SUBOXONE

Peak

buprenorphine hydrochloride, naloxone hydrochloride

NDABUCCAL, SUBLINGUALFILM
Approved
Aug 2010
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
9

Clinical Trials (5)

NCT02038790Phase 4Completed

Usability of Zubsolv Sublingual Tablets 5.7/1.4 to Suboxone Sublingual Film 8/2 In Buprenorphine/Naloxone Treated Opioid Dependent Population

Started Nov 2013
33 enrolled
Opioid Dependence
NCT01846455Phase 4Completed

Single Dose Pharmacokinetics of Suboxone Study in Hepatic Impaired Subjects

Started Sep 2012
43 enrolled
Hepatic FailureHepatic ImpairmentChronic Hepatitis C Infection With Hepatic Coma
NCT01582347Phase 2Completed

Transfer of Subjects From Subutex/Suboxone to RBP-6300

Started Mar 2012
143 enrolled
Opioid Related Disorder
NCT00901875Phase 4Completed

Multicentre Trial of Suboxone in Opiate-dependent Subjects in Taiwan

Started Mar 2009
127 enrolled
Opiate Dependence
NCT00725608N/ACompleted

Acceptability and Safety of Switching From Subutex or Other Opioid Drug Dependence Therapy to Suboxone (NIS P05444)

Started May 2008
339 enrolled
Opioid-Related DisordersOpiate DependenceDrug Abuse

Loss of Exclusivity

LOE Date
Mar 26, 2030
49 months away
Patent Expiry
Mar 26, 2030

Patent Records (3)

Patent #ExpiryTypeUse Code
11135216
Aug 7, 2029
Product
U-3111
9687454
Aug 7, 2029
Product
U-1464
8475832
Mar 26, 2030
Product
U-1411