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Last Updated: November 30, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210365


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NDA 210365 describes EPIDIOLEX, which is a drug marketed by Gw Res Ltd and is included in one NDA. It is available from one supplier. There are eighteen patents protecting this drug. Additional details are available on the EPIDIOLEX profile page.

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.
Summary for 210365
Tradename:EPIDIOLEX
Applicant:Gw Res Ltd
Ingredient:cannabidiol
Patents:18
Formulation / Manufacturing:see details
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 210365
Generic Entry Date for 210365*:
Constraining patent/regulatory exclusivity:
TREATMENT OF SEIZURES ASSOCIATED WITH TUBEROUS SCLEROSIS COMPLEX (TSC) IN PATIENTS 1 YEAR OF AGE AND OLDER
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.

Suppliers and Packaging for NDA: 210365
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EPIDIOLEX cannabidiol SOLUTION;ORAL 210365 NDA Greenwich Biosciences, Inc. 70127-100 70127-100-10 1 BOTTLE, GLASS in 1 CARTON (70127-100-10) > 100 mL in 1 BOTTLE, GLASS (70127-100-01)
EPIDIOLEX cannabidiol SOLUTION;ORAL 210365 NDA Greenwich Biosciences, Inc. 70127-100 70127-100-60 1 BOTTLE, GLASS in 1 CARTON (70127-100-60) > 60 mL in 1 BOTTLE, GLASS (70127-100-06)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength100MG/ML
Approval Date:Sep 28, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 28, 2025
Regulatory Exclusivity Use:INDICATED FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME (LGS) OR DRAVET SYNDROME (DS) IN PATIENTS 2 YEARS OF AGE AND OLDER
Regulatory Exclusivity Expiration:Sep 28, 2023
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Jul 31, 2023
Regulatory Exclusivity Use:NEW PATIENT POPULATION

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Serving leading biopharmaceutical companies globally:

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Johnson and Johnson

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