SUBOXONE
LOE ApproachingNDASUBLINGUALTABLETPriority Review
Approved
Oct 2002
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
11
Data completeness
5/8 — Partial
Priority Review
SUBOXONE by Indivior is naloxone. Approved for opioid dependence. First approved in 2002.
Drug data last refreshed 9h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SUBOXONE is a sublingual tablet containing buprenorphine and naloxone, approved in 2002 for opioid use disorder treatment. It works through partial opioid agonism (buprenorphine) combined with opioid antagonism (naloxone) to reduce cravings and withdrawal symptoms. The combination formulation improves safety by discouraging intravenous misuse.
$95MPart D
LOE ApproachingProduct approaching loss of exclusivity with moderate Medicare spending; brand team likely focused on lifecycle extension and market protection strategies.
Mechanism of Action
naloxone. Buprenorphine is a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor. Naloxone is a potent antagonist at mu opioid receptors and produces opioid withdrawal signs and symptoms in individuals physically dependent on full opioid agonists when…
Indications (1)
Clinical Trials (11)
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
Single Dose Pharmacokinetics of Suboxone Study in Hepatic Impaired Subjects
Started Sep 2012
43 enrolled
Hepatic FailureHepatic ImpairmentChronic Hepatitis C Infection With Hepatic Coma
Transfer of Subjects From Subutex/Suboxone to RBP-6300
Started Mar 2012
143 enrolled
Opioid Related Disorder
Multicentre Trial of Suboxone in Opiate-dependent Subjects in Taiwan
Started Mar 2009
127 enrolled
Opiate Dependence
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
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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.