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Last Updated: September 26, 2023

EPIDIOLEX Drug Patent 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 twenty-six patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and thirty-two patent family members in twenty-three 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.

DrugPatentWatch® Generic Entry Outlook for Epidiolex

Epidiolex was eligible for patent challenges on September 28, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 26, 2039. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for EPIDIOLEX
Drug Prices for EPIDIOLEX

See drug prices for EPIDIOLEX

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for EPIDIOLEX
Generic Entry Date for EPIDIOLEX*:
Constraining patent/regulatory exclusivity:
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
National Cancer Institute (NCI)Early Phase 1
City of Hope Medical CenterEarly Phase 1
Jazz PharmaceuticalsPhase 4

See all EPIDIOLEX clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for EPIDIOLEX
Paragraph IV (Patent) Challenges for EPIDIOLEX
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
EPIDIOLEX Oral Solution cannabidiol 100 mg/mL 210365 10 2022-09-28

US Patents and Regulatory Information for EPIDIOLEX

EPIDIOLEX is protected by forty-six US patents and five FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of EPIDIOLEX is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting EPIDIOLEX

Use of cannabinoids in the treatment of epilepsy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE FOR THE TREATMENT OF DROP SEIZURES IN PATIENTS WITH DRAVET SYNDROME

Use of cannabinoids in the treatment of epilepsy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE FOR THE TREATMENT OF ATONIC SEIZURES IN PATIENTS WITH DRAVET SYNDROME

Use of cannabinoids in the treatment of epilepsy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE FOR THE TREATMENT OF ATONIC SEIZURES IN PATIENTS WITH LENNOX-GASTAUT SYNDROME

Use of cannabinoids in the treatment of epilepsy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE FOR THE TREATMENT OF DROP SEIZURES IN PATIENTS WITH LENNOX-GASTAUT SYNDROME

Use of cannabinoids in the treatment of epilepsy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE IN COMBINATION WITH CLOBAZAM FOR TREATMENT OF DROP SEIZURES IN PATIENTS WITH LENNOX GASTAUT SYNDROME

Use of cannabinoids in the treatment of epilepsy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH LENNOX-GASTAUT SYNDROME

Use of cannabinoids in the treatment of epilepsy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH DRAVET SYNDROME

Use of cannabinoids in the treatment of epilepsy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE FOR REDUCING CONVULSIVE SEIZURE FREQUENCY IN PATIENTS WITH LENNOX GASTAUT SYNDROME

Use of cannabinoids in the treatment of epilepsy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE FOR REDUCING CONVULSIVE SEIZURE FREQUENCY IN PATIENTS WITH DRAVET SYNDROME

Use of cannabinoids in the treatment of epilepsy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE FOR THE TREATMENT OF FOCAL SEIZURES IN PATIENTS WITH DRAVET SYNDROME

Use of cannabinoids in the treatment of epilepsy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Use of cannabinoids in the treatment of epilepsy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH DRAVET SYNDROME

Use of cannabinoids in the treatment of epilepsy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH LENNOX-GASTAUT SYNDROME


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE FOR THE TREATMENT OF DROP SEIZURES IN PATIENTS WITH DRAVET SYNDROME


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE FOR THE TREATMENT OF DROP SEIZURES IN PATIENTS WITH LENNOX-GASTAUT SYNDROME

Use of cannabidiol in the treatment of epilepsy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE FOR THE TREATMENT OF GENERALIZED SEIZURES OR FOCAL SEIZURES WITH IMPAIRMENT IN PATIENTS WITH TUBEROUS SCLEROSIS COMPLEX

Use of cannabidiol in the treatment of epilepsy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH TUBEROUS SCLEROSIS COMPLEX

Use of cannabidiol in the treatment of epilepsy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE FOR REDUCING SEIZURE FREQUENCY IN PATIENTS WITH TUBEROUS SCLEROSIS COMPLEX


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH LENNOX-GASTAUT SYNDROME


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH DRAVET SYNDROME

Use of cannabidiol in the treatment of epilepsy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH TUBEROUS SCLEROSIS COMPLEX

Use of cannabinoids in the treatment of epilepsy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH LENNOX-GASTAUT SYNDROME

Use of cannabinoids in the treatment of epilepsy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH DRAVET SYNDROME

Use of cannabinoids in the treatment of epilepsy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME

Use of cannabinoids in the treatment of epilepsy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME

Methods of treating tuberous sclerosis complex with cannabidiol and everolimus
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH TUBEROUS SCLEROSIS COMPLEX IN PATIENTS TAKING EVEROLIMUS

Cannabidiol preparations and its uses
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME

Cannabidiol preparations and its uses
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH TUBEROUS SCLEROSIS COMPLEX

Cannabidiol preparations and its uses
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME

Use of cannabinoids in the treatment of epilepsy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE FOR THE TREATMENT OF ABSENCE SEIZURES IN PATIENTS WITH DRAVET SYNDROME

Use of cannabinoids in the treatment of epilepsy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE FOR THE TREATMENT OF ABSENCE SEIZURES IN PATIENTS WITH LENNOX-GASTAUT SYNDROME

Use of cannabinoids in the treatment of epilepsy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE FOR THE TREATMENT OF FOCAL SEIZURES IN PATIENTS WITH DRAVET SYNDROME

Use of cannabidiol in the treatment of epilepsy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH TUBEROUS SCLEROSIS COMPLEX

Methods of treating tuberous sclerosis complex with cannabidiol and everolimus
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH TUBEROUS SCLEROSIS COMPLEX IN PATIENTS TAKING EVEROLIMUS


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH LENNOX-GASTAUT SYNDROME


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH DRAVET SYNDROME


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH TUBEROUS SCLEROSIS COMPLEX


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH LENNOX-GASTAUT SYNDROME


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH TUBEROUS SCLEROSIS COMPLEX


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH DRAVET SYNDROME

Use of cannabinoids in the treatment of epilepsy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE IN COMBINATION WITH CLOBAZAM FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH DRAVET SYNDROME

Use of cannabinoids in the treatment of epilepsy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE IN COMBINATION WITH CLOBAZAM FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH LENNOX GASTAUT SYNDROME WHO HAVE BEEN PREVIOUSLY TREATED WITH CLOBAZAM

Use of cannabinoids in the treatment of epilepsy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE IN COMBINATION WITH CLOBAZAM FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH DRAVET SYNDROME WHO HAVE BEEN PREVIOUSLY TREATED WITH CLOBAZAM

Use of cannabinoids in the treatment of epilepsy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE IN COMBINATION WITH CLOBAZAM FOR TREATMENT OF SEIZURES IN PATIENTS WITH LENNOX GASTAUT SYNDROME

Use of cannabinoids in the treatment of epilepsy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE FOR THE TREATMENT OF CONVULSIVE SEIZURES IN PATIENTS WITH DRAVET SYNDROME

Use of cannabinoids in the treatment of epilepsy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE FOR THE TREATMENT OF CONVULSIVE SEIZURES IN PATIENTS WITH LENNOX GASTAUT SYNDROME

FDA Regulatory Exclusivity protecting EPIDIOLEX

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Try a Trial

INDICATED FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME (LGS) OR DRAVET SYNDROME (DS) IN PATIENTS 2 YEARS OF AGE AND OLDER
Exclusivity Expiration: ⤷  Try a Trial

TREATMENT OF SEIZURES ASSOCIATED WITH TUBEROUS SCLEROSIS COMPLEX (TSC) IN PATIENTS 1 YEAR OF AGE AND OLDER
Exclusivity Expiration: ⤷  Try a Trial

NEW PATIENT POPULATION
Exclusivity Expiration: ⤷  Try a Trial

TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME (LGS) OR DRAVET SYNDROME (DS) IN PATIENTS BETWEEN 1 AND 2 YEARS OF AGE
Exclusivity Expiration: ⤷  Try a Trial

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

EU/EMA Drug Approvals for EPIDIOLEX

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Jazz Pharmaceuticals Ireland Limited Epidyolex cannabidiol EMEA/H/C/004675
Epidyolex is indicated for use as adjunctive therapy of seizures associated with Lennox Gastaut syndrome (LGS) or Dravet syndrome (DS), in conjunction with clobazam, for patients 2 years of age and older.
Authorised no no yes 2019-09-19
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for EPIDIOLEX

When does loss-of-exclusivity occur for EPIDIOLEX?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 19259230
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2020021884
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 97665
Estimated Expiration: ⤷  Try a Trial

China

Patent: 2512585
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 2092582
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 84283
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 8224
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 21522261
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 20011163
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 210005128
Estimated Expiration: ⤷  Try a Trial

United Kingdom

Patent: 74321
Estimated Expiration: ⤷  Try a Trial

Patent: 1806953
Estimated Expiration: ⤷  Try a Trial

Patent: 1905876
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering EPIDIOLEX around the world.

Country Patent Number Title Estimated Expiration
Canada 2963208 UTILISATION DE CANNABINOIDES DANS LE TRAITEMENT DE L'EPILEPSIE (USE OF CANNABINOIDS IN THE TREATMENT OF EPILEPSY) ⤷  Try a Trial
South Korea 20210005128 칸나비디올 제제 및 이의 용도 ⤷  Try a Trial
United Kingdom 2531093 Use of cannabidiol in the reduction of convulsive seizure frequency in treatment-resistant epilepsy ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Johnson and Johnson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.