Natalizumab - Biologic Drug Details

Summary for natalizumab

Tradenames:	1
High Confidence Patents:	6
Applicants:	2
BLAs:	2
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for natalizumab
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for natalizumab

Recent Clinical Trials for natalizumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
BioLineRx, Ltd.	Phase 1
Washington University School of Medicine	Phase 1
Queen Mary University of London	Phase 2

See all natalizumab clinical trials

Recent Litigation for natalizumab

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
AbbVie Inc. v. Hetero USA, Inc.	2024-08-08
AbbVie Inc. v. Hetero USA, Inc.	2023-11-20
Janssen Biotech, Inc. v. Amgen Inc.	2022-11-29

See all natalizumab litigation

PTAB Litigation

Petitioner	Date
Miltenyi Biomedicine GmbH et al.	2022-04-12
Swiss Pharma International AG et al.	2016-04-18

See all natalizumab litigation

Pharmacology for natalizumab

Mechanism of Action	Integrin Receptor Antagonists
Established Pharmacologic Class	Integrin Receptor Antagonist

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 natalizumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Biogen Inc.	TYSABRI	natalizumab	Injection	125104		2009-12-01	Company disclosures
Biogen Inc.	TYSABRI	natalizumab	Injection	125104		2005-01-30	Company disclosures
Biogen Inc.	TYSABRI	natalizumab	Injection	125104		2015-03-24	Company disclosures
Biogen Inc.	TYSABRI	natalizumab	Injection	125104		2014-01-25	Company disclosures

3) Low Certainty: US Patents for natalizumab 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
Biogen Inc.	TYSABRI	natalizumab	Injection	125104		2033-01-08	Patent claims search
Biogen Inc.	TYSABRI	natalizumab	Injection	125104		2032-02-15	Patent claims search
Biogen Inc.	TYSABRI	natalizumab	Injection	125104		2033-05-28	Patent claims search
Biogen Inc.	TYSABRI	natalizumab	Injection	125104		2032-04-02	Patent claims search

International Patents for natalizumab

Country	Patent Number	Estimated Expiration
Greece	3031692
Japan	2006290897
Spain	2137354
Finland	20050941

Supplementary Protection Certificates for natalizumab

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
SPC/GB06/025	United Kingdom		PRODUCT NAME: NATALIZUMAB, ANTI -4 INTEGRIN HUMANIZED MONOCLONAL ANTIBODY; REGISTERED: UK EU/1/06/346/001 20060627
91271	Luxembourg		PRODUCT NAME: NATALIZUMAB ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES ( TYSABRI ); AUTHORISATION NUMBER AND DATE: EU/1/06/346/001
06C0027	France		PRODUCT NAME: NATALIZUMAB; NAT. REGISTRATION NO/DATE: EU/1/06/346/001 20060627; FIRST REGISTRATION: FR - EU/1/06/346/001 20060627
C00804237/01	Switzerland		FORMER OWNER: ELAN PHARMACEUTICALS, INC., US

Market Dynamics and Financial Trajectory for the Biologic Drug: Natalizumab

Introduction

Natalizumab, a biologic drug primarily used to treat Multiple Sclerosis (MS) and Crohn’s Disease, has been a significant player in the pharmaceutical market. This article delves into the market dynamics, financial trajectory, and the various factors influencing the growth and adoption of natalizumab.

Market Size and Growth

The global natalizumab market has experienced substantial growth over recent years. The market size is projected to continue expanding from 2024 to 2031, driven by increasing prevalence of neurological and autoimmune diseases such as MS and Crohn’s Disease. As of 2024, over 2.3 million people worldwide suffer from MS, and the incidence of Crohn’s Disease is also on the rise, driving the demand for advanced therapies like natalizumab[3].

Key Drivers of Market Growth

Increasing Prevalence of Autoimmune Diseases

The rising incidence of MS and Crohn’s Disease, particularly in developed regions, is a major driver of the natalizumab market. These diseases are becoming more prevalent, leading to an increased demand for effective treatments[3].

Innovations in Biologics

The trend towards biologic therapies is a significant factor. Biologics are preferred for their targeted action and efficacy in treating chronic autoimmune conditions. As healthcare systems shift towards precision medicine, the demand for biologics like natalizumab is expected to grow[3].

Expanding Clinical Applications

Beyond MS and Crohn’s Disease, researchers are exploring natalizumab’s potential in treating other neurological diseases such as Parkinson’s Disease and Alzheimer’s Disease. Early-stage trials indicate promising results, which could further expand the market for natalizumab[3].

Combination Therapies

Combining natalizumab with other drugs, such as immune-modulating agents, is another area of research. This approach aims to increase efficacy while reducing side effects, making treatments more personalized and effective[3].

Innovations in Drug Delivery

Advancements in drug delivery methods, including subcutaneous injections and long-acting formulations, are making natalizumab more accessible and improving patient compliance. These innovations contribute to the growing market demand for the drug[3].

Financial Impact of Biosimilar Natalizumab

The introduction of biosimilar natalizumab is expected to have a significant financial impact on the market. Studies have shown that transitioning to biosimilar natalizumab can result in substantial cost savings for health plans.

Cost Savings

A budget impact analysis revealed that the inclusion of biosimilar natalizumab onto a formulary could result in cumulative cost savings of $452,611 over three years. This translates to mean savings per treated member per year of $1,179, $1,769, and $2,359 in years one, two, and three, respectively[2][4].

Reduced Drug Acquisition Costs

The primary driver of these savings is the reduction in drug acquisition costs. Biosimilar natalizumab offers a more cost-effective alternative to the reference drug, making high-efficacy disease-modifying therapies more accessible to patients with relapsing-remitting MS (RRMS)[2][4].

Regional Market Dynamics

Developed Regions

The market for natalizumab is predominantly strong in developed regions where the incidence of autoimmune diseases is higher. However, these regions also face high competition and stringent regulatory environments[3].

Emerging Markets

Regions like Asia-Pacific and Latin America are seeing rising incidences of autoimmune diseases, providing lucrative expansion opportunities for drug manufacturers. As healthcare systems in these regions improve, the demand for natalizumab is expected to increase[3].

Competitive Landscape

The biologics market is highly competitive, with companies seeking to expand their portfolios through mergers, acquisitions, and partnerships. These collaborations often lead to faster market penetration and the development of combination therapies that can make treatments more effective and profitable[3].

Safety and Risk Profile

While natalizumab is generally well-tolerated, it comes with risks such as infections and allergic reactions. The most significant risk is the development of Progressive Multifocal Leukoencephalopathy (PML), with a global risk estimate of 3.71 to 4.36 cases per 1000 patients exposed. Despite these risks, the drug’s benefits often outweigh the risks, especially when closely monitored by healthcare professionals[5].

Investment Opportunities

The expanding biologics market, particularly for natalizumab, presents attractive investment opportunities. The increasing adoption of biologic therapies, new innovations, and expanding indications make the market an appealing option for investors. The trend towards precision medicine and the exploration of new indications further solidify the investment potential in this sector[3].

Market Attractiveness and Forecast

The market attractiveness for natalizumab is high due to its clinical efficacy, expanding applications, and cost-effectiveness, especially with the introduction of biosimilars. The forecast indicates continued growth from 2025 to 2031, driven by the factors mentioned above. The base year for calculations is 2023, with historical data from 2019 to 2023 and forecasted data from 2025 to 2031[1].

Technological Trends and Innovations

Technological advancements in drug delivery and formulation are key trends in the natalizumab market. Innovations such as subcutaneous injections and long-acting formulations are making the drug more accessible and improving patient compliance. Additionally, research into new indications and combination therapies is ongoing, which is expected to further expand the market[3].

Regulatory and ESG Considerations

Regulatory approvals and environmental, social, and governance (ESG) factors play crucial roles in the natalizumab market. The drug’s safety profile, particularly the risk of PML, is closely monitored by regulatory bodies. ESG considerations, including the ethical use of biologics and their environmental impact, are also important for market sustainability[1].

Consumer Behavior and Patient Compliance

Consumer behavior and patient compliance are critical for the success of natalizumab. Innovations in drug delivery and formulation have improved patient compliance, making the treatment more accessible and manageable for patients. Healthcare professionals also play a vital role in monitoring patient safety and ensuring the effective use of the drug[3].

Key Takeaways

• The global natalizumab market is expected to grow significantly from 2024 to 2031, driven by increasing prevalence of autoimmune diseases.
• Biosimilar natalizumab offers substantial cost savings, making high-efficacy treatments more accessible.
• Expanding clinical applications, including potential treatments for Parkinson’s Disease and Alzheimer’s Disease, are driving market growth.
• Innovations in drug delivery and formulation are improving patient compliance and market demand.
• The market is attractive for investors due to its expanding applications and cost-effectiveness.

FAQs

What are the primary uses of natalizumab?

Natalizumab is primarily used to treat Multiple Sclerosis (MS) and Crohn’s Disease. It is also being explored for other neurological diseases such as Parkinson’s Disease and Alzheimer’s Disease.

How does the introduction of biosimilar natalizumab impact the market financially?

The introduction of biosimilar natalizumab can result in significant cost savings for health plans, with estimated cumulative savings of $452,611 over three years.

What are the key drivers of the natalizumab market growth?

Key drivers include the increasing prevalence of autoimmune diseases, innovations in biologics, expanding clinical applications, and advancements in drug delivery methods.

What are the risks associated with natalizumab?

The primary risk associated with natalizumab is the development of Progressive Multifocal Leukoencephalopathy (PML), with a global risk estimate of 3.71 to 4.36 cases per 1000 patients exposed.

Which regions are expected to dominate the natalizumab market?

Developed regions currently dominate the market, but emerging markets like Asia-Pacific and Latin America are expected to see significant growth as healthcare systems improve.

Sources

1. Global Natalizumab Drug Market Report 2024 Edition. Cognitivemarketresearch.com.
2. Budget impact analysis of biosimilar natalizumab in the US. PubMed.
3. Natalizumab Drug Market Size And Projection. Marketresearchintellect.com.
4. Budget Impact Analysis of Biosimilar Natalizumab in the US. The American Journal of Managed Care.
5. A decade of natalizumab and PML: Has there been a tacit transfer of risk?. Discovery.ucl.ac.uk.