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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Modafinil
Trade Name: Provigil
Date Designated: 03/15/1993
Orphan Designation: Treatment of excessive daytime sleepiness in narcolepsy.
Orphan Designation Status: Designated/Approved
Cephalon, Inc.
145 Brandywine Parkway
West Chester, Pennsylvania 19380
United States

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

Marketing approved:

1 Generic Name: Modafinil
Trade Name: Provigil
Marketing Approval Date: 12/24/1998
Approved Labeled Indication: Improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy.
Exclusivity End Date: 12/24/2005 
Exclusivity Protected Indication* :  

*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.