Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
  • Print
  • Share
  • E-mail
-
Generic Name: anakinra
Trade Name: Kineret
Date Designated: 06/29/2020
Orphan Designation: Treatment of Deficiency of IL-1 Receptor Antagonist
Orphan Designation Status: Designated/Approved
Swedish Orphan Biovitrum AB (PUBL)
Tomtebodavägen 23A
Stockholm
Sweden

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: anakinra
Trade Name: Kineret
Marketing Approval Date: 12/18/2020
Approved Labeled Indication: treatment of Deficiency of Interleukin-1 Receptor Antagonist (DIRA)
Exclusivity End Date: 12/18/2027 
Exclusivity Protected Indication* :  treatment of Deficiency of Interleukin-1 Receptor Antagonist (DIRA)
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-