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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: eculizumab
Trade Name: Soliris
Date Designated: 06/24/2013
Orphan Designation: Treatment of neuromyelitis optica
Orphan Designation Status: Designated/Approved
Alexion Pharmaceuticals, Inc.
121 Seaport Boulevard
Boston, Massachusetts 02210
United States

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

Marketing approved:

1 Generic Name: eculizumab
Trade Name: Soliris
Marketing Approval Date: 06/27/2019
Approved Labeled Indication: Soliris is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.
Exclusivity End Date: 06/27/2026 
Exclusivity Protected Indication* :  For the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive
2 Generic Name: ravulizumab-cwvz
Trade Name: Ultomiris
Marketing Approval Date: 03/22/2024
Approved Labeled Indication: treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive
Exclusivity End Date: TBD  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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