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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: selexipag
Trade Name: Uptravi
Date Designated: 04/30/2010
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: selexipag
Trade Name: Uptravi
Marketing Approval Date: 12/21/2015
Approved Labeled Indication: For treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH
Exclusivity End Date: 12/21/2022 
Exclusivity Protected Indication* :  For treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH
2 Generic Name: selexipag
Trade Name: Uptravi
Marketing Approval Date: 07/29/2021
Approved Labeled Indication: Treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH
Exclusivity End Date: TBD  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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