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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: 06/12/2014
Orphan Designation: Treatment of Myasthenia Gravis
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: 10/23/2017
Approved Labeled Indication: for the treatment of adult patients with generalized Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody positive
Exclusivity End Date: 10/23/2024 
Exclusivity Protected Indication* :  for the treatment of adult patients with generalized Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody positive
2 Generic Name: ravulizumab-cwvz
Trade Name: Ultomiris
Marketing Approval Date: 04/27/2022
Approved Labeled Indication: Treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) 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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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