Details for New Drug Application (NDA): 206709

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

The generic ingredient in DIACOMIT is stiripentol. Additional details are available on the stiripentol profile page.

Summary for 206709

Tradename:	DIACOMIT
Applicant:	Biocodex Sa
Ingredient:	stiripentol
Patents:	0

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 206709

Constraining patent/regulatory exclusivity:

TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME (DS) IN PATIENTS TAKING CLOBAZAM WHO ARE 6 MONTHS TO LESS THAN 2 YEARS OF AGE AND WEIGHING 7 KG OR MORE

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.

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	250MG
Approval Date:	Aug 20, 2018	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Jul 14, 2029
Regulatory Exclusivity Use:	TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME (DS) IN PATIENTS TAKING CLOBAZAM WHO ARE 6 MONTHS TO LESS THAN 2 YEARS OF AGE AND WEIGHING 7 KG OR MORE

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	500MG
Approval Date:	Aug 20, 2018	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Jul 14, 2029
Regulatory Exclusivity Use:	TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME (DS) IN PATIENTS TAKING CLOBAZAM WHO ARE 6 MONTHS TO LESS THAN 2 YEARS OF AGE AND WEIGHING 7 KG OR MORE

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