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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
Trade Name: Opsumit
Date Designated: 09/03/2009
Orphan Designation: Treatment of pulmonary arterial hypertension
Orphan Designation Status: Designated/Approved
Actelion Pharmaceuticals Ltd
Gewerbestrasse 16
Allschwil
Switzerland

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

Marketing approved:

1 Generic Name: macitentan
Trade Name: Opsumit
Marketing Approval Date: 10/18/2013
Approved Labeled Indication: Treatment of pulmonary arterial hypertension (PAH, WHO Group 1) to delay disease progression. Disease progression included: death, initiation of intravenous (IV) or subcutaneous prostanoids, or clinical worsening of PAH (decreased 6-minute walk distance, worsened PAH symptoms and need for additional PAH treatment). Opsumit also reduced hospitalization for PAH.
Exclusivity End Date: 10/18/2020 
Exclusivity Protected Indication* :  Treatment of pulmonary arterial hypertension (PAH, WHO Group 1) to delay disease progression. Disease progression included: death, initiation of intravenous (IV) or subcutaneous prostanoids, or clinical worsening of PAH (decreased 6-minute walk distance, worsened PAH symptoms and need for additional PAH treatment). Opsumit also reduced hospitalization for PAH.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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