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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: riociguat
Trade Name: Adempas
Date Designated: 09/19/2013
Orphan Designation: Treatment of pulmonary arterial 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 pulmonary arterial hypertension (PAH) WHO Group 1, to improve exercise capacity, WHO functional class and to delay clinical worsening.
Exclusivity End Date: 10/08/2020 
Exclusivity Protected Indication* :  Treatment of adults with pulmonary arterial hypertension (PAH) WHO Group 1, to improve exercise capacity, WHO functional class and to delay clinical worsening.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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