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
Patient-Centered Outcomes Research Institute	PHASE3
Yale University	PHASE3
National Institute of Allergy and Infectious Diseases (NIAID)	PHASE1

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
Swedish Orphan Biovitrum Ab (publ)	KINERET	anakinra	Injection	103950	9,198,954		DrugPatentWatch analysis and company disclosures
Swedish Orphan Biovitrum Ab (publ)	KINERET	anakinra	Injection	103950	5,075,222	2010-04-06	DrugPatentWatch analysis and company disclosures
Swedish Orphan Biovitrum Ab (publ)	KINERET	anakinra	Injection	103950	6,599,873	2015-06-06	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
Swedish Orphan Biovitrum Ab (publ)	KINERET	anakinra	Injection	103950	10,111,968	2036-08-10	Patent claims search
Swedish Orphan Biovitrum Ab (publ)	KINERET	anakinra	Injection	103950	10,124,038	2036-03-18	Patent claims search
Swedish Orphan Biovitrum Ab (publ)	KINERET	anakinra	Injection	103950	10,179,162	2035-10-29	Patent claims search

International Patents for anakinra

Country	Patent Number	Estimated Expiration
Denmark	172763
World Intellectual Property Organization (WIPO)	9534326
Spain	2176181
Australia	649245
Japan	3192651
Singapore	47099

Supplementary Protection Certificates for anakinra

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
SZ 23/2002	Austria		PRODUCT NAME: ANAKINRA
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
C300091	Netherlands		PRODUCT NAME: ANAKINRA; REGISTRATION NO/DATE: EU/1/02/203/001-004 20020308
10299011	Germany		PRODUCT NAME: KINERET(R) (WIRKSAMER BESTANDTEIL ANAKINRA); REGISTRATION NO/DATE: EU/1/02/203/001-004 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

Anakinra Market Analysis and Financial Projection

Last updated: February 12, 2026

What Are the Market Dynamics for Anakinra?

Anakinra is a recombinant human interleukin-1 receptor antagonist approved for treating rheumatoid arthritis (RA) and certain autoinflammatory conditions. Its market is influenced by several factors, including competition, regulatory developments, and emerging therapeutic indications.

Key Market Drivers

• Approved indications: Anakinra is approved for RA, Still's disease, and familial Mediterranean fever (FMF). Its use in these niches provides a foundation for sales.
• Therapeutic positioning: It functions as an IL-1 blocker, targeting specific inflammatory pathways. Its differentiation stems from its mechanism compared to TNF inhibitors, which dominate RA treatment.
• Pricing and reimbursement: A high-cost biologic, reimbursed variably across markets. Pricing strategies influence its adoption rate.

Market Challenges and Competition

• Lower efficacy compared to alternatives: Biologics like adalimumab and etanercept typically outperform anakinra in RA management, limiting market share.
• Limited convenience: Daily injections can reduce patient adherence relative to weekly or biweekly options.
• Emerging therapies: Novel IL-1 inhibitors, such as canakinumab, offer advantages in dosing frequency and efficacy, pressuring anakinra's market position.

Regulatory and Market Expansion Opportunities

• New indications: FDA approval for cryopyrin-associated periodic syndromes (CAPS) and other autoinflammatory syndromes creates growth avenues.
• Geographical expansion: Growing healthcare access in Asia and Latin America may elevate demand if approved.

How Does the Financial Trajectory of Anakinra Evolve?

The financial outlook hinges on sales volume, pricing, patent status, and R&D investment.

Sales and Revenue Dynamics

• Historical sales: In 2022, global sales were approximately $100 million, predominantly from RA patients in Europe and North America, reflective of its niche market.
• Sales trends: Sales declined modestly over recent years as competing biologics gained market share, with some stabilization in markets where anakinra remains the primary IL-1 blocker.
• Market share: Anakinra holds an estimated 2-5% of the biologic RA treatment market, with fluctuations driven by new entrant therapies.

Cost and Pricing Considerations

• Pricing: Approximate annual cost per patient exceeds $40,000 in the US, with variability by country.
• Manufacturing and R&D: Biologics production incurs high costs, influencing overall profitability. R&D investments focus on expanding indications and improving formulations.

Patent and Market Exclusivity

• Patent status: Patents on anakinra expired or are nearing expiration in key markets, risking generic biosimilar entry.
• Biosimilar impact: Entry of biosimilars could reduce pricing, compress margins, and alter revenue projections significantly.

Future Financial Growth Factors

• New indications: Revenue potential increases if regulatory approval expands to new autoinflammatory conditions.
• Pricing adjustments: Market pressures may lead to slight price erosion, offset by volume growth if new markets or indications are secured.
• Potential collaborations: Licensing and partnerships for broader distribution can influence sales trajectories.

What Is the Outlook for Anakinra’s Market and Financials?

Aspect	Current Status	Future Outlook
Market Penetration	Niche within RA and autoinflammatory diseases, limited by competition	Growth probable with expanded indications and geographic reach
Sales Volume	Stable to declining in established markets, risk of decline post-patent expiry	Potential increase with new indications and biosimilar competition
Pricing	High, variable by region	Likely to decrease as biosimilars enter markets
Patent and Regulatory Risks	Patents expiring in key regions	Biosimilar entries, increased regulation, and pricing pressure
Investment in R&D	Focused on expanding biological indications in rare autoinflammatory disorders	Likely to continue; success depends on regulatory approval outcomes

Key Takeaways

• Anakinra's market is constrained by competition with more effective or convenient biologics.
• Revenue remains modest but stable, with growth potential tied to additional indications and market expansion.
• Patent expiration threatens future profitability; biosimilar competition is imminent.
• Pricing pressures are likely to increase as biosimilars enter, but expanded geographical areas may offset this trend.
• R&D investments aim to broaden therapeutic applications, possibly altering the drug's market trajectory.

FAQs

1. What are the primary indications for anakinra?
   Rheumatoid arthritis, Still’s disease, and familial Mediterranean fever.

2. How does anakinra compare to other IL-1 inhibitors?
   It requires daily injections and has a lower efficacy profile in RA compared to canakinumab, which is dosed less frequently.

3. When will biosimilars for anakinra likely enter the market?
   Biosimilar development is underway; market entry could occur within 1-3 years following patent expiration, starting with the US and Europe.

4. What regulatory actions could improve anakinra's market position?
   Approval for new autoinflammatory indications and expanded dosing guidelines could enhance sales.

5. What is the main financial risk for anakinra?
   Patent expiry and biosimilar entry could reduce revenue and profit margins significantly.

References

1. Pfizer. (2021). Kineret (Anakinra) Prescribing Information.
2. EvaluatePharma. (2022). Biologic Market Overview.
3. FDA. (2022). Regulatory Approvals for Biologics.
4. IQVIA. (2022). Global Biologics Market Data.
5. Biosimilar Market Reports. (2022). Impact of Biosimilar Entry on Established Biologic Drugs.