Search Orphan Drug Designations and Approvals
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Generic Name: | treprostinil | ||||||||||||||||
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Trade Name: | Remodulin;Orenitram | ||||||||||||||||
Date Designated: | 06/04/1997 | ||||||||||||||||
Orphan Designation: | Treatment of pulmonary arterial hypertension. | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
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. |
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Marketing approved: |
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1 | Generic Name: | treprostinil |
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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 | ||||||||||||||||
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Trade Name: | Remodulin;Orenitram | ||||||||||||||||
Date Designated: | 06/04/1997 | ||||||||||||||||
Orphan Designation: | Treatment of pulmonary arterial hypertension. | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
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. |
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Marketing approved: |
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1 | Generic Name: | treprostinil |
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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 | ||||||||||||||||
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Trade Name: | Remodulin;Orenitram | ||||||||||||||||
Date Designated: | 06/04/1997 | ||||||||||||||||
Orphan Designation: | Treatment of pulmonary arterial hypertension. | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
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. |
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Marketing approved: |
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1 | Generic Name: | treprostinil |
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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. | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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