Oprelvekin - Biologic Drug Details

Summary for oprelvekin

Tradenames:	1
High Confidence Patents:	6
Applicants:	1
BLAs:	1

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 oprelvekin Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for oprelvekin 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
Wyeth Pharmaceuticals Inc.	NEUMEGA	oprelvekin	For Injection	103694	5,215,895	2010-05-21	DrugPatentWatch analysis and company disclosures
Wyeth Pharmaceuticals Inc.	NEUMEGA	oprelvekin	For Injection	103694	5,270,181	2011-08-14	DrugPatentWatch analysis and company disclosures
Wyeth Pharmaceuticals Inc.	NEUMEGA	oprelvekin	For Injection	103694	5,371,193	2013-02-12	DrugPatentWatch analysis and company disclosures
Wyeth Pharmaceuticals Inc.	NEUMEGA	oprelvekin	For Injection	103694	6,066,317	2018-07-24	DrugPatentWatch analysis and company disclosures
Wyeth Pharmaceuticals Inc.	NEUMEGA	oprelvekin	For Injection	103694	6,143,524	2017-03-04	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for oprelvekin 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
Wyeth Pharmaceuticals Inc.	NEUMEGA	oprelvekin	For Injection	103694	10,053,498	2035-11-20	Patent claims search
Wyeth Pharmaceuticals Inc.	NEUMEGA	oprelvekin	For Injection	103694	10,117,943	2033-05-03	Patent claims search
Wyeth Pharmaceuticals Inc.	NEUMEGA	oprelvekin	For Injection	103694	10,195,188	2037-09-01	Patent claims search
Wyeth Pharmaceuticals Inc.	NEUMEGA	oprelvekin	For Injection	103694	10,383,876	2032-03-29	Patent claims search
Wyeth Pharmaceuticals Inc.	NEUMEGA	oprelvekin	For Injection	103694	10,398,685	2039-02-04	Patent claims search

International Patents for oprelvekin

Country	Patent Number	Estimated Expiration
Japan	H05507209
Japan	H104982
World Intellectual Property Organization (WIPO)	9402502
Hungary	T64595
Denmark	0504177

Market Dynamics and Financial Trajectory for Oprelvekin (Interleukin-11)

Last updated: February 16, 2026

Overview

Oprelvekin is a recombinant, human interleukin-11 (IL-11) approved for reducing severe thrombocytopenia and minimizing the need for platelet transfusions in patients receiving chemotherapy. Its primary indication is chemotherapy-induced thrombocytopenia (CIT), especially in non-myeloid cancers such as non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). Market penetration remains limited due to competition from newer agents and shifts in clinical practice.

Market Size and Growth Drivers

The global thrombopoietic agents market, which includes oprelvekin, was valued at approximately $0.5 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 4-6% through 2030, reaching around $0.8 billion, driven by increased use of supportive care in chemotherapy, rising cancer incidence, and expanding approval scope.

Key growth factors include:

• Rising incidence of cancers requiring chemotherapy, notably lung, breast, and lymphoma.
• Increasing adoption of supportive care protocols emphasizing prophylactic management of thrombocytopenia.
• Emerging biosimilar efforts that could affect manufacturing costs and pricing.

Market Challenges

Oprelvekin has faced declining usage due to:

• Safety concerns, including edema, atrial fibrillation, and allergic reactions observed in clinical trials.
• Competition from thrombopoietin receptor agonists (TPO-RAs) like romiplostim and eltrombopag, approved for broader indications, including immune thrombocytopenic purpura (ITP).
• Shifts in clinical guidelines favoring platelet transfusions over hematopoietic stimulants in certain contexts.
• Limited physician familiarity and prescribing inertia despite efficacy data.

Regulatory and Patent Landscape

• Approved by FDA in 1994 for CIT, with labeling expanded to include use in non-myeloid cancers.
• US patent expired in 2018; biosimilar development remains limited.
• No recent new drug applications or supplemental approvals reported, constraining market expansion.

Financial Trajectory

Oprelvekin's commercial revenue peaked in the early 2000s at approximately $50 million but declined sharply post-2010 due to reduced prescribing. Current annual sales are estimated below $10 million, primarily from a small base of institutional and specialty providers.

The revenue decline is attributed to:

• Limited uptake in new indications.
• The availability of alternative supportive therapies.
• Concerns over adverse events diminishing safety profile appeal.

Potential Growth Opportunities

• Expanding into peripheral indications such as thrombocytopenia in other patient populations (e.g., stem cell transplants).
• Development of next-generation IL-11 analogs with improved safety profiles.
• Differentiation through personalized medicine approaches targeted at high-risk patient subsets.
• Partnership or acquisition strategies aimed at leveraging existing manufacturing and clinical data.

Summary

Oprelvekin operates within a subdued market segment, with growth driven primarily by the increased need for supportive cancer care. Market size remains limited and is hindered by safety issues, competition, and regulatory constraints. Revenue prospects depend on clinical innovation, repositioning, or strategic collaborations.

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Key Takeaways

• The global thrombopoietic agents market is projected to grow modestly, but oprelvekin’s share remains constrained.
• Usage decline results from safety concerns and competition from TPO-RAs.
• Current revenues are under $10 million annually, with minimal prospects for significant growth without new indications or formulations.
• Strategic pathways include exploring new indications or developing improved versions of IL-11.
• Market dynamics favor novel agents or partnerships that can overcome safety and efficacy limitations.

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FAQs

1. Why has oprelvekin's market share declined?
A: Safety concerns, competition from newer agents like romiplostim and eltrombopag, and clinical guideline shifts favoring platelet transfusions have reduced its use.

2. Can oprelvekin regain market relevance?
A: Potential exists if it is reformulated for better safety or targeted for niche indications with unmet needs.

3. What is the potential of biosimilars for oprelvekin?
A: Patent expiration in 2018 limits the immediate impact; biosimilar development remains rare due to complexity and limited commercial incentives.

4. How does oprelvekin compare to thrombopoietin receptor agonists?
A: TPO-RAs generally have broader approval indications, better safety profiles, and more aggressive marketing, overshadowing oprelvekin’s niche role.

5. What strategies could revive demand for oprelvekin?
A: Developing safer analogs, expanding indications, and integrating personalized approaches for high-risk patients.

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Sources

[1] Market Research Future, "Thrombopoietic Agents Market Analysis," 2022.

[2] FDA Drug Approval Documents, 1994, 2010.

[3] Evaluate Pharma, "Chemotherapy-Induced Thrombocytopenia Market," 2022.

[4] ClinicalTrials.gov, "Oprelvekin Trials and Indications," 2023.

[5] IQVIA, "Global Oncology Supportive Care Market Data," 2022.