Last reviewed · How we verify
SL Buprenorphine
SL Buprenorphine, marketed by Indivior Inc., holds a significant position in the treatment of opioid dependence. The drug's key strength lies in its well-established market presence, supported by a key composition patent that remains in effect until 2028. The primary risk to consider is the eventual patent expiry in 2028, which could lead to increased competition from generic alternatives.
At a glance
| Generic name | SL Buprenorphine |
|---|---|
| Also known as | Subutex |
| Sponsor | Indivior Inc. |
| Modality | Small molecule |
| Phase | FDA-approved |
Approved indications
Common side effects
Key clinical trials
- Medication Treatment for Opioid Use Disorder in Expectant Mothers: Conceptual Model Assessments Sub-study
- Medication Treatment for Opioid Use Disorder in Expectant Mothers: Infant Neurodevelopmental Outcomes Sub-study
- NOTRE: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings (PHASE4)
- Buprenorphine for Individuals in Jail (PHASE3)
- A Study Comparing Oral Buprenorphine and Injectable Buprenorphine for the Treatment of Opioid Use Disorder (PHASE4)
- Extended-release Buprenorphine Compared to Sublingual Buprenorphine in Rural Settings (RXR) (PHASE3)
- Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD) (PHASE2)
- EXHIT ENTRE Comparative Effectiveness Trial (PHASE2, PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- SL Buprenorphine CI brief — competitive landscape report
- SL Buprenorphine updates RSS · CI watch RSS
- Indivior Inc. portfolio CI