SUBLOCADE

Peak

buprenorphine

Indivior
NDASUBCUTANEOUSSOLUTION, EXTENDED RELEASEPriority Review
Approved
Nov 2017
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20

Mechanism of Action

Partial Opioid Agonists

Pharmacologic Class:

Partial Opioid Agonist

Clinical Trials (5)

NCT07176351Phase 4Not Yet Recruiting

Acceptability and Feasibility of Extended-Release Subcutaneous Buprenorphine on a Mobile Pharmacy Clinic

Started Mar 2026
60 enrolled
Opioid Use Disorder
NCT06651177Phase 2Recruiting

Evaluation of Tirzepatide as an Adjunct to Buprenorphine for the Treatment of Opioid Use Disorder

Started Dec 2025
NCT07314346Phase 1Not Yet Recruiting

Drug-drug Interaction Study of Bemnifosbuvir/Ruzasvir (BEM/RZR) and Buprenorphine/Naloxone or Methadone

Started Dec 2025
NCT06628622Phase 1Recruiting

A Study to Test Whether BI 1356225 Improves Impulsive Behavior in People With Opioid Use Disorder Who Are Taking Buprenorphine

Started Jan 2025
60 enrolled
Opioid Use Disorder
NCT05878210N/ACompleted

Evaluating the SUBLOCADE Treatment Exit Strategy

Started Nov 2023
12 enrolled
Opioid Use Disorder

Loss of Exclusivity

LOE Date
Jun 22, 2038
149 months away
Patent Expiry
Jun 22, 2038
Exclusivity Expiry
Feb 21, 2028

Patent Records (5)

Patent #ExpiryTypeUse Code
10198218
Jun 6, 2031
U-2489
10592168
Jun 6, 2031
U-2489
9272044
Jun 6, 2031
U-2177
9498432
Jun 6, 2031
Product
U-2179
9782402
Jun 6, 2031
Product
U-2176
Company
Indivior
Indivior
UK - Slough
External Resources
DailyMed
Full prescribing information
FDA Drugs@FDA
FDA approval history
RxNorm
Drug nomenclature & identifiers