Data updated: Mar 10, 2026
SUBOXONE
BUPRENORPHINE HYDROCHLORIDE
Approved 2002-10-08
5
Indications
--
Phase 3 Trials
1
Priority Reviews
23
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2002-10-08
- Routes
- SUBLINGUAL, BUCCAL, SUBLINGUAL
- Dosage Forms
- TABLET, FILM
Companies
Website: ↗
SUBOXONE Approval History
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What SUBOXONE Treats
5 FDA approvalsOriginally approved for its first indication in 2002 . Covers 5 distinct patient populations.
- Other (5)
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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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
ProSUBOXONE Patents & Exclusivity
Latest Patent: Mar 2030
Patents (48 active)
US8475832
Expires Mar 26, 2030
US9687454
Expires Aug 7, 2029
US11135216
Expires Aug 7, 2029
+ 38 more patents
Source: FDA Orange Book
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.