ZEVALIN Drug Profile

Summary for Tradename: ZEVALIN

High Confidence Patents:	10
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for ZEVALIN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZEVALIN

Recent Clinical Trials for ZEVALIN

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
TerSera Therapeutics	Phase 2
TerSera Therapeutics LLC	Phase 2
JDP Therapeutics, Inc.	Phase 2

See all ZEVALIN clinical trials

Recent Litigation for ZEVALIN

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 ZEVALIN litigation

PTAB Litigation

Petitioner	Date
	2017-12-20

See all ZEVALIN 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 ZEVALIN Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for ZEVALIN 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
Acrotech Biopharma Inc.	ZEVALIN	ibritumomab tiuxetan	Injection	125019		2019-06-04	Company disclosures
Acrotech Biopharma Inc.	ZEVALIN	ibritumomab tiuxetan	Injection	125019		2021-01-27	Company disclosures
Acrotech Biopharma Inc.	ZEVALIN	ibritumomab tiuxetan	Injection	125019		2019-03-01	Company disclosures

3) Low Certainty: US Patents for ZEVALIN 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
Acrotech Biopharma Inc.	ZEVALIN	ibritumomab tiuxetan	Injection	125019		2036-03-16	Patent claims search
Acrotech Biopharma Inc.	ZEVALIN	ibritumomab tiuxetan	Injection	125019		2039-02-26	Patent claims search
Acrotech Biopharma Inc.	ZEVALIN	ibritumomab tiuxetan	Injection	125019		2033-01-04	Patent claims search

International Patents for ZEVALIN

Country	Patent Number	Estimated Expiration
Portugal	1157004
Portugal	1005870
Greece	3020731
New Zealand	258392
Hungary	227986
Estonia	05582
Norway	329146

Supplementary Protection Certificates for ZEVALIN

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C02000149/01	Switzerland		PRODUCT NAME: RITUXIMABUM; REGISTRATION NO/DATE: IKS 54378 19971127
04C0018	France		PRODUCT NAME: IBRITUMOMAB TIUXETAN; REGISTRATION NO/DATE: EU/1/03/264/001 20040116
91620	Luxembourg		91620, EXPIRES: 20181112
C00669836/01	Switzerland		FORMER OWNER: BIOGEN INC., US
2004C/016	Belgium		PRODUCT NAME: IBRITUMOMAB; AUTHORISATION NUMBER AND DATE: EU/1/03/264/001 20040119
122004000036	Germany		PRODUCT NAME: IBRITUMOMAB TIUXETAN; REGISTRATION NO/DATE: EU/1/03/264/001 20040116
C300156	Netherlands		PRODUCT NAME: IBRITUMOMAB; REGISTRATION NO/DATE: EU/1/03/264/001 20040116

Market Dynamics and Financial Trajectory for the Biologic Drug: ZEVALIN

Introduction

ZEVALIN, also known as ibritumomab tiuxetan, is a biologic drug used in the treatment of non-Hodgkin's lymphoma (NHL). Despite its clinical efficacy, the drug has faced significant market and financial challenges. Here, we delve into the market dynamics and financial trajectory of ZEVALIN.

Clinical Efficacy and Approval

ZEVALIN is a targeted radiotherapeutic agent approved for the treatment of adult patients with relapsed or refractory low-grade or follicular B-cell NHL, including those who are rituximab-refractory or rituximab-naive[4][5].

Market Launch and Initial Projections

When ZEVALIN first entered the market, it was met with high expectations. Wall Street analysts predicted that sales could reach $100 million in 2003 and potentially hit $500 million in the future, equivalent to approximately 20,000 doses per year[2].

Commercial Challenges

Despite its efficacy and acceptable safety profile, ZEVALIN failed to meet these initial sales forecasts. Several factors contributed to its slow uptake and declining sales:

High Price and Complexity

The drug's high price and the complicated process of prescribing, administering, and monitoring it were significant barriers. Physicians often preferred familiar, non-radioactive treatments over ZEVALIN[2].

Market Competition

The market for NHL treatments evolved rapidly, introducing numerous non-radioactive competitors. This competition further diminished ZEVALIN's market share[2].

Safety Concerns

Although not directly related to ZEVALIN, safety concerns in similar therapeutic areas can impact market confidence. For instance, safety issues in other radiotherapeutic trials affected the broader perception of such treatments[2].

Financial Performance

Initial Sales

In the first decade after its launch, ZEVALIN's annual sales were significantly lower than projected, ranging from $15 to $30 million. This was a far cry from the anticipated $100 million or more[2].

Decline in Sales

By 2013, ZEVALIN's sales began a steady decline. The financial reports from Biogen and Spectrum Pharmaceuticals reflect this downward trend, with sales failing to recover to earlier levels[2][3].

Ownership and Distribution Changes

Spectrum Pharmaceuticals Acquisition

In 2009, Spectrum Pharmaceuticals acquired 100% control of ZEVALIN from RIT Oncology, LLC. This acquisition was part of Spectrum's strategy to expand its portfolio and improve patient access to the drug. Despite this, the drug's sales did not significantly improve[4][5].

Global Market Expansion

Spectrum Pharmaceuticals also sought to expand ZEVALIN's market globally, recognizing that the global market for NHL treatments was several times larger than the US market. However, this expansion did not translate into substantial financial gains for the drug[5].

Regulatory and Reimbursement Efforts

Spectrum Pharmaceuticals anticipated that regulatory and reimbursement changes, along with their marketing efforts, would improve ZEVALIN's market position. For example, the company expected FDA approval for first-line consolidation therapy to increase the addressable patient population by approximately 18,000. However, these efforts did not reverse the drug's declining sales trend[4].

Current Status

ZEVALIN is currently marketed by Aurobindo Pharma Ltd. in Europe and by its subsidiary Acrotech Biopharma L.L.C. in the US. Despite its clinical benefits, the drug's commercial performance has not met initial expectations, and it continues to face challenges in a competitive market[2].

Key Takeaways

• Clinical Efficacy: ZEVALIN is clinically effective but has struggled with market acceptance.
• Commercial Challenges: High price, complexity, and market competition have hindered its sales.
• Financial Performance: Sales have been significantly lower than projected and have declined over time.
• Ownership Changes: Spectrum Pharmaceuticals' acquisition did not reverse the decline.
• Regulatory Efforts: Anticipated regulatory changes did not improve the drug's market position.

FAQs

What is ZEVALIN used for?

ZEVALIN is used for the treatment of adult patients with relapsed or refractory low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL), including those who are rituximab-refractory or rituximab-naive.

Why did ZEVALIN fail to meet sales forecasts?

ZEVALIN faced several challenges, including its high price, the complexity of its administration, and strong competition from non-radioactive treatments.

Who currently markets ZEVALIN?

ZEVALIN is currently marketed by Aurobindo Pharma Ltd. in Europe and by its subsidiary Acrotech Biopharma L.L.C. in the US.

What were the regulatory efforts to boost ZEVALIN's sales?

Spectrum Pharmaceuticals anticipated that FDA approval for first-line consolidation therapy and other regulatory changes would increase the addressable patient population and improve sales.

How has the ownership of ZEVALIN changed over time?

ZEVALIN was initially marketed by Biogen, then acquired by Spectrum Pharmaceuticals in 2009, and is now marketed by Aurobindo Pharma Ltd. and its subsidiary Acrotech Biopharma L.L.C.

Sources

1. Frontiers in Medicine: Commercial and business aspects of alpha radioligand therapeutics.
2. FierceBiotech: Spectrum Pharmaceuticals Acquires 100% of ZEVALIN, an FDA-Approved, Proprietary, Biological Drug for Non-Hodgkin's Lymphoma.
3. Biogen Investor Relations: Untitled - Biogen | Investor Relations.
4. Drug Development: Spectrum Pharmaceuticals to Acquire Worldwide Rights to Market ZEVALIN.