DrugPatentWatch Database Preview

EPIDIOLEX Drug Profile

« Back to Dashboard

Which patents cover Epidiolex, and when can generic versions of Epidiolex launch?

Epidiolex is a drug marketed by Gw Res Ltd and is included in one NDA. There are seven patents protecting this drug.

This drug has thirty patent family members in ten countries.

The generic ingredient in EPIDIOLEX is cannabidiol. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cannabidiol profile page.

Summary for EPIDIOLEX

International Patents:	30
US Patents:	7
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	25
Clinical Trials:	11
Patent Applications:	1,454
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for EPIDIOLEX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EPIDIOLEX
DailyMed Link:	EPIDIOLEX at DailyMed

Generic Entry Opportunity Date for EPIDIOLEX

Constraining patent/regulatory exclusivity:

INDICATED FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME (LGS) OR DRAVET SYNDROME (DS) IN PATIENTS 2 YEARS OF AGE AND OLDER

NDA:

210365

Dosage:

SOLUTION;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Synonyms for EPIDIOLEX

(-)-Cannabidiol

(-)-Cannabidiol 1.0 mg/ml in Methanol

(-)-CBD

(-)-trans-2-p-Mentha-1,8-dien-3-yl-5-pentylresorcinol

(-)-trans-Cannabidiol

(1'R,2'R)-5'-methyl-4-pentyl-2'-(prop-1-en-2-yl)-1',2',3',4'-tetrahydrobiphenyl-2,6-diol

(3R,4R)-2-p-mentha-1,8-dien-3-yl-5-pentylresorcinol

1,3-Benzenediol, 2-(3-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl)-5-pentyl-, (1R-trans)-

1,3-benzenediol, 2-[(1R,6R)-3-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl]-5-pentyl-

1,3-Benzenediol, 2-[3-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl]-5-pentyl-, (1R-trans)-

1,3-Benzenediol,2-[(1R,6R)-3-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl]-5-pentyl-

13956-29-1

18436-46-9

19GBJ60SN5

2-((1R,6R)-6-Isopropenyl-3-methyl-cyclohex-2-enyl)-5-pentyl-benzene-1,3-diol

2-(3-methyl-6-prop-1-en-2-yl-1-cyclohex-2-enyl)-5-pentyl-benzene-1,3-diol

2-(6-Isopropenyl-3-methyl-2-cyclohexen-1-yl)-5-pentyl-1,3-benzenediol #

2-(6-Isopropenyl-3-methyl-cyclohex-2-enyl)-5-pentyl-benzene-1,3-diol

2-(6-Isopropenyl-3-methyl-cyclohex-2-enyl)-5-pentyl-benzene-1,3-diol (Cannabidiol)

2-[(1R,6R)-3-methyl-6-prop-1-en-2-yl-1-cyclohex-2-enyl]-5-pentylbenzene-1,3-diol

2-[(1R,6R)-3-methyl-6-prop-1-en-2-ylcyclohex-2-en-1-yl]-5-pentylbenzene-1,3-diol

2-[3-Methyl-6-(methylethenyl)-2-cyclohexen-1-yl]-5-pentyl-1,3-benzenediol

20547-66-4

3556-78-3

4CN-1161

521-37-9

AC1LD8G2

AKOS032948358

BDBM50121429

BDBM50318484

C07578

cannabidiol

Cannabidiol (7CI)

Cannabidiol (USAN/INN)

Cannabidiol [USAN]

Cannabidiol solution

Cannabidiol solution, ~10 mg/mL in ethanol, analytical standard, for drug analysis

Cannabidiol solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material

Cannabidiol solution, 1.0 mg/mL in methanol, analytical standard, for drug analysis

cannabidiolum

CBD

CHEBI:69478

CHEMBL190461

D0O1UZ

D1(2)-trans-Cannabidiol

D10915

DB09061

Delta(1(2))-trans-cannabidiol

delta1(2)-trans-Cannabidiol

Epidiolex (TN)

GTPL4150

GWP42003-P

QHMBSVQNZZTUGM-ZWKOTPCHSA-N

Resorcinol, 2-p-mentha-1,8-dien-3-yl-5-pentyl-, (-)-(E)-

Resorcinol, 2-p-mentha-1,8-dien-3-yl-5-pentyl-, (+-)-

Resorcinol, 2-p-mentha-1,8-dien-3-yl-5-pentyl-, trans-(-)- (8CI)

SCHEMBL119679

UNII-19GBJ60SN5

UNII-K4H93P747O component QHMBSVQNZZTUGM-ZWKOTPCHSA-N

ZINC4097406

ZYN002

US Patents and Regulatory Information for EPIDIOLEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gw Res Ltd	EPIDIOLEX	cannabidiol	SOLUTION;ORAL	210365-001	Sep 28, 2018		RX	Yes	Yes
Gw Res Ltd	EPIDIOLEX	cannabidiol	SOLUTION;ORAL	210365-001	Sep 28, 2018		RX	Yes	Yes
Gw Res Ltd	EPIDIOLEX	cannabidiol	SOLUTION;ORAL	210365-001	Sep 28, 2018		RX	Yes	Yes
Gw Res Ltd	EPIDIOLEX	cannabidiol	SOLUTION;ORAL	210365-001	Sep 28, 2018		RX	Yes	Yes

International Patents for EPIDIOLEX

Country	Patent Number	Estimated Expiration
Brazil	112016029498
Canada	2952994
United Kingdom	201418171
Australia	2015275887