ARCALYST Drug Profile

Summary for Tradename: ARCALYST

High Confidence Patents:	4
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for ARCALYST

Recent Clinical Trials for ARCALYST

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Regeneron Pharmaceuticals	Early Phase 1
Stanley Cohen	Early Phase 1
Regeneron Pharmaceuticals	Phase 2

See all ARCALYST 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

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 ARCALYST Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for ARCALYST 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
Kiniksa Pharmaceuticals (uk), Ltd.	ARCALYST	rilonacept	For Injection	125249	11,026,997	2038-09-26	DrugPatentWatch analysis and company disclosures
Kiniksa Pharmaceuticals (uk), Ltd.	ARCALYST	rilonacept	For Injection	125249	5,844,099	2015-11-27	DrugPatentWatch analysis and company disclosures
Kiniksa Pharmaceuticals (uk), Ltd.	ARCALYST	rilonacept	For Injection	125249	6,472,179	2019-05-19	DrugPatentWatch analysis and company disclosures
Kiniksa Pharmaceuticals (uk), Ltd.	ARCALYST	rilonacept	For Injection	125249	6,927,044	2022-10-28	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for ARCALYST 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
Kiniksa Pharmaceuticals (uk), Ltd.	ARCALYST	rilonacept	For Injection	125249	10,040,859	2035-04-21	Patent claims search
Kiniksa Pharmaceuticals (uk), Ltd.	ARCALYST	rilonacept	For Injection	125249	10,064,948	2032-03-09	Patent claims search
Kiniksa Pharmaceuticals (uk), Ltd.	ARCALYST	rilonacept	For Injection	125249	10,213,444	2035-12-04	Patent claims search
Kiniksa Pharmaceuticals (uk), Ltd.	ARCALYST	rilonacept	For Injection	125249	10,329,620	2037-07-13	Patent claims search
Kiniksa Pharmaceuticals (uk), Ltd.	ARCALYST	rilonacept	For Injection	125249	10,428,059	2037-10-06	Patent claims search
Kiniksa Pharmaceuticals (uk), Ltd.	ARCALYST	rilonacept	For Injection	125249	10,507,262	2037-03-23	Patent claims search
Kiniksa Pharmaceuticals (uk), Ltd.	ARCALYST	rilonacept	For Injection	125249	10,517,933	2036-05-11	Patent claims search

International Patents for ARCALYST

Country	Patent Number	Estimated Expiration
Poland	201246
Denmark	1572967
European Patent Office	4541367
European Patent Office	1115876
Germany	60325892
China	1878871
Japan	H09504030

Supplementary Protection Certificates for ARCALYST

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
10C0025	France		PRODUCT NAME: RILONACEPT; REGISTRATION NO/DATE: EU/1/09/582/001 20091023
94 5007-2010	Slovakia		PRODUCT NAME: RILONACEPT; REGISTRATION NO/DATE: EU/1/09/582/001 20091023
372	Finland
CR 2010 00016	Denmark		PRODUCT NAME: RILONACEPT; REG. NO/DATE: EU/1/09/582/001 20091023
SPC/GB10/027	United Kingdom		PRODUCT NAME: RILONACEPT; REGISTERED: UK EU/1/09/582/001 20091023
SZ 15/2010	Austria		PRODUCT NAME: RILONACEPT
C300448	Netherlands		PRODUCT NAME: RILONACEPT; REGISTRATION NO/DATE: EU/1/09/582/001 20091023

Market Dynamics and Financial Trajectory for the Biologic Drug: ARCALYST

Last updated: September 26, 2025

Introduction

Arcalyst (rilonacept) stands as a notable biologic therapy in the treatment landscape for various autoinflammatory conditions, including cryopyrin-associated periodic syndromes (CAPS) and gout flares. As with many biologic agents, its market trajectory hinges on evolving clinical needs, competitive pressures, regulatory landscapes, and healthcare economics. This analysis explores the current market dynamics and forecasts Arcalyst’s financial trajectory within the global pharmaceutical ecosystem.

Market Overview and Therapeutic Indications

Arcalyst’s approval by the U.S. Food and Drug Administration (FDA) in 2010 marked its entry into the biologic space targeting cytokine-driven inflammatory diseases. Its primary indications, CAPS and recurrent gout flares, represent niches within the broader inflammatory and rare disease markets—areas characterized by high unmet needs and limited treatment options. While its initial focus was on rare conditions, expanded uses, such as its off-label applications for other inflammatory syndromes, underscore its potential to penetrate larger segments of the biologic market.

The global biologics market, estimated at over $430 billion in 2022 [1], continues expansive growth fueled by advances in molecular biology, increased prevalence of autoimmune diseases, and regulatory incentives for orphan drugs. Biologics like Arcalyst, with their specificity and targeted mechanisms, hold a competitive edge in treating traditionally challenging conditions.

Market Dynamics

Competitive Landscape

Arcalyst faces competition from other IL-1 inhibitors, such as canakinumab (Ilaris) and anakinra (Kineret), both of which target similar inflammatory pathways. For CAPS, canakinumab has largely overshadowed Arcalyst due to superior dosing convenience, longer half-life, and broader approved indications. This competition influences prescribing patterns and market share allocations.

Moreover, emerging pipeline agents and biosimilars threaten future dominance. Although biosimilars are either not yet developed or approved for Arcalyst, the potential for biosimilar entry in the future remains a factor to monitor, especially considering patent expirations and market consolidation.

Regulatory and Reimbursement Factors

Regulatory decisions across key markets—U.S., European Union (EU), and emerging economies—continuously reshape accessibility. The orphan drug designation affords Arcalyst incentives such as market exclusivity, but reimbursement landscape complexities—particularly in cost-sensitive healthcare systems—limit commercial potential. Clearer payer recognition of value, via health technology assessments (HTAs), influences revenue projections.

Market Penetration and Adoption

Clinical adoption patterns depend heavily on physician familiarity, treatment guidelines, and patient access. The rarity of conditions like CAPS constrains large-scale sales; however, the significant disease burden among affected populations keeps demand stable. The consolidation of specialty centers and advocacy groups accelerates awareness and diagnosis, indirectly boosting Arcalyst’s utilization.

Pricing and Market Access

Biologic pricing remains a contentious issue globally. Arcalyst’s premium positioning is justified by its targeted therapy nature but invites scrutiny under pricing reforms aiming for affordability. The manufacturer’s ability to negotiate favorable reimbursement terms critically affects revenue trajectories.

Financial Trajectory and Forecasting

Current Revenue and Growth Trends

Since its market release, Arcalyst’s revenues have been modest, primarily driven by its niche indications. Earnings reports from the pharmaceutical company (e.g., Regeneron Pharmaceuticals, which markets Arcalyst) reveal slow but steady growth, with revenue increases observed as new labels or expanded indications secure regulatory approval.

In 2021, Arcalyst’s sales figures were reported at approximately $XX million, reflecting stable demand but limited growth, constrained by its narrow indication spectrum [2]. The stability suggests a committed niche market, while an expanded pipeline and indication approvals could catalyze future growth.

Forecasting the Market

Industry analysts project moderate compound annual growth rates (CAGR) of around 4-6% for targeted biologics in rare inflammatory diseases over the next five years [3]. For Arcalyst, this growth hinges on several catalysts:

• Expanded indications: Recent or forthcoming approvals can broaden the treatment landscape. For example, Investigational use for still unapproved inflammatory syndromes could unlock new patient populations.

• Pricing strategies: Any price adjustments aligned with value-based healthcare will influence revenue potential.

• Market penetration: Increased physician education and patient diagnosis will improve utilization rates.

• Pipeline development: Second-generation formulations or biosimilars could affect market share, either through competition or by facilitating broader access.

Analyzing current trends, industry experts estimate that Arcalyst’s global sales could reach $XX million by 2030, assuming successful expansion into adjacent indications and sustained market access.

Impact of Healthcare Policy and Medical Innovation

Healthcare reforms aimed at cost containment and the advent of personalized medicine pose both threats and opportunities. The rise of biosimilar competition, especially in Europe, might erode premium pricing privileges. Conversely, innovations such as gene therapies targeting similar pathways could redefine treatment paradigms, indirectly influencing Arcalyst’s market share.

Emerging Opportunities and Challenges

Opportunities

• Orphan Drug Exclusivity: Leveraging exclusivity periods in the U.S. and EU to maximize market penetration.

• Portfolio Diversification: Developing combination therapies or new formulations improves market reach.

• Personalized Medicine: Biomarker-driven patient selection enhances efficacy and justifies premium pricing.

Challenges

• Market Competition: Intracategory competition, especially from canakinumab, challenges sales.

• Pricing Pressures: Payer reluctance to reimburse high-cost biologics affects accessibility.

• Regulatory Hurdles: Delays or denials for label expansions stall revenue growth.

• Patent Lifecycles: Patent expirations threaten biosimilar entry, risking market share erosion.

Conclusion

Arcalyst’s market outlook exhibits a complex interplay of niche opportunity, competitive rivalry, and policy influence. Its financial trajectory will depend on strategic expansion, innovation, and navigating the evolving reimbursement landscape. Although its current revenue remains modest, targeted indications and potential pipeline advancements suggest that with effective market positioning, Arcalyst can sustain a stable revenue stream within the expanding biologic therapies market.

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Key Takeaways

• Niche Positioning: Arcalyst benefits from its designation for rare autoinflammatory diseases but faces stiff competition from other IL-1 inhibitors, particularly canakinumab.

• Market Potential: Expanding indications and increased diagnosis of rare diseases present growth opportunities; however, market penetration remains limited by high costs and regulatory hurdles.

• Revenue Stability: As of recent years, Arcalyst’s revenues demonstrate stability with modest growth, but substantial upside depends on pipeline success and broader adoption.

• Competitive Risks: Biosimilar threats and pricing pressures necessitate strategic innovation and cost management to sustain market relevance.

• Future Outlook: With ongoing clinical development, potential label expansions, and strategic market access initiatives, Arcalyst’s financial trajectory could see improvements, especially if it adapts to evolving healthcare dynamics.

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FAQs

1. What are the main indications for Arcalyst, and are there plans for new approvals?
   Arcalyst is approved for cryopyrin-associated periodic syndromes and recurrent gout flares. Ongoing clinical trials explore additional inflammatory conditions, which may lead to new regulatory approvals and expanded markets.

2. How does Arcalyst compare to its competitors like canakinumab?
   Arcalyst has a shorter dosing interval and is approved for narrower indications, whereas canakinumab offers broader approval and less frequent dosing. Competition is driven by efficacy, convenience, and price considerations.

3. What factors influence Arcalyst’s market penetration in developed versus emerging markets?
   Developed markets benefit from established reimbursement frameworks and clinician familiarity, while emerging markets face challenges in affordability, regulatory approval, and infrastructure but offer growth potential due to unmet needs.

4. What is the impact of biosimilar entrants on Arcalyst’s future revenue?
   As biosimilars for IL-1 inhibitors emerge, price competition could significantly reduce Arcalyst’s market share unless it maintains a differentiation strategy or achieves new indications.

5. What strategies can enhance Arcalyst’s market presence?
   Strategies include expanding approved indications, optimizing pricing and reimbursement negotiations, investing in clinical research for new uses, and leveraging patient advocacy for awareness.

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References

[1] IQVIA, "Global Biologic Market Size and Forecast," 2022.
[2] Regeneron Pharmaceuticals, "Annual Report 2021."
[3] EvaluatePharma, "Biologics Market Outlook," 2022.