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Last Updated: January 23, 2020

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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

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Drug patent expirations by year for EPIDIOLEX
Drug Prices for EPIDIOLEX

See drug prices for EPIDIOLEX

Generic Entry Opportunity Date for EPIDIOLEX
Generic Entry 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:
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

SponsorPhase
Brigham and Women's HospitalPhase 2
GW Research LtdPhase 4
Massachusetts General HospitalPhase 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   Start Trial   Start Trial   Start Trial
Gw Res Ltd EPIDIOLEX cannabidiol SOLUTION;ORAL 210365-001 Sep 28, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Gw Res Ltd EPIDIOLEX cannabidiol SOLUTION;ORAL 210365-001 Sep 28, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Gw Res Ltd EPIDIOLEX cannabidiol SOLUTION;ORAL 210365-001 Sep 28, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Gw Res Ltd EPIDIOLEX cannabidiol SOLUTION;ORAL 210365-001 Sep 28, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Gw Res Ltd EPIDIOLEX cannabidiol SOLUTION;ORAL 210365-001 Sep 28, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Gw Res Ltd EPIDIOLEX cannabidiol SOLUTION;ORAL 210365-001 Sep 28, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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