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Last Updated: January 30, 2023

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 is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Cenobamate has twenty-three patent family members in nineteen countries.

One supplier is listed for this compound.

Summary for cenobamate
International Patents:23
US Patents:1
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 14
Clinical Trials: 11
Patent Applications: 72
What excipients (inactive ingredients) are in cenobamate?cenobamate excipients list
DailyMed Link:cenobamate at DailyMed
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

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 212839-002 Mar 10, 2020 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Sk Life XCOPRI cenobamate TABLET;ORAL 212839-001 Mar 10, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Sk Life XCOPRI cenobamate TABLET;ORAL 212839-004 Mar 10, 2020 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Sk Life XCOPRI cenobamate TABLET;ORAL 212839-004 Mar 10, 2020 RX Yes No 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 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

International Patents for cenobamate

Country Patent Number Title Estimated Expiration
South Korea 101286499 See Plans and Pricing
Russian Federation 2007143073 АЗОЛЬНЫЕ СОЕДИНЕНИЯ С НЕЙТРОТЕРАПЕВТИЧЕСКОЙ АКТИВНОСТЬЮ See Plans and Pricing
Taiwan 200722085 Neurotherapeutic azole compounds See Plans and Pricing
South Africa 200709994 Neurotherapeutic Azole Compounds See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for cenobamate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1879873 CA 2021 00015 Denmark See Plans and Pricing PRODUCT NAME: CENOBAMAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1530 20210330
1879873 301106 Netherlands See Plans and Pricing PRODUCT NAME: CENOBAMAAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/21/1530 20210330
1879873 132021000000101 Italy See Plans and Pricing PRODUCT NAME: CENOBAMATO(ONTOZRY); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/21/1530, 20210330
1879873 2190019-6 Sweden See Plans and Pricing PRODUCT NAME: CENOBAMATE OR A PHARMACEUTICAL ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/21/1530 20210330
>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.