TYSABRI Drug Profile

Summary for Tradename: TYSABRI

High Confidence Patents:	6
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for TYSABRI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TYSABRI

Recent Clinical Trials for TYSABRI

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 TYSABRI clinical trials

Recent Litigation for TYSABRI

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 TYSABRI litigation

PTAB Litigation

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

See all TYSABRI litigation

Pharmacology for TYSABRI

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 TYSABRI Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for TYSABRI 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 TYSABRI 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 TYSABRI

Country	Patent Number	Estimated Expiration
Germany	122006000044
Singapore	44845
South Korea	970700513
World Intellectual Property Organization (WIPO)	9103252

Supplementary Protection Certificates for TYSABRI

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
122006000044	Germany		PRODUCT NAME: NATALIZUMAB; REGISTRATION NO/DATE: EU/1/06/346/001 20060627
122006000043	Germany		PRODUCT NAME: NATALIZUMAB; NAT. REGISTRATION NO/DATE: EU /1/06/346/001 20060627; FIRST REGISTRATION: EU EU/1/06/346/001 20060627
91273	Luxembourg		91273, EXPIRES: 20150831
C300238	Netherlands		PRODUCT NAME: NATALIZUMAB; REGISTRATION NO/DATE: EU/1/06/346/001 20060627

Market Dynamics and Financial Trajectory for the Biologic Drug: TYSABRI

Introduction

TYSABRI, a biologic drug developed by Biogen, is primarily used for the treatment of relapsing forms of multiple sclerosis (MS) and, in some cases, Crohn's disease. Understanding the market dynamics and financial trajectory of TYSABRI is crucial for stakeholders, including investors, healthcare providers, and patients.

Market Size and Forecast

The TYSABRI market has shown varying projections depending on the source. According to Verified Market Research, the TYSABRI market size was valued at USD 2.30 billion in 2023 and is projected to reach USD 3.24 billion by 2030, growing at a CAGR of 5% during the forecast period 2024-2030[1].

However, another report suggests a different outlook, indicating that the global TYSABRI market was valued at US$ 2030.9 million in 2023 and is anticipated to decline to US$ 1463.4 million by 2030, with a CAGR of -4.5% during the forecast period 2024-2030[4].

Key Drivers of the Market

Growing Incidence of Multiple Sclerosis

The increasing incidence of multiple sclerosis globally is a significant driver for the demand of TYSABRI. As the number of MS cases rises, the need for effective treatment alternatives like TYSABRI is expected to increase, thereby driving market growth[1].

Strategic Partnerships and Collaborations

Partnerships and collaborations among research organizations, pharmaceutical corporations, and healthcare facilities play a crucial role in the development, promotion, and availability of TYSABRI. These alliances can enhance market penetration and improve the drug's availability[1].

Reimbursement Policies and Support

Favorable reimbursement policies and support from healthcare systems and insurance providers can significantly impact the accessibility and affordability of TYSABRI, contributing to its market expansion[1].

Sustained Research and Development

Ongoing research and development aimed at strengthening TYSABRI's formulation, extending its indications, and investigating combination therapies support market growth by raising the drug's profile and potential uses[1].

Market Segmentation

By Indication

TYSABRI is primarily indicated for the treatment of relapsing forms of multiple sclerosis, which represents the core market for this drug. It is also used in some cases for Crohn's disease, although MS remains the dominant indication[1].

By Distribution Channel

TYSABRI is often administered in hospital settings through intravenous infusion, making hospitals a key distribution channel. Specialty clinics focusing on neurology or MS treatment also play an important role[1].

By Patient Setting

The drug can be administered in both inpatient and outpatient settings. Inpatient settings are common for the initiation of treatment, while outpatient settings, including infusion centers and clinics, are used for ongoing treatments[1].

By Geography

The market is analyzed across various regions including North America, Europe, Asia-Pacific, Middle East and Africa, and Latin America. Each region has its own market dynamics and demand patterns[1].

Financial Performance

Revenue Trends

Biogen's financial reports indicate that TYSABRI, along with other MS products, contributed significantly to the company's revenue. In the second quarter of 2024, Biogen's MS product revenue, which includes TYSABRI, was $1,150 million, down 5% from the previous year[2].

Cost and Expense Structure

The cost of sales, research and development (R&D), and selling, general, and administrative (SG&A) expenses are key components of Biogen's financial structure. The company has seen savings in R&D and cost of sales due to portfolio prioritization and Fit for Growth initiatives, which have impacted the overall financial performance of TYSABRI[2].

Competitive Landscape

Main Players

The main players in the TYSABRI market include Biogen and Novartis. Biogen is the primary developer and marketer of TYSABRI, while Novartis may have interests through partnerships or licensing agreements[4].

Market Competition

The multiple sclerosis therapies market is competitive, with various disease-modifying therapies (DMTs) available. The market size for MS therapies is expected to reach USD 37.8 billion by 2032, driven by innovative treatments and increasing demand[3].

Royalty and Financial Transactions

In 2017, Perrigo divested its TYSABRI royalty stream to Royalty Pharma for a cash purchase price of $2.2 billion plus additional payments of $250 million if certain royalty thresholds were met. This transaction highlights the significant financial value associated with TYSABRI royalties[5].

Challenges and Opportunities

Patent Expiry and Generic Competition

The potential expiry of patents and the introduction of generic or biosimilar versions could impact TYSABRI's market share and revenue. This is a significant challenge that Biogen and other stakeholders need to address.

Expanding Indications

Ongoing research aimed at expanding TYSABRI's indications could open new market opportunities. Investigating combination therapies and strengthening the drug's formulation are critical for maintaining its market position.

Key Takeaways

• Market Growth: The TYSABRI market is projected to grow, albeit with varying forecasts, driven by the increasing incidence of MS and favorable reimbursement policies.
• Strategic Partnerships: Collaborations are crucial for the drug's development, promotion, and availability.
• Financial Performance: TYSABRI contributes significantly to Biogen's revenue, with ongoing efforts to optimize costs and expenses.
• Competitive Landscape: The MS therapies market is competitive, with TYSABRI facing competition from other DMTs.
• Royalty Transactions: Significant financial transactions involving TYSABRI royalties highlight the drug's financial value.

FAQs

What is the primary indication for TYSABRI?

TYSABRI is primarily indicated for the treatment of relapsing forms of multiple sclerosis.

Who are the main players in the TYSABRI market?

The main players in the TYSABRI market include Biogen and Novartis.

What are the key drivers of the TYSABRI market?

Key drivers include the growing incidence of MS, strategic partnerships, favorable reimbursement policies, and sustained research and development.

How is TYSABRI administered?

TYSABRI is often administered through intravenous infusion in hospital settings and specialty clinics.

What is the forecasted market size for TYSABRI by 2030?

Forecasts vary, with one source indicating a market size of USD 3.24 billion and another suggesting a decline to US$ 1463.4 million by 2030.

Sources

1. Verified Market Research - Tysabri Drugs Market Size, Share, Scope, Analysis & Forecast
2. Biogen - Q2 2024 Press Release
3. Biospace - Multiple Sclerosis Therapies Market Size to Reach USD 37.8 Billion by 2032
4. Valuates Reports - Tysabri - Market, Report Size, Worth, Revenue, Growth, Industry
5. PR Newswire - Perrigo Signs Agreement To Divest Tysabri® Royalty Stream For Up To $2.85 Billion