AFLURIA, AFLURIA QUADRIVALENT Drug Profile

Summary for Tradename: AFLURIA, AFLURIA QUADRIVALENT

High Confidence Patents:	7
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 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	10,124,067	2037-04-13	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	11,179,469	2038-03-26	DrugPatentWatch analysis and company disclosures
Seqirus Pty Ltd.	AFLURIA, AFLURIA QUADRIVALENT	influenza vaccine	Injection	125254	8,101,188	2028-12-11	DrugPatentWatch analysis and company disclosures
Seqirus Pty Ltd.	AFLURIA, AFLURIA QUADRIVALENT	influenza vaccine	Injection	125254	8,236,315	2029-01-23	DrugPatentWatch analysis and company disclosures
Seqirus Pty Ltd.	AFLURIA, AFLURIA QUADRIVALENT	influenza vaccine	Injection	125254	8,828,399	2032-03-01	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for AFLURIA, AFLURIA 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 Pty Ltd.	AFLURIA, AFLURIA QUADRIVALENT	influenza vaccine	Injection	125254	10,004,803	2036-10-12	Patent claims search
Seqirus Pty Ltd.	AFLURIA, AFLURIA QUADRIVALENT	influenza vaccine	Injection	125254	10,030,231	2034-01-23	Patent claims search
Seqirus Pty Ltd.	AFLURIA, AFLURIA QUADRIVALENT	influenza vaccine	Injection	125254	10,034,931	2034-09-23	Patent claims search
Seqirus Pty Ltd.	AFLURIA, AFLURIA QUADRIVALENT	influenza vaccine	Injection	125254	10,059,925	2035-08-03	Patent claims search
Seqirus Pty Ltd.	AFLURIA, AFLURIA QUADRIVALENT	influenza vaccine	Injection	125254	10,124,056	2035-08-18	Patent claims search
Seqirus Pty Ltd.	AFLURIA, AFLURIA QUADRIVALENT	influenza vaccine	Injection	125254	10,155,932	2036-05-09	Patent claims search

International Patents for AFLURIA, AFLURIA QUADRIVALENT

Country	Patent Number	Estimated Expiration
South Korea	20100113589
Eurasian Patent Organization	201070730
South Africa	201005373
Brazil	PI0905761
Taiwan	201946617
Japan	2016128418

Market Dynamics and Financial Trajectory for the Biologic Drugs: AFLURIA and AFLURIA Quadrivalent

Last updated: September 29, 2025

Introduction

AFLURIA and AFLURIA Quadrivalent are intramuscular influenza vaccines developed by Sanofi Pasteur. These biologic agents play a vital role in seasonal influenza prevention, a major global health challenge. As the landscape shifts toward more immunologically advanced, strain-specific vaccines, understanding the market dynamics and financial trajectory of these products is essential for stakeholders. This analysis explores the competitive considerations, regulatory environment, clinical efficacy, market demand, and economic prospects shaping AFLURIA's future in a rapidly evolving vaccine market.

Market Landscape and Competitive Positioning

The global influenza vaccine market is projected to reach USD 7.2 billion by 2028, with a CAGR of approximately 6.5% from 2021 to 2028. Influenza vaccines, including AFLURIA and AFLURIA Quadrivalent, comprise a significant segment of this growth. Key competitors include vaccines from GlaxoSmithKline (Fluarix), AstraZeneca's Vaxzevria, and local players targeting emerging markets.

AFLURIA’s primary positioning lies within the trivalent (AFLURIA) and quadrivalent (AFLURIA Quadrivalent) formulations that cover multiple influenza strains. The quadrivalent version, introduced in 2015, offers broader antigenic coverage, aligning with WHO recommendations, and gaining preference among healthcare providers and health authorities.

The increasing adoption of quadrivalent vaccines has propelled AFLURIA Quadrivalent’s market share, especially in the wake of WHO's shift toward quadrivalent formulations in global immunization programs. This shift signifies a strategic move by Sanofi to capitalize on the broader efficacy profile, ensuring competitive advantage and sustained revenue growth.

Regulatory Environment and Approvals

Regulatory approvals and public health endorsements significantly influence market penetration and financial outlooks. Both AFLURIA and AFLURIA Quadrivalent have received approval from the US FDA, European Medicines Agency (EMA), and other regional regulators.

The US CDC’s recommendation for seasonal influenza vaccines bolsters demand, emphasizing the importance of quadrivalent formulations. Additionally, vaccine manufacturers’ commitment to regulatory compliance and ongoing post-market surveillance fortify market confidence. However, regulatory uncertainties regarding interseasonal efficacy and strain variability require manufacturers to invest heavily in surveillance and adaptability strategies, impacting R&D costs and profitability.

Clinical Efficacy and Public Perception

Efficacy data underpin vaccine adoption. AFLURIA has demonstrated comparable effectiveness to other authorized vaccines in preventing influenza-related illness, supported by peer-reviewed clinical studies. The quadrivalent version provides enhanced protection by covering two additional influenza B strains, a key advantage acknowledged in health policy and clinical practice.

Public perception and vaccine hesitancy issues remain an influential factor in market dynamics. Enhanced education, demonstrated efficacy, and safety profile bolster confidence, potentially expanding market penetration. Conversely, negative perceptions or spike in adverse event reports can constrain growth and influence revenue streams.

Market Demand Drivers

Several factors drive demand for AFLURIA products:

• Epidemiological Burden: Seasonal influenza causes significant morbidity and mortality globally, with annual outbreaks impacting economic productivity. The increasing burden elevates demand for effective vaccines.
• Government Immunization Policies: Many governments now include influenza vaccination in national immunization schedules, particularly targeting vulnerable populations such as the elderly, children, and healthcare workers.
• Pandemic Preparedness: The COVID-19 pandemic has heightened awareness of infectious diseases, prompting investments in vaccination infrastructure, which indirectly benefits influenza vaccine markets.
• Healthcare Infrastructure and Access: Expanding healthcare coverage, especially in emerging markets, opens new revenue streams. Sanofi’s distribution channels and partnerships in these regions will underpin future growth.

Financial Trajectory and Revenue Outlook

Sanofi’s influenza vaccine segment has historically contributed approximately 10-15% of its vaccine division revenue, translating into annual earnings in the hundreds of millions USD. The introduction of AFLURIA Quadrivalent has demonstrated strong sales growth, bolstered by increased preference for broad-spectrum vaccines.

Projected financial trajectories indicate:

• Steady Revenue Growth: A CAGR of approximately 5-7% over the next five years, driven by dose volume increases and expanded market access.
• Pricing Dynamics: Influenza vaccines generally maintain stable pricing; however, regional pricing policies, procurement contracts, and reimbursement frameworks influence profitability.
• R&D Investment: Sanofi continues to invest in next-generation influenza vaccines, including thermostability and universal vaccine research, which could refine the financial landscape over a decade.
• Intellectual Property and Competition: Patent protections for manufacturing processes and formulations expire at varying intervals, potentially impacting margins. Increased prevalence of biosimilar or generic-like products poses a competitive challenge.

Strategic Considerations

To ensure positive financial trajectories, Sanofi focuses on:

• Expanding Geographic Coverage: Entering emerging markets via partnerships and subsidies, especially where influenza vaccination programs are nascent.
• Product Innovation: Developing universal, high-efficacy vaccines that could transform the market away from seasonal vaccines toward global, long-lasting solutions.
• Public-Private Partnerships: Collaborating with health organizations and governments to enhance vaccine access, leveraging bulk procurement and subsidies to stabilize sales.

Risks and Challenges

• Strain Variability: The seasonal nature and virus mutation pose constant challenges to vaccine efficacy, affecting projected sales.
• Regulatory Hurdles: Delays or restrictive approvals in new regions may impact market expansion.
• Market Competition: Increased adoption of competitor quadrivalent vaccines and potential biosimilars could compress margins.
• Public Hesitancy: Vaccine skepticism remains an obstacle to widespread immunization, limiting forecasted uptake.

Key Takeaways

• AFLURIA and AFLURIA Quadrivalent remain integral to the global influenza vaccine market, with a trajectory driven by broader strain coverage and expanding immunization programs.
• The quadrivalent formulation dominates growth potential, reflecting epidemiological trends and regulatory recommendations.
• Sanofi’s strategic focus on innovation and geographic expansion is crucial for maintaining revenue streams amid intensifying competition.
• The overall financial outlook remains optimistic, provided that vaccine efficacy, public acceptance, and regulatory pathways align favorably.
• Long-term prospects hinge on advancements toward universal influenza vaccines, which could revolutionize market dynamics and economic returns.

FAQs

1. What differentiates AFLURIA Quadrivalent from other influenza vaccines?
   AFLURIA Quadrivalent covers four influenza strains—two A strains and two B strains—offering broader protection compared to trivalent formulations, enhancing its clinical efficacy and public health relevance.

2. How has the global shift toward quadrivalent vaccines impacted AFLURIA’s market share?
   The shift has significantly bolstered AFLURIA Quadrivalent’s market adoption, aligning with WHO and CDC recommendations, leading to increased sales and strategic market positioning.

3. What factors could threaten the financial growth of AFLURIA products?
   Factors include virus mutation reducing vaccine efficacy, the emergence of biosimilars, regulatory delays, and vaccine hesitancy reducing overall demand.

4. How does Sanofi plan to sustain growth in influenza vaccines?
   Through investing in next-generation vaccine research (e.g., universal vaccines), expanding geographies, and forming public-private collaborations.

5. What role does government policy play in the revenue forecast for AFLURIA?
   Robust immunization policies and procurement contracts in key markets like the US and Europe serve as growth catalysts, whereas policy restrictions can inhibit expansion.

References

1. [1] Grand View Research. Influenza Vaccine Market Size, Share & Trends Analysis Report. 2021.
2. [2] CDC. Seasonal Influenza Vaccine Effectiveness, 2020-2021.
3. [3] Sanofi Pasteur. AFLURIA Quadrivalent Product Monograph. 2015.
4. [4] World Health Organization. Global Influenza Strategy 2019-2030.
5. [5] Statista. Global Influenza Vaccine Market Revenue Forecast. 2022.

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