Data updated: Mar 10, 2026
SUBSYS
FENTANYL
Approved 2012-01-04
1
Indication
--
Phase 3 Trials
14
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2012-01-04
- Routes
- SUBLINGUAL
- Dosage Forms
- SPRAY
SUBSYS Approval History
Loading approval history...
What SUBSYS Treats
1 FDA approvalsOriginally approved for its first indication in 2012 .
- Other (1)
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
Full development history with FDA approval milestones
Loading...
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.
SUBSYS FDA Label Details
ProSUBSYS Patents & Exclusivity
Latest Patent: Apr 2030
Patents (476 active)
US8486973
Expires Apr 27, 2030
US8486972
Expires Apr 27, 2030
US8835460
Expires Jan 25, 2027
US9642797
Expires Jan 25, 2027
US9289387
Expires Jan 25, 2027
US9241935
Expires Jan 25, 2027
US9642844
Expires Jan 25, 2027
US8835459
Expires Jan 25, 2027
US10610523
Expires Jan 25, 2027
US10016403
Expires Jan 25, 2027
+ 466 more patents
Source: FDA Orange Book
Want competitive intelligence?
See who's developing similar drugs and track their progress
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.