Search Orphan Drug Designations and Approvals

Marketing approved:
Generic Name:	macitentan
Trade Name:	Opsumit
Date Designated:	09/03/2009
Orphan Designation:	Treatment of pulmonary arterial hypertension
Orphan Designation Status:	Designated/Approved
Sponsor:	Actelion Pharmaceuticals Ltd Gewerbestrasse 16 Allschwil Switzerland The sponsor address listed is the last reported by the sponsor to OOPD.

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 Jan. 1, 2013, to the present.