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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: 02/27/2014
Orphan Designation: Treatment of Lennox-Gastaut syndrome
Orphan Designation Status: Designated/Approved
Jazz Pharmaceuticals Research UK Limited
Building 730, Kent Science Park
Sittingbourne, Kent ME9 8AG
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 Lennox-Gastaut syndrome (LGS) 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, Dravet syndrome, 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 Lennox-Gastaut syndrome (LGS) in patients between 1 and 2 years of age
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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