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Generated: August 20, 2019

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 eight 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:8
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 210365
Generic Entry Date for 210365*:
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
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)

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
Patent:➤ Sign UpPatent Expiration:Jun 17, 2035Product Flag?Substance Flag?Delist Request?
Patented Use:USE FOR THE TREATMENT OF DROP SEIZURES IN PATIENTS WITH DRAVET SYNDROME

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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 verifification 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.