Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
  • Print
  • Share
  • E-mail
-
Generic Name: bosentan
Trade Name: Tracleer
Date Designated: 10/06/2000
Orphan Designation: Treatment of pulmonary arterial hypertension
Orphan Designation Status: Designated/Approved
Actelion Pharmaceuticals Ltd
1840 Gateway Drive
Suite 300
Cherry Hill, New Jersey 08002
United States

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

Marketing approved:

1 Generic Name: bosentan
Trade Name: Tracleer
Marketing Approval Date: 11/20/2001
Approved Labeled Indication: Treatment of pulmonary arterial hypertension.
Exclusivity End Date: 11/20/2008 
Exclusivity Protected Indication* :  
2 Generic Name: bosentan
Trade Name: Tracleer
Marketing Approval Date: 09/05/2017
Approved Labeled Indication: Treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability
Exclusivity End Date: 09/05/2024 
Exclusivity Protected Indication* :  Treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-