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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 hydrochloride
Trade Name:  Subutex; Sublocade
Date Designated:  06/15/1994
Orphan Designation:  Treatment of opiate addiction in opiate users.
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  11/30/2017 
Approved Labeled Indication:  SUBLOCADE is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a transmucosal buprenorphine-containing product, followed by dose adjustment for a minimum of 7 days.
Exclusivity End Date:    TBD
Indivior, Inc.
10710 Midlothian Turnpike
Suite 125
North Chesterfield, Virginia 23235
USA

The sponsor address listed is the last reported by the sponsor to OOPD.
 
Generic Name:  Buprenorphine hydrochloride
Trade Name:  Subutex; Sublocade
Date Designated:  06/15/1994
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
Indivior, Inc.
10710 Midlothian Turnpike
Suite 125
North Chesterfield, Virginia 23235
USA

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