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Data updated: Mar 10, 2026

EPIDIOLEX

CANNABIDIOL Cytochrome P450 2C8 Inhibitors
Neurology Approved 2018-06-25
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
3
Indications
--
Phase 3 Trials
2
Priority Reviews
7
Years on Market

Details

Status
Prescription
First Approved
2018-06-25
Routes
ORAL
Dosage Forms
SOLUTION

Companies

JAZZ PHARMS RES
Active Ingredient: CANNABIDIOL

EPIDIOLEX Approval History

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What EPIDIOLEX Treats

4 indications

EPIDIOLEX is approved for 4 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Lennox-Gastaut Syndrome
  • Dravet Syndrome
  • Tuberous Sclerosis Complex
  • Seizures
Source: FDA Label

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

EPIDIOLEX FDA Label Details

Pro

Indications & Usage

FDA Label (PDF)

EPIDIOLEX is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in patients 1 year of age and older. EPIDIOLEX is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex in patients 1 year of age and older

EPIDIOLEX Patents & Exclusivity

Latest Patent: Feb 2041
Exclusivity: Jul 2027

Patents (57 active)

US12102619 Expires Mar 1, 2041
US11160795 Expires Mar 1, 2041
US11406623 Expires Mar 1, 2041
US11207292 Expires Apr 26, 2039
US11865102 Expires Apr 26, 2039
US11065209 Expires Oct 13, 2035
US10918608 Expires Oct 13, 2035
US11400055 Expires Oct 13, 2035
US11096905 Expires Oct 13, 2035
US9956186 Expires Jun 17, 2035
+ 47 more patents

Exclusivity

M-270 Until Oct 2026
ODE-326 Until Jul 2027
ODE-332 Until Jul 2027
Source: FDA Orange Book

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Data Sources

FDA Approval: NDA210365 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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