Palivizumab - Biologic Drug Details

Summary for palivizumab

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for palivizumab
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for palivizumab

Recent Clinical Trials for palivizumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Sanofi Pasteur, a Sanofi Company	Phase 3
AstraZeneca	Phase 3
National Children's Hospital, Vietnam	N/A

See all palivizumab clinical trials

Recent Litigation for palivizumab

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Janssen Biotech, Inc. v. Amgen Inc.	2022-11-29
AbbVie Inc. v. Alvotech hf.	2021-05-28
Alvotech USA Inc. v. Abbvie Inc	2021-05-11

See all palivizumab litigation

PTAB Litigation

Petitioner	Date
	2017-12-20

See all palivizumab litigation

Pharmacology for palivizumab

Mechanism of Action	Fusion Protein Inhibitors
Established Pharmacologic Class	Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody
Chemical Structure	Antibodies, Monoclonal

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. General brand-side disclosures

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.

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 palivizumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for the Biologic Drug: Palivizumab

Introduction

Palivizumab, a monoclonal antibody, is a crucial biologic drug in the prevention of Respiratory Syncytial Virus (RSV) infections, particularly in high-risk populations such as preterm infants and those with certain underlying health conditions. Here, we delve into the market dynamics and financial trajectory of palivizumab, exploring its current status, future prospects, and the factors influencing its market performance.

Current Market Status

Revenue and Sales

Palivizumab, marketed by AstraZeneca's MedImmune, has been a significant player in the RSV prevention market. In 2016, it generated $677 million in sales in the United States alone[4].

Market Share

Despite the expiration of its patents in the United States and Europe in 2015, palivizumab remains a dominant force in the market. However, biosimilar developers such as Bioexpress Therapeutics, mAbxience, and Celltrion are eyeing this lucrative market, although no biosimilars have yet been approved in these regions[4].

Clinical Efficacy and Cost-Effectiveness

Reduction in Hospital Admissions

Clinical trials have demonstrated that prophylaxis with palivizumab results in a significant reduction in hospital admissions for RSV infections. For instance, it has been shown to reduce hospital admissions by 55% in preterm infants without chronic lung disease and children with chronic lung disease, and by 45% in children with congenital heart disease[5].

Economic Evaluations

The cost-effectiveness of palivizumab varies widely depending on the population and risk factors. While it is generally not considered cost-effective for unselected use, it meets conventional cost-effectiveness thresholds in high-risk groups such as children with chronic lung disease or congenital heart disease who are younger than 6 months and born prematurely. The incremental cost-effectiveness ratios range from £3,200 to £1,489,700 per quality-adjusted life year (QALY) in different subgroups[5].

Pricing and Cost Considerations

Dosage and Administration

Palivizumab requires high doses, often administered in multiple injections, which can be a significant factor in its cost. For example, the drug costs €490.37 for a 50mg vial and €814.34 for a 100mg vial[2].

Economic Burden

The economic burden of RSV infections is substantial, with mean inpatient hospitalization costs per episode estimated at around $12,000 in the United States. Outpatient care costs also add to the overall economic impact, highlighting the need for effective preventive measures like palivizumab[3].

Future Prospects and Market Growth

Emerging Competitors

The RSV market is witnessing significant advancements with the development of new vaccines and therapeutic agents. Novavax, for instance, is developing an RSV vaccine targeting multiple susceptible populations, including infants via maternal immunization, older adults, and children. This could potentially alter the market dynamics for palivizumab[4].

Next-Generation Therapeutics

Sanofi's MEDI8897, a fully-human antibody with an extended half-life, is in phase 2 trials and has been granted fast-track designation by the FDA. This new drug could offer a less frequent dosing regimen, potentially challenging palivizumab's market position[4].

Regional Market Dominance

North America

North America, particularly the United States, is expected to continue dominating the global RSV market, including the segment for palivizumab. Recent FDA approvals for RSV vaccines and treatments have further solidified this region's leadership[1].

Financial Projections

Market Size and Growth

The global RSV market, which includes palivizumab, is projected to grow significantly. The market was valued at $2,331.3 million in 2023 and is expected to reach $8,137.2 million by 2032, growing at a CAGR of 14.9% from 2024 to 2032[1].

Segment Growth

The antiviral medication segment, which includes palivizumab, is anticipated to grow at a CAGR of 15.9% from 2024 to 2032, driven by increasing awareness and diagnosis of RSV infections[1].

Challenges and Opportunities

Regulatory Environment

The regulatory environment plays a crucial role in the approval and market entry of biosimilars and new therapeutic agents. Strict regulatory guidelines in regions like the European Union and the United States can delay the entry of biosimilars, protecting the market share of innovator drugs like palivizumab[4].

Innovation and Competition

The ongoing development of new RSV vaccines and therapeutics presents both challenges and opportunities for palivizumab. While new competitors could erode its market share, innovations in delivery methods and efficacy could also enhance its position and expand its market[1][4].

Key Takeaways

• Clinical Efficacy: Palivizumab significantly reduces hospital admissions for RSV infections in high-risk populations.
• Cost-Effectiveness: While generally not cost-effective for unselected use, palivizumab is cost-effective in high-risk groups.
• Market Growth: The global RSV market is projected to grow at a CAGR of 14.9% from 2024 to 2032.
• Emerging Competitors: New RSV vaccines and therapeutics are being developed, which could impact palivizumab's market share.
• Regional Dominance: North America is expected to continue leading the global RSV market.

FAQs

What is the current market size of the RSV market, and how is it projected to grow?

The global RSV market was valued at $2,331.3 million in 2023 and is projected to reach $8,137.2 million by 2032, growing at a CAGR of 14.9% from 2024 to 2032[1].

How effective is palivizumab in preventing RSV infections?

Palivizumab has been shown to reduce hospital admissions for RSV infections by 55% in preterm infants without chronic lung disease and children with chronic lung disease, and by 45% in children with congenital heart disease[5].

What are the key factors influencing the cost-effectiveness of palivizumab?

The cost-effectiveness of palivizumab is influenced by factors such as the population's risk profile, the cost of the drug, and its efficacy. It is generally more cost-effective in high-risk groups[5].

Are there any biosimilars of palivizumab available in the market?

Despite the expiration of palivizumab's patents, no biosimilars have yet been approved in the United States or Europe. However, several companies are developing biosimilars[4].

What are the emerging competitors in the RSV market that could impact palivizumab's market share?

Novavax is developing an RSV vaccine targeting multiple susceptible populations, and Sanofi's MEDI8897 is a next-generation therapeutic agent that could challenge palivizumab's market position[4].

Sources

1. Astute Analytica: Respiratory Syncytial Virus Market Size | Report 2032
2. PLOS ONE: A new cost-utility analysis assessing risk factor-guided prophylaxis ...
3. FDA: Considerations for Respiratory Syncytial Virus (RSV) Vaccine Safety ...
4. Center for Biosimilars: Biosimilar Developers Eye Palivizumab Market
5. The BMJ: Palivizumab and the importance of cost effectiveness