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.
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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 206709
Generic Entry 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.
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: | Jul 14, 2025 | ||||||||
| Regulatory Exclusivity Use: | REVISIONS TO THE LABELING TO PROVIDE FOR THE EXPANSION OF THE USE OF STIRIPENTOL FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME IN PATIENTS TAKING CLOBAZAM TO INCLUDE PEDIATRIC PATIENTS WHO ARE 6 MONTHS TO LESS THAN 2 YEARS OF AGE AND WEIGHING 7 KG OR MORE | ||||||||
| 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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