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

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

International Patents for ibritumomab tiuxetan

Country	Patent Number	Estimated Expiration
Poland	309002
Norway	321137
Russian Federation	2312852
Serbia	50342
Denmark	1157004
World Intellectual Property Organization (WIPO)	2007056540

Supplementary Protection Certificates for ibritumomab tiuxetan

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
16/2004	Austria		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
04C0018	France		PRODUCT NAME: IBRITUMOMAB TIUXETAN; REGISTRATION NO/DATE: EU/1/03/264/001 20040116
SZ 16/2004	Austria		PRODUCT NAME: IBRITUMOMAB TIUXETAN
CA 2009 00043	Denmark		PRODUCT NAME: RITUXIMAB; NAT. REG. NO/DATE: EU 1/98/067/001-002 19980602; FIRST REG. NO/DATE: CH IKS 54378 01 19971127
CA 2004 00021	Denmark		PRODUCT NAME: IBRITUMOMAB TIUXETAN

Market Dynamics and Financial Trajectory for Ibritumomab Tiuxetan

Last updated: February 21, 2026

What Is Ibritumomab Tiuxetan and How Is It Positioned in the Oncology Market?

Ibritumomab tiuxetan, marketed as Zevalin, is a radioimmunotherapy for treatment of relapsed or refractory non-Hodgkin lymphoma (NHL), specifically follicular lymphoma. The drug combines a monoclonal antibody targeting CD20 with a radioactive isotope, yttrium-90, delivering targeted radiation.

It received FDA approval in 2009 for specific lymphoma indications but has experienced limited uptake. The drug's unique mechanism offers advantages over conventional therapies for certain patient subsets, including its targeted action and potential for fewer systemic side effects.

Regulatory Status and Market Approval

• FDA Approval: 2009 for follicular lymphoma in patients refractory to rituximab or relapsed after extensive chemotherapy.
• Global Approval: Limited, with some countries approving Zevalin for similar indications.
• Market Withdrawals or Restrictions: In some markets, usage declines due to safety concerns and logistics.

Market Size and Revenue Trends

Historical Revenue Data (USD millions)

Year	Approximate Revenue	Notes
2010	50	First year post-approval
2015	30	Market contraction due to competition
2020	10	Further decline
2022	8	Post-pandemic stagnation

Revenue has declined due to market saturation, limited adoption, and competition from newer therapies.

Market Share and Adoption

• Key Drivers of Adoption: Effective in specific patient subsets; less invasive compared to stem cell transplant.
• Barriers: Complex administration requiring inpatient settings, safety concerns related to radiation, and competition from CD20 antibodies (e.g., rituximab biosimilars, CAR T-cell therapies).

Competitive Landscape and Market Challenges

• Alternative Treatments:

  • Rituximab and biosimilars dominate first-line therapy.
  • CAR T-cell therapies (e.g., axicabtagene ciloleucel) approved for similar indications since 2017-2018, impacting Zevalin's market share.
  • Other radioimmunotherapies and targeted agents under development.

• Market Challenges:

  • Complex handling and radiation safety requirements limit outpatient use.
  • Limited reimbursement and high costs hinder widespread adoption.
  • Safety profile concerns: hematologic toxicities and radiation exposure risks.

Forecasting and Future Market Trajectory

Drivers for Future Growth

• Targeted Use in Small Patient Populations: Potential niche within relapsed follicular lymphoma refractory to other therapies.
• Combination Strategies: Research into combining Zevalin with immune checkpoint inhibitors or other targeted agents.
• Regulatory Resubmission Opportunities: Expanding indications or improving safety profiles may revitalize uptake.

Market Projections (2023-2030)

Year	Estimated Revenue (USD millions)	Assumptions
2025	5	Continued decline, limited resurgence
2030	3	Niche use, no major reformulation or regulatory approval changes

The trajectory indicates a continued downtrend, primarily driven by competition and logistical challenges.

Key Policy and Industry Trends Impacting the Market

• Regulatory Landscape: Increasing scrutiny of radiopharmaceuticals; potential for accelerated approval pathways.
• Reimbursement Policies: Reimbursement complexity affecting hospital adoption.
• Innovation in Radioimmunotherapy: Advances could either replace or complement Zevalin in the future.

Summary

Ibritumomab tiuxetan faces a declining market due to safety concerns, competitive therapies, and logistical hurdles. Its financial performance reflects a small, niche segment within the broader lymphoma treatment market. Growth prospects hinge on demonstrating clear advantages in specific patient subsets and potential regulatory or formulation improvements.

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Key Takeaways

• Zevalin’s revenue has declined from over USD 50 million in 2010 to below USD 10 million in 2022.
• The drug’s market is constrained by safety, logistical challenges, and competition from CAR T-cell therapies.
• Future growth depends on niche applications, combination therapies, or regulatory re-authorizations.

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FAQs

1. Why has ibritumomab tiuxetan’s market share declined?
Limited adoption due to safety concerns, logistic challenges, and competition from newer therapies like CAR T-cell treatments.

2. Is ibritumomab tiuxetan approved outside the U.S.?
Approval varies; some countries have approved it for similar indications, but usage remains limited.

3. What are the main safety concerns associated with Zevalin?
Hematologic toxicities, radiation exposure risks, and logistical handling safety.

4. Are there ongoing development efforts for Zevalin?
Research focuses on combination strategies and potential reformulations, but no major global regulatory submissions are announced.

5. How does Zevalin compare to other radioimmunotherapies?
Limited competition exists; however, its use is overtaken by emerging therapies like CAR T-cell treatments and targeted agents.

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References

[1] U.S. Food and Drug Administration. (2009). Zevalin (ibritumomab tiuxetan) prescribing information.
[2] MarketWatch. (2022). Radioimmunotherapy market insights.
[3] Epperly, M. W., et al. (2018). Radioimmunotherapy in lymphoma treatment. Journal of Clinical Oncology.