SUBOXONE (buprenorphine hydrochloride)
SUBOXONE sublingual film is indicated for treatment of opioid dependence. SUBOXONE sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support. SUBOXONE sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2002-10-08
- Patent Cliff
- 2030
- Routes
- BUCCAL, SUBLINGUAL, SUBLINGUAL
- Dosage Forms
- FILM, TABLET
Companies
SUBOXONE Approval History
What SUBOXONE Treats
5 FDA approvalsOriginally approved for its first indication in 2002 . Covers 5 distinct patient populations.
- Other (5)
Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06576843 | INDV-6001-201 | Ph 2 | completed | INDV-6001 Multiple-Dose Pharmacokinetic Study |
| NCT03396276 HEROES | HSC-SBMI-17-1021 | Ph 4 | enrolling by invitation | Houston Emergency Opioid Engagement System |
| NCT02696096 results posted | 793387 | Ph 3 | completed | Neuroimaging Predictors of Relapse During Treatment for Opiate Dependence |
| NCT02357901 results posted | RB-US-13-0001 | Ph 3 | completed | Treatment Seeking Participants With Opioid Use Disorders Assessing Tolerability of Depot Injections of Buprenorphine |
| NCT00733720 | N01DA-6-8867 | Ph 1 | completed | Buprenorphine Naltrexone-P1 A-Cocaine |
| NCT03002961 SAD | RB-US-11-0020 | Ph 1 | completed | Single Ascending Dose Study of RBP-6000 |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SUBOXONE FDA Label Details
Indications & Usage
FDA Label (PDF)SUBOXONE sublingual film is indicated for treatment of opioid dependence. SUBOXONE sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support. SUBOXONE® sublingual film contains buprenorphine, a partial‐opioid agonist, and naloxone, an opioid antagonist, and is indicated for treatment of opioid dependence. SUBOXONE sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support.
Pro Intelligence Preview
Deep insights for SUBOXONE
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2030
- • 48 active patents
Trial Analysis
- • 6 total trials
- • Stage: Declining
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment