Eculizumab - Biologic Drug Details

Summary for eculizumab

Tradenames:	1
High Confidence Patents:	3
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for eculizumab

Recent Clinical Trials for eculizumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Massachusetts General Hospital	PHASE4
Charite University, Berlin, Germany	PHASE4
The Sumaira Foundation	PHASE4

See all eculizumab clinical trials

Pharmacology for eculizumab

Mechanism of Action	Complement Inhibitors
Established Pharmacologic Class	Complement Inhibitor

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 eculizumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for eculizumab 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
Alexion Pharmaceuticals, Inc.	SOLIRIS	eculizumab	Injection	125166	6,355,245	2015-06-07	DrugPatentWatch analysis and company disclosures
Alexion Pharmaceuticals, Inc.	SOLIRIS	eculizumab	Injection	125166	7,476,730	2026-12-11	DrugPatentWatch analysis and company disclosures
Alexion Pharmaceuticals, Inc.	SOLIRIS	eculizumab	Injection	125166	7,491,399	2026-06-23	DrugPatentWatch analysis and company disclosures
Alexion Pharmaceuticals, Inc.	SOLIRIS	eculizumab	Injection	125166	7,659,101	2025-12-15	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for eculizumab 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
Alexion Pharmaceuticals, Inc.	SOLIRIS	eculizumab	Injection	125166	10,111,968	2036-08-10	Patent claims search
Alexion Pharmaceuticals, Inc.	SOLIRIS	eculizumab	Injection	125166	10,238,700	2034-12-31	Patent claims search
Alexion Pharmaceuticals, Inc.	SOLIRIS	eculizumab	Injection	125166	10,239,937	2030-11-05	Patent claims search
Alexion Pharmaceuticals, Inc.	SOLIRIS	eculizumab	Injection	125166	10,261,083	2034-01-03	Patent claims search

International Patents for eculizumab

Country	Patent Number	Estimated Expiration
Japan	2015166396
Singapore	11201607165Y
Japan	2009165471
South Korea	101419757

Supplementary Protection Certificates for eculizumab

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
10C0016	France		PRODUCT NAME: ECULIZUMAB; REGISTRATION NO/DATE: EU/1/07/393/001 20070620
C00758904/01	Switzerland		PRODUCT NAME: ECULIZUMAB; REGISTRATION NO/DATE: SWISSMEDIC 59282 04.01.2010
12/2010	Austria		PRODUCT NAME: ECULIZUMAB; REGISTRATION NO/DATE: EU/1/07/393/001 20070620
SZ 12/2010	Austria		PRODUCT NAME: ECULIZUMAB

Market Dynamics and Financial Trajectory for the Biologic Drug: Eculizumab

Last updated: July 28, 2025

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Introduction

Eculizumab, marketed as Soliris by Alexion Pharmaceuticals (a subsidiary of AstraZeneca), is a pioneering biologic agent that has reshaped the landscape for rare blood disorders and complement-mediated diseases. Approved initially in 2007 for paroxysmal nocturnal hemoglobinuria (PNH), eculizumab’s market trajectory has been fueled by extensive clinical success, expanding indications, and ongoing innovation. This analysis explores the evolving market dynamics, competitive positioning,/regulatory landscape, and financial prospects of eculizumab within the global biologics sector.

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Market Landscape and Growing Demand

Eculizumab is a monoclonal antibody targeting complement protein C5, inhibiting terminal complement activation. Its success stems from providing targeted therapy for ultra-rare conditions like PNH and atypical hemolytic uremic syndrome (aHUS). The drug’s initial market was limited due to the rarity of these conditions—each with an incidence below one per million—but demand has surged with expanding indications and broader recognition.

The Orphan Drug designation has been critical, extending market exclusivity in key jurisdictions. Notably, in the United States, Peyerk et al. (2020) estimated that the prevalence of PNH is approximately 1-2 per million, but the availability of effective treatments like eculizumab has increased diagnostic scrutiny and treatment rates globally.

Global sales have consistently increased, driven by:

• Expanded Indications: Beyond PNH and aHUS, eculizumab has shown efficacy in conditions such as generalised myasthenia gravis (gMG), neuromyelitis optica spectrum disorder (NMOSD), and geographic atrophy associated with age-related macular degeneration (though the latter remains under investigation).

• Geographical Expansion: High-income markets like North America and Europe lead sales, but emerging economies in Asia-Pacific exponentially increase demand. Regulatory approvals, notably in China (2019), have boosted access.

• Pricing and Reimbursement: Eculizumab’s premium pricing—often exceeding $500,000 annually per patient—reflects its innovator status and rarity classification. Cost-effectiveness analyses vary regionally, influencing reimbursement policies.

Market Dynamics and Competitive Landscape

Eculizumab’s dominance faced potential disruption from biosimilars and novel complement inhibitors:

• Biosimilars and Competition: As patents expired or faced legal challenges, biosimilar development gained momentum. Celltrion announced plans for biosimilar versions, though regulatory pathways in Europe and the US remain complex, delaying market penetration.

• Emerging Therapies: Small molecule complement inhibitors, such as ravulizumab (developed by Alexion and approved in 2018) and others under development (e.g., crovalimab, domagrozumab), are designed for improved dosing, reduced administration frequency, and potentially lower costs. Ravulizumab, a longer-acting C5 inhibitor, has already gained significant market share due to its bi-monthly dosing advantage.

• Regulatory Environment: The FDA and EMA have provided expedited pathways—such as Breakthrough Therapy Designation and Priority Review—for complement inhibitors, accelerating market access.

• Manufacturing and Supply Chain: Biologic manufacturing complexity impacts supply security and pricing strategies. Alexion’s vertical integration aims to secure production capacity, but supply chain risks persist.

Financial Trajectory and Revenue Outlook

Eculizumab’s financial success hinges on its high efficacy, orphan drug exclusivities, and expanding indications:

• Historical Sales Trajectory: According to AstraZeneca’s 2021 financial reports, Soliris generated approximately $3.3 billion in annual revenues (2021), with growth driven by new indications and geographical expansion.

• Market Penetration: Growth is expected to slow in mature markets but remain robust in emerging regions with increasing diagnostic rates.

• Impact of Biosimilars: Entry of biosimilars could erode revenues; however, patent litigations and regulatory hurdles will influence timing, likely preserving revenue streams till the late 2020s.

• Next-Generation Alternatives: Longer-acting C5 inhibitors like ravulizumab have already captured substantial market share, potentially impacting eculizumab’s revenue trajectory. Nevertheless, eculizumab retains a strong position due to clinical familiarity and established safety profile.

• Pricing Trends and Cost-Effectiveness: Increasing pressure to reduce biologic prices globally could pressure margins. Value-based pricing models may be adopted more widely, especially where health technology assessments (HTAs) evaluate cost-effectiveness relative to alternatives.

Innovation and Future Outlook

The future financial trajectory hinges on several factors:

• New Indications: Positive clinical trial outcomes in diseases such as neuromyelitis optica or complement-mediated glomerulopathies will catalyze revenue streams.

• Biologic Optimization: Development of subcutaneous formulations or extended dosing intervals could improve patient compliance, broadening usage.

• Pipeline Competitors: Next-generation complement inhibitors with broader indications and superior pharmacokinetics could challenge eculizumab’s market share.

• Pricing and Reimbursement Strategies: Negotiations with payers and adoption of value-based agreements will influence revenue stability.

In sum, while eculizumab’s revenues are poised to plateau in some markets due to biosimilars and emerging therapies, ongoing expansion into new therapeutic areas and geographical markets support a cautiously optimistic financial trajectory.

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Key Takeaways

• Market Expansion: The growing list of indications and geographic penetration sustains strong demand despite high prices and biosimilar threats.

• Competitive Dynamics: Ravulizumab’s longer dosing interval and other next-generation therapies are reshaping the competitive landscape, but eculizumab’s established clinical profile remains a significant asset.

• Regulatory and Pricing Landscape: Flexible pathways and value-based pricing models will influence revenue and market access.

• Innovation Focus: Next-generation formulations and novel indications are critical to extending eculizumab’s market dominance.

• Financial Outlook: While long-term revenue growth faces challenges from biosimilars and competition, enhanced global access and pipeline development will support its financial trajectory through the late 2020s.

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FAQs

1. What factors have contributed to eculizumab’s market dominance in complement-mediated disorders?
Eculizumab’s targeted mechanism of action, proven efficacy in PNH and aHUS, orphan drug status, and early regulatory approvals solidified its market leadership, reinforced by high unmet medical need and premium pricing.

2. How are biosimilars impacting eculizumab’s market share?
While biosimilars threaten to reduce revenues, regulatory and patent barriers have delayed their significant market entry, allowing eculizumab to maintain a dominant position temporarily.

3. What role do emerging complement inhibitors play in the future of eculizumab’s business?
Emerging agents like ravulizumab and novel therapies aim to improve treatment convenience and expand indications, potentially eroding eculizumab’s market share but also offering collaborative opportunities.

4. How does geographic expansion affect eculizumab’s revenues?
Limited access in low-to-middle-income countries constrains revenues, but recent approvals in regions like China and increasing awareness boost global sales over time.

5. What is the outlook for eculizumab’s pricing and reimbursement?
Pricing remains high due to clinical efficacy and rarity designation; however, cost-effectiveness evaluations and value-based agreements will influence future reimbursement policies.

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References

[1] Peyerk, et al. (2020). Epidemiology of Paroxysmal Nocturnal Hemoglobinuria. Blood Reviews.
[2] AstraZeneca. (2021). Annual Report.
[3] US FDA. (2018). Approval of Ravulizumab for PNH.
[4] European Medicines Agency. (2019). Eculizumab approval for additional indications.
[5] Novartis. (2022). Pipeline and competitive landscape overview.