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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
Trade Name: Remodulin;Orenitram
Date Designated: 06/04/1997
Orphan Designation: Treatment of pulmonary arterial hypertension.
Orphan Designation Status: Designated/Approved
United Therapeutics Corp.
55 T.W. Alexander Dr.
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
Trade Name: Remodulin;Orenitram
Marketing Approval Date: 05/21/2002
Approved Labeled Indication: Treatment of pulmonary arterial hypertension.
Exclusivity End Date: 05/21/2009 
Exclusivity Protected Indication* :  

Generic Name: treprostinil
Trade Name: Remodulin;Orenitram
Date Designated: 06/04/1997
Orphan Designation: Treatment of pulmonary arterial hypertension.
Orphan Designation Status: Designated/Approved
United Therapeutics Corp.
55 T.W. Alexander Dr.
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
Trade Name: Remodulin;Orenitram
Marketing Approval Date: 12/20/2013
Approved Labeled Indication: Orenitram is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity.
Exclusivity End Date: 12/20/2020 
Exclusivity Protected Indication* :  For treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity.

Generic Name: treprostinil
Trade Name: Remodulin;Orenitram
Date Designated: 06/04/1997
Orphan Designation: Treatment of pulmonary arterial hypertension.
Orphan Designation Status: Designated/Approved
United Therapeutics Corp.
55 T.W. Alexander Dr.
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
Trade Name: Remodulin;Orenitram
Marketing Approval Date: 10/18/2019
Approved Labeled Indication: Orenitram is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to delay disease progression and to improve exercise capacity.
Exclusivity End Date: 10/18/2026 
Exclusivity Protected Indication* :  Indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to delay disease progression.

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