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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: cannabidiol
Trade Name: Epidiolex
Date Designated: 04/19/2016
Orphan Designation: Treatment of tuberous sclerosis complex.
Orphan Designation Status: Designated/Approved
GW Research Ltd.
Sovereign House
Histon
Cambridge
United Kingdom

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

Marketing approved:

1 Generic Name: cannabidiol
Trade Name: Epidiolex
Marketing Approval Date: 07/31/2020
Approved Labeled Indication: treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in patients 1 year of age and older
Exclusivity End Date: 07/31/2027 
Exclusivity Protected Indication* :   treatment of seizures associated with tuberous sclerosis complex (TSC) in patients 1 year of age and older

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