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Last Updated: December 26, 2024

AREXVY Drug Profile


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Summary for Tradename: AREXVY
High Confidence Patents:0
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. General brand-side disclosures
  4. These patents were identified from searching 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 AREXVY Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for AREXVY Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for AREXVY Derived from Patent Text Search

No patents found based on company disclosures

AREXVY Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for GSK's Arexvy

Introduction

GSK's Arexvy, the world's first approved vaccine for respiratory syncytial virus (RSV), has made significant waves in the pharmaceutical market since its launch. Here, we delve into the market dynamics and financial trajectory of this groundbreaking biologic drug.

Market Dominance of Arexvy

Arexvy has swiftly established itself as the leading RSV vaccine, capturing a substantial market share. In its first year on the market, Arexvy generated £1.2 billion in sales and secured more than two-thirds of the RSV market share in the U.S.[1][3][4].

Competitive Landscape

The RSV vaccine market is becoming increasingly competitive, with Pfizer's Abrysvo and Sanofi's Beyfortus (nirsevimab) entering the scene. However, Arexvy remains the frontrunner. Pfizer's Abrysvo, approved just a month after Arexvy, has seen notable but lower sales, with $145 million in quarterly sales compared to Arexvy's $227 million[1][4].

Sales Performance

Arexvy's sales have been robust, contributing significantly to GSK's overall revenue. In its first full commercial quarter, Arexvy generated $859 million, which constituted 10% of GSK's total sales[4]. The vaccine has been administered to over 3 million of the approximately 80 million adults at risk, specifically those aged 60 and above[4].

Expansion Plans

GSK is not resting on its laurels. The company is seeking to expand Arexvy's indication to include adults aged 50 to 59 who are at higher risk due to certain medical conditions. This expansion could add another 50 million U.S. adults to its potential market[1][3].

Regulatory Approvals

Arexvy has received FDA approval for use in adults aged 60 and older and has recently gained EU approval for use in adults aged 50-59 at increased risk. Positive data indicates protection over three RSV seasons, further solidifying its market position[2][3].

Financial Impact on GSK

The success of Arexvy has significantly boosted GSK's financial performance. The vaccine contributed to GSK's vaccines segment, which saw 16% growth, driven largely by Arexvy and the shingles vaccine, Shingrix[1][3].

Quarterly and Annual Sales

In the first quarter of 2024, Arexvy sales reached £182 million ($227 million), while Pfizer's Abrysvo posted $145 million in sales. Arexvy's first-year sales were £1.2 billion ($1.5 billion), and GSK predicts peak sales to reach £3 billion annually[1][3].

Impact on GSK's Revenue

GSK's total quarterly revenues were £7.4 billion ($9.2 billion), with vaccines, specialty medicines, and general medicines contributing almost evenly. The strong performance of Arexvy and Shingrix helped drive this revenue growth[1].

Challenges and Future Outlook

Despite its dominance, Arexvy faces challenges. Changes in ACIP guidelines and prioritization of COVID-19 vaccinations in the U.S. have impacted sales in Q3 2024, with Arexvy sales dropping by 72% compared to the previous year[2].

However, GSK remains optimistic about Arexvy's future. The company is confident in the underlying demand for the vaccine and is preparing for the potential impact of Moderna's mRNA RSV vaccine, which is expected to enter the market soon[1].

Strategic Significance

Arexvy's success is a testament to GSK's strategic focus on vaccines and specialty medicines. The vaccine has strengthened GSK's position in the infectious diseases segment and highlights the company's ability to innovate and address global health challenges[3][4].

Industry Expert Insights

GSK CEO Emma Walmsley has expressed her confidence in Arexvy's growth potential, noting that the vaccine has "lots of headroom for growth"[4]. Chief Commercial Officer Luke Miels has also emphasized the company's readiness for competition, stating that GSK "welcomes competition" and remains confident in Arexvy's market position[1].

Illustrative Statistics

  • Market Share: Arexvy holds more than two-thirds of the RSV market share in the U.S.[1].
  • Sales: £1.2 billion in the first year, with peak sales predicted to reach £3 billion annually[1][3].
  • Administration: Over 3 million of the approximately 80 million adults at risk have been vaccinated with Arexvy[4].
  • Revenue Contribution: Arexvy contributed 10% of GSK's total sales in its first full commercial quarter[4].

Key Takeaways

  • Market Dominance: Arexvy is the leading RSV vaccine, capturing a significant market share.
  • Financial Performance: The vaccine has generated substantial revenue, contributing to GSK's overall financial growth.
  • Expansion Plans: GSK is seeking to expand Arexvy's indication to include younger at-risk adults.
  • Regulatory Approvals: Arexvy has received key regulatory approvals, including FDA and EU approvals.
  • Challenges: The vaccine faces challenges such as changes in ACIP guidelines and COVID-19 vaccination prioritization.

FAQs

What is Arexvy and why is it significant?

Arexvy is the world's first approved vaccine for respiratory syncytial virus (RSV), significant for its robust sales and market dominance in the RSV vaccine market.

How has Arexvy performed in terms of sales?

Arexvy generated £1.2 billion in sales in its first year and continues to dominate the market with over two-thirds of the RSV market share in the U.S.

What are the expansion plans for Arexvy?

GSK is seeking to expand Arexvy's indication to include adults aged 50 to 59 who are at higher risk due to certain medical conditions.

How does Arexvy compare to other RSV vaccines?

Arexvy leads the market, outperforming Pfizer's Abrysvo and Sanofi's Beyfortus (nirsevimab) in terms of sales and market share.

What challenges is Arexvy facing?

Changes in ACIP guidelines and prioritization of COVID-19 vaccinations have impacted Arexvy's sales in Q3 2024, and the vaccine may face competition from Moderna's mRNA RSV vaccine.

Sources

  1. FiercePharma: GSK's Arexvy dominates RSV market ahead of new competition
  2. GSK: Q3 2024 Results Announcement
  3. GSK: Annual Report 2023
  4. The Healthcare Technology Report: GSK's Arexvy Makes Waves with Strong Sales and Market Dominance
  5. GSK: Q4 2023 Announcement

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