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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for eculizumab

Recent Clinical Trials for eculizumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
AstraZeneca	N/A
Alexion	N/A
AstraZeneca	Phase 3

See all eculizumab clinical trials

Recent Litigation for eculizumab

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Alexion Pharmaceuticals, Inc. v. Samsung Bioepis Co. Ltd.	2024-05-20
Alexion Pharmaceuticals, Inc. v. Samsung Bioepis Co. Ltd.	2024-01-03
Janssen Biotech, Inc. v. Amgen Inc.	2022-11-29

See all eculizumab litigation

PTAB Litigation

Petitioner	Date
Samsung Bioepis Co., Ltd.	2023-05-31
Samsung Bioepis Co., Ltd.	2023-05-18
Amgen Inc.	2019-02-28

See all eculizumab litigation

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. 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 eculizumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for eculizumab Derived from 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		2019-03-12	Company disclosures
Alexion Pharmaceuticals, Inc.	SOLIRIS	eculizumab	Injection	125166		2027-03-15	Company disclosures
Alexion Pharmaceuticals, Inc.	SOLIRIS	eculizumab	Injection	125166		2027-03-15	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		2032-02-15	Patent claims search
Alexion Pharmaceuticals, Inc.	SOLIRIS	eculizumab	Injection	125166		2034-01-02	Patent claims search
Alexion Pharmaceuticals, Inc.	SOLIRIS	eculizumab	Injection	125166		2029-11-05	Patent claims search
Alexion Pharmaceuticals, Inc.	SOLIRIS	eculizumab	Injection	125166		2033-01-04	Patent claims search
Alexion Pharmaceuticals, Inc.	SOLIRIS	eculizumab	Injection	125166		2039-05-17	Patent claims search
Alexion Pharmaceuticals, Inc.	SOLIRIS	eculizumab	Injection	125166		2026-09-10	Patent claims search
Alexion Pharmaceuticals, Inc.	SOLIRIS	eculizumab	Injection	125166		2033-03-19	Patent claims search

International Patents for eculizumab

Country	Patent Number	Estimated Expiration
Japan	2018165277
European Patent Office	2001490
South Korea	20090076960
European Patent Office	2270047
European Patent Office	2270046
South Korea	20040000388
European Patent Office	2910253

Supplementary Protection Certificates for eculizumab

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2010C/010	Belgium		PRODUCT NAME: ECULIZUMAB; AUTHORISATION NUMBER AND DATE: EU/1/07/393/001 20070620
122009000075	Germany		PRODUCT NAME: ECULIZUMAB; REGISTRATION NO/DATE: EU/1/07/393/001 20070620
10C0016	France		PRODUCT NAME: ECULIZUMAB; REGISTRATION NO/DATE: EU/1/07/393/001 20070620
12/2010	Austria		PRODUCT NAME: ECULIZUMAB; REGISTRATION NO/DATE: EU/1/07/393/001 20070620
SPC/GB10/015	United Kingdom		PRODUCT NAME: ECULIZUMAB; REGISTERED: UK EU/1/07/393/001 20070620
SZ 12/2010	Austria		PRODUCT NAME: ECULIZUMAB
CA 2010 00003	Denmark

Market Dynamics and Financial Trajectory of Eculizumab

Introduction

Eculizumab, marketed under the brand name Soliris, is a groundbreaking drug developed by Alexion Pharmaceuticals Inc. for the treatment of rare and severe diseases. This article delves into the market dynamics and financial trajectory of eculizumab, highlighting its growth, regulatory landscape, and financial performance.

Market Growth and Projections

The eculizumab market is poised for substantial growth, driven by several key factors. The global market is expected to expand significantly between 2024 and 2032, with a projected Compound Annual Growth Rate (CAGR) of XX.X%[1].

• Forecasted Value: By 2032, the market is estimated to reach a value of USD xx.x billion, underscoring the long-term potential of the sector.
• Regional Dominance: North America, particularly the United States, and Europe are expected to play crucial roles in the market's growth due to the high adoption of advanced technology and the presence of major players in these regions[1].

Regulatory Landscape

Eculizumab's success is closely tied to its regulatory approvals and orphan drug designations.

• Orphan Drug Status: Eculizumab has been designated as an orphan drug in the US, Europe, Japan, and other countries, except in Brazil. This status has provided significant market exclusivity and regulatory benefits[2][4].
• Patent Protection: The first patent for eculizumab was filed in 1995, and since then, 32 patent families with 98 applications have been granted. This extensive patent protection has helped extend the monopoly period for Alexion Pharmaceuticals[2][4].

Clinical Indications and Expansion

Eculizumab has been approved for several rare diseases, including paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic-uremic syndrome (aHUS), refractory generalized myasthenia gravis (gMG), and neuromyelitis optica spectrum disorder (NMOSD).

• Therapeutic Expansion: The drug's clinical indications have progressively expanded, contributing to its market growth. For instance, its approval for gMG marked one of the best launches for Alexion in the first year following regulatory approval[3].
• Geographic Expansion: The drug's marketing approvals have been extended across various regions, further enhancing its market reach and revenue[2][4].

Financial Performance

Alexion Pharmaceuticals has seen significant financial gains from eculizumab.

• Revenue Contribution: Between 2007 and 2019, Alexion's revenues from eculizumab exceeded $25 billion, with the drug accounting for 79.1% of the company's total revenues in 2019[2][4].
• Annual Sales: In 2018, Soliris (eculizumab) net product sales reached $3,563.0 million, a 13% increase from 2017. This trend reflects the drug's consistent market performance[3].

Pricing and Cost Implications

Eculizumab is known for its high pricing, which is a common characteristic of orphan drugs.

• Cost per Patient: The estimated annual cost of eculizumab per patient in the US was around $410,000 in 2010, making it one of the most expensive drugs in the world[2].
• Total Annual Expenditure: For patients with PNH, the total annual expenditure based on FDA-approved dosing ranged from $432,240 to $542,640 per patient[2].

Competitive Landscape

While eculizumab remains a dominant player, other drugs are emerging as competitors.

• Ravulizumab: Developed by Alexion Pharmaceuticals as well, ravulizumab has shown to reduce the lost productivity costs associated with treatment compared to eculizumab. This could potentially impact the market dynamics in the future[5].

Regional Market Analysis

The market for eculizumab is distributed across several key regions.

• North America: This region, particularly the United States, is expected to continue playing a significant role due to high technology adoption and the presence of major pharmaceutical companies[1].
• Europe: Europe also shows a magnificent growth in CAGR during the forecast period, driven by similar factors[1].
• Asia-Pacific: Countries like China, Japan, and India are emerging markets with growing potential for eculizumab due to increasing healthcare spending and regulatory support[1].

Entry Strategies and Market Penetration

For companies looking to enter or expand in the eculizumab market, several strategies are crucial.

• Regulatory Navigations: Understanding and leveraging orphan drug designations and patent protections are key to market success[2][4].
• Public Procurement: Focusing on public procurement niches can enhance revenue and market penetration[2].
• Therapeutic Expansion: Continuously expanding the therapeutic indications and geographic reach of the drug can drive growth[2][4].

Economic Impact and Productivity

The economic impact of eculizumab extends beyond direct revenues.

• Lost Productivity Costs: Studies have shown that treatments like ravulizumab can reduce lost productivity costs associated with eculizumab, highlighting the need for efficient treatment regimens[5].

Key Takeaways

• Market Growth: The eculizumab market is expected to grow significantly between 2024 and 2032.
• Regulatory Benefits: Orphan drug designations and extensive patent protection have been crucial for the drug's market success.
• Financial Performance: Eculizumab has generated over $25 billion in revenues for Alexion Pharmaceuticals between 2007 and 2019.
• High Pricing: The drug is known for its high cost, which is typical for orphan drugs.
• Competitive Landscape: Emerging drugs like ravulizumab may impact the market dynamics in the future.

FAQs

What is eculizumab used for?

Eculizumab is used to treat rare and severe diseases such as paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic-uremic syndrome (aHUS), refractory generalized myasthenia gravis (gMG), and neuromyelitis optica spectrum disorder (NMOSD)[2][4].

Who is the largest manufacturer of eculizumab?

The largest manufacturer of eculizumab is Alexion Pharmaceuticals Inc.[1][2].

What is the estimated annual cost of eculizumab per patient?

The estimated annual cost of eculizumab per patient in the US was around $410,000 in 2010[2].

How has the market for eculizumab grown over the years?

The market for eculizumab has shown consistent growth, with revenues exceeding $25 billion between 2007 and 2019. In 2018, Soliris (eculizumab) net product sales reached $3,563.0 million, a 13% increase from 2017[2][3].

What are the key regions driving the growth of the eculizumab market?

North America, particularly the United States, and Europe are expected to drive the growth of the eculizumab market due to high technology adoption and the presence of major pharmaceutical companies[1].

Sources

1. Global Market Statistics - Soliris (Eculizumab) Market Size, Share, Scope, Analysis 2032
2. PLOS ONE - Dynamics of patents, orphan drug designation, licensing, and revenues from drugs for rare diseases: The market expansion of eculizumab
3. Alexion Pharmaceuticals - Alexion Reports Fourth Quarter and Full Year 2018 Results
4. PubMed - Dynamics of patents, orphan drug designation, licensing, and marketing authorization process in different countries and regulatory systems
5. PubMed - Quantifying the economic effects of ravulizumab versus eculizumab