EPANOVA (omega-3-carboxylic acids)
Development Insights
Details
- Status
- Discontinued
- First Approved
- 2014-05-05
- Patent Cliff
- 2033
- Routes
- ORAL
- Dosage Forms
- CAPSULE
EPANOVA Approval History
What EPANOVA Treats
1 FDA approvalsOriginally approved for its first indication in 2014 .
- Other (1)
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02009865 EVOLVEII results posted | D5880C00001 OM-EPA-011 | Ph 3 | completed | Epanova® for Lowering Very High Triglycerides II (EVOLVE II) |
| NCT03574142 | D5881C00001 | Ph 1 | completed | A Ph 1 Study of Epanova® in Healthy Chineses |
| NCT02189252 ECLIPSEIV results posted | D5880C00003 OM-EPA-013 | Ph 1 | completed | An Open-Label Crossover Study to Compare the Relative Bioavailability, Efficacy and Safety of Epanova® and Lovaza® in Men and Women With a History of Pancreatitis |
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.
EPANOVA FDA Label Details
EPANOVA Patents & Exclusivity
Patents (4 active)
Pro Intelligence Preview
Deep insights for EPANOVA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2033
- • 4 active patents
Trial Analysis
- • 5 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