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Last Updated: February 12, 2025

SOLIRIS Drug Profile


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Recent Clinical Trials for SOLIRIS

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Turgut Ardika PTY LTDPhase 1
NovelMed TherapeuticsPhase 2
Regeneron PharmaceuticalsPhase 3

See all SOLIRIS clinical trials

Recent Litigation for SOLIRIS

Identify key patents and potential future biosimilar entrants

District Court Litigation
Case NameDate
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 SOLIRIS litigation

PTAB Litigation
PetitionerDate
Samsung Bioepis Co., Ltd.2023-05-31
Samsung Bioepis Co., Ltd.2023-05-18
Amgen Inc.2019-02-28

See all SOLIRIS litigation

Pharmacology for SOLIRIS
Mechanism of ActionComplement Inhibitors
Established Pharmacologic ClassComplement 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
  2. 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.

  3. General brand-side disclosures
  4. 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.

  5. Patents from broad patent text search
  6. 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 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 ⤷  Try for Free 2019-03-12 Company disclosures
Alexion Pharmaceuticals, Inc. SOLIRIS eculizumab Injection 125166 ⤷  Try for Free 2027-03-15 Company disclosures
Alexion Pharmaceuticals, Inc. SOLIRIS eculizumab Injection 125166 ⤷  Try for Free 2027-03-15 Company disclosures
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Patent No. >Estimated Patent Expiration >Source

3) Low Certainty: US Patents for SOLIRIS Derived from Patent Text Search

These patents were obtained by searching patent claims

Supplementary Protection Certificates for SOLIRIS

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C300433 Netherlands ⤷  Try for Free PRODUCT NAME: ECULIZUMAB; REGISTRATION NO/DATE: EU/1/07/393/001 20070620
SPC002/2010 Ireland ⤷  Try for Free SPC002/2010: 20100902, EXPIRES: 20200430
122009000075 Germany ⤷  Try for Free PRODUCT NAME: ECULIZUMAB; REGISTRATION NO/DATE: EU/1/07/393/001 20070620
>Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Market Dynamics and Financial Trajectory for SOLIRIS

Introduction

SOLIRIS, a drug developed by Alexion Pharmaceuticals (now part of AstraZeneca), is a groundbreaking treatment for several rare and autoimmune diseases, including Paroxysmal Nocturnal Hemoglobinuria (PNH), atypical Hemolytic Uremic Syndrome (aHUS), and generalized Myasthenia Gravis (gMG). Here, we delve into the market dynamics and financial trajectory of SOLIRIS.

Market Size and Growth

The SOLIRIS market has experienced significant growth over the years. As of 2020, the global SOLIRIS market size was valued at USD 4.1 billion and is projected to reach USD 7.2 billion by 2028, growing at a Compound Annual Growth Rate (CAGR) of 7.3% during the forecast period[1].

Key Indications and Market Share

PNH is the largest indication for SOLIRIS, accounting for over 50% of the global market revenue in 2020. However, aHUS is the fastest-growing indication, with a projected CAGR of 9.5% during the forecast period[1].

Regional Market Analysis

  • North America: This region is the largest market for SOLIRIS, accounting for over 50% of the global market revenue in 2020. The United States dominates this market, driven by high prevalence of rare diseases, well-established healthcare infrastructure, and favorable reimbursement policies[1].
  • Europe: Europe is the second-largest market, driven by increasing awareness and diagnosis of rare diseases, growing demand for targeted therapies, and a favorable regulatory environment. However, cost-containment measures and competition from biosimilars and novel therapies temper the growth[1].
  • Asia Pacific: This is the fastest-growing regional market, with a projected CAGR of 10.5% during the forecast period. The growth is driven by a large and growing patient population, increasing healthcare spending, and improving diagnostic capabilities and treatment access[1].

Market Drivers

Several factors drive the growth of the SOLIRIS market:

  • Increasing Awareness and Diagnosis: Growing awareness and diagnosis of rare diseases are key drivers.
  • High Efficacy and Safety: SOLIRIS has a strong efficacy and safety profile, making it a preferred treatment option.
  • Targeted Therapies: The increasing demand for targeted therapies, which specifically address the underlying pathophysiology of diseases, also fuels market growth[1].

Market Restraints

Despite the strong growth prospects, several challenges restrain the market:

  • High Cost: The high cost of SOLIRIS, exceeding $500,000 per patient per year, leads to significant reimbursement and access challenges, particularly in countries with limited healthcare budgets[1].
  • Competition from Biosimilars: Increasing competition from biosimilars and other novel therapies targeting the same indications is another significant challenge[1].

Competitive Landscape

The SOLIRIS market is highly consolidated, with Alexion Pharmaceuticals (now part of AstraZeneca) being the dominant player, accounting for over 90% of the global market revenue in 2020. The company's strong patent portfolio, extensive clinical development programs, and effective commercialization strategies have maintained its market leadership[1].

Financial Performance

The integration of Alexion Pharmaceuticals into AstraZeneca has had a significant impact on the financial performance of SOLIRIS. In the fourth quarter of 2022, the Rare Disease segment, which includes SOLIRIS, saw a decline due to the transition and competition, but Ultomiris, another drug in the same class, showed strong growth[2].

Future Outlook

The future outlook for the SOLIRIS market is promising but also faces several challenges:

  • Expanding Indications: The drug's expanding indications and growing adoption in emerging markets are expected to provide additional growth opportunities.
  • Competition and Patent Expiration: However, the market is expected to face increased competition from biosimilars and other novel therapies, especially as key patents for SOLIRIS expire in the coming years[1].

Impact of Biosimilars and Novel Therapies

The emergence of biosimilars and other novel therapies is a significant factor that could impact the market growth of SOLIRIS. These alternatives are expected to provide more affordable options, potentially reducing the market share of SOLIRIS[1][3].

Geographical Variations and Economic Factors

Geographical variations play a crucial role in the market dynamics of SOLIRIS. Regions with well-established healthcare infrastructures and favorable reimbursement policies, such as North America and Europe, drive the market. However, regions like Asia Pacific face challenges related to reimbursement coverage and high drug costs[1].

Key Takeaways

  • Market Growth: SOLIRIS is expected to continue growing, driven by increasing awareness and diagnosis of rare diseases and the high demand for targeted therapies.
  • Regional Dominance: North America remains the largest market, followed by Europe and Asia Pacific.
  • Challenges: High cost, competition from biosimilars, and potential patent expirations are significant challenges.
  • Future Prospects: Expanding indications and growing adoption in emerging markets offer future growth opportunities.

FAQs

Q: What is the current market size of SOLIRIS? A: As of 2020, the global SOLIRIS market size was valued at USD 4.1 billion and is expected to reach USD 7.2 billion by 2028[1].

Q: What are the main indications for SOLIRIS? A: The main indications for SOLIRIS include Paroxysmal Nocturnal Hemoglobinuria (PNH), atypical Hemolytic Uremic Syndrome (aHUS), and generalized Myasthenia Gravis (gMG)[1].

Q: Who is the leading player in the SOLIRIS market? A: Alexion Pharmaceuticals, now part of AstraZeneca, is the dominant player, accounting for over 90% of the global market revenue in 2020[1].

Q: What are the major challenges facing the SOLIRIS market? A: The high cost of the drug, competition from biosimilars and other novel therapies, and potential safety concerns are significant challenges[1].

Q: What is the projected growth rate for the SOLIRIS market? A: The SOLIRIS market is expected to grow at a CAGR of 7.3% during the forecast period from 2020 to 2028[1].

Cited Sources

  1. DataHorizzon Research: Soliris Market Size, Share & Forecast 2033.
  2. AstraZeneca: Full year and Q4 2022 results announcement.
  3. Market Research Intellect: Global Soliris Drug Consumption Market Size And Forecast.
  4. Valuates Reports: Soliris Drug - Market, Report Size, Worth, Revenue, Growth, Industry.

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