KINERET Drug Profile

Summary for Tradename: KINERET

High Confidence Patents:	3
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for KINERET
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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

Recent Litigation for KINERET

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
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 KINERET litigation

PTAB Litigation

Petitioner	Date
	2015-06-02
	2012-09-25

See all KINERET litigation

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. General 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 KINERET Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for KINERET 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	5,075,222	2008-12-24	Company disclosures
Swedish Orphan Biovitrum Ab (publ)	KINERET	anakinra	Injection	103950	6,599,873	2020-07-29	Company disclosures
Swedish Orphan Biovitrum Ab (publ)	KINERET	anakinra	Injection	103950	6,858,409	2022-02-22	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	10,016,338	2033-03-11	Patent claims search
Swedish Orphan Biovitrum Ab (publ)	KINERET	anakinra	Injection	103950	10,023,841	2034-05-23	Patent claims search
Swedish Orphan Biovitrum Ab (publ)	KINERET	anakinra	Injection	103950	10,081,657	2030-05-21	Patent claims search
Swedish Orphan Biovitrum Ab (publ)	KINERET	anakinra	Injection	103950	10,111,968	2032-02-15	Patent claims search
Swedish Orphan Biovitrum Ab (publ)	KINERET	anakinra	Injection	103950	10,124,038	2035-03-20	Patent claims search
Swedish Orphan Biovitrum Ab (publ)	KINERET	anakinra	Injection	103950	10,179,162	2031-02-11	Patent claims search

International Patents for KINERET

Country	Patent Number	Estimated Expiration
Hungary	9603442
World Intellectual Property Organization (WIPO)	9534326
Australia	633831
Hong Kong	1017821
South Korea	100230156
Poland	286089

Supplementary Protection Certificates for KINERET

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

KINERET Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for KINERET (Anakinra)

Introduction to KINERET

KINERET, also known as anakinra, is an interleukin-1 (IL-1) receptor antagonist used in the treatment of various inflammatory conditions, including rheumatoid arthritis (RA), cryopyrin-associated periodic syndromes (CAPS), and other autoimmune diseases. Understanding the market dynamics and financial trajectory of KINERET is crucial for investors, healthcare professionals, and patients alike.

Clinical Efficacy and Indications

KINERET has demonstrated significant clinical efficacy in several indications. For RA, it has been shown to reduce signs and symptoms and slow the progression of structural damage, particularly in patients who have failed one or more disease-modifying antirheumatic drugs (DMARDs)[2][4].

• RA Efficacy: In a randomized, double-blind, placebo-controlled trial involving 899 patients with active RA, KINERET significantly reduced acute-phase reactant levels, with a 47.2% decrease in ESR and a 77% decrease in CRP levels from baseline at 6 months[1].
• CAPS and Other Conditions: KINERET has also shown rapid and significant improvements in symptoms for patients with CAPS, familial Mediterranean fever, and Still’s disease[4].

Market Position and Competition

KINERET operates in a competitive market dominated by biologics and other immunotherapies. The success of KINERET is partly due to its unique mechanism of action as an IL-1 receptor antagonist, which differentiates it from other treatments.

• Biologics Market: The biologics market, which includes drugs like KINERET, is growing rapidly due to the increasing global burden of chronic diseases. This market is projected to exceed $1.4 trillion by 2028, driven by the need for effective treatments for conditions like RA and CAPS[3].

Financial Performance and Revenue Potential

The financial performance of KINERET is influenced by its clinical efficacy, market demand, and the competitive landscape.

• Revenue Projections: While specific revenue figures for KINERET are not publicly disclosed, the drug's approval and use in multiple indications suggest a significant revenue stream. The success of similar biologics, such as Dupixent, which generates over $8 billion annually, indicates the potential revenue scale for effective biologic treatments[3].
• Cost and Affordability: The high cost of biologic therapies, including KINERET, can be a barrier to access. However, the drug's benefits in reducing disease progression and improving quality of life often justify the investment for patients and healthcare systems[3].

Clinical Trials and Research

Continuous investment in clinical trials and research is crucial for the long-term success of KINERET.

• COVID-19 Trials: Recent data from the SAVE-MORE trial showed that KINERET improved clinical outcomes in hospitalized patients with COVID-19 pneumonia, preventing death and progression to severe respiratory failure by 64%[2].
• Ongoing Studies: The drug's efficacy in various inflammatory conditions is being further explored in ongoing studies, which could expand its indications and market reach.

Regulatory Approvals and Safety Profile

Regulatory approvals and a favorable safety profile are essential for the market success of KINERET.

• European and US Approvals: KINERET has received marketing authorizations in both the European Union and the United States for various indications, including RA and CAPS[2][4].
• Safety Profile: Common side effects include headache, injection site reactions, and increased blood cholesterol. However, the European Medicines Agency has concluded that the benefits of KINERET outweigh its risks for the approved indications[4].

Market Trends and Future Outlook

The pharmaceutical market is driven by several trends that impact KINERET's financial trajectory.

• Precision Medicine: The increasing use of precision medicine, which involves tailoring treatments to individual patients based on genetic and molecular profiles, could enhance the efficacy and safety of KINERET[3].
• Global Demand: The escalating global burden of chronic diseases, such as RA and CAPS, ensures a steady demand for effective treatments like KINERET.

Investment Landscape

Investing in pharmaceutical research and development is risky but potentially highly rewarding.

• Development Costs: The average cost of bringing a new drug to market is about $2.6 billion, with a development timeline spanning 10 to 15 years. However, successful drugs can generate substantial revenue streams[3].
• Risk and Reward: The high attrition rate of drug candidates underscores the risks involved, but the success of KINERET in clinical trials and its market performance indicate significant potential returns.

Key Takeaways

• Clinical Efficacy: KINERET has demonstrated significant clinical efficacy in treating RA, CAPS, and other inflammatory conditions.
• Market Position: It operates in a competitive biologics market with growing demand driven by chronic diseases.
• Financial Performance: The drug's revenue potential is substantial, though specific figures are not publicly disclosed.
• Regulatory Approvals: KINERET has received approvals in the EU and US for multiple indications.
• Future Outlook: The drug's future is influenced by trends in precision medicine and the global demand for effective treatments.

FAQs

What is KINERET used for?

KINERET is used to treat the signs and symptoms associated with rheumatoid arthritis (RA), cryopyrin-associated periodic syndromes (CAPS), and systemic juvenile idiopathic arthritis (SJIA)[5].

How effective is KINERET in treating RA?

KINERET has been shown to reduce acute-phase reactant levels and slow the progression of structural damage in RA patients, with a 47.2% decrease in ESR and a 77% decrease in CRP levels from baseline at 6 months[1].

What are the common side effects of KINERET?

Common side effects include headache, injection site reactions, and increased blood cholesterol[4].

Has KINERET been used in COVID-19 treatment?

Yes, KINERET has been used in clinical trials for COVID-19 pneumonia and has shown to improve clinical outcomes by preventing death and progression to severe respiratory failure[2].

What is the regulatory status of KINERET?

KINERET has received marketing authorizations in the European Union and the United States for various indications, including RA and CAPS[2][4].

Sources

1. KINERET® (anakinra) Official HCP Website: RA Efficacy.
2. European Pharmaceutical Review: Kineret® improves clinical outcomes in patients with COVID-19 pneumonia.
3. DrugBank Blog: Investment Trends in Pharmaceutical Research and Development.
4. European Medicines Agency: Kineret.
5. NPS MedicineWise: KINERET - Consumer Medicine Information (CMI) summary.