Data updated: Mar 10, 2026
PENNSAID
DICLOFENAC SODIUM
Approved 2009-11-04
2
Indications
--
Phase 3 Trials
16
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2009-11-04
- Routes
- TOPICAL
- Dosage Forms
- SOLUTION
PENNSAID Approval History
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What PENNSAID Treats
2 FDA approvalsOriginally approved for its first indication in 2009 . Covers 2 distinct patient populations.
- Other (2)
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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.
PENNSAID FDA Label Details
ProPENNSAID Patents & Exclusivity
Latest Patent: Aug 2030
Patents (25 active)
US8546450
Expires Aug 9, 2030
US8217078
Expires Jul 10, 2029
US8618164
Expires Jul 10, 2029
US8741956
Expires Jul 10, 2029
US9370501
Expires Jul 10, 2029
US9375412
Expires Jul 10, 2029
US9415029
Expires Jul 10, 2029
US8252838
Expires Apr 21, 2028
US9132110
Expires Oct 17, 2027
US9168305
Expires Oct 17, 2027
+ 15 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.