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Details for New Drug Application (NDA): 206709
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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 |
DrugPatentWatch® Estimated 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 |
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: | 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: | RX | Dosage: | CAPSULE;ORAL | Strength | 500MG | ||||
Approval Date: | Aug 20, 2018 | TE: | 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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