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Last Updated: August 15, 2022

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.

One supplier is listed for this compound.

Summary for stiripentol
Recent Clinical Trials for stiripentol

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SponsorPhase
BiocodexPhase 4
BiocodexPhase 2
BiocodexPhase 1

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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 FOR SUSPENSION;ORAL 207223-001 Aug 20, 2018 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Biocodex Sa DIACOMIT stiripentol CAPSULE;ORAL 206709-001 Aug 20, 2018 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Biocodex Sa DIACOMIT stiripentol CAPSULE;ORAL 206709-002 Aug 20, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Biocodex Sa DIACOMIT stiripentol FOR SUSPENSION;ORAL 207223-002 Aug 20, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Biocodex Sa DIACOMIT stiripentol FOR SUSPENSION;ORAL 207223-001 Aug 20, 2018 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Biocodex Sa DIACOMIT stiripentol CAPSULE;ORAL 206709-001 Aug 20, 2018 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Biocodex Sa DIACOMIT stiripentol CAPSULE;ORAL 206709-002 Aug 20, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

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