Data updated: Mar 10, 2026
DSUVIA
SUFENTANIL CITRATE
Approved 2018-11-02
1
Indication
--
Phase 3 Trials
7
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2018-11-02
- Routes
- SUBLINGUAL
- Dosage Forms
- TABLET
DSUVIA Approval History
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What DSUVIA Treats
1 FDA approvalsOriginally approved for its first indication in 2018 .
- Other (1)
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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.
DSUVIA FDA Label Details
ProDSUVIA Patents & Exclusivity
Latest Patent: Feb 2038
Patents (21 active)
US11672738
Expires Feb 2, 2038
US8945592
Expires Jul 29, 2031
US8202535
Expires Oct 22, 2030
US8865743
Expires Oct 22, 2030
US12033733
Expires Mar 16, 2030
US10896751
Expires Mar 16, 2030
US8574189
Expires Mar 16, 2030
US11676691
Expires Mar 16, 2030
US8778393
Expires Jan 5, 2027
US9320710
Expires Jan 5, 2027
+ 11 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.