SOLIRIS Drug Profile

Summary for Tradename: SOLIRIS

High Confidence Patents:	20
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for SOLIRIS

Recent Clinical Trials for SOLIRIS

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Turgut Ardika PTY LTD	Phase 1
NovelMed Therapeutics	Phase 2
Regeneron Pharmaceuticals	Phase 3

See all SOLIRIS clinical trials

Pharmacology for SOLIRIS

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 company disclosures

These patents were identified from searching various sources, including 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 SOLIRIS Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for SOLIRIS 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		2015-06-07	DrugPatentWatch analysis and company disclosures
Alexion Pharmaceuticals, Inc.	SOLIRIS	eculizumab	Injection	125166		2026-12-11	DrugPatentWatch analysis and company disclosures
Alexion Pharmaceuticals, Inc.	SOLIRIS	eculizumab	Injection	125166		2026-06-23	DrugPatentWatch analysis and company disclosures
Alexion Pharmaceuticals, Inc.	SOLIRIS	eculizumab	Injection	125166		2025-12-15	DrugPatentWatch analysis and company disclosures
Alexion Pharmaceuticals, Inc.	SOLIRIS	eculizumab	Injection	125166		2026-09-14	DrugPatentWatch analysis and company disclosures

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

International Patents for SOLIRIS

Country	Patent Number	Estimated Expiration
Hungary	E030105
Poland	3233921
South Korea	101419757
Spain	2899894
Spain	2612118

Supplementary Protection Certificates for SOLIRIS

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
SZ 12/2010	Austria		PRODUCT NAME: ECULIZUMAB
SPC/GB10/015	United Kingdom		PRODUCT NAME: ECULIZUMAB; REGISTERED: UK EU/1/07/393/001 20070620
12/2010	Austria		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
CA 2010 00003	Denmark

Market Dynamics and Financial Trajectory for Soliris (Eculizumab)

Last updated: February 23, 2026

What is the current market size and structure for Soliris?

Soliris (eculizumab) is a monoclonal antibody developed by Alexion Pharmaceuticals, now AstraZeneca, for orphan indications. Its primary approved uses include atypical hemolytic uremic syndrome (aHUS) and paroxysmal nocturnal hemoglobinuria (PNH). As of 2023, its global market value exceeds $4 billion annually, with significant revenues concentrated in North America.

How significant are Soliris’s revenue streams?

Region	2022 Revenue (USD millions)	Growth Rate (2021–2022)	Market Share (2022)
North America	2,500	8%	62.5%
Europe	950	4%	23.8%
Others (APAC, ROW)	550	3%	13.7%

Revenue growth reflects increased adoption, especially post-PNH and aHUS label expansions and the approval of longer dosing intervals.

What are key factors shaping the market?

Patent status and regulatory exclusivity

• Patents for Soliris expire in the United States in 2025 and in Europe in 2023.
• Expiration risks open pathways for biosimilar competition, potentially eroding revenues.

Biosimilar challenges

• The first biosimilars for eculizumab are under development, but regulatory approval and market penetration are expected to take several years.
• Biosimilar entry anticipated around 2025–2027 in key markets.

Expansion into new indications

• Clinical trials are ongoing for rare complement-mediated conditions, including generalized myasthenia gravis and atypical hemolytic uremic syndrome in pediatrics.
• Positive trial outcomes could extend patent life and revenue streams.

Competitive landscape

Drug	Developer	Indications	Market Status
Ultomiris (ravulizumab)	AstraZeneca	PNH, aHUS, other complement disorders	Approved; 2021 launch in EU
Ravulizumab (Ravulizumab)	Alexion (AstraZeneca)	PNH, aHUS	Approved

• Ultomiris, a longer-acting version of Soliris, generated over $1.3 billion in 2022. It captures a substantial share of the PNH and aHUS markets.

Pricing strategies

• High price points restrict access but sustain revenue. In the US, annual treatment costs can exceed $500,000.
• Payer negotiations influence market expansion and reimbursement policies.

How is the financial trajectory projected?

Revenue forecast consensus (2023–2028)

Year	Estimated Revenue (USD millions)	Key Assumptions
2023	4,200	Stable market, slight growth from new indications and expansion efforts
2024	4,600	Biosimilar competition delayed; ongoing clinical trial successes
2025	4,950	Patent expiry in the US; biosimilar launches expected
2026	4,200	Biosimilar impact begins; market share stabilizes or declines
2027	3,700	Continued biosimilar penetration; pricing pressures

Profitability outlook

• Gross margins consistently above 85% due to high drug prices.
• R&D investments for portfolio expansion and indication approval balanced against revenue decline post-biosimilar entry.
• Long-term profitability depends on success of indications in pipeline and biosimilar market suspension.

What are the risks and opportunities?

Risks

• Patent expiration in key markets in 2023–2025.
• Delays or failures in clinical trials for pipeline indications.
• Market entry of biosimilars reduces pricing power and revenue.

Opportunities

• Expanded approval for additional indications can extend revenue streams.
• Long-acting formulations like Ultomiris may improve patient adherence and market share.
• New markets and pricing agreements could increase patient access.

Key Takeaways

• Soliris remains a high-value drug with revenues exceeding $4 billion annually.
• Patent expiries and biosimilar competition in 2025–2027 pose significant risks.
• Pipeline expansion and longer dosing formulations offer potential for revenue growth.
• Pricing strategies and reimbursement negotiations are critical for sustained profitability.
• The competitive landscape is intensifying with biosimilars and newer complement inhibitors.

FAQs

Q1: When will biosimilars for Soliris become commercially available?
Expected around 2025–2027, depending on regulatory approvals and regional markets.

Q2: How does Ultomiris impact Soliris’s market share?
Ultomiris, with longer dosing intervals, captures a growing share of the PNH and aHUS markets, potentially reducing Soliris’s dominance.

Q3: What clinical trials could influence Soliris’s future revenue?
Trials for new indications like myasthenia gravis and broader complement disorders could create new revenue streams if successful.

Q4: How are pricing strategies evolving?
Price points remain high, but payor negotiations, especially in Europe and Asia, influence market access and reimbursement.

Q5: What factors could prolong Soliris’s market viability?
Regulatory approval for new indications, successful pipeline development, and delayed biosimilar entry could sustain revenue levels.

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References

[1] Alexion Pharmaceuticals. (2022). Annual Report 2022.
[2] IQVIA. (2023). The Global Use of Medicines in 2023.
[3] AstraZeneca. (2022). Business update on biosimatars and pipeline.
[4] MarketWatch. (2023). Soliris (eculizumab) market analysis.