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 product11 listings count towards this date. The exact date and each listing are in the product.
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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 product1 company is on route B because of Cannabidiol.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| CNR1 | Cannabinoid receptor 1 | P21554 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 30 | 15 | 5 | 1 |
| Phase 1 | 51 | 23 | 14 | 10 |
| Phase 2 | 112 | 48 | 34 | 14 |
| Phase 3 | 42 | 15 | 9 | 12 |
| Phase 4 | 12 | 7 | 3 | 2 |
| All trials | 247 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| CNX Therapeutics | Applicant | 2005 to now |
| Jazz Pharmaceuticals | Applicant, Later holder and Lead sponsor of trials | 2011 to now |