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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: treprostinil (inhalational)
Trade Name: Tyvaso
Date Designated: 06/17/2010
Orphan Designation: Treatment of pulmonary arterial hypertension
Orphan Designation Status: Designated/Approved
United Therapeutics Corporation
PO Box 14186
55 TW Alexander Drive
Research Triangle Park, North Carolina 27709
United States

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

Marketing approved:

1 Generic Name: treprostinil (inhalational)
Trade Name: Tyvaso
Marketing Approval Date: 07/30/2009
Approved Labeled Indication: Treatment of pulmonary arterial hypertension (WHO Group I) in patients with NYHA Class III symptoms, to increase walk distance
Exclusivity End Date: 07/30/2016 
Exclusivity Protected Indication* :  
2 Generic Name: treprostinil
Trade Name: Tyvaso DPI
Marketing Approval Date: 05/23/2022
Approved Labeled Indication: Treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability
Exclusivity End Date: TBD  

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