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Last Updated: February 16, 2025

Nirsevimab-alip - Biologic Drug Details


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Summary for nirsevimab-alip
Tradenames:1
High Confidence Patents:0
Applicants:1
BLAs:1
Suppliers: see list1
Pharmacology for nirsevimab-alip
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 nirsevimab-alip Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for nirsevimab-alip Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for nirsevimab-alip Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Nirsevimab-Alip

Introduction to Nirsevimab-Alip

Nirsevimab-alip, a long-acting monoclonal antibody, has been approved by the FDA for the prevention of Respiratory Syncytial Virus (RSV) infections in newborns, infants, and young children. This drug represents a significant advancement in the treatment and prevention of RSV, a common and potentially severe respiratory virus.

Market Size and Growth

The RSV therapeutics market, driven in part by the approval and adoption of nirsevimab-alip, is expected to experience substantial growth. As of 2022, the RSV therapeutics market was valued at $1.1 billion, and it is projected to reach $3.8 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 14.6% between 2023 and 2031[1].

Key Drivers of Market Growth

Increasing Demand for Effective RSV Prophylaxis

The rising burden of RSV infections, particularly among children under five years old and vulnerable adult populations, is a major driver of market growth. High hospitalization rates associated with RSV infections have created a significant demand for effective prophylactic treatments like nirsevimab-alip[4].

Innovative Treatment Options

Nirsevimab-alip offers a once-per-season dosing regimen, which is more convenient and potentially more effective than existing treatments like palivizumab. This innovation is expected to capture a significant share of the market, especially as it has shown efficacy comparable to, or even higher than, palivizumab in some studies[2][4].

Collaboration and Commercialization

The development and commercialization of nirsevimab-alip are the result of a collaborative agreement between Sanofi and AstraZeneca. This partnership has facilitated the drug's development, manufacturing, and commercialization, ensuring a robust market presence. Sanofi leads commercialization activities and records revenues, while AstraZeneca handles development and manufacturing[3].

Market Segmentation

By Dosage Form

The market is segmented by dosage form, with injectable formulations being the most dominant, accounting for 50.6% of the market. Nirsevimab-alip, being an injectable monoclonal antibody, fits squarely into this category[4].

By Distribution Channel

Hospitals are the primary distribution channel for RSV therapeutics, accounting for 40.6% of the market. This is due to the high hospitalization rates associated with severe RSV infections, making hospitals a critical point of care for these patients[4].

By Region

The global RSV therapeutics market is segmented by region, with North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa being key markets. The growth in these regions is driven by varying factors, including healthcare infrastructure, population demographics, and the prevalence of RSV infections[1].

Financial Considerations

Cost Effectiveness

Nirsevimab-alip has been evaluated for its cost-effectiveness, particularly in preventing severe RSV disease. For infants under 8 months entering their first RSV season, the cost-effectiveness was estimated at $102,811 per quality-adjusted life year (QALY). For those entering their second RSV season, the cost-effectiveness is higher due to reduced risk, estimated at $1,557,544 per QALY[2].

Pricing and Billing

Nirsevimab is priced at $445 per dose for infants under 8 months and $890 per dose for those entering their second RSV season. The drug does not typically require insurance preauthorization, making it more accessible to patients. Sanofi also offers flexible return policies and credit for expired products, which can help manage inventory and costs for healthcare providers[5].

Competitive Landscape

The RSV therapeutics market is marked by intense competition and innovation. Key players such as Pfizer, GSK, AstraZeneca, and Sanofi are leading the charge. While Synagis (palivizumab) has historically dominated the market, nirsevimab-alip is poised to challenge this dominance due to its once-per-season dosing and potentially higher efficacy[4].

Future Outlook

The approval of nirsevimab-alip in 2023 marked a breakthrough year for pharmaceutical companies operating in the RSV market. As the drug continues to gain traction, it is expected to become a new standard of care, especially given its long-lasting protection, which is expected to last at least 5 months, covering the typical length of an RSV season[5].

Precision and Personalized Treatment

Future RSV therapy may focus on precision and personalized treatment, leveraging genetic variations and immunological responses to tailor treatments to specific patient profiles. This approach could lead to fewer side effects and better outcomes, further solidifying nirsevimab-alip's position in the market[1].

Key Takeaways

  • Market Growth: The RSV therapeutics market is expected to grow significantly, reaching $3.8 billion by 2031.
  • Innovative Treatment: Nirsevimab-alip offers a once-per-season dosing regimen, making it a competitive alternative to existing treatments.
  • Cost Effectiveness: The drug has been shown to be cost-effective, particularly in preventing severe RSV disease.
  • Competitive Landscape: The market is highly competitive, with nirsevimab-alip challenging the dominance of Synagis.
  • Future Outlook: The drug is expected to become a new standard of care, with potential for precision and personalized treatment in the future.

FAQs

What is nirsevimab-alip used for?

Nirsevimab-alip is used for the prevention of Respiratory Syncytial Virus (RSV) infections in newborns, infants, and young children.

How is nirsevimab-alip administered?

Nirsevimab-alip is administered via an injectable formulation, typically given as a single dose per RSV season.

What is the cost-effectiveness of nirsevimab-alip?

The cost-effectiveness of nirsevimab-alip varies by age group, with estimates ranging from $102,811 to $1,557,544 per quality-adjusted life year (QALY) depending on the patient's age and RSV season.

Does nirsevimab-alip require insurance preauthorization?

In most instances, nirsevimab-alip does not require insurance preauthorization, making it more accessible to patients.

What are the key benefits of nirsevimab-alip over existing treatments?

Nirsevimab-alip offers a once-per-season dosing regimen and has shown efficacy comparable to, or higher than, existing treatments like palivizumab.

Sources

  1. GlobeNewswire: "Respiratory Syncytial Virus Therapeutics Market to Rise at a 14.6% CAGR from 2023 to 2031, Reaching a Value of USD 3.8 billion - Exclusive Report by Transparency Market Research Inc."
  2. CDC: "Use of Nirsevimab for the Prevention of Respiratory Syncytial Virus Infection"
  3. Sanofi: "Press Release: New nirsevimab data analyses reinforce efficacy and safety profile"
  4. GlobeNewswire: "Global Respiratory Syncytial Virus market to Hit Market Valuation of US$ 8,137.2 million by 2032 - Astute Analytica"
  5. AAP: "Nirsevimab Frequently Asked Questions"

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