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Arcalyst

rilonacept

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Arcalyst

Proper name

rilonacept

Licence type

351(a)

BLA number

125249

Applicant

Kiniksa Pharmaceuticals (UK), Ltd.

Center

CDER

Presentations

1

First licensure

—

Presentations

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
220MG	For Injection	Subcutaneous	Single-Dose Vial	Rx	February 27, 2008

Exclusivity

Source: Purple Book

Kind	Expires
Orphan exclusivity	March 18, 2028

Sources for this page

Purple Book	FDA	Licence type, presentations, reference product, exclusivity