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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: tasimelteon
Trade Name: Hetlioz LQ
Date Designated: 04/30/2010
Orphan Designation: Treatment of sleep disorder in Smith-Magenis syndrome associated with diurnal melatonin secretion
Orphan Designation Status: Designated/Approved
Vanda Pharmaceuticals, Inc.
9605 Medical Center Drive
Rockville, Maryland 20850
United States

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

Marketing approved:

1 Generic Name: tasimelteon
Trade Name: Hetlioz LQ
Marketing Approval Date: 12/01/2020
Approved Labeled Indication: Treatment of nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in pediatric patients 3 to 15 years of age
Exclusivity End Date: 12/01/2027 
Exclusivity Protected Indication* :  Treatment of nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in pediatric patients 3 to 15 years of age
2 Generic Name: tasimelteon
Trade Name: Hetlioz
Marketing Approval Date: 12/01/2020
Approved Labeled Indication: Treatment of nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients 16 years of age and older
Exclusivity End Date: 12/01/2027 
Exclusivity Protected Indication* :  Treatment of nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients 16 years of age and older.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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