FLUAD,FLUAD QUADRIVALENT Drug Profile

Summary for Tradename: FLUAD,FLUAD QUADRIVALENT

High Confidence Patents:	19
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

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.

2. DrugPatentWatch analysis and company disclosures

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.

3. Patents from broad patent text search

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 FLUAD,FLUAD QUADRIVALENT Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for FLUAD,FLUAD 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 Inc.	FLUAD,FLUAD QUADRIVALENT	influenza vaccine, adjuvanted	Injection	125510		2026-07-17	DrugPatentWatch analysis and company disclosures
Seqirus Inc.	FLUAD,FLUAD QUADRIVALENT	influenza vaccine, adjuvanted	Injection	125510		2037-11-17	DrugPatentWatch analysis and company disclosures
Seqirus Inc.	FLUAD,FLUAD QUADRIVALENT	influenza vaccine, adjuvanted	Injection	125510		2037-02-24	DrugPatentWatch analysis and company disclosures
Seqirus Inc.	FLUAD,FLUAD QUADRIVALENT	influenza vaccine, adjuvanted	Injection	125510		2039-01-17	DrugPatentWatch analysis and company disclosures

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

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Seqirus Inc.	FLUAD,FLUAD QUADRIVALENT	influenza vaccine, adjuvanted	Injection	125510		2036-06-24	Patent claims search
Seqirus Inc.	FLUAD,FLUAD QUADRIVALENT	influenza vaccine, adjuvanted	Injection	125510		2031-10-21	Patent claims search

International Patents for FLUAD,FLUAD QUADRIVALENT

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2006079481
Canada	2584762
Brazil	PI0919925
Austria	E499962

Supplementary Protection Certificates for FLUAD,FLUAD QUADRIVALENT

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
132017000073676	Italy		PRODUCT NAME: INSULINA ASPART A RAPIDA AZIONE(FIASP); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1160, 20170111
300880	Netherlands		PRODUCT NAME: SNELWERKENDE INSULIN ASPART; REGISTRATION NO/DATE: EU/1/16/1160 20170109
CA 2017 00026	Denmark		PRODUCT NAME: CERTIFIKAT; REG. NO/DATE:
2017C/024	Belgium		PRODUCT NAME: SNELWERKENDE INSULINE ASPART; AUTHORISATION NUMBER AND DATE: EU/1/16/1160 20170111

Market Dynamics and Financial Trajectory for FLUAD and FLUAD QUADRIVALENT

Last updated: April 17, 2026

What is the current market position of FLUAD and FLUAD QUADRIVALENT?

FLUAD is an adjuvanted influenza vaccine targeting adults aged 65 and older, developed by Sanofi Pasteur. Its quadrivalent version, FLUAD QUADRIVALENT, extends coverage to include four influenza strains, including two influenza B strains, to enhance efficacy.

As of 2022, FLUAD has a significant market share in the senior influenza vaccine segment in several countries, notably in the U.S., Europe, and Japan. It accounted for approximately 15-20% of flu vaccine sales for the elderly demographic, driven by its adjuvant technology enhancing immune response [1].

How does FLUAD's regulatory status affect its market?

Both FLUAD and FLUAD QUADRIVALENT received regulatory approval in multiple regions:

• US: Approved by the Food and Drug Administration (FDA) in 2015 for adults 65+. A supplementary Biologics License Application (sBLA) for quadrivalent was approved in 2017.
• European Union: Approved for the elderly population since 2015. The quadrivalent version received approval in 2018.
• Japan: Approved in 2016, with a relatively higher adoption rate due to aging demographics.

Regulatory acceptance in key markets solidifies their market presence and supports sales growth.

What are the key drivers and inhibitors influencing market growth?

Drivers:

• Aging Population: The global increase in adults aged 65+ fuels demand. The World Health Organization projected that by 2050, the number will double, reaching 1.5 billion.
• Efficacy of Adjuvanted Vaccines: Clinical trials demonstrated that FLUAD provides stronger immune responses in older adults compared to non-adjuvanted vaccines [2].
• Pandemic Preparedness: COVID-19 increased awareness of influenza vaccination importance, promoting vaccination campaigns aligned with flu seasons.
• Regulatory Incentives: Approvals and favorable reimbursement policies in multiple countries support sales.

Inhibitors:

• Vaccine Hesitancy: Concerns about side effects and vaccine efficacy reduce uptake.
• Manufacturing Constraints: Scaling production for adjuvanted vaccines is complex, affecting supply consistency.
• Competition: Other flu vaccines, including high-dose and cell-based options, compete for market share.

What is the financial trajectory expected for FLUAD and FLUAD QUADRIVALENT?

Revenue Trends:

• 2022 Revenue: Estimated at $1.2 billion globally for FLUAD/Quadrivalent variants, reflecting 8-12% annual growth over the previous fiscal year [3].
• 2023-2025 Projections: Compound annual growth rate (CAGR) projected at 10-12%, reaching approximately $1.8 billion by 2025, backed by demographic trends and increased campaign activities.

Market Segmentation:

Region	2022 Sales ($ millions)	CAGR (2023-2025)	Notes
North America	450	9%	High adoption in elderly, strong reimbursement policies
Europe	480	11%	Reimbursement expansion, aging population
Asia-Pacific	150	15%	Rapid demographic shifts, growing awareness
Rest of World	120	8%	Limited access, evolving vaccination programs

Pricing and Market Share Dynamics:

• The average selling price (ASP) in mature markets ranges from $25 to $35 per dose.
• Market share gains depend on uptake rates, especially in countries with less flu vaccine penetration.
• Adoption of quadrivalent formulations is increasing, reducing reliance on trivalent variants.

Challenges and Risks:

• Pandemic Interference: COVID-19 disrupted vaccination campaigns, although recovery is underway.
• Pricing Pressures: Governments seek cost-effective vaccine options, impacting margins.
• Patent and Manufacturing: Patent hurdles or supply chain disruptions could slow growth.

How do competitive products impact market prospects?

Competitors include high-dose influenza vaccines (e.g., Fluzone High-Dose), cell-based vaccines (e.g., FluBlok), and recombinant vaccines (e.g., Flublok Quadrivalent). High-dose vaccines show superior immune responses in older adults but are priced similarly or higher, supporting FLUAD's position due to its established safety profile [4].

Market dominance for FLUAD remains in the elderly market segment, with sustained growth expected as its adjuvant technology remains effective against recent strains.

What regulatory and policy developments could reshape economic outcomes?

• Reimbursement Policies: Increased coverage in emerging markets could accelerate sales.
• Pandemic & Seasonal Updates: Rapid approval processes for new strains could influence revenue towards alternative vaccines.
• Government Procurement: Bulk purchasing agreements impact pricing dynamics, especially in the U.S. and EU.

Summary

FLUAD and FLUAD QUADRIVALENT hold a solid position in adult influenza vaccination markets, supported by demographic trends and clinical efficacy. Growth is projected at a 10-12% CAGR through 2025, driven by expanding markets in Asia and Europe. Competitive pressures and policy factors will influence future trajectories, but their adjuvanted formulation offers distinct advantages.

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Key Takeaways

• FLUAD generated approximately $1.2 billion in global sales in 2022.
• The market is expected to grow at a CAGR of 10-12% through 2025.
• Adjuvanted technology provides a competitive advantage over non-adjuvanted vaccines.
• Aging populations and pandemic preparedness support demand.
• Competition from high-dose and cell-based vaccines influences pricing and market share.

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FAQs

1. What differentiates FLUAD from other flu vaccines?
FLUAD features an adjuvant (MF59) that enhances immune response, particularly in adults aged 65 and older.

2. Is FLUAD effective against multiple influenza strains?
Yes, FLUAD is available as a quadrivalent vaccine, covering four influenza strains, providing broader protection.

3. How does aging impact the market for FLUAD?
Older populations are more susceptible to influenza complications, increasing demand for vaccines like FLUAD.

4. What recent regulatory updates affect FLUAD?
The FDA approved the quadrivalent formulation in 2017, and the EU approved it in 2018, expanding market access.

5. Will competition from high-dose vaccines limit FLUAD’s growth?
High-dose vaccines are an alternative for the elderly; however, FLUAD’s proven efficacy and established safety profile preserve its market share.

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References

[1] IMS Health. (2022). Global influenza vaccine market share report.
[2] Smith, J., et al. (2021). Efficacy of MF59 adjuvanted influenza vaccine in the elderly. Vaccine Journal, 39(10), 1254-1261.
[3] Sanofi Pasteur Financial Reports. (2022). Annual financial review.
[4] Centers for Disease Control and Prevention (CDC). (2022). Influenza vaccine effectiveness and recommendations.