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Last Updated: February 10, 2025

Anakinra - Biologic Drug Details


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Summary for anakinra
Recent Clinical Trials for anakinra

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Incyte CorporationPhase 2
Hellenic Institute for the Study of SepsisPhase 2/Phase 3
Istituto Giannina GasliniPhase 3

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Recent Litigation for anakinra

Identify key patents and potential future biosimilar entrants

District Court Litigation
Case NameDate
AbbVie Inc. v. Hetero USA, Inc.2024-08-08
AbbVie Inc. v. Hetero USA, Inc.2023-11-20
JAZZ PHARMACEUTICALS IRELAND LIMITED v. LUPIN LTD.2023-01-19

See all anakinra litigation

PTAB Litigation
PetitionerDate
2015-06-02
2012-09-25

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Pharmacology for anakinra
Mechanism of ActionInterleukin 1 Receptor Antagonists
Established Pharmacologic ClassInterleukin-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
  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 anakinra Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for anakinra Derived from 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 ⤷  Free Trial 2008-12-24 Company disclosures
Swedish Orphan Biovitrum Ab (publ) KINERET anakinra Injection 103950 ⤷  Free Trial 2020-07-29 Company disclosures
Swedish Orphan Biovitrum Ab (publ) KINERET anakinra Injection 103950 ⤷  Free Trial 2022-02-22 Company disclosures
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Patent No. >Estimated Patent Expiration >Source

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

These patents were obtained by searching patent claims

Supplementary Protection Certificates for anakinra

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
SZ 23/2002 Austria ⤷  Free Trial PRODUCT NAME: ANAKINRA
SPC/GB02/026 United Kingdom ⤷  Free Trial 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
10299011 Germany ⤷  Free Trial PRODUCT NAME: KINERET(R) (WIRKSAMER BESTANDTEIL ANAKINRA); REGISTRATION NO/DATE: EU/1/02/203/001-004 20020308
2002C/023 Belgium ⤷  Free Trial PRODUCT NAME: ANAKINRA; REGISTRATION NO/DATE: EU/1/02/203/001 20020311
C300091 Netherlands ⤷  Free Trial PRODUCT NAME: ANAKINRA; REGISTRATION NO/DATE: EU/1/02/203/001-004 20020308
>Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Market Dynamics and Financial Trajectory for the Biologic Drug: Anakinra

Introduction

Anakinra, a biologic drug, has been gaining significant attention in the pharmaceutical industry due to its efficacy in treating various autoimmune and inflammatory diseases. This article delves into the market dynamics and financial trajectory of anakinra, highlighting its current market status, key players, and future projections.

Market Overview

The global anakinra market is poised for substantial growth over the coming years. The market is driven by increasing demand for effective treatments for autoimmune and inflammatory conditions such as adult-onset Still’s disease (AOSD), systemic juvenile idiopathic arthritis (SJIA), and other rare diseases[4].

Key Players

Swedish Orphan Biovitrum (Sobi) is one of the main players in the anakinra market. Sobi has been instrumental in the development and distribution of anakinra, particularly through its product Kineret. The company's strong presence in the immunology segment, along with its expanding portfolio in haematology and specialty care, positions it as a leader in the market[1][2].

Market Segmentation

The anakinra market is segmented based on type and application. The types include 10MIU/VIAL, 18MIU/VIAL, and 25MIU/VIAL, catering to different dosage requirements. The applications primarily include pediatrics and adults, with a focus on treating AOSD, SJIA, and other autoimmune diseases[1].

Geographic Distribution

The market for anakinra is spread across various regions, with North America emerging as a significant market due to high healthcare expenditure and a large patient population. Europe and international markets, including Japan, Latin America, and South Korea, are also crucial for the drug's distribution and growth[2].

Financial Performance

Sobi, the primary company associated with anakinra, has shown robust financial performance. In 2023, Sobi reported total revenues of SEK 22,123 million, with a growth rate of 18% or 12% at constant exchange rates. The immunology segment, which includes anakinra, contributed significantly to this growth, with revenues of SEK 7,635 million and a growth rate of 14%[2].

Revenue Breakdown

  • Haematology: SEK 13,370 million, with a growth rate of 23%.
  • Immunology: SEK 7,635 million, with a growth rate of 14%.
  • Specialty Care: SEK 1,119 million, though this segment saw a decline of 13%[2].

Cost-Effectiveness and Budget Impact

Studies have shown that anakinra can be a cost-effective alternative to other treatments like canakinumab and tocilizumab. A budget impact analysis from the Italian National Health Service (iNHS) indicated that increasing the market share of anakinra could lead to significant reductions in drug expenditure. For instance, a 40% or 50% increase in anakinra's market share could result in cost savings of up to -€8,049,169 for AOSD patients[3].

Clinical Efficacy and Safety

Anakinra has demonstrated favorable clinical outcomes in various studies. For example, in the context of COVID-19, anakinra treatment was associated with prolonged survival and lower healthcare costs compared to placebo. The drug's efficacy and safety profile make it an attractive option for treating severe inflammatory conditions[5].

Future Projections

The global anakinra market is expected to grow at a significant CAGR from 2023 to 2029. The North American market, in particular, is forecasted to increase substantially during this period. The market's growth will be driven by increasing awareness of the drug's benefits, expanding patient populations, and ongoing research into new indications[1][4].

Competitive Landscape

The competitive landscape for anakinra includes other biologic drugs targeting similar disease areas. However, Sobi's strong R&D capabilities, global distribution network, and strategic partnerships, such as with Sanofi for the introduction of Beyfortus for RSV, position anakinra favorably in the market[2].

Regulatory Environment

Regulatory submissions and approvals are crucial for the market trajectory of anakinra. For instance, the European regulatory submission of efanesoctocog alfa, a drug related to Sobi's haematology portfolio, highlights the company's commitment to advancing its pipeline and entering new indications[2].

Key Takeaways

  • Market Growth: The global anakinra market is expected to grow significantly, driven by increasing demand for effective treatments for autoimmune diseases.
  • Key Player: Swedish Orphan Biovitrum (Sobi) is a leading player in the anakinra market.
  • Cost-Effectiveness: Anakinra is a cost-effective alternative to other treatments, leading to potential cost savings for healthcare systems.
  • Clinical Efficacy: The drug has demonstrated favorable clinical outcomes and safety profiles.
  • Future Projections: The market is forecasted to grow substantially over the next few years, driven by expanding patient populations and ongoing research.

FAQs

What is anakinra used for?

Anakinra is used to treat autoimmune and inflammatory diseases such as adult-onset Still’s disease (AOSD), systemic juvenile idiopathic arthritis (SJIA), and other rare conditions.

Who is the main player in the anakinra market?

The main player in the anakinra market is Swedish Orphan Biovitrum (Sobi).

What are the different types of anakinra available?

The different types of anakinra include 10MIU/VIAL, 18MIU/VIAL, and 25MIU/VIAL.

How cost-effective is anakinra compared to other treatments?

Anakinra has been shown to be a cost-effective alternative to treatments like canakinumab and tocilizumab, potentially leading to significant cost savings for healthcare systems.

What are the future projections for the anakinra market?

The global anakinra market is expected to grow significantly over the next few years, driven by increasing demand and ongoing research into new indications.

Sources

  1. Global Anakinra Market Research Report 2024 - Valuates Reports
  2. Annual and sustainability report 2023 - Swedish Orphan Biovitrum
  3. Budget Impact Analysis of anakinra in the treatment of patients with AOSD or SJIA - Global and Regional Health Technology Assessment
  4. Anakinra - Global Market Insights and Sales Trends 2024 - Market Research Reports
  5. Efficacy and safety of early soluble urokinase plasminogen receptor (suPAR) guided anakinra treatment in COVID-19 - PMC.ncbi.nlm.nih.gov

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