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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: macitentan and tadalafil
Trade Name: Opsynvi
Date Designated: 10/19/2016
Orphan Designation: Treatment of pulmonary arterial hypertension
Orphan Designation Status: Designated/Approved
Actelion Pharmaceuticals US, Inc.
1125 Trenton-Harbourton Road,
1st Floor/B-Wing
Titusville, New Jersey 08560
United States

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

Marketing approved:

1 Generic Name: macitentan and tadalafil
Trade Name: Opsynvi
Marketing Approval Date: 03/22/2024
Approved Labeled Indication: chronic treatment of adults with pulmonary arterial hypertension (PAH, WHO Group I and WHO Functional Class (FC) II-III)
Exclusivity End Date: 03/22/2031 
Exclusivity Protected Indication* :  chronic treatment of adults with pulmonary arterial hypertension (PAH, WHO Group I and WHO Functional Class (FC) II-III)
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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