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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
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.

Marketing approved:

1 Generic Name: buprenorphine in combination with naloxone
Trade Name: Suboxone
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* :  

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