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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: sotatercept-csrk
Trade Name: Winrevair
Date Designated: 09/05/2019
Orphan Designation: Treatment of pulmonary arterial hypertension
Orphan Designation Status: Designated/Approved
Merck Sharp & Dohme LLC
126 East Lincoln Avenue
P.O. Box 2000
Rahway, New Jersey 07065
United States

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

Marketing approved:

1 Generic Name: sotatercept-csrk
Trade Name: Winrevair
Marketing Approval Date: 03/26/2024
Approved Labeled Indication: treatment of adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) to increase exercise capacity, improve WHO functional class (FC), and reduce the risk of clinical worsening events
Exclusivity End Date: 03/26/2031 
Exclusivity Protected Indication* :  treatment of adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) to increase exercise capacity, improve WHO functional class (FC), and reduce the risk of clinical worsening events
2 Generic Name: sotatercept-csrk
Trade Name: Winrevair
Marketing Approval Date: 10/24/2025
Approved Labeled Indication: treatment of adults with pulmonary arterial hypertension (PAH, Group 1 pulmonary hypertension) to improve exercise capacity and World Health Organization (WHO) functional class (FC), and reduce the risk of clinical worsening events including hospitalization for PAH, lung transplantation and death
Exclusivity End Date: TBD  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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