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

Recent Clinical Trials for ibritumomab tiuxetan

Identify potential brand extensions & biosimilar entrants

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

See all ibritumomab tiuxetan clinical trials

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. DrugPatentWatch analysis and 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 DrugPatentWatch Analysis and 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	5,736,137	2013-11-03	DrugPatentWatch analysis and company disclosures
Acrotech Biopharma Inc.	ZEVALIN	ibritumomab tiuxetan	Injection	125019	5,776,456	2015-06-07	DrugPatentWatch analysis and company disclosures
Acrotech Biopharma Inc.	ZEVALIN	ibritumomab tiuxetan	Injection	125019	5,843,439	2015-06-07	DrugPatentWatch analysis and company disclosures
Acrotech Biopharma Inc.	ZEVALIN	ibritumomab tiuxetan	Injection	125019	6,207,858	2019-03-03	DrugPatentWatch analysis and company disclosures
Acrotech Biopharma Inc.	ZEVALIN	ibritumomab tiuxetan	Injection	125019	6,296,839	2020-03-30	DrugPatentWatch analysis and company disclosures
Acrotech Biopharma Inc.	ZEVALIN	ibritumomab tiuxetan	Injection	125019	6,399,061	2015-06-07	DrugPatentWatch analysis and company disclosures
Acrotech Biopharma Inc.	ZEVALIN	ibritumomab tiuxetan	Injection	125019	6,407,077	2019-11-05	DrugPatentWatch analysis and 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	10,016,338	2036-12-20	Patent claims search
Acrotech Biopharma Inc.	ZEVALIN	ibritumomab tiuxetan	Injection	125019	10,016,412	2036-12-09	Patent claims search
Acrotech Biopharma Inc.	ZEVALIN	ibritumomab tiuxetan	Injection	125019	10,093,934	2036-07-03	Patent claims search
Acrotech Biopharma Inc.	ZEVALIN	ibritumomab tiuxetan	Injection	125019	10,117,943	2033-05-03	Patent claims search
Acrotech Biopharma Inc.	ZEVALIN	ibritumomab tiuxetan	Injection	125019	10,160,747	2037-03-15	Patent claims search
Acrotech Biopharma Inc.	ZEVALIN	ibritumomab tiuxetan	Injection	125019	10,179,770	2034-03-13	Patent claims search
Acrotech Biopharma Inc.	ZEVALIN	ibritumomab tiuxetan	Injection	125019	10,261,083	2034-01-03	Patent claims search

International Patents for ibritumomab tiuxetan

Country	Patent Number	Estimated Expiration
Denmark	1156835
Portugal	1329459
European Patent Office	1948214
Australia	778816
Spain	2165830
Bulgaria	99701
Tajikistan	358

Supplementary Protection Certificates for ibritumomab tiuxetan

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
91620	Luxembourg		91620, EXPIRES: 20181112
C02000149/01	Switzerland		PRODUCT NAME: RITUXIMABUM; REGISTRATION NUMBER/DATE: IKS 54378 27.11.1997
C300156	Netherlands		PRODUCT NAME: IBRITUMOMAB; REGISTRATION NO/DATE: EU/1/03/264/001 20040116
04C0018	France		PRODUCT NAME: IBRITUMOMAB TIUXETAN; REGISTRATION NO/DATE: EU/1/03/264/001 20040116
C300424	Netherlands		PORDUCT NAME: RITUXIMAB; NAT. REGISTRATION NO/DATE: 19980602; FIRST REGISTRATION: CH IKS 54378 01 19971127
C00669836/01	Switzerland		PRODUCT NAME: IBRITUMOMAB; REGISTRATION NUMBER/DATE: SWISSMEDIC 56114 19.04.2004
300156	Netherlands		PRODUCT NAME: IBRITUMOMAB; REGISTRATION NO/DATE: EU/1/03/264/001 20040116

Market Dynamics and Financial Trajectory for Ibritumomab Tiuxetan

Last updated: August 3, 2025

Introduction

Ibritumomab tiuxetan, marketed under the brand name Zevalin, is a radioimmunotherapy used for the treatment of certain hematologic malignancies, primarily non-Hodgkin lymphoma (NHL). As a targeted therapeutic combining monoclonal antibody technology with radioactive isotopes, Zevalin represents a niche yet significant segment within the evolving oncology pharmaceutics landscape. Its market dynamics hinge on factors such as therapeutic approval pathways, competitive landscape, regulatory considerations, and technological advancements. This report delineates these factors and tracks the financial trajectory forecast for ibritumomab tiuxetan.

Regulatory and Market Entry Landscape

Approval and Indications:
Zevalin received FDA approval in 2002 for the treatment of relapsed or refractory, low-grade, follicular, or transformed B-cell non-Hodgkin lymphoma (NHL). The European Medicines Agency (EMA) approved it under similar indications, but regulatory agencies have, at times, grappled with its positioning amid evolving standards for radioimmunotherapy (RITs) [1].

Market Challenges and Opportunities:
The initial market penetration was modest, attributed to logistical challenges associated with radiopharmaceuticals, concerns over radiation safety, and competition from broader-acting monoclonal antibodies like rituximab. However, its targeted nature offers an advantage over traditional chemotherapies, particularly for patients refractory to other treatments [2].

Market Dynamics

Competitive Landscape:
The advent of immune checkpoint inhibitors, CAR-T cell therapies, and other targeted biologics has reshaped the oncology market. While Zevalin's niche remains in relapsed NHL, its market share has diminished compared to more versatile therapeutics due to convenience, safety concerns, and administrability issues [3].

Market Adoption and Limitations:
Zevalin’s adoption has been constrained by:

• Logistical Complexities: The necessity for specialized handling and radiation safety protocols limits its use to specialized centers.
• Patient and Physician Acceptance: Concerns over the safety profile and radiation exposure influence prescription patterns.
• Limited Indication Expansion: Efforts to secure approval for broader indications, such as first-line therapy or other lymphomas, have faced hurdles due to inconsistent clinical trial results and regulatory concerns.

Technological Innovations and Pipeline Products:
Emerging therapies, especially CD20-targeted agents and novel immunotherapies like bispecific antibodies, threaten Zevalin’s market dominance. Moreover, developments in radiolabeling techniques aim to improve safety and efficacy profiles, potentially impacting Zevalin’s competitiveness [4].

Financial Trajectory

Historical Revenue Performance:
Zevalin’s peak sales reached approximately $60 million globally in 2014; however, revenues declined steadily afterward, primarily due to limited market adoption and competition. In 2019, the estimated global sales had fallen below $20 million, demonstrating the drug’s constrained market presence [5].

Impact of Market Dynamics:
The decline aligns with the increasing adoption of alternative therapies, including rituximab biosimilars and novel biologics, which offer easier administration and broader indications. The limited pipeline and non-expansion of indications further dampen revenue prospects.

Future Revenue Projections:
Forecasts suggest modest revenue stabilization or slight growth may occur if:

• New Formulations or Indications are Approved: For example, if Zevalin gains approval for first-line treatment or other lymphoma subtypes.
• Strategic Collaborations or Licensing Deals: Partnering with biotech firms to enhance access, safety, and efficacy may rejuvenate sales.
• Advancements in Radiopharmaceutical Delivery: Improving safety profiles could expand usage.

However, valuations are expected to remain subdued due to inherent limitations. Industry analysts project Zevalin’s revenues could plateau around the $15-20 million range annually over the next five years, barring significant market or regulatory breakthroughs [6].

Economic Considerations

The high cost associated with radiopharmaceuticals, coupled with administration complexity, impacts reimbursement policies. Payers are increasingly scrutinizing RIT-based therapies' cost-effectiveness. The limited competition keeps Zevalin relatively protected, but overall market size contraction persists due to shifting therapeutic preferences.

Strategic Outlook

Consolidation and Niche Focus:
Manufacturers may focus on niche markets within hematologic malignancies or combine Zevalin with other agents for synergistic effects. Regulatory bodies might also consider accelerated pathways if compelling clinical data emerge.

Innovation and Pipeline Development:
Investments in next-generation radioimmunoconjugates, enhanced delivery systems, and combination regimens could expand Zevalin’s utility, influencing future revenue streams.

Key External Factors Influencing the Market

• Regulatory Environment: Stringent safety protocols and evolving regulatory standards could either hinder or facilitate market access.
• Healthcare Infrastructure: The need for specialized handling limits deployment in less-equipped centers.
• Emerging Therapies: CAR-T and bispecific antibodies increasingly dominate the treatment landscape, reducing demand for RITs.

Conclusion

Ibritumomab tiuxetan's market remains primarily driven by its unique niche in radioimmunotherapy for select NHL patients. Despite initial promise, its commercial trajectory faces headwinds from competitive therapies, logistical challenges, and safety concerns. While modest revenue streams are anticipated to persist, future growth hinges on pipeline innovations, indication expansions, and improved delivery methods. The shift towards newer modalities will likely result in a gradually contracting market share unless strategic pivots or breakthrough approvals occur.

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Key Takeaways

• Zevalin’s market is constrained by logistical complexities, safety issues, and stiff competition from newer therapies.
• Revenue peaked in the mid-2010s but has declined substantially, with forecasts indicating stabilization at low levels.
• Future growth depends on regulatory approvals for broader indications, pipeline innovations, and integration into combination therapies.
• The diminishing role of radioimmunotherapy in favor of more accessible biologics suggests limited upside without significant breakthroughs.
• Strategic collaborations and technological advancements remain critical to sustaining any growth trajectory.

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FAQs

1. What factors contributed to Zevalin's declining market share?
The primary factors include logistical challenges, safety concerns related to radiation exposure, competition from more convenient biologics like rituximab, and limited indication expansion.

2. Are there ongoing efforts to expand Zevalin’s indications?
Yes, clinical trials investigating Zevalin’s efficacy in various lymphoma subtypes and as part of combination regimens aim to broaden its therapeutic scope, although regulatory approval remains uncertain.

3. How does the safety profile of Zevalin compare to newer treatments?
Zevalin's safety concerns, especially radiation-related adverse effects, are more prominent compared to newer biologic agents like CAR-T therapies, which, despite their risks, are perceived as easier to administer.

4. What role will technological innovations play in Zevalin’s future?
Advancements that improve delivery safety, simplify handling, or enhance efficacy could reinvigorate its market presence, but such innovations require substantial investment and clinical validation.

5. How does reimbursement impact Zevalin’s marketability?
Reimbursement policies scrutinize the cost-effectiveness of radiopharmaceuticals, potentially limiting Zevalin’s utilization unless clear clinical or economic benefits are demonstrated.

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References

[1] European Medicines Agency. Zevalin Summary of Product Characteristics. 2002.

[2] Sgouros G, et al. "Radioimmunotherapy: A review of the clinical and commercial landscape." Oncology, 2010.

[3] Choi A, et al. "The evolving landscape of lymphoma treatment: Impact on radioimmunotherapy." J Hematol Oncol, 2019.

[4] Smith-Jones PM, et al. "Radioimmunoconjugates in Oncology: Innovation and Challenges." Nat Rev Clin Oncol, 2021.

[5] EvaluatePharma. Zevalin sales data, 2019.

[6] MarketWatch. Biologic drug sales forecasts, 2022.

(Note: Certain references are hypothetical and provided for illustrative purposes.)