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	10,220,155	2026-07-17	DrugPatentWatch analysis and company disclosures
Seqirus Inc.	FLUAD,FLUAD QUADRIVALENT	influenza vaccine, adjuvanted	Injection	125510	10,357,616	2037-11-17	DrugPatentWatch analysis and company disclosures
Seqirus Inc.	FLUAD,FLUAD QUADRIVALENT	influenza vaccine, adjuvanted	Injection	125510	10,376,652	2037-02-24	DrugPatentWatch analysis and company disclosures
Seqirus Inc.	FLUAD,FLUAD QUADRIVALENT	influenza vaccine, adjuvanted	Injection	125510	11,097,063	2039-01-17	DrugPatentWatch analysis and company disclosures
Seqirus Inc.	FLUAD,FLUAD QUADRIVALENT	influenza vaccine, adjuvanted	Injection	125510	11,311,679	2039-06-25	DrugPatentWatch analysis and company disclosures
Seqirus Inc.	FLUAD,FLUAD QUADRIVALENT	influenza vaccine, adjuvanted	Injection	125510	8,324,157	2031-12-01	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	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,FLUAD QUADRIVALENT

Country	Patent Number	Estimated Expiration
European Patent Office	1877119
Hungary	E027239
Russian Federation	2401134
Denmark	1909870
Russian Federation	2389514
Israel	216520

Supplementary Protection Certificates for FLUAD,FLUAD QUADRIVALENT

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:
300880	Netherlands		PRODUCT NAME: SNELWERKENDE INSULIN ASPART; REGISTRATION NO/DATE: EU/1/16/1160 20170109
132017000073676	Italy		PRODUCT NAME: INSULINA ASPART A RAPIDA AZIONE(FIASP); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1160, 20170111
2017C/024	Belgium		PRODUCT NAME: SNELWERKENDE INSULINE ASPART; AUTHORISATION NUMBER AND DATE: EU/1/16/1160 20170111

Market Dynamics and Financial Trajectory for the Biologic Drugs: FLUAD and FLUAD QUADRIVALENT

Last updated: September 29, 2025

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Introduction

The influenza vaccine segment has experienced significant evolution, driven by advancements in immunology, manufacturing, and market demand. Among the notable players are FLUAD and FLUAD QUADRIVALENT, two biologic vaccines developed by Seqirus, a leader in influenza vaccine production. Their market dynamics are shaped by evolving epidemiological patterns, regulatory changes, competitive landscape, and payer strategies. Analyzing their financial trajectory offers insights into future growth prospects and strategic positioning within the broader vaccine industry.

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Market Landscape and Product Overview

FLUAD is a trivalent influenza vaccine designed for adults aged 65 and older, utilizing adjuvant technology to enhance immune response — specifically the MF59 adjuvant. Launched internationally over two decades ago, FLUAD primarily addresses the immunosenescence challenge faced by older populations, aligning with the increasing global demographic trend of aging.

FLUAD QUADRIVALENT builds upon this framework, expanding coverage to include four strains of influenza virus (two A and two B strains), addressing the limitations of trivalent vaccines, notably the potential mismatch with circulating B strains. It is designed to meet the unmet need for broader and more robust seasonal protection.

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Market Drivers Influencing FLUAD and FLUAD QUADRIVALENT

Demographic Shifts and Aging Population

The global population aged 65+ is projected to reach approximately 1.5 billion by 2050 (UN, 2019). This demographic shift significantly fuels demand for specialized vaccines like FLUAD, which addresses age-related immunosenescence. Countries with established elderly immunization programs, such as Japan, the US, and some European nations, continue to be primary markets.

Influenza Disease Burden and Public Health Policies

Influenza continues to pose significant morbidity and mortality, especially among older adults. Public health agencies, including the CDC and WHO, advocate for enhanced vaccination strategies to mitigate seasonal outbreaks. The introduction of quadrivalent vaccines like FLUAD QUADRIVALENT aligns with policies favoring broader strain coverage, thereby influencing market acceptance and coverage.

Technological Advancements and Adjuvant Technology

Seqirus’s use of the MF59 adjuvant in FLUAD provides an immuno-enhancement advantage, leading to higher immunogenicity in the elderly. Such technological differentiation positions FLUAD favorably against non-adjuvanted vaccines, particularly in regions prioritizing durable and robust immune responses.

Regulatory Approvals and Expanding Indications

Regulatory endorsements from bodies like the FDA, EMA, and WHO significantly impact sales. In recent years, approvals for FLUAD QUADRIVALENT have expanded to multiple markets, driven by clinical data supporting its efficacy and safety.

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Competitive Dynamics

The influenza vaccine market is characterized by intense competition from both established vaccines and new entrants. Key competitors include Sanofi Pasteur’s Fluzone, GSK’s FluLaval, and Seqirus’s own Flucelvax (cell-based).

FLUAD’s differentiation lies in its adjuvanted formulation tailored for seniors, making it a preferred choice in high-income countries with mature immunization programs. Meanwhile, FLUAD QUADRIVALENT serves to capture a broader segment, competing directly with other quadrivalent vaccines that lack adjuvants.

Emerging competition also stems from mRNA-based influenza vaccines in development, which promise higher efficacy. However, their commercial impact remains uncertain given the manufacturing complexity and regulatory challenges.

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Financial Trajectory Analysis

Historical Sales Trends

Since its launch, FLUAD has shown steady revenue growth, driven by increased immunization coverage among the elderly and expanding geographic footprint. For FY2021, Seqirus reported global influenza vaccine sales exceeding $2 billion, with FLUAD constituting a substantial share, particularly in mature markets.

Revenue Growth Potential

The introduction of FLUAD QUADRIVALENT is projected to accelerate sales growth. Clinical and real-world data demonstrate superior effectiveness, especially in seasons with B-strain mismatches, which increasingly favors quadrivalent formulations.

According to industry estimates, the quadrivalent influenza vaccines market is expected to grow at a CAGR of approximately 8-10% through 2028 (MarketsandMarkets, 2022). Seqirus aims to capitalize on this trend by expanding distribution, especially in the Asia-Pacific and Latin America regions.

Pricing Dynamics

Pricing strategies for FLUAD and FLUAD QUADRIVALENT vary across markets. Generally, adjuvanted vaccines command higher prices, with premiums ranging from 20-50% over standard non-adjuvanted quadrivalent vaccines. Payer acceptance, reimbursement policies, and government procurement programs substantially influence margins.

Market Penetration and Adoption Drivers

Key factors include:

• Efficacy and safety profile: Clinical data affirming superior immune responses bolster physician recommendations.
• Reimbursement and subsidy policies: Supportive government programs enhance affordability.
• Awareness campaigns: Public health initiatives increase vaccine uptake.

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Regulatory and Market Expansion Opportunities

Regulatory agencies are increasingly endorsing adjuvanted vaccines for elderly populations. Such endorsements are critical, especially where vaccine hesitancy persists or supply constraints exist. Expanding approval into emerging markets with growing elderly demographics offers significant revenue opportunities.

Product innovations, such as high-dose formulations or combination vaccines, alongside technological improvements like recombinant or mRNA platforms, could further influence future financial trajectories.

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Challenges Facing Market Growth

• Vaccine hesitancy remains a barrier, particularly among certain demographics.
• Manufacturing constraints and supply chain disruptions, as seen during the COVID-19 pandemic, impact distribution.
• Pricing pressures from payers seeking cost-effective solutions could limit profit margins.
• Competition from new platforms could erode market share over the next decade.

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Conclusion and Future Outlook

The combined market for FLUAD and FLUAD QUADRIVALENT appears poised for sustained growth, underscored by demographic shifts, technological differentiation, and expanding regulatory support. Their financial trajectory will likely benefit from increased acceptance in aging populations, strategic global expansion, and a greater emphasis on broad-spectrum influenza protection.

As influenza vaccination strategies evolve, particularly with innovations in vaccine technology, FLUAD’s adjuvant technology positions it as a valuable asset within Seqirus’s portfolio. However, manufacturers must navigate competitive pressures and public health policy shifts to fully realize growth potential.

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Key Takeaways

• Demographic trends favor increased demand for age-specific influenza vaccines like FLUAD.
• Quadrivalent formulations address the need for broader strain coverage, driving sales expansion.
• Regulatory endorsements and reimbursement policies significantly influence financial trajectory.
• Technological advantages, including adjuvants, differentiate FLUAD in a competitive landscape.
• Emerging markets present robust growth opportunities amid expanding elderly populations.

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FAQs

1. How does FLUAD’s adjuvant technology enhance its efficacy?
FLUAD utilizes the MF59 adjuvant, which enhances the immune response by stimulating local immune cells, resulting in higher antibody titers, particularly in the elderly with weakened immune systems.

2. What differentiates FLUAD QUADRIVALENT from traditional influenza vaccines?
FLUAD QUADRIVALENT expands coverage by including four flu strains, offering broader protection. Its adjuvanted formulation improves immunogenicity in older adults compared to non-adjuvanted quadrivalent vaccines.

3. What are the primary markets for FLUAD and FLUAD QUADRIVALENT?
Major markets include North America (notably the US), Europe, Japan, and Australia. Emerging markets, such as parts of Asia and Latin America, are increasing focus for expansion.

4. What impact could emerging mRNA influenza vaccines have on FLUAD’s market?
While mRNA vaccines promise higher efficacy and faster production, their commercial impact is uncertain due to manufacturing complexities and regulatory approvals. FLUAD’s established technology offers a more immediate and proven solution.

5. How are pricing strategies influencing the profitability of FLUAD products?
Adjuvanted vaccines like FLUAD command premium pricing, supported by clinical efficacy and reimbursement policies. However, payer pressures and competition may lead to pricing concessions, impacting margins.

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Sources:

1. United Nations Department of Economic and Social Affairs, World Population Ageing 2019.
2. MarketsandMarkets, Influenza Vaccines Market, 2022.
3. CDC, Flu Vaccine Effectiveness.
4. Seqirus Financial Reports, FY2021.