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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
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* :  
Cephalon, Inc.
145 Brandywine Parkway
West Chester, Pennsylvania 19380
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.