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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 chronic thromboembolic pulmonary hypertension
Orphan Designation Status:  Designated/Approved
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
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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