Purple Book reference family · 351(a) biologic
rilonacept (Arcalyst)
rilonacept is an FDA-licensed reference biologic from Kiniksa Pharmaceuticals (UK), Ltd..
351(a) biologicBLA 125249 Kiniksa Pharmaceuticals (UK), Ltd.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2008
Reference product
Originator biologic
351(a)BLA 125249
Arcalyst rilonacept
Kiniksa Pharmaceuticals (UK), Ltd.
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference rilonacept product.
18 yr 10 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 1 yr 6 mo
rilonacept: frequently asked questions
Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.
Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for rilonacept.
Related FDA reference tools
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- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
