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	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 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	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 SOLIRIS

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

Supplementary Protection Certificates for SOLIRIS

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: SOLIRIS

Last updated: September 23, 2025

Introduction

SOLIRIS (eculizumab) is a pioneering biologic drug developed by Alexion Pharmaceuticals, now a subsidiary of AstraZeneca, targeting complement-mediated disorders. Since its launch in 2007, SOLIRIS has become a cornerstone in the treatment of rare and severe conditions such as paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and neuromyelitis optica spectrum disorder (NMOSD). Its unique mechanism of action, high unmet medical need, and regulatory approvals drive its market dynamics and financial trajectory. This analysis explores the key factors influencing SOLIRIS’s growth, competitive landscape, market challenges, and future outlook.

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Market Dynamics of SOLIRIS

1. Therapeutic Indications and Clinical Validation

SOLIRIS operates by inhibiting the complement component C5, pivotal in immune-mediated hemolytic and neuro-inflammatory conditions. The drug’s initial approval for PNH in 2007 significantly addressed an unmet medical need, positioning it as a first-in-class therapy [1]. Subsequently, approvals expanded for aHUS in 2013 and NMOSD in 2019, reflecting its broad potential within complement dysregulation disorders.

Clinical trial data underpin its efficacy and safety profile, with studies demonstrating substantial reductions in hemolysis and improved quality of life. For instance, pivotal trials like the PEGASUS study for PNH indicated that SOLIRIS markedly decreased hemolytic episodes and transfusion dependence, fostering clinician confidence [2].

2. Market Penetration and Patient Access

The high price point associated with biologics limits widespread adoption but is offset by the rarity and severity of target conditions. SOLIRIS’s orphan drug designation grants market exclusivity, shielding against generic competition until 2024 (EU) and 2027 (US).

Global penetration remains uneven, with North America representing the largest market due to advanced healthcare infrastructure, regulatory support, and high disease awareness. Europe and Japan follow, supported by reimbursement pathways. Emerging markets exhibit growth potential, contingent on regulatory approvals and cost access strategies.

3. Competitive Landscape and Next-Generation Therapies

While SOLIRIS maintains a dominant position, competition arises from emerging complement inhibitors, such as AstraZeneca's Ultomiris (ravulizumab), which offers longer dosing intervals, and experimental agents targeting alternative complement pathways. The advent of biosimilars is unlikely in the near term due to complex manufacturing and patent protections.

Furthermore, gene therapies and small molecules targeting upstream complement components threaten to disrupt current treatment paradigms, pressuring SOLIRIS to innovate or expand its indications.

4. Regulatory and Patent Factors

Intellectual property rights have historically shielded SOLIRIS, but expiry of exclusivity could facilitate biosimilar entry. Strategic patent shielding and continuous clinical development underpin its sustained market presence.

Regulatory agencies are increasingly emphasizing real-world evidence and safety monitoring, influencing post-approval strategies and market infusion.

5. Pricing, Reimbursement, and Market Access

Pricing strategies for SOLIRIS hinge on its clinical benefits and rarity status. Payors negotiate discounts and employ cost-effectiveness models to determine reimbursement. In the US, high list prices (~$500,000 annually for PNH treatment) integrate with value-based contracts to optimize accessibility.

Global reimbursement challenges and healthcare budget constraints threaten sustained market penetration, especially outside high-income regions.

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Financial Trajectory of SOLIRIS

1. Revenue Generation and Growth Patterns

Since its launch, SOLIRIS has generated substantial revenue, with peak sales reaching over $3.8 billion in 2021. The drug’s revenue growth reflects expanding indications, increased patient acceptance, and global market expansion.

The introduction of Ultomiris in 2020, offering less frequent dosing, has impacted SOLIRIS’s sales trajectory but also expanded the market size by catering to different patient preferences and clinical scenarios.

2. Impact of Market Exclusivity and Patent Expirations

Patent protections have been critical in maintaining high margins. The upcoming patent expiries incentivize continued investment in new indications and formulations, vital for sustaining revenue streams.

AstraZeneca’s strategic acquisitions of rare disease assets also aim to leverage the cash flow from SOLIRIS to fund pipeline diversification.

3. Cost of Sales and Research & Development

High manufacturing costs associated with biologics, combined with ongoing R&D investments, influence profit margins. The company’s focus on manufacturing efficiencies and biosimilar risk mitigation remain pivotal.

4. Future Revenue Prospects

Projections indicate continued growth through pipeline expansion and new indications, notably complement-driven diseases outside current approval scope. The potential approval for generalized musculoskeletal disorders or age-related diseases may unlock additional revenue channels.

Furthermore, price negotiations and reimbursement policies globally will significantly influence future sales.

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Factors Influencing Future Trajectory

1. Regulatory Approvals and Pipeline Expansion

Current efforts focus on expanding SOLIRIS's indications, including neurology and rare inflammatory diseases. Positive trial outcomes and regulatory approvals will catalyze revenue growth.

2. Competitive Innovation

Sustaining market share requires innovation, especially as biosimilars and alternative therapies enter the landscape. AstraZeneca’s investment in next-generation complement inhibitors and gene therapies indicates strategic foresight.

3. Pricing Strategies and Market Access

Economic pressures necessitate value-based pricing models. Expanded payer negotiations and collaborations will determine affordability and adoption rates, especially in emerging markets.

4. Global Access and Affordability

Addressing global health disparities through tiered pricing, partnerships, and philanthropic initiatives can facilitate broader access, bolstering long-term growth.

5. Technological Advancements

Advances in biologics manufacturing, personalized medicine, and biomarker-driven treatment selection will shape the future of SOLIRIS’s commercial success.

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Key Takeaways

• SOLIRIS's leadership position stems from its efficacy in rare complement-mediated disorders and strong patent protections.
• Market growth hinges on expanding indications, global access, and navigating reimbursement landscapes.
• Competitive threats include newer therapies, biosimilars, and evolving treatment options like gene therapies.
• Financial performance remains robust, with revenues influenced by patent expiries, pipeline progress, and market access strategies.
• Innovation and strategic adaptation are crucial for maintaining market dominance amid rapid scientific and regulatory changes.

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FAQs

1. What are the primary indications for SOLIRIS?
SOLIRIS is primarily indicated for paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and neuromyelitis optica spectrum disorder (NMOSD).

2. How does the patent landscape affect SOLIRIS’s market exclusivity?
Patent protections have historically safeguarded SOLIRIS from biosimilar competition until 2024-2027, ensuring high revenue margins but presenting imminent competition risks.

3. What are the key challenges facing SOLIRIS’s market growth?
Challenges include patent expiries, competition from alternative therapies, pricing pressures, and disparities in global reimbursement and access.

4. How does AstraZeneca plan to sustain SOLIRIS’s market position?
Through pipeline expansion, indication growth, pricing strategies, global market access initiatives, and development of next-generation complement inhibitors.

5. What is the future outlook for SOLIRIS’s financial trajectory?
Expect steady growth driven by new indications, improved formulations, and expanding geographic reach, provided that regulatory and reimbursement hurdles are managed effectively.

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References

[1] Hillmen P, et al. "Eculizumab in paroxysmal nocturnal hemoglobinuria." N Engl J Med. 2006;355(12):1233-1243.
[2] Röth A, et al. "Pegcetacoplan for Complement-Mediated Hemolytic Anemia." N Engl J Med. 2021;385(9):806-816.