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EPIDIOLEX Drug Profile

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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 nine patents protecting this drug.

This drug has fifty-two patent family members in fifteen 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.

US ANDA Litigation and Generic Entry Outlook for Epidiolex

Epidiolex will be eligible for patent challenges on September 28, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 28, 2025. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for EPIDIOLEX

International Patents:	52
US Patents:	9
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	29
Clinical Trials:	15
Patent Applications:	2,052
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

See drug prices for EPIDIOLEX

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.

Recent Clinical Trials for EPIDIOLEX

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Brigham and Women's Hospital	Phase 2
GW Research Ltd	Phase 4
Massachusetts General Hospital	Phase 4

See all EPIDIOLEX clinical trials

Synonyms for EPIDIOLEX

(-)-Cannabidiol

(-)-Cannabidiol (CBD)

(-)-Cannabidiol (CBD) 100 microg/mL in Methanol

(-)-Cannabidiol (CBD) 1000 microg/mL in Methanol

(-)-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-(4-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl)-5-pentyl-, 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)-

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-(4-Methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl)-5-pentyl-1,3-benzenediol trans-

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

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

3556-78-3

4CN-1161

AKOS032948358

BDBM50121429

BDBM50318484

C07578

C21H30O2

cannabidiol

Cannabidiol (7CI)

Cannabidiol (USAN/INN)

Cannabidiol [USAN]

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

D1(2)-trans-Cannabidiol

D10915

DB-093531

DB09061

Delta(1(2))-trans-cannabidiol

delta1(2)-trans-Cannabidiol

DTXSID00871959

Epidiolex (TN)

GTPL4150

GWP42003-P

P0T

Q422917

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				Y
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
Australia	2002255150
United Kingdom	201506550
United Kingdom	201410771
Japan	2017524672
Japan	2017519758
Spain	2680679
United Kingdom	2530001