Anakinra - Biologic Drug Details

Summary for anakinra

Tradenames:	1
High Confidence Patents:	3
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for anakinra

Recent Clinical Trials for anakinra

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
National Institute of Allergy and Infectious Diseases (NIAID)	PHASE1
NYU Langone Health	PHASE2
Swedish Orphan Biovitrum	PHASE4

See all anakinra clinical trials

Pharmacology for anakinra

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 brand-side disclosures

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.

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 anakinra Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for anakinra 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	5,075,222		DrugPatentWatch analysis and company disclosures
Swedish Orphan Biovitrum Ab (publ)	KINERET	anakinra	Injection	103950	6,599,873		DrugPatentWatch analysis and company disclosures
Swedish Orphan Biovitrum Ab (publ)	KINERET	anakinra	Injection	103950	6,858,409		DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for anakinra 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	10,016,338	2036-12-20	Patent claims search
Swedish Orphan Biovitrum Ab (publ)	KINERET	anakinra	Injection	103950	10,023,841	2035-05-22	Patent claims search
Swedish Orphan Biovitrum Ab (publ)	KINERET	anakinra	Injection	103950	10,081,657	2035-11-12	Patent claims search

International Patents for anakinra

Country	Patent Number	Estimated Expiration
Japan	H09118632
Hungary	9803037
South Africa	894052

Supplementary Protection Certificates for anakinra

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
10299011	Germany		PRODUCT NAME: KINERET(R) (WIRKSAMER BESTANDTEIL ANAKINRA); REGISTRATION NO/DATE: EU/1/02/203/001-004 20020308
SZ 23/2002	Austria		PRODUCT NAME: ANAKINRA
2002C/023	Belgium		PRODUCT NAME: ANAKINRA; REGISTRATION NO/DATE: EU/1/02/203/001 20020311

Market Dynamics and Financial Trajectory for the Biologic Drug: Anakinra

Last updated: July 27, 2025

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Introduction

Anakinra (brand name: Kineret) is a recombinant human interleukin-1 receptor antagonist (IL-1Ra) developed and marketed by Swedish pharmaceutical giant Swedish Orphan Biovitrum (Sobi) in collaboration with Amgen. Initially approved by the U.S. Food and Drug Administration (FDA) in 2001 for the treatment of rheumatoid arthritis (RA), anakinra has expanded its indications to encompass rare autoinflammatory conditions such as cryopyrin-associated periodic syndromes (CAPS) and neonatal-onset multisystem inflammatory disease (NOMID). Its unique mechanism impairs the inflammatory cascade driven by IL-1, positioning it as a crucial biologic in systemic inflammatory and autoinflammatory diseases.

This analysis explores the prevailing market dynamics, competitive landscape, regulatory considerations, and future financial trajectories influencing anakinra, providing business professionals with comprehensive insights into its commercial prospects.

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Market Landscape and Key Drivers

Global Market Size and Growth Trends

The biologic drug market—estimated to reach approximately USD 680 billion by 2025 [1]—is highly dynamic, driven by rising prevalence of chronic inflammatory diseases, advances in biologic therapies, and unmet medical needs. Anakinra's current niche aligns primarily with orphan and rare disease treatments, which tend to exhibit stable demand due to limited competition but face challenges related to market penetration and pricing.

Despite being over two decades old, anakinra exhibits a niche yet resilient demand. The global RA market alone was valued at USD 24 billion in 2022, with biologic drugs accounting for a significant share [2]. Anakinra's sales constitute a minor fraction, constrained by competition from other IL-1 inhibitors like canakinumab (Ilaris) and rilonacept (Arcalyst).

Driving Factors

1. Expanded Indications: Recent approvals for indications such as systemic juvenile idiopathic arthritis (sJIA), macrophage activation syndrome (MAS), and off-label applications in COVID-19-related cytokine storms have temporarily supported sales.

2. Unmet Medical Need: In rare autoinflammatory syndromes where treatment options are limited, anakinra remains a first-line therapy, reinforcing its ongoing relevance.

3. Biologic Monotherapy Trends: Growing preference for targeted biologics over traditional DMARDs benefits drugs like anakinra for specific patient segments.

4. Pricing and Reimbursement Policies: Variability across regions impacts revenue; while U.S. and Europe offer reimbursement pathways, pricing pressures remain.

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Market Challenges and Competitive Dynamics

Intense Competition from Alternative IL-1 Blockers

Anakinra faces stiff competition from newer IL-1 inhibitors with improved administration profiles:

• Canakinumab (Ilaris): A human monoclonal antibody with longer dosing intervals (quarterly) compared to daily anakinra injections, approved for various autoinflammatory syndromes. Its superior convenience and expanding indications have eroded anakinra's market share [3].

• Rilonacept (Arcalyst): Fusion protein that inhibits IL-1α and IL-1β, approved for CAPS. Its less frequent dosing and comparable efficacy pose challenges to anakinra [4].

Manufacturing and Pricing Constraints

Manufacturers of biologics like anakinra often face high production costs. The introduction of biosimilars is limited given the complexity of production and patent protections, but patent expirations—if they occur—could result in biosimilar competition.

Regulatory and Reimbursement Barriers

Regulatory approvals for new indications are vital. Moreover, reimbursement constraints, especially in cost-sensitive healthcare markets, limit broader adoption.

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Regulatory and Patent Landscape

While anakinra's original patents have expired in certain jurisdictions, such as Europe, they remain upheld in others. Patent litigation and exclusivity periods significantly influence market entry timing for biosimilars.

Recent regulatory approvals, including for pediatric indications, are expanding therapeutic use, potentially boosting revenues. Conversely, any delays or adverse regulatory decisions could diminish growth prospects.

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Financial Trajectory and Revenue Projections

Historical Revenue Analysis

Initially, anakinra experienced rapid uptake following its 2001 approval, particularly for RA. However, sales plateaued as newer biologics matured and gained approval, with estimates indicating global annual sales of approximately USD 250 million in recent years [5].

Forecasted Growth Factors

• Orphan and Rare Disease Indications: Continued reliance on niche markets sustains a baseline revenue, especially where alternatives are limited.

• Pipeline Development: No significant new formulations or indications are publicly confirmed, constraining substantial growth.

• Market Share Shifts: The dominance of canakinumab in autoinflammatory diseases likely suppresses anakinra's market share unless compelling cost advantages or new indications emerge.

Projected Trends

Industry analysts project a modest CAGR of around 2-3% over the next five years, stabilizing around USD 275–300 million annually, barring major disruptors or new approvals [6].

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Emerging Opportunities and Strategic Outlook

COVID-19 and Cytokine Storm Therapeutics

During the pandemic, anakinra gained emergency-use authorization in some regions to treat cytokine storms associated with severe COVID-19 cases. While this surge was transient, it underscores the potential of repurposing existing biologics for emergent indications.

Combination Therapy Potential

Combining anakinra with other biologics or small molecules for refractory conditions remains an investigational area, potentially opening new revenue streams if clinical success ensues.

Market Expansion Strategies

• Geographic Expansion: Developing markets with growing healthcare infrastructure could marginally increase penetration.

• Regulatory Filings for Additional Indications: Pursuing approvals for new autoinflammatory diseases could diversify revenue streams.

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Key Challenges and Considerations

• Competitive Pressure: The prominence of canakinumab and rilonacept dilutes anakinra's market share.

• Pricing Pressures: Reimbursement and cost containment strategies threaten margins.

• Pipeline Limitations: Without innovative formulations or indications, growth prospects remain constrained.

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Conclusion

Anakinra's market dynamics are characterized by stable demand within niche and rare disease segments, tempered by intense competition from longer-acting IL-1 inhibitors. Its financial trajectory is likely to remain modest over the coming years, with incremental growth supported by expanding indications and off-label uses. To sustain its relevance, strategic efforts should focus on regulatory advancements, exploring new indications, optimizing manufacturing efficiencies, and capitalizing on emerging therapeutic niches.

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Key Takeaways

• Anakinra maintains a vital role in niche inflammatory and autoinflammatory conditions despite stiff competition.

• The advent of more convenient IL-1 inhibitors like canakinumab has exerted downward pressure on anakinra’s market share.

• Future growth hinges on expanding indications, exploring combination therapies, and strategic geographic expansion.

• Patent positions and biosimilar entry remain pivotal factors affecting pricing and long-term revenue potential.

• The drug’s relevance was temporarily amplified during the COVID-19 pandemic, illustrating potential for repurposing in emergent health crises.

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FAQs

1. How does anakinra compare to other IL-1 inhibitors in terms of efficacy?
Anakinra demonstrates comparable efficacy in certain autoinflammatory conditions; however, its daily injection regimen and shorter half-life contrast with less frequent dosing of canakinumab and rilonacept, influencing adherence and preference.

2. Will biosimilars threaten anakinra’s market share?
Potentially in regions where patents have expired, biosimilars could reduce prices and erode profits. Nonetheless, complex manufacturing and regulatory hurdles limit immediate biosimilar availability.

3. Are there ongoing clinical trials that could expand anakinra’s indications?
Yes, ongoing research explores its efficacy in conditions like type 2 diabetes and COVID-19 cytokine storm management, which could open new markets if successful.

4. What pricing strategy could enhance anakinra’s competitiveness?
Cost-reduction through manufacturing efficiencies and strategic pricing, especially in price-sensitive markets, could improve accessibility and market penetration.

5. How might regulatory developments impact anakinra’s future?
Favorable approvals for new indications or formulations could extend its market life, whereas restrictive decisions may limit growth opportunities.

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References

1. Grand View Research. Biologic Drugs Market Size & Trends. 2022.
2. EvaluatePharma. World Preview: Outlook to 2025. 2022.
3. Prieur, A.M. et al.. "Canakinumab in the treatment of autoinflammatory syndromes." Therapeutic Advances in Musculoskeletal Disease, 2020.
4. Royle, J. et al.. "Rilonacept: Development, clinical efficacy, and safety." Expert Opinion on Biological Therapy, 2018.
5. Global Data. Anakinra Sales Analysis, 2022.
6. MarketWatch. Biologics Market Forecast, 2022–2027.