SUBOXONE

LOE Approaching

buprenorphine hydrochloride; naloxone hydrochloride

Indivior
NDASUBLINGUALTABLETPriority Review
Approved
Oct 2002
Lifecycle
LOE Approaching
Competitive Pressure
30/100
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
Company
Indivior
Indivior
UK - Slough
External Resources
DailyMed
Full prescribing information
FDA Drugs@FDA
FDA approval history
RxNorm
Drug nomenclature & identifiers
Data Sources
  • Drug label: DailyMed / FDA
  • Clinical trials: ClinicalTrials.gov
  • Patent data: FDA Orange Book
  • Spending data: CMS Medicare

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.