Details for New Drug Application (NDA): 207223
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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 207223
Tradename: | DIACOMIT |
Applicant: | Biocodex Sa |
Ingredient: | stiripentol |
Patents: | 0 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 207223
Generic Entry Date for 207223*:
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:
FOR SUSPENSION;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: 207223
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DIACOMIT | stiripentol | FOR SUSPENSION;ORAL | 207223 | NDA | BIOCODEX, INC. | 68418-7941 | 68418-7941-6 | 60 PACKET in 1 CARTON (68418-7941-6) / 1 POWDER, FOR SUSPENSION in 1 PACKET |
DIACOMIT | stiripentol | FOR SUSPENSION;ORAL | 207223 | NDA | BIOCODEX, INC. | 68418-7942 | 68418-7942-6 | 60 PACKET in 1 CARTON (68418-7942-6) / 1 POWDER, FOR SUSPENSION in 1 PACKET |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 250MG/PACKET | ||||
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: | Jul 14, 2025 | ||||||||
Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
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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