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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: valbenazine
Trade Name: Ingrezza
Date Designated: 05/10/2022
Orphan Designation: Treatment of Huntington disease
Orphan Designation Status: Designated/Approved
Neurocrine Biosciences Inc.
12780 El Camino Real
San Diego, California 92130
United States

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

Marketing approved:

1 Generic Name: valbenazine
Trade Name: Ingrezza
Marketing Approval Date: 08/18/2023
Approved Labeled Indication: treatment of adults with chorea associated with Huntington's disease
Exclusivity End Date: 08/18/2030 
Exclusivity Protected Indication* :  treatment of adults with chorea associated with Huntington's disease
2 Generic Name: valbenazine
Trade Name: Ingrezza
Marketing Approval Date: 04/30/2024
Approved Labeled Indication: treatment of adults with chorea associated with Huntington's disease
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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