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

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

International Patents for oprelvekin

Country	Patent Number	Estimated Expiration
Germany	69233779
Japan	2688539
Japan	H05504560
Mexico	9203295

Market Dynamics and Financial Trajectory for the Biologic Drug: Oprelvekin

Last updated: July 30, 2025

Introduction

Oprelvekin, commercially known as Neumega, is a recombinant human interleukin-11 used primarily to mitigate severe thrombocytopenia induced by chemotherapy. Approved by the U.S. Food and Drug Administration (FDA) in 1997, this biologic addresses a niche yet significant segment within oncology supportive care. With its specialized indication, Oprelvekin's market dynamics are shaped by evolving clinical practices, competitive landscape, regulatory considerations, and economic factors. This analysis dissects these elements to project its future financial trajectory.

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Therapeutic Profile and Clinical Positioning

Oprelvekin functions by stimulating megakaryocyte proliferation and differentiation, thereby increasing platelet production. Its primary indication involves the prevention of chemotherapy-induced thrombocytopenia in patients with non-myeloid malignancies. Despite its targeted application, limitations such as adverse effects (e.g., fluid retention, anemia) and the advent of alternative therapies have constrained its widespread adoption (FDA prescribing information, 1997).

Alternatives, including thrombopoietin receptor agonists like romiplostim and eltrombopag, have gained prominence, impacting Oprelvekin's market share. However, its unique mechanism and established clinical track record continue to sustain demand within specific patient populations.

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Market Dynamics

1. Market Size and Segmentation

The global oncology supportive care market is projected to reach USD 14 billion by 2025, with thrombopoietic agents accounting for a significant slice (Grand View Research, 2020). Oprelvekin's addressable market remains limited mainly due to its narrow indication and competition from newer therapies.

The U.S. remains the primary market, driven by extensive clinical use and reimbursement frameworks. Emerging markets present growth opportunities; however, drug affordability and differing treatment protocols temper this potential.

2. Competitive Landscape

The competitive landscape is characterized by:

• Direct Competitors: Eltrombopag (Promacta), romiplostim (Nplate), which are thrombopoietin receptor agonists approved for several thrombocytopenic disorders.
• Indirect Competition: Blood transfusions and other supportive care measures.
• Emerging Therapies: Novel biologics and small-molecule agents that modulate platelet production or protect against thrombocytopenia.

Oprelvekin's positioning as an injectable biologic with a specific indication limits its agility against oral agents offering convenience and broader indications. Nonetheless, some clinicians favor Oprelvekin for its established safety profile, especially in cases where newer agents are contraindicated.

3. Regulatory and Reimbursement Environment

Regulatory agencies emphasize safety profiles alongside efficacy. Post-marketing surveillance reported adverse events led to implementation of usage guidelines, which constrained broader adoption.

Reimbursement policies influence access; in regions with favorable coverage, high adoption persists, whereas otherwise may restrict utilization.

4. Clinical Adoption Trends

The utilization of Oprelvekin has declined over the past decade, primarily attributable to the availability of alternative therapies with more convenient routes of administration and improved safety profiles. Nonetheless, residual demand remains among clinicians favoring its proven efficacy in specific clinical scenarios.

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Financial Trajectory

Historical Revenue Performance

Oprelvekin's revenues peaked in the late 1990s and early 2000s, with estimates of annual sales reaching hundreds of millions USD globally. These figures steadily declined owing to market saturation, adverse event concerns, and competition, stabilizing at modest levels in recent years.

Current Market Valuation

Based on market reports, current annual sales are estimated between USD 50–100 million, primarily within the U.S. healthcare setting. Patent expiry has yet to occur, as the drug’s initial patent protections have long since lapsed, though exclusivity provisions or orphan drug status, if applicable, could influence future market exclusivity.

Projected Growth and Revenue Trends

Projections suggest a continued decline in Oprelvekin's market share unless significant new clinical data or regulatory designations emerge. Its niche status might offer opportunities for specialty-focused marketing strategies, but significant growth potential appears limited.

Potential factors influencing future revenue include:

• Market erosion: Due to alternatives with better safety profiles.
• Orphan or accelerated approvals: For new indications could temporarily revive interest.
• Manufacturing and supply chain considerations: Stable supply and cost management could preserve margin viability.

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Future Outlook and Strategic Considerations

1. Innovations and Label Expansion

Incorporating real-world evidence or novel formulations (e.g., longer-acting versions) might bolster usage. However, regulatory approval for new indications remains challenging given existing data and competition.

2. M&A and Licensing Opportunities

Partnerships or acquisitions could extend product relevance, especially if linked with broader tumor supportive care portfolios.

3. Market Penetration in Emerging Economies

Clinical adoption in emerging markets hinges on affordability, local regulatory pathways, and clinician familiarity. Tailored pricing models and joint ventures may facilitate entry.

4. Regulatory and Policy Influences

Changes in oncology supportive care guidelines or reimbursement policies significantly affect demand. Health authorities emphasizing patient safety and cost-effectiveness could further marginalize Oprelvekin unless it demonstrates clear advantages.

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Key Takeaways

• Oprelvekin remains a niche therapeutic with a limited but steady market mainly within North America.
• Competitive pressure from thrombopoietin receptor agonists and evolving clinical practice reduces its adoption.
• Revenue projections suggest a downtrend unless strategic measures—such as label expansion, formulation innovation, or strategic partnerships—are implemented.
• Market dynamics favor high-specialization and targeted use cases, making Oprelvekin's role more confined but potentially vital within specific clinical protocols.
• The biologic's entrenched position and regulatory history require careful navigation for stakeholders aiming to optimize its market and financial performance.

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FAQs

1. What are the key factors limiting Oprelvekin's market growth?
Limitations include competition from oral thrombopoietin receptor agonists, adverse event profiles, limited indications, and declining clinician preference for newer agents with better safety and convenience profiles.

2. Can Oprelvekin expand its indications to enhance revenue?
Potentially, but regulatory approval depends on clinical evidence demonstrating its safety and efficacy beyond current indications. Expansion efforts require substantial investment and strategic clinical trials.

3. How do regulatory policies impact Oprelvekin’s market trajectory?
Regulatory agencies' safety concerns and evolving guidelines influence clinician prescribing practices, often limiting usage and confining the drug within narrow indications.

4. Is there a significant opportunity for Oprelvekin in emerging markets?
Yes, if pricing strategies are adapted, and if there is increased awareness, but market penetration depends on infrastructure, affordability, and local clinical preferences.

5. What strategic moves could sustain Oprelvekin’s market presence?
Investing in clinical research for new indications, developing longer-acting formulations, forming strategic alliances, and securing favorable reimbursement policies would be beneficial.

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Sources:

1. FDA Prescribing Information for Oprelvekin, 1997.
2. Grand View Research, "Oncology Supportive Care Market Analysis," 2020.
3. MarketWatch, "Biologics in Thrombocytopenia," 2022.