FLUAD Drug Profile

Summary for Tradename: FLUAD

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 Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for FLUAD 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	influenza vaccine, adjuvanted	Injection	125510	10,220,155	2026-07-17	DrugPatentWatch analysis and company disclosures
Seqirus Inc.	FLUAD	influenza vaccine, adjuvanted	Injection	125510	10,357,616	2037-11-17	DrugPatentWatch analysis and company disclosures
Seqirus Inc.	FLUAD	influenza vaccine, adjuvanted	Injection	125510	10,376,652	2037-02-24	DrugPatentWatch analysis and company disclosures
Seqirus Inc.	FLUAD	influenza vaccine, adjuvanted	Injection	125510	11,097,063	2039-01-17	DrugPatentWatch analysis and company disclosures
Seqirus Inc.	FLUAD	influenza vaccine, adjuvanted	Injection	125510	11,311,679	2039-06-25	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for FLUAD 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	influenza vaccine, adjuvanted	Injection	125510	11,013,795	2036-06-24	Patent claims search
Seqirus Inc.	FLUAD	influenza vaccine, adjuvanted	Injection	125510	9,821,051	2031-10-21	Patent claims search
Seqirus Inc.	FLUAD,FLUAD QUADRIVALENT	influenza vaccine, adjuvanted	Injection	125510	11,013,795	2036-06-24	Patent claims search
Seqirus Inc.	FLUAD,FLUAD QUADRIVALENT	influenza vaccine, adjuvanted	Injection	125510	9,821,051	2031-10-21	Patent claims search

International Patents for FLUAD

Country	Patent Number	Estimated Expiration
Japan	6026485
Japan	5568157
European Patent Office	2612677
Germany	602005017182
Israel	182613

Supplementary Protection Certificates for FLUAD

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
122017000040	Germany		PRODUCT NAME: SCHNELL-WIRKENDES 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
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

Market Dynamics and Financial Trajectory for FLUAD

Last updated: April 17, 2026

What is FLUAD?

FLUAD is a seasonal influenza vaccine developed by Seqirus, a subsidiary of CSL Limited. It is a quadrivalent formulation containing adjuvants that enhance immune responses, primarily targeting adults aged 65 and older. Its key differentiator in the vaccine market is the MF59 adjuvant, designed to boost efficacy among older populations with weaker immune responses.

Market Size and Growth Drivers

Global Influenza Vaccine Market

• Valued at approximately USD 4.2 billion in 2022.
• Expected compound annual growth rate (CAGR) of 8% from 2023 to 2030 (Grand View Research, 2023).

Target Demographics

• Elderly populations, particularly those 65 and older, drive demand.
• Increasing proportion of aging populations in North America, Europe, and Asia-Pacific amplifies market growth.

Key Markets

Region	Market Size (USD billion, 2022)	CAGR (2023-2030)	Notes
North America	1.4	8.2%	Largest market; high vaccination coverage
Europe	1.0	7.8%	Growing awareness, established vaccination programs
Asia-Pacific	0.8	9.1%	Rapid aging, increased healthcare spending
Rest of World	1.0	8.4%	Emerging markets, vaccine accessibility

Impact of COVID-19

• Driven demand for flu vaccines due to heightened awareness of respiratory illnesses.
• Accelerated vaccine development and supply chain investments.

Competitive Landscape

Major Players

Company	Product Name	Market Share (Estimate, 2022)	Differentiators
Seqirus	FLUAD	45%	MF59 adjuvant, strong presence in elderly market
Sanofi Pasteur	Fluzone	20%	Multiple formulations, broad distribution
GlaxoSmithKline	Arepanrix, Fluarix	15%	Global reach, diverse formulations
Others	Various	20%	Niche and regional players

Market Entry and Trends

• Increasing interest in adjuvanted vaccines for higher efficacy in older age groups.
• Some markets begin transitioning from trivalent to quadrivalent formulations.
• Emerging biotechs exploring next-generation mRNA flu vaccines threaten traditional vaccine incumbents.

Financial Trajectory

Sales Performance

• Seqirus reported estimated sales of USD 1.2 billion for FLUAD globally in 2022.
• Approximate annual growth rate of 7%, partly driven by aging demographics and increased vaccination rates.

Revenue Drivers

• Expansion into Asian and Latin American markets.
• COVID-19 pandemic's influence on public health policies keeping vaccination a priority.
• Indicative pipeline developments, including enhanced formulations and new adjuvants.

Pricing and Reimbursement

• Pricing varies by region; premium pricing in North America and Europe.
• Reimbursement policies favor adherence to vaccination guidelines, supporting sales.
• Influenza vaccination campaigns and national immunization programs subsidize costs.

Potential Risks

• Competition from mRNA-based flu vaccines in development.
• Regulatory delays in approval for new formulations or indications.
• Market saturation in mature regions.

Regulatory and Policy Environment

• Approval processes follow stringent standards by agencies such as FDA, EMA, and counterparts.
• Policies favor seasonal vaccination; some governments recommend high-risk population coverage.
• Patent protections extend into the late 2020s, ensuring exclusivity until then.

Outlook and Opportunities

• CAGR projection for FLUAD-related vaccines: ~8% through 2030.
• Growth driven by aging populations, expanding immunization programs, and enhanced vaccine formulations.
• Opportunities exist in emerging markets and through collaborations with public health agencies.
• Risks from novel vaccine technologies could challenge traditional flu vaccine franchises.

Key Takeaways

• FLUAD holds a significant share of the elderly influenza vaccine market, with sustained growth driven by demographic shifts.
• The global influenza vaccine market is expanding at 8% CAGR, with North America and Europe as primary markets.
• Competition centers around adjuvanted, quadrivalent formulations, with emerging mRNA approaches.
• Sales in 2022 approximate USD 1.2 billion, with continued growth forecasted due to aging populations and expanded immunization policies.
• Regulatory diligence and reimbursement policies strongly influence market penetration.

Frequently Asked Questions

1. How does FLUAD differentiate itself from other influenza vaccines?

It contains the MF59 adjuvant, which enhances immune responses in older adults, leading to higher efficacy in this demographic.

2. What is the growth outlook for FLUAD in the coming years?

The market expects an average CAGR of approximately 8% through 2030, driven by demographic shifts and expanding immunization programs.

3. Which regions are the most important for FLUAD’s growth?

North America and Europe are mature markets; Asia-Pacific is emerging rapidly due to demographic aging and increased healthcare investment.

4. What are the main competitive threats to FLUAD?

Emerging mRNA-based flu vaccines and shifts to alternative adjuvant systems pose potential competition.

5. How does government policy impact FLUAD sales?

Vaccination recommendations and reimbursement schemes directly affect adoption rates; government campaigns and subsidies support sustained demand.

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[1] Grand View Research. (2023). Influenza Vaccine Market Size, Share & Trends Analysis Report.