TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

EPANOVA

OMEGA-3-CARBOXYLIC ACIDS
Approved 2014-05-05
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
11
Years on Market

Details

Status
Discontinued
First Approved
2014-05-05
Routes
ORAL
Dosage Forms
CAPSULE

Companies

AstraZeneca
Active Ingredient: OMEGA-3-CARBOXYLIC ACIDS

EPANOVA Approval History

Loading approval history...

What EPANOVA Treats

1 FDA approvals

Originally approved for its first indication in 2014 .

  • Other (1)
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

EPANOVA FDA Label Details

Pro

EPANOVA Patents & Exclusivity

Latest Patent: Jan 2033

Patents (4 active)

US10117844 Expires Jan 4, 2033
US9050308 Expires Jan 4, 2033
US9050309 Expires Jan 4, 2033
US7960370 Expires Dec 20, 2026
Source: FDA Orange Book

Want competitive intelligence?

See who's developing similar drugs and track their progress

View Pipeline Dashboard

Data Sources

FDA Approval: NDA205060 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.