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Generated: March 21, 2019

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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 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.

Drug patent expirations by year 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.

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 ➤ Sign Up ➤ Sign Up ➤ Sign Up
Gw Res Ltd EPIDIOLEX cannabidiol SOLUTION;ORAL 210365-001 Sep 28, 2018 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Gw Res Ltd EPIDIOLEX cannabidiol SOLUTION;ORAL 210365-001 Sep 28, 2018 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Gw Res Ltd EPIDIOLEX cannabidiol SOLUTION;ORAL 210365-001 Sep 28, 2018 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
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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