KINERET Drug Profile

Summary for Tradename: KINERET

High Confidence Patents:	7
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for KINERET

Recent Clinical Trials for KINERET

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
CMIC Co, Ltd. Japan	Phase 3
Monash Medical Centre	Phase 1/Phase 2
Monash University	Phase 1/Phase 2

See all KINERET clinical trials

Pharmacology for KINERET

Mechanism of Action	Interleukin 1 Receptor Antagonists
Established Pharmacologic Class	Interleukin-1 Receptor Antagonist

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 KINERET Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for KINERET 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
Swedish Orphan Biovitrum Ab (publ)	KINERET	anakinra	Injection	103950			DrugPatentWatch analysis and company disclosures
Swedish Orphan Biovitrum Ab (publ)	KINERET	anakinra	Injection	103950			DrugPatentWatch analysis and company disclosures
Swedish Orphan Biovitrum Ab (publ)	KINERET	anakinra	Injection	103950			DrugPatentWatch analysis and company disclosures
Swedish Orphan Biovitrum Ab (publ)	KINERET	anakinra	Injection	103950			DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for KINERET 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
Swedish Orphan Biovitrum Ab (publ)	KINERET	anakinra	Injection	103950		2036-12-20	Patent claims search
Swedish Orphan Biovitrum Ab (publ)	KINERET	anakinra	Injection	103950		2035-05-22	Patent claims search
Swedish Orphan Biovitrum Ab (publ)	KINERET	anakinra	Injection	103950		2035-11-12	Patent claims search
Swedish Orphan Biovitrum Ab (publ)	KINERET	anakinra	Injection	103950		2036-08-10	Patent claims search

International Patents for KINERET

Country	Patent Number	Estimated Expiration
Japan	3192651
Hungary	893412
South Korea	970002917
South Korea	900700618

Supplementary Protection Certificates for KINERET

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
SPC/GB02/026	United Kingdom		PRODUCT NAME: ANAKINRA (ALSO KNOWN AS HUMAN IL-1RA); REGISTERED: UK EU/1/02/203/001 20020308; UK EU/1/02/203/002 20020308; UK EU/1/02/203/003 20020308; UK EU/1/02/203/004 20020308
23/2002	Austria		PRODUCT NAME: ANAKINRA; REGISTRATION NO/DATE: EU/1/02/203/001- EU/1/02/203/004 20020308
2002C/023	Belgium		PRODUCT NAME: ANAKINRA; REGISTRATION NO/DATE: EU/1/02/203/001 20020311
C300091	Netherlands		PRODUCT NAME: ANAKINRA; REGISTRATION NO/DATE: EU/1/02/203/001-004 20020308

Market Dynamics and Financial Trajectory for KINERET

Last updated: September 29, 2025

Introduction

Kineret (anakinra) is a biologic drug developed by Swedish pharmaceutical company Swedish Orphan Biovitrum (Sobi). It is primarily indicated for the treatment of rheumatoid arthritis (RA), neonatal-onset multisystem inflammatory disease (NOMID), and other auto-inflammatory conditions. As a recombinant human interleukin-1 receptor antagonist, Kineret plays a critical role in modulating immune responses. This analysis evaluates the current market landscape, growth drivers, competitive environment, and financial outlook of Kineret, providing insights for stakeholders and investors.

Market Overview

Global Rheumatoid Arthritis Market

Rheumatoid arthritis remains a significant driving force for Kineret's sales. The global RA market, valued at approximately USD 25 billion in 2022, demonstrates steady growth owing to increasing disease prevalence, earlier diagnosis, and evolving treatment paradigms favoring biologics over conventional DMARDs (Disease-Modifying Anti-Rheumatic Drugs). The adoption of targeted biologics like Kineret is anticipated to expand further as treatment guidelines evolve to include cytokine inhibitors when traditional therapies fail.

Indications Expansion

Beyond RA, Kineret's approved indications include systemic juvenile idiopathic arthritis (sJIA), cryopyrin-associated periodic syndromes (CAPS), NOMID, and adult-onset Still’s disease. The drug’s role in these rare auto-inflammatory diseases presents a niche but lucrative market segment, especially due to orphan drug incentives and high unmet needs in these areas.

Market Penetration and Patient Access

Kineret's utilization varies globally, with higher adoption rates in North America and Europe, driven by robust healthcare systems and specialist familiarity. However, competition from other IL-1 inhibitors such as canakinumab and rilonacept, and advances in biologic therapy against TNF-alpha and IL-6, influence market share and pricing strategies.

Market Dynamics

Competitive Landscape

Kineret faces competition from several IL-1 blockers, notably canakinumab (Ilaris), with broader patent protection and longer dosing intervals. The competitive environment has prompted price competition, influencing profitability. Additionally, newer biologics and small molecule inhibitors targeting pathways like JAK-STAT threaten to erode market share.

Regulatory and Pricing Dynamics

Regulatory agencies have tightened standards for biologics, emphasizing comparative effectiveness and cost-efficiency. The introduction of biosimilars and price negotiation mechanisms across markets pressures pricing. Nevertheless, orphan indications often command premium pricing due to limited competition, especially in rare inflammatory conditions.

Innovation and Pipeline Developments

While Kineret's primary usage remains steady, research into combination therapies and novel indications such as osteoarthritis or COVID-19-associated cytokine storms (where IL-1 pathways are implicated) could expand its market application. Trials investigating long-acting formulations aim to improve adherence, potentially augmenting sales.

Market Challenges

Key challenges encompass patent expirations, biosimilar entry in some jurisdictions, and the emergence of alternative pathways for diseases traditionally treated with IL-1 antagonists. Moreover, safety concerns associated with immunomodulation and the high costs of biologics influence prescribing patterns.

Financial Trajectory

Historical Financial Performance

Kineret's sales peaked around 2014-2015, with revenues exceeding USD 500 million globally. Since then, sales have exhibited a decline owing to increased competition, patent cliff effects, and market saturation. In 2022, estimates suggest revenues hovered around USD 300-350 million, with North America accounting for the majority share.

Revenue Drivers

• Market Penetration and Prescriber Acceptance: Expansion in pediatric and rare disease indications.
• Pricing Strategies: Premiums maintained in orphan indications.
• Geographic Expansion: Increased penetration in emerging markets, where biologic adoption is increasing but pricing pressures are less intense.

Cost Structure and Margins

Manufacturing costs for biologics like Kineret remain high due to complex biologic production processes. R&D expenditures are substantial, especially for pipeline development. Gross margins are likely in the 60-70% range, but net margins are impacted by distribution, marketing, and pricing pressures.

Future Revenue Projections

Projections vary but generally indicate a declining trend unless the company sustains innovation or expands indications. Market analysts forecast a compound annual decline rate (CADR) of approximately 4-6% over the next five years unless new markets or therapeutic uses are realized.

Strategic Initiatives

Sobi's strategic focus on optimizing manufacturing efficiencies, expanding into rare disease markets, and exploring biosimilar partnerships may stabilize or slightly augment revenues. Preclinical and clinical trials for Kineret in COVID-19 cytokine storm management symbolize potential for new revenue streams, contingent on successful outcomes.

Market Growth Drivers

• Increasing Prevalence: RA affects an estimated 0.5-1% of the global population, with rising incidence linked to aging demographics.
• Advancements in Biologic Therapies: Continued shift toward targeted cytokine inhibitors enhances biologic sales.
• Orphan Disease Status: Facilitates favorable pricing and market exclusivity in rare inflammatory conditions.

Market Restraints

• Competitive Biosimilars: Entry in some markets reduces Kineret’s market share.
• Cost-Effectiveness Concerns: Heightened scrutiny of biologic costs causes reimbursement challenges.
• Evolving Treatment Guidelines: Favor newer, longer-acting agents potentially supplanting Kineret.

Regulatory Outlook and Implications

Regulatory agencies are increasingly emphasizing value-based assessments, affecting reimbursement strategies. The potential for expanded approvals hinges on clinical trial outcomes, especially in new indications such as autoinflammatory syndromes or COVID-19. These developments could either bolster or curtail Kineret's market trajectory.

Conclusion

Kineret operates in a highly competitive, dynamic landscape driven by advances in biologic therapy, pricing pressures, and regulatory shifts. While current revenues indicate a declining trend, strategic repositioning toward orphan indications and innovative formulations may sustain its relevance. Continued investment in pipeline development and geographic expansion remains critical to offset market headwinds.

---

Key Takeaways

• Established niche presence in auto-inflammatory diseases provides revenue stability amid competitive pressures.
• Market decline driven by biosimilars and newer biologics necessitates innovation and indication expansion.
• Pricing and reimbursement strategies must adapt to global regulatory and economic landscapes, especially in emerging markets.
• Pipeline prospects, including long-acting formulations and novel indications, could mitigate revenue erosion.
• Stakeholders should monitor regulatory developments and clinical trial outcomes to inform investment decisions.

---

FAQs

1. What are the primary indications for Kineret, and how do they influence its market size?
   Kineret is primarily indicated for RA, NOMID, CAPS, and sJIA. Its niche in rare autoinflammatory diseases sustains revenue through orphan drug status and high per-patient pricing, but the overall market size is limited compared to broader autoimmune indications.

2. How does competition from biosimilars impact Kineret’s future sales?
   Biosimilar entry, particularly in European and other mature markets, exerts downward pressure on pricing and market share, especially as patent protections expire, potentially reducing revenues by up to 30-50% in affected regions.

3. Are there promising pipeline developments that could revitalize Kineret’s market?
   Yes, research into longer-acting formulations and new indications like COVID-19 cytokine storm intervention could open additional revenue streams if clinical trials demonstrate safety and efficacy.

4. What strategies are Sobi employing to maintain Kineret’s market relevance?
   Sobi focuses on expanding into rare indications, optimizing manufacturing, and exploring strategic partnerships for biosimilars and combination therapies to sustain sales.

5. What are the key risks influencing Kineret’s financial outlook?
   Risks include patent expirations, competitive biosimilar entry, regulatory restrictions, safety concerns, and reimbursement challenges that could accelerate revenue decline.

---

References

[1] Market Research Future, "Global Rheumatoid Arthritis Market Report," 2022.
[2] Sobi Annual Reports, 2019-2022.
[3] EvaluatePharma, "Biologic Drugs Market Analysis," 2022.
[4] FDA and EMA Regulatory Guidelines, 2021.
[5] GlobalData, "Auto-inflammatory Disease Market Outlook," 2022.