenza vaccines presents evolving competitive landscapes.

What is the Future Outlook?

The future outlook for AFLURIA and AFLURIA QUADRIVALENT will be shaped by ongoing influenza epidemiology, public health policies, and technological advancements in vaccine development and manufacturing.

Market Growth Drivers

  • Increased Vaccination Rates: Continued public health campaigns and government mandates aimed at increasing influenza vaccination coverage will drive demand.
  • Pandemic Preparedness: The emphasis on pandemic preparedness and the broader recognition of the importance of vaccines in public health could lead to increased investment in vaccine manufacturing and distribution capabilities.
  • Population Growth: A growing global population will naturally increase the total demand for influenza vaccines.

Potential Disruptions

  • New Vaccine Technologies: Advancements in cell-culture-based or recombinant vaccine platforms could offer advantages in production speed, scalability, or strain adaptation, potentially altering the competitive landscape.
  • Evolving Regulatory Requirements: Changes in regulatory standards for vaccine approval or manufacturing could impact market entry and product lifecycle.
  • Global Health Crises: Unexpected global health events can shift public health priorities and resource allocation, potentially influencing the influenza vaccine market.

CSL Seqirus's strategy will likely involve continued investment in its manufacturing capabilities, ongoing research and development for vaccine improvement, and strategic partnerships to maintain its competitive position in the dynamic influenza vaccine market.

Key Takeaways

  • AFLURIA and AFLURIA QUADRIVALENT are inactivated influenza vaccines manufactured by CSL Seqirus, competing in a seasonal and highly regulated global market.
  • The market is characterized by significant annual demand driven by public health recommendations and government purchasing programs.
  • CSL Seqirus's influenza vaccine sales reached A$2.3 billion in fiscal year 2023, reflecting its substantial market presence.
  • Key competitive advantages include an established market position and a dual trivalent/quadrivalent product offering, while challenges include intense competition and seasonal demand volatility.
  • The future market trajectory will be influenced by vaccination rates, public health policies, and the adoption of new vaccine technologies.

Frequently Asked Questions

  1. How does the WHO strain selection process impact AFLURIA and AFLURIA QUADRIVALENT? The World Health Organization's annual selection of influenza virus strains for vaccines directly dictates the composition of AFLURIA and AFLURIA QUADRIVALENT for the subsequent influenza season. Manufacturers must adapt their production processes to align with these selected strains to ensure the vaccines target currently circulating viruses.

  2. What is the primary difference in protection offered by AFLURIA versus AFLURIA QUADRIVALENT? AFLURIA is a trivalent vaccine, protecting against two influenza A strains and one influenza B strain. AFLURIA QUADRIVALENT is a quadrivalent vaccine, providing broader protection by including two influenza A strains and two influenza B strains. This quadrivalent formulation aims to offer enhanced protection against both major lineages of influenza B viruses.

  3. Are AFLURIA and AFLURIA QUADRIVALENT suitable for all age groups? Both AFLURIA and AFLURIA QUADRIVALENT are approved for individuals aged 6 months and older. Specific age-related administration guidelines and precautions are detailed in the product's prescribing information.

  4. What manufacturing technology is used for AFLURIA and AFLURIA QUADRIVALENT? AFLURIA and AFLURIA QUADRIVALENT are manufactured using egg-based technology. This traditional method involves growing influenza viruses in fertilized hen's eggs.

  5. How do CSL Seqirus's influenza vaccine sales compare to its overall revenue? CSL Seqirus's influenza vaccine sales constitute a significant portion of CSL Limited's total revenue. For instance, in fiscal year 2023, CSL Limited reported total revenue of A$13.3 billion, with CSL Seqirus contributing A$2.3 billion from influenza vaccines alone, highlighting the segment's financial importance to the parent company. [1]

Citations

[1] CSL Limited. (2023). CSL Limited Full Year Results 2023. Retrieved from [CSL Limited Investor Relations website] (Note: Specific URL would be provided if accessible for the report. General reference to their annual reports is standard).

[2] Centers for Disease Control and Prevention. (2023). Vaccines for Children (VFC) Program. Retrieved from [CDC website] (Note: Specific URL would be provided if accessible for the program details).

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