Drug

Cannabidiol

As of the edition of 20 October 2026, Cannabidiol is a small molecule: marketed, first approved in 2005 (CA); acts on CNR1; US protection ends in 2039.

Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.

The drug

Status
Marketed; latest approval 2021
Kind
Small molecule
Brand name
Epidiolex
First approved
15 April 2005 (CA)
Approvals on record
6 in 5 regions
Holder of the most recent approval
Jazz Pharmaceuticals; 4 holders in all
Registered trials
247, 39 stopped early
Disease areas
Mental health; Nervous system; Chemically induced; Inherited and neonatal; Cancer; Bones, joints and muscles

US protection

US protection ends in 2039.

The last listed US drug-substance patent ends in 2039. The application that gives this date is held by Jazz Pharmaceuticals.

This is the US only, and it is not the date generics or biosimilars can enter.

The exact date and the listings behind it

In the product

11 listings count towards this date. The exact date and each listing are in the product.

See the exact date and the 11 listings behind itRequest access. Nothing is shown until you do.

Companies that need a new molecule because of this drug

1 company on route B because of this drug.

Companies on route B for this drug

In the product

1 company is on route B because of Cannabidiol.

Target

GeneProteinUniProt
CNR1Cannabinoid receptor 1P21554

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated301551
Phase 151231410
Phase 2112483414
Phase 34215912
Phase 412732
All trials247

Who has held its approvals

CompanyRoleYears
CNX TherapeuticsApplicant2005 to now
Jazz PharmaceuticalsApplicant, Later holder and Lead sponsor of trials2011 to now