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Last Updated: August 8, 2020

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EPIDIOLEX Drug Profile

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When do Epidiolex patents expire, and what generic alternatives are available?

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

This drug has fifty-nine 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

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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
Zin W MyintPhase 1
Mayo ClinicPhase 2/Phase 3
National Center for Complementary and Integrative Health (NCCIH)Early Phase 1

See all EPIDIOLEX clinical trials

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   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
>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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