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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for anakinra

Recent Clinical Trials for anakinra

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Istituto Giannina Gaslini	Phase 3
Oxford University Clinical Research Unit, Vietnam	Phase 2
Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam	Phase 2

See all anakinra clinical trials

Recent Litigation for anakinra

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
AbbVie Inc. v. Hetero USA, Inc.	2023-11-20
JAZZ PHARMACEUTICALS IRELAND LIMITED v. LUPIN LTD.	2023-01-19
AMGEN INC. v. APOTEX INC.	2022-06-14

See all anakinra litigation

PTAB Litigation

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

See all anakinra litigation

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. 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 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		2008-12-24	Company disclosures
Swedish Orphan Biovitrum Ab (publ)	KINERET	anakinra	Injection	103950		2020-07-29	Company disclosures
Swedish Orphan Biovitrum Ab (publ)	KINERET	anakinra	Injection	103950		2022-02-22	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		2033-03-11	Patent claims search
Swedish Orphan Biovitrum Ab (publ)	KINERET	anakinra	Injection	103950		2034-05-23	Patent claims search
Swedish Orphan Biovitrum Ab (publ)	KINERET	anakinra	Injection	103950		2030-05-21	Patent claims search
Swedish Orphan Biovitrum Ab (publ)	KINERET	anakinra	Injection	103950		2032-02-15	Patent claims search
Swedish Orphan Biovitrum Ab (publ)	KINERET	anakinra	Injection	103950		2035-03-20	Patent claims search
Swedish Orphan Biovitrum Ab (publ)	KINERET	anakinra	Injection	103950		2031-02-11	Patent claims search
Swedish Orphan Biovitrum Ab (publ)	KINERET	anakinra	Injection	103950		2024-12-29	Patent claims search

International Patents for anakinra

Country	Patent Number	Estimated Expiration
Denmark	8591
Canada	1341322
Ireland	902608
Australia	708533
South Korea	100230156
Norway	306728
Mexico	16206

Supplementary Protection Certificates for anakinra

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
SZ 23/2002	Austria		PRODUCT NAME: ANAKINRA
23/2002	Austria		PRODUCT NAME: ANAKINRA; REGISTRATION NO/DATE: EU/1/02/203/001- EU/1/02/203/004 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
C300091	Netherlands		PRODUCT NAME: ANAKINRA; REGISTRATION NO/DATE: EU/1/02/203/001-004 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