Anakinra
As of the edition of 20 October 2026, Anakinra is a protein: marketed, first approved in 2001 (US); acts on IL1R1; US protection ends in 2027.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2002
- Kind
- Protein
- Brand name
- Kineret
- First approved
- 14 November 2001 (US)
- Approvals on record
- 3 in 3 regions
- Holder of the most recent approval
- Swedish Orphan Biovitrum
- Registered trials
- 143, 29 stopped early
- Disease areas
- Immune system; Skin and connective tissue; Heart and blood vessels; Bones, joints and muscles; Infections; Lungs and airways
US protection
US protection ends in 2027.
The orphan exclusivity ends in 2027 (it covers one use only). The application that gives this date is held by Swedish Orphan Biovitrum.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product2 listings count towards this date. The exact date and each listing are in the product.
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Target
| Gene | Protein | UniProt |
|---|---|---|
| IL1R1 | Interleukin-1 receptor type 1 | P14778 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 12 | 7 | 2 | 1 |
| Phase 1 | 20 | 11 | 2 | 4 |
| Phase 2 | 79 | 42 | 13 | 18 |
| Phase 3 | 25 | 15 | 6 | 2 |
| Phase 4 | 7 | 2 | 1 | 4 |
| All trials | 143 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Swedish Orphan Biovitrum | Applicant and Lead sponsor of trials | 2001 to now |