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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
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.
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.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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