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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  buprenorphine in combination with naloxone
Trade Name:  Suboxone
Date Designated:  10/27/1994
Orphan Designation:  Treatment of opiate addiction in opiate users
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  10/08/2002 
Approved Labeled Indication:  Treatment of opioid dependence in patients 16 years of age or older
Exclusivity End Date:    10/08/2009 
Exclusivity Protected Indication* :  
Indivior, Inc.
10710 Midlothian Turnpike
Suite 430
Richmond, Virginia 23235
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.