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Last Updated: May 21, 2022

DIACOMIT Drug Patent Profile


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When do Diacomit patents expire, and when can generic versions of Diacomit launch?

Diacomit is a drug marketed by Biocodex Sa and is included in two NDAs.

The generic ingredient in DIACOMIT is stiripentol. One supplier is listed for this compound. Additional details are available on the stiripentol profile page.

Drug patent expirations by year for DIACOMIT
Drug Prices for DIACOMIT

See drug prices for DIACOMIT

DrugPatentWatch® Estimated Generic Entry Opportunity Date for DIACOMIT
Generic Entry Dates for DIACOMIT*:
Constraining patent/regulatory exclusivity:
INDICATED FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME (DS) IN PATIENTS 2 YEARS OF AGE AND OLDER TAKING CLOBAZAM
NDA:
Dosage:
CAPSULE;ORAL
Generic Entry Dates for DIACOMIT*:
Constraining patent/regulatory exclusivity:
INDICATED FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME (DS) IN PATIENTS 2 YEARS OF AGE AND OLDER TAKING CLOBAZAM
NDA:
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 DIACOMIT

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
BiocodexPhase 2

See all DIACOMIT clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for DIACOMIT

US Patents and Regulatory Information for DIACOMIT

DIACOMIT is protected by zero US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of DIACOMIT is See Plans and Pricing.

This potential generic entry date is based on INDICATED FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME (DS) IN PATIENTS 2 YEARS OF AGE AND OLDER TAKING CLOBAZAM.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

FDA Regulatory Exclusivity protecting DIACOMIT

INDICATED FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME (DS) IN PATIENTS 2 YEARS OF AGE AND OLDER TAKING CLOBAZAM
Exclusivity Expiration: See Plans and Pricing

NEW CHEMICAL ENTITY
Exclusivity Expiration: 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
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 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 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

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Serving leading biopharmaceutical companies globally:

Dow
Harvard Business School
McKesson
Mallinckrodt
Johnson and Johnson
Moodys

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.