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: riociguat
Trade Name: Adempas
Date Designated: 09/19/2013
Orphan Designation: Treatment of chronic thromboembolic pulmonary hypertension
Orphan Designation Status: Designated/Approved
Bayer HealthCare Pharmaceuticals, Inc.
100 Bayer Blvd.
Whippany, New Jersey 07981
United States

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

Marketing approved:

1 Generic Name: riociguat
Trade Name: Adempas
Marketing Approval Date: 10/08/2013
Approved Labeled Indication: Treatment of adults with persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH) WHO Group 4, after surgical treatment, or inoperable CTEPH, to improve exercise capacity and WHO functional class
Exclusivity End Date: 10/08/2020 
Exclusivity Protected Indication* :  Treatment of adults with persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH) WHO Group 4, after surgical treatment, or inoperable CTEPH, to improve exercise capacity and WHO functional class
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
-
-