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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: tolvaptan
Trade Name: Jynarque
Date Designated: 04/06/2012
Orphan Designation: Treatment of autosomal dominant polycystic kidney disease
Orphan Designation Status: Designated/Approved
Otsuka Pharmaceutical Company, Ltd.
2-9, Kanda-Tsukasamachi
Tokyo
Japan

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

Marketing approved:

1 Generic Name: tolvaptan
Trade Name: Jynarque
Marketing Approval Date: 04/23/2018
Approved Labeled Indication: JYNARQUE is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD)
Exclusivity End Date: 04/23/2025 
Exclusivity Protected Indication* :  JYNARQUE is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD)
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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