Stiripentol - Generic Drug Details
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What are the generic sources for stiripentol and what is the scope of freedom to operate?
Stiripentol
is the generic ingredient in one branded drug marketed by Biocodex Sa and is included in two NDAs. Additional information is available in the individual branded drug profile pages.Summary for stiripentol
| US Patents: | 0 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 74 |
| Clinical Trials: | 13 |
| Patent Applications: | 1,595 |
| Formulation / Manufacturing: | see details |
| What excipients (inactive ingredients) are in stiripentol? | stiripentol excipients list |
| DailyMed Link: | stiripentol at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for stiripentol
Generic Entry Dates for stiripentol*:
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 |
Generic Entry Dates for stiripentol*:
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.
Recent Clinical Trials for stiripentol
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Zogenix, Inc. | Phase 3 |
| University Health Network, Toronto | Phase 3 |
| Biocodex | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for stiripentol
US Patents and Regulatory Information for stiripentol
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Biocodex Sa | DIACOMIT | stiripentol | CAPSULE;ORAL | 206709-002 | Aug 20, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Biocodex Sa | DIACOMIT | stiripentol | CAPSULE;ORAL | 206709-002 | Aug 20, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Biocodex Sa | DIACOMIT | stiripentol | FOR SUSPENSION;ORAL | 207223-002 | Aug 20, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Biocodex Sa | DIACOMIT | stiripentol | CAPSULE;ORAL | 206709-002 | Aug 20, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for stiripentol
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Biocodex | Diacomit | stiripentol | EMEA/H/C/000664 Diacomit is indicated for use in conjunction with clobazam and valproate as adjunctive therapy of refractory generalized tonic-clonic seizures in patients with severe myoclonic epilepsy in infancy (SMEI, Dravet's syndrome) whose seizures are not adequately controlled with clobazam and valproate. |
Authorised | no | no | no | 2007-01-03 | 2009-02-11 |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
