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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: 11/14/2013
Orphan Designation: Treatment of Dravet syndrome
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: 09/28/2018
Approved Labeled Indication: EPIDIOLEX is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS) in patients 2 years of age and older.
Exclusivity End Date: 09/28/2025 
Exclusivity Protected Indication* :  EPIDIOLEX is indicated for the treatment of seizures associated with Dravet syndrome (DS) in patients 2 years of age and older.
2 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 Dravet syndrome (DS) in patients between 1 and 2 years of age

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