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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: trientine tetrahydrochloride
Trade Name: Cuvrior
Date Designated: 03/10/2016
Orphan Designation: Treatment of Wilson's disease excluding patients intolerant to penicillamine
Orphan Designation Status: Designated/Approved
Orphalan
226 boulevard Voltaire
Paris 75011
France

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

Marketing approved:

1 Generic Name: trientine tetrahydrochloride
Trade Name: Cuvrior
Marketing Approval Date: 04/28/2022
Approved Labeled Indication: Treatment of adult patients with stable Wilson¿s disease who are de-coppered and tolerant to penicillamine
Exclusivity End Date: 04/28/2029 
Exclusivity Protected Indication* :  Treatment of adult patients with stable Wilson¿s disease who are de-coppered and tolerant to penicillamine
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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