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Last Updated: January 6, 2025

ILARIS Drug Profile


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Summary for Tradename: ILARIS
High Confidence Patents:0
Applicants:1
BLAs:1
Recent Clinical Trials: See clinical trials for ILARIS
Recent Clinical Trials for ILARIS

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Uma BoratePhase 2
Mario Negri Institute for Pharmacological ResearchPhase 3
AbbViePhase 4

See all ILARIS clinical trials

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 ILARIS Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for ILARIS Derived from Company Disclosures

No patents found based on company disclosures

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

These patents were obtained by searching patent claims

ILARIS Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for the Drug: ILARIS

Introduction

ILARIS, developed by Novartis, is a monoclonal antibody used for the treatment of various inflammatory diseases, including systemic juvenile idiopathic arthritis (sJIA), tumor necrosis factor receptor-associated periodic syndrome (TRAPS), and familial cold autoinflammatory syndrome (FCAS), among others. Here, we delve into the market dynamics and financial trajectory of ILARIS.

Product Overview

Indication

ILARIS is indicated for the treatment of several rare and severe inflammatory diseases. Its mechanism of action involves binding to and inhibiting interleukin-1 beta (IL-1β), a cytokine involved in the inflammatory response[4].

Mechanism of Action

ILARIS works by neutralizing IL-1β, thereby reducing inflammation and the associated symptoms of the treated conditions. This targeted approach has made ILARIS a valuable treatment option for patients with these rare diseases[4].

Dosage and Administration

The drug is administered via subcutaneous injection, typically every 4-8 weeks, depending on the specific indication and patient response[5].

Market Assessment

Historical and Forecasted Sales

The sales data for ILARIS from 2017 to 2030 indicates a steady growth trajectory. As of the latest reports, ILARIS has seen significant sales growth across all regions, particularly in the US and Europe. For instance, in the third quarter of 2024, ILARIS sales grew by 12% in constant currency, driven by strong performance in these key markets[3].

Market Forecast

The market forecast suggests that ILARIS will continue to grow due to extensive research in the treatment of its indicated conditions and increasing healthcare spending globally. The report from ResearchAndMarkets.com provides historical and forecasted sales data, indicating a positive outlook for ILARIS through 2030[1][4].

Regional Performance

United States

In the US, ILARIS has seen substantial growth, contributing significantly to Novartis's overall sales. The drug's performance in this market is driven by its efficacy and the lack of alternative treatments for the conditions it addresses[3].

Europe

In Europe, particularly in the EU5 countries (Germany, France, Italy, Spain, and the UK), ILARIS has also shown strong sales growth. This is partly due to the drug's approval and reimbursement in these regions, as well as its clinical benefits[1][4].

Japan

In Japan, ILARIS has a smaller but growing market presence. The drug's sales in this region are expected to increase as more patients become aware of and gain access to this treatment option[1].

Competitive Landscape

Market Competitors

ILARIS faces competition from other approved products for the same indications. However, its unique mechanism of action and clinical efficacy have helped it maintain a strong market position. The launch of late-stage emerging therapies in the near future could impact the market dynamics, but ILARIS is expected to remain a significant player due to its established presence and patient loyalty[1][4].

Late-Stage Emerging Therapies

The development of novel therapies targeting the same inflammatory pathways as ILARIS could pose a challenge. However, these therapies are still in the late stages of development, and ILARIS's established market presence and clinical data will likely help it retain its market share[1][4].

Regulatory Milestones and Development Activities

Regulatory Approvals

ILARIS has received regulatory approvals in several major markets, including the US, Europe, and Japan. These approvals have been crucial in expanding its market reach and ensuring patient access to the drug[1][4].

Development Activities

Novartis and other stakeholders are continuously involved in research and development activities to improve ILARIS's efficacy and expand its indications. This ongoing research is expected to further solidify ILARIS's position in the market[1].

Financial Performance

Sales Growth

In the third quarter of 2024, ILARIS sales were reported at $372 million, with a 12% growth in constant currency. This growth is part of a broader trend of increasing sales for ILARIS across all regions[3].

Operating Income and Net Income

The overall financial performance of Novartis, driven in part by ILARIS, has been strong. For the third quarter of 2024, Novartis reported a 10% increase in sales and a 20% increase in core operating income. This performance is attributed to the strong sales of key products, including ILARIS[3].

SWOT Analysis

Strengths

  • Established Market Presence: ILARIS has a well-established presence in the market, with a strong brand and patient loyalty.
  • Clinical Efficacy: The drug's unique mechanism of action and proven clinical efficacy make it a preferred treatment option.
  • Regulatory Approvals: ILARIS has received regulatory approvals in major markets, ensuring widespread availability[1][4].

Weaknesses

  • Competition from Emerging Therapies: The potential launch of new therapies could challenge ILARIS's market position.
  • High Development Costs: Continuous research and development to maintain and expand ILARIS's indications can be costly[1][4].

Opportunities

  • Expanding Indications: Ongoing research could lead to the approval of ILARIS for additional indications, expanding its market potential.
  • Increasing Healthcare Spending: Global increases in healthcare spending could further boost ILARIS sales[1][4].

Threats

  • Generic Competition: Although not immediate, the potential for generic competition in the future could impact ILARIS's sales.
  • Regulatory Changes: Changes in regulatory environments or reimbursement policies could affect ILARIS's market access[1][4].

Key Takeaways

  • ILARIS has shown strong sales growth across major markets, driven by its clinical efficacy and established brand.
  • The drug faces competition from emerging therapies but remains a significant player due to its unique mechanism of action and regulatory approvals.
  • Ongoing research and development activities are expected to further solidify ILARIS's market position.
  • Financial performance indicators suggest a positive outlook for ILARIS through 2030.

FAQs

What is ILARIS used for?

ILARIS is used for the treatment of several rare and severe inflammatory diseases, including systemic juvenile idiopathic arthritis (sJIA), tumor necrosis factor receptor-associated periodic syndrome (TRAPS), and familial cold autoinflammatory syndrome (FCAS)[5].

How is ILARIS administered?

ILARIS is administered via subcutaneous injection, typically every 4-8 weeks, depending on the specific indication and patient response[5].

What are the key regions for ILARIS sales?

The key regions for ILARIS sales include the United States, Europe (particularly EU5 countries), and Japan[1][3].

What are the potential challenges for ILARIS in the market?

ILARIS faces potential challenges from emerging therapies, generic competition, and regulatory changes. However, its established market presence and ongoing research activities are expected to mitigate these risks[1][4].

What is the forecasted market scenario for ILARIS?

The market forecast indicates continued growth for ILARIS through 2030, driven by extensive research, increasing healthcare spending, and its established market presence[1][4].

Sources

  1. ResearchAndMarkets.com - "Ilaris - Drug Insight and Market Forecast - 2030"
  2. Novartis - "Condensed Interim Financial Report – Supplementary Data"
  3. Novartis - "Novartis continues strong momentum in Q3 with 10% sales growth"
  4. Business Wire - "Ilaris Drug Insight and Market Forecast to 2030"
  5. Minnesota Department of Human Services - "Ilaris"

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