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Last Updated: April 13, 2024

Cenobamate - Generic Drug Details


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What are the generic sources for cenobamate and what is the scope of patent protection?

Cenobamate is the generic ingredient in one branded drug marketed by Sk Life and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cenobamate has twenty-six patent family members in twenty countries.

One supplier is listed for this compound.

Summary for cenobamate
International Patents:26
US Patents:2
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 15
Clinical Trials: 11
Patent Applications: 73
What excipients (inactive ingredients) are in cenobamate?cenobamate excipients list
DailyMed Link:cenobamate at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for cenobamate
Generic Entry Date for cenobamate*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;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 cenobamate

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

SponsorPhase
SK Life Science, Inc.Phase 3
SK Life Science, Inc.Phase 1
SK Life SciencePhase 1

See all cenobamate clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for cenobamate

US Patents and Regulatory Information for cenobamate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sk Life XCOPRI cenobamate TABLET;ORAL 212839-006 Mar 10, 2020 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sk Life XCOPRI cenobamate TABLET;ORAL 212839-002 Mar 10, 2020 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sk Life XCOPRI cenobamate TABLET;ORAL 212839-005 Mar 10, 2020 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sk Life XCOPRI cenobamate TABLET;ORAL 212839-003 Mar 10, 2020 RX Yes No ⤷  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 cenobamate

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Angelini Pharma S.p.A Ontozry cenobamate EMEA/H/C/005377
Adjunctive treatment of focal-onset seizures with or without secondary generalisation in adult patients with epilepsy who have not been adequately controlled despite a history of treatment with at least 2 anti-epileptic medicinal products.
Authorised no no no 2021-03-26
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Supplementary Protection Certificates for cenobamate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1879873 C202130027 Spain ⤷  Try a Trial PRODUCT NAME: CENOBAMATO; NATIONAL AUTHORISATION NUMBER: EU/1/21/1530; DATE OF AUTHORISATION: 20210326; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1530; DATE OF FIRST AUTHORISATION IN EEA: 20210326
1879873 21C1027 France ⤷  Try a Trial PRODUCT NAME: CENOBAMATE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/21/1530 20210330
1879873 19/2021 Austria ⤷  Try a Trial PRODUCT NAME: CENOBAMAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1530 (MITTEILUNG) 20210330
1879873 122021000027 Germany ⤷  Try a Trial PRODUCT NAME: CENOBAMAT; REGISTRATION NO/DATE: EU/1/21/1530 20210326
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.