anakinra (Kineret)
anakinra is an FDA-licensed reference biologic from Swedish Orphan Biovitrum AB (publ). Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2001
Reference approved
Reference product
Kineret anakinra
Swedish Orphan Biovitrum AB (publ)
- Approved
- Nov 14, 2001
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for anakinra, in chronological order.
Reference approval
Approval date of the reference anakinra product.
24 yr 11 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 1 yr 7 mo
Frequently asked questions
Are there biosimilars approved for anakinra (Kineret)?
No 351(k) biosimilars or interchangeable biosimilars referencing anakinra are listed in the FDA Purple Book yet.
Explore the full FDA Purple Book
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