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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Ravulizumab-cwvz
Trade Name: Ultomiris
Date Designated: 01/04/2017
Orphan Designation: Treatment of paroxysmal nocturnal hemoglobinuria
Orphan Designation Status: Designated/Approved
Alexion Pharmaceuticals, Inc.
100 College Street
New Haven, Connecticut 06510
United States

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

Marketing approved:

1 Generic Name: Ravulizumab-cwvz
Trade Name: Ultomiris
Marketing Approval Date: 12/21/2018
Approved Labeled Indication: ULTOMIRIS is indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH).
Exclusivity End Date: 12/21/2025 
Exclusivity Protected Indication* :  ULTOMIRIS¿ is indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH).
2 Generic Name: ravulizumab-cwvz
Trade Name: Ultomiris
Marketing Approval Date: 10/09/2020
Approved Labeled Indication: ULTOMIRIS is indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH).
Exclusivity End Date: N/A  
3 Generic Name: ravulizumab-cwvz
Trade Name: Ultomiris
Marketing Approval Date: 06/07/2021
Approved Labeled Indication: Treatment of adult and pediatric patients one month of age and older with paroxysmal nocturnal hemoglobinuria (PNH)
Exclusivity End Date: 06/07/2028 
Exclusivity Protected Indication* :  Treatment of pediatric patients one month of age and older with paroxysmal nocturnal hemoglobinuria (PNH)
4 Generic Name: ravulizumab-cwvz
Trade Name: Ultomiris
Marketing Approval Date: 07/22/2022
Approved Labeled Indication: Treatment of adult and pediatric patients one month of age and older with paroxysmal nocturnal hemoglobinuria (PNH)
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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