SUBUTEX
LOE ApproachingNDASUBLINGUALTABLET
Approved
Oct 2002
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
2/8 — Basic
Drug data last refreshed 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SUBUTEX is a sublingual tablet containing buprenorphine, a partial mu-opioid receptor agonist used to treat opioid dependence and substance use disorder. It is a foundational medication in opioid maintenance therapy, offering a safer alternative to full opioid agonists with lower abuse potential. The drug works by reducing cravings and withdrawal symptoms while providing a partial opioid effect.
LOE Approaching
Product faces imminent loss of exclusivity with moderate competitive pressure (30% rating), signaling potential team downsizing or transition focus to next-generation formulations.
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 (5)
Transfer of Subjects From Subutex/Suboxone to RBP-6300
Started Mar 2012
143 enrolled
Opioid Related Disorder
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
A Randomized Acceptability and Safety Study of the Transfer From Subutex to Suboxone in Opioid- Dependent Subjects (Study P04843)(COMPLETED)
Started Mar 2008
241 enrolled
Opiate DependenceDrug Dependence
Preference for Subutex® (Buprenorphine) Versus Suboxone® (Buprenorphine/Naloxone) in Opioid Dependent Patients on Subutex® (Study P05094)(COMPLETED)
Started Jul 2007
60 enrolled
Opiate-related DisordersOpiate DependenceDrug Abuse
Observational Study of Misuse of High Dose Buprenorphine (Subutex® or Generic) in Opiate-Addicted Patients in France (Study P05186AM1)(COMPLETED)
Started May 2007
1,307 enrolled
BuprenorphineNaloxoneOpiate-related Disorders+2 more
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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.