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Generated: November 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206709

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NDA 206709 describes DIACOMIT, which is a drug marketed by Biocodex Sa and is included in two NDAs. It is available from one supplier. Additional details are available on the DIACOMIT profile page.

The generic ingredient in DIACOMIT is stiripentol. One supplier is listed for this compound. Additional details are available on the stiripentol profile page.
Summary for 206709
Tradename:DIACOMIT
Applicant:Biocodex Sa
Ingredient:stiripentol
Patents:0
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 206709
Generic Entry Date for 206709*:
Constraining patent/regulatory exclusivity:
INDICATED FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME (DS) IN PATIENTS 2 YEARS OF AGE AND OLDER TAKING CLOBAZAM
Dosage:
CAPSULE;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: 206709
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIACOMIT stiripentol CAPSULE;ORAL 206709 NDA BIOCODEX INC. 68418-7939 68418-7939-6 1 BOTTLE in 1 CARTON (68418-7939-6) > 60 CAPSULE in 1 BOTTLE
DIACOMIT stiripentol CAPSULE;ORAL 206709 NDA BIOCODEX INC. 68418-7940 68418-7940-6 1 BOTTLE in 1 CARTON (68418-7940-6) > 60 CAPSULE in 1 BOTTLE (68418-7940-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength250MG
Approval Date:Aug 20, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 20, 2025
Regulatory Exclusivity Use:INDICATED FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME (DS) IN PATIENTS 2 YEARS OF AGE AND OLDER TAKING CLOBAZAM
Regulatory Exclusivity Expiration:Aug 20, 2023
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength500MG
Approval Date:Aug 20, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 20, 2025
Regulatory Exclusivity Use:INDICATED FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME (DS) IN PATIENTS 2 YEARS OF AGE AND OLDER TAKING CLOBAZAM

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