NDABUCCAL, SUBLINGUALFILM
Approved
Aug 2010
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
11
Data completeness
3/8 — Basic
Schedule 3
Drug data last refreshed 4h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SUBOXONE is a combination buprenorphine/naloxone sublingual film indicated for opioid use disorder maintenance treatment. Buprenorphine acts as a partial mu-opioid agonist to reduce cravings and withdrawal symptoms, while naloxone is included to deter intravenous misuse. The formulation leverages a buccal/sublingual delivery route optimized for clinical efficacy and abuse deterrence.
Peak3.6 years to LOE
SUBOXONE remains in peak commercial phase with 3.7 years of patent exclusivity remaining, supporting continued investment in established brand management and field teams before generic erosion accelerates.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
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.