Ibritumomab tiuxetan - Biologic Drug Details

Summary for ibritumomab tiuxetan

Tradenames:	1
High Confidence Patents:	10
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for ibritumomab tiuxetan
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ibritumomab tiuxetan

Recent Clinical Trials for ibritumomab tiuxetan

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
National Cancer Institute (NCI)	Phase 3
Joseph Tuscano	Phase 2
University of California, Davis	Phase 2

See all ibritumomab tiuxetan clinical trials

Recent Litigation for ibritumomab tiuxetan

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
AbbVie Inc. v. Alvotech hf.	2021-05-28
Alvotech USA Inc. v. Abbvie Inc	2021-05-11
AbbVie Inc. v. Alvotech hf.	2021-04-27

See all ibritumomab tiuxetan litigation

PTAB Litigation

Petitioner	Date
	2017-12-20

See all ibritumomab tiuxetan litigation

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 ibritumomab tiuxetan Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Acrotech Biopharma Inc.	ZEVALIN	ibritumomab tiuxetan	Injection	125019		2015-04-07	Company disclosures
Acrotech Biopharma Inc.	ZEVALIN	ibritumomab tiuxetan	Injection	125019		2015-07-07	Company disclosures
Acrotech Biopharma Inc.	ZEVALIN	ibritumomab tiuxetan	Injection	125019		2015-12-01	Company disclosures
Acrotech Biopharma Inc.	ZEVALIN	ibritumomab tiuxetan	Injection	125019		2039-03-29	Company disclosures

3) Low Certainty: US Patents for ibritumomab tiuxetan 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
Acrotech Biopharma Inc.	ZEVALIN	ibritumomab tiuxetan	Injection	125019		2033-03-11	Patent claims search
Acrotech Biopharma Inc.	ZEVALIN	ibritumomab tiuxetan	Injection	125019		2021-05-01	Patent claims search
Acrotech Biopharma Inc.	ZEVALIN	ibritumomab tiuxetan	Injection	125019		2030-09-09	Patent claims search
Acrotech Biopharma Inc.	ZEVALIN	ibritumomab tiuxetan	Injection	125019		2039-02-26	Patent claims search

International Patents for ibritumomab tiuxetan

Country	Patent Number	Estimated Expiration
Russian Federation	2221807
Netherlands	300424
Germany	69334285
Germany	69329503

Supplementary Protection Certificates for ibritumomab tiuxetan

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
CA 2004 00021	Denmark		PRODUCT NAME: IBRITUMOMAB TIUXETAN
16/2004	Austria		PRODUCT NAME: IBRITUMOMAB TIUXETAN; REGISTRATION NO/DATE: EU/1/03/264/001 20040116
91089	Luxembourg		91089, EXPIRES: 20181112
SPC/GB04/025	United Kingdom		PRODUCT NAME: IBRITUMOMAB COMPRISING A CHELATING AGENT FOR YTTRIUM (90); REGISTERED: UK EU/1/03/264/001 20040116

Market Dynamics and Financial Trajectory for Ibritumomab Tiuxetan

Introduction

Ibritumomab tiuxetan, marketed under the brand name Zevalin, is a monoclonal anti-CD20 antibody used in the treatment of B-cell non-Hodgkin's lymphoma. This biologic drug has been a significant player in the oncology market, and its market dynamics and financial trajectory are worth examining in detail.

Market Size and Growth

The global market for ibritumomab tiuxetan is anticipated to experience robust growth over the forecast period from 2023 to 2031. Recent years have seen substantial growth, and this trend is expected to continue due to the increasing prevalence of non-Hodgkin's lymphoma and the drug's efficacy in treating this condition[1][4].

Segmentation

The market for ibritumomab tiuxetan is segmented based on several key factors:

By Type

The drug is available in two primary types: 0.05 and 0.25, which cater to different patient needs and treatment protocols[1][4].

By Application

Ibritumomab tiuxetan is primarily used for treating Follicular Non-Hodgkin Lymphoma and Metastatic B-cell Non-Hodgkin Lymphoma. These applications drive the demand for the drug and influence its market dynamics[1][4].

By Geography

The market is geographically segmented into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Each region has its own growth trajectory based on factors such as healthcare infrastructure, regulatory environment, and patient population[1][4].

Key Players

The market for ibritumomab tiuxetan is dominated by several key players, including:

• CASI Pharmaceuticals
• Biogen
• Bayer
• Spectrum
• CSL Behring
• Grifols
• Baxalta
• Octapharma
• Kedrion

These companies play a crucial role in the development, distribution, and marketing of the drug, influencing its market share and financial performance[1][4].

Financial Forecast

The financial forecast for ibritumomab tiuxetan indicates a positive and sustained expansion. The market size is projected to increase significantly from 2023 to 2031, measured in USD million. This growth is driven by increasing demand, advancements in treatment protocols, and the expanding patient base[1][4].

Market Dynamics

Drivers

Several factors drive the growth of the ibritumomab tiuxetan market:

• Increasing Prevalence of Non-Hodgkin's Lymphoma: The rising incidence of non-Hodgkin's lymphoma globally increases the demand for effective treatments like ibritumomab tiuxetan.
• Efficacy and Safety: The drug's proven efficacy and safety profile in treating B-cell non-Hodgkin's lymphoma contribute to its market growth.
• Advancements in Healthcare Infrastructure: Improvements in healthcare infrastructure, especially in emerging markets, enhance the accessibility and affordability of the drug[1][4].

Restraints

Despite the positive growth trajectory, there are several restraints to consider:

• High Cost: Ibritumomab tiuxetan is a costly treatment, which can limit its adoption in some regions.
• Regulatory Challenges: Stringent regulatory requirements and the need for clinical trials can slow down market entry and expansion.
• Competition from Biosimilars: The emergence of biosimilars could pose a competitive threat to the original biologic drug, potentially affecting its market share[1][3][4].

Opportunities

The market also presents several opportunities:

• Expanding into New Markets: There is potential for growth in emerging markets where healthcare infrastructure is improving.
• Research and Development: Continuous R&D can lead to new indications and improved treatment protocols, further expanding the market.
• Partnerships and Collaborations: Strategic partnerships among key players can enhance distribution, marketing, and patient access to the drug[1][4].

Challenges

Challenges such as market competition, regulatory hurdles, and the high development costs of biologic drugs must be navigated:

• Market Competition: The biologics market is highly competitive, with several players vying for market share.
• Regulatory Hurdles: Navigating complex regulatory environments can be challenging and time-consuming.
• High Development Costs: The development of biologic drugs is costly and involves significant investment in R&D[1][3][4].

Pharmacokinetics and Mechanism of Action

Ibritumomab tiuxetan is a monoclonal anti-CD20 antibody conjugated with a radioactive isotope, either indium-111 or yttrium-90. It targets the CD20 antigen found on the surface of normal and malignant B lymphocytes. The drug's mechanism of action involves binding to these cells and delivering the radioactive isotope to induce cell death[5].

Adverse Effects and Safety Profile

While ibritumomab tiuxetan is generally well-tolerated, it can have adverse effects such as infusion reactions, myelosuppression, and secondary malignancies. The safety profile is closely monitored, and patients are advised to follow strict treatment protocols to minimize risks[5].

Recent Developments

Recent developments in the market include:

• CASI Pharmaceuticals' Registration Trial: CASI Pharmaceuticals planned a registration trial for non-Hodgkin's lymphoma in China in early 2021[2].
• Spectrum Pharmaceuticals' Sale: Spectrum Pharmaceuticals completed the sale of ibritumomab tiuxetan to Acrotech Biopharma in 2019[2].
• Clinical Trial Approvals: The National Medical Products Administration (NMPA) of China approved a clinical trial application for a confirmatory clinical trial of ibritumomab tiuxetan in non-Hodgkin's lymphoma[2].

Conclusion

The market for ibritumomab tiuxetan is poised for significant growth driven by its efficacy in treating B-cell non-Hodgkin's lymphoma, increasing demand, and advancements in healthcare infrastructure. However, the market must navigate challenges such as high costs, regulatory hurdles, and competition from biosimilars.

Key Takeaways

• Robust Growth: The market is expected to experience robust growth from 2023 to 2031.
• Segmentation: The market is segmented by type, application, and geography.
• Key Players: Major players include CASI Pharmaceuticals, Biogen, Bayer, and others.
• Drivers and Restraints: Increasing prevalence of non-Hodgkin's lymphoma and efficacy of the drug drive growth, while high costs and regulatory challenges act as restraints.
• Mechanism of Action: The drug targets CD20 antigen on B lymphocytes using a radioactive isotope.

FAQs

What is ibritumomab tiuxetan used for?

Ibritumomab tiuxetan is used to treat B-cell non-Hodgkin's lymphoma, specifically follicular non-Hodgkin's lymphoma and metastatic B-cell non-Hodgkin's lymphoma[5].

Who are the key players in the ibritumomab tiuxetan market?

Key players include CASI Pharmaceuticals, Biogen, Bayer, Spectrum, CSL Behring, Grifols, Baxalta, Octapharma, and Kedrion[1][4].

What are the main types of ibritumomab tiuxetan available?

The drug is available in two primary types: 0.05 and 0.25[1][4].

What are the potential restraints to the growth of the ibritumomab tiuxetan market?

High costs, regulatory challenges, and competition from biosimilars are potential restraints to market growth[1][3][4].

How does ibritumomab tiuxetan work?

Ibritumomab tiuxetan works by targeting the CD20 antigen on B lymphocytes and delivering a radioactive isotope to induce cell death[5].

Sources

1. Market Research Intellect - Ibritumomab Tiuxetan Market Size, Scope And Forecast Report[1].
2. AdisInsight - Ibritumomab tiuxetan - Acrotech Biopharma /Biogen[2].
3. FTC - Biologics Market Dynamics: Setting the Stage for Biosimilars[3].
4. Valuates Reports - Ibritumomab Tiuxetan Market, Report Size, Worth, Revenue, Growth[4].
5. DrugBank - Ibritumomab tiuxetan: Uses, Interactions, Mechanism of Action[5].

Last updated: 2024-12-19