NDASUBCUTANEOUSSOLUTION, EXTENDED RELEASEPriority Review
Approved
Nov 2017
Lifecycle
Peak
Competitive Pressure
15/100
Clinical Trials
20
Data completeness
6/8 — Strong
Priority ReviewSchedule 3
SUBLOCADE (buprenorphine) by Indivior is partial opioid agonists [moa]. Approved for partial opioid agonist [epc]. First approved in 2017.
Drug data last refreshed 14h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SUBLOCADE is a subcutaneous extended-release buprenorphine solution approved by the FDA in November 2017 for opioid use disorder treatment. It functions as a partial opioid agonist, providing sustained therapeutic levels via monthly or bi-monthly injections to reduce cravings and withdrawal symptoms. The product represents a long-acting alternative to daily sublingual buprenorphine formulations.
$38.0MPart D
Peak11.8 years to LOEProduct is in peak commercial lifecycle with $38M in annual Part D spending, suggesting a mature, stable revenue base and established commercial team infrastructure.
Mechanism of Action
Partial Opioid Agonists
Pharmacologic Class:
Partial Opioid Agonist
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Acceptability and Feasibility of Extended-Release Subcutaneous Buprenorphine on a Mobile Pharmacy Clinic
Started Aug 2026
60 enrolled
Opioid Use Disorder
Evaluation of Tirzepatide as an Adjunct to Buprenorphine for the Treatment of Opioid Use Disorder
Started Dec 2025
A Study to Test Whether BI 1356225 Improves Impulsive Behavior in People With Opioid Use Disorder Who Are Taking Buprenorphine
Started Jan 2025
12 enrolled
Opioid Use Disorder
Drug-drug Interaction Study of Bemnifosbuvir/Ruzasvir (BEM/RZR) and Buprenorphine/Naloxone or Methadone
Started Jan 2025
32 enrolled
Healthy Volunteer Study
An Exploratory Clinical Study of a Low-dose Buprenorphine Patch for the Treatment of Autism Spectrum Disorders
Started Jan 2025
60 enrolled
Autism Spectrum Disorder
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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.