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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  Rilonacept
Trade Name:  Arcalyst
Date Designated:  12/20/2004
Orphan Designation:  Treatment of CIAS1-Associated Periodic Syndromes
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  02/27/2008 
Approved Labeled Indication:  Treatment of Cryopyrin-Assisted Periodic Syndromes (CAPS)
Exclusivity End Date:    02/27/2015 
Exclusivity Protected Indication* :  
Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
Tarrytown, New York 10591
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.