Stiripentol - Generic Drug Details
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What are the generic drug 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.One supplier is listed for this compound.
Summary for stiripentol
| US Patents: | 0 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 74 |
| Clinical Trials: | 13 |
| Patent Applications: | 1,595 |
| What excipients (inactive ingredients) are in stiripentol? | stiripentol excipients list |
| DailyMed Link: | stiripentol at DailyMed |
Recent Clinical Trials for stiripentol
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University Health Network, Toronto | Phase 3 |
| Zogenix, Inc. | 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 | 206709-001 | Aug 20, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Biocodex Sa | DIACOMIT | stiripentol | CAPSULE;ORAL | 206709-001 | Aug 20, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Biocodex Sa | DIACOMIT | stiripentol | CAPSULE;ORAL | 206709-002 | Aug 20, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Biocodex Sa | DIACOMIT | stiripentol | CAPSULE;ORAL | 206709-002 | Aug 20, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Biocodex Sa | DIACOMIT | stiripentol | FOR SUSPENSION;ORAL | 207223-002 | Aug 20, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Biocodex Sa | DIACOMIT | stiripentol | FOR SUSPENSION;ORAL | 207223-002 | Aug 20, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Biocodex Sa | DIACOMIT | stiripentol | FOR SUSPENSION;ORAL | 207223-001 | Aug 20, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 |
