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-one patents protecting this drug.
This drug has one hundred and thirty-two patent family members in twenty-five 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 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 April 26, 2039. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for EPIDIOLEX
| International Patents: | 132 |
| US Patents: | 21 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 44 |
| Clinical Trials: | 54 |
| Patent Applications: | 3,386 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for EPIDIOLEX |
| What excipients (inactive ingredients) are in EPIDIOLEX? | EPIDIOLEX excipients list |
| DailyMed Link: | EPIDIOLEX at DailyMed |
DrugPatentWatch® Estimated Generic Entry Opportunity 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
| Sponsor | Phase |
|---|---|
| Mayo Clinic | Phase 2 |
| National Cancer Institute (NCI) | Phase 2 |
| Jazz Pharmaceuticals | Phase 3 |
Pharmacology for EPIDIOLEX
Anatomical Therapeutic Chemical (ATC) Classes for EPIDIOLEX
US Patents and Regulatory Information for EPIDIOLEX
EPIDIOLEX is protected by thirty-six US patents and five FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of EPIDIOLEX is See Plans and Pricing.
This potential generic entry date is based on patent See Plans and Pricing.
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE FOR THE TREATMENT OF DROP SEIZURES IN PATIENTS WITH DRAVET SYNDROME
Use of cannabinoids in the treatment of epilepsy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE FOR THE TREATMENT OF ATONIC SEIZURES IN PATIENTS WITH DRAVET SYNDROME
Use of cannabinoids in the treatment of epilepsy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE IN COMBINATION WITH CLOBAZAM FOR TREATMENT OF DROP SEIZURES IN PATIENTS WITH LENNOX GASTAUT SYNDROME
Processes and apparatus for extraction of active substances and enriched extracts from natural products
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Use of cannabinoids in the treatment of epilepsy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH LENNOX-GASTAUT SYNDROME
Use of cannabinoids in the treatment of epilepsy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH DRAVET SYNDROME
Use of cannabinoids in the treatment of epilepsy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE FOR REDUCING CONVULSIVE SEIZURE FREQUENCY IN PATIENTS WITH LENNOX GASTAUT SYNDROME
Use of cannabinoids in the treatment of epilepsy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE FOR REDUCING CONVULSIVE SEIZURE FREQUENCY IN PATIENTS WITH DRAVET SYNDROME
Use of cannabinoids in the treatment of epilepsy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE FOR THE TREATMENT OF FOCAL SEIZURES IN PATIENTS WITH DRAVET SYNDROME
Use of cannabinoids in the treatment of epilepsy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Use of cannabinoids in the treatment of epilepsy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH DRAVET SYNDROME
Use of cannabinoids in the treatment of epilepsy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH LENNOX-GASTAUT SYNDROME
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE FOR THE TREATMENT OF DROP SEIZURES IN PATIENTS WITH DRAVET SYNDROME
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH TUBEROUS SCLEROSIS COMPLEX
Use of cannabidiol in the treatment of epilepsy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE FOR REDUCING SEIZURE FREQUENCY IN PATIENTS WITH TUBEROUS SCLEROSIS COMPLEX
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH LENNOX-GASTAUT SYNDROME
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH DRAVET SYNDROME
Use of cannabidiol in the treatment of epilepsy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH TUBEROUS SCLEROSIS COMPLEX
Use of cannabinoids in the treatment of epilepsy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH LENNOX-GASTAUT SYNDROME
Use of cannabinoids in the treatment of epilepsy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH DRAVET SYNDROME
Use of cannabinoids in the treatment of epilepsy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME
Use of cannabinoids in the treatment of epilepsy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH TUBEROUS SCLEROSIS COMPLEX IN PATIENTS TAKING EVEROLIMUS
Cannabidiol preparations and its uses
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME
Cannabidiol preparations and its uses
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH TUBEROUS SCLEROSIS COMPLEX
Cannabidiol preparations and its uses
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME
Use of cannabinoids in the treatment of epilepsy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE FOR THE TREATMENT OF CONVULSIVE SEIZURES IN PATIENTS WITH DRAVET SYNDROME
Use of cannabinoids in the treatment of epilepsy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
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: See Plans and Pricing
TREATMENT OF SEIZURES ASSOCIATED WITH TUBEROUS SCLEROSIS COMPLEX (TSC) IN PATIENTS 1 YEAR OF AGE AND OLDER
Exclusivity Expiration: See Plans and Pricing
NEW PATIENT POPULATION
Exclusivity Expiration: See Plans and Pricing
TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME (LGS) OR DRAVET SYNDROME (DS) IN PATIENTS BETWEEN 1 AND 2 YEARS OF AGE
Exclusivity Expiration: See Plans and Pricing
Expired US Patents for EPIDIOLEX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Gw Res Ltd | EPIDIOLEX | cannabidiol | SOLUTION;ORAL | 210365-001 | Sep 28, 2018 | See Plans and Pricing | See Plans and Pricing |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for EPIDIOLEX
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| GW Pharma (International) B.V. | 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: See Plans and Pricing
Brazil
Patent: 2020021884
Estimated Expiration: See Plans and Pricing
Canada
Patent: 97665
Estimated Expiration: See Plans and Pricing
China
Patent: 2512585
Estimated Expiration: See Plans and Pricing
Eurasian Patent Organization
Patent: 2092582
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 84283
Estimated Expiration: See Plans and Pricing
Israel
Patent: 8224
Estimated Expiration: See Plans and Pricing
Japan
Patent: 21522261
Estimated Expiration: See Plans and Pricing
South Korea
Patent: 210005128
Estimated Expiration: See Plans and Pricing
United Kingdom
Patent: 74321
Estimated Expiration: See Plans and Pricing
Patent: 1806953
Estimated Expiration: See Plans and Pricing
Patent: 1905876
Estimated Expiration: See Plans and Pricing
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 |
|---|---|---|---|
| United Kingdom | 2531281 | Use of cannabidiol in the treatment of intractable epilepsy | See Plans and Pricing |
| Canada | 3097665 | PREPARATIONS DE CANNABIDIOL ET LEURS UTILISATIONS (CANNABIDIOL PREPARATIONS AND ITS USES) | See Plans and Pricing |
| Poland | 3206716 | See Plans and Pricing | |
| United Kingdom | 201806953 | See Plans and Pricing | |
| Spain | 2813431 | See Plans and Pricing | |
| United Kingdom | 0409385 | See Plans and Pricing | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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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.
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