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
Formulation / Manufacturing:	see details
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

See all stiripentol clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for stiripentol

N03AX	Other antiepileptics
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

US Patents and Regulatory Information for stiripentol

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Glossary

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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	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

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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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