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Last Updated: September 25, 2022

XCOPRI Drug Patent Profile


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When do Xcopri patents expire, and what generic alternatives are available?

Xcopri is a drug marketed by Sk Life and is included in one NDA. There is one patent protecting this drug.

This drug has twenty-three patent family members in nineteen countries.

The generic ingredient in XCOPRI is cenobamate. Additional details are available on the cenobamate profile page.

DrugPatentWatch® Generic Entry Outlook for Xcopri

Xcopri will be eligible for patent challenges on March 10, 2024. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 30, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for XCOPRI
International Patents:23
US Patents:1
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 13
Clinical Trials: 2
Patent Applications: 46
Drug Prices: Drug price information for XCOPRI
What excipients (inactive ingredients) are in XCOPRI?XCOPRI excipients list
DailyMed Link:XCOPRI at DailyMed
Drug patent expirations by year for XCOPRI
Drug Prices for XCOPRI

See drug prices for XCOPRI

DrugPatentWatch® Estimated Generic Entry Opportunity Date for XCOPRI
Generic Entry Date for XCOPRI*:
Constraining patent/regulatory exclusivity:
NDA:
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 XCOPRI

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

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

See all XCOPRI clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for XCOPRI

US Patents and Regulatory Information for XCOPRI

XCOPRI is protected by one US patents and one FDA Regulatory Exclusivity.

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

This potential generic entry date is based on patent See Plans and Pricing.

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

Patents protecting XCOPRI

Neurotherapeutic azole compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting XCOPRI

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
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 212839-002 Mar 10, 2020 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sk Life XCOPRI cenobamate TABLET;ORAL 212839-006 Mar 10, 2020 RX Yes No See Plans and Pricing See Plans and Pricing 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
Sk Life XCOPRI cenobamate TABLET;ORAL 212839-001 Mar 10, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
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
>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 XCOPRI

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 XCOPRI

When does loss-of-exclusivity occur for XCOPRI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 3065
Estimated Expiration: See Plans and Pricing

Australia

Patent: 06237798
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0607529
Estimated Expiration: See Plans and Pricing

Canada

Patent: 06258
Estimated Expiration: See Plans and Pricing

China

Patent: 1228138
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 79873
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 79873
Estimated Expiration: See Plans and Pricing

Japan

Patent: 35238
Estimated Expiration: See Plans and Pricing

Patent: 08538557
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 8589
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 07013197
Estimated Expiration: See Plans and Pricing

Netherlands

Patent: 1106
Estimated Expiration: See Plans and Pricing

Poland

Patent: 79873
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 79873
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 18792
Estimated Expiration: See Plans and Pricing

Patent: 07143073
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0709994
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1286499
Estimated Expiration: See Plans and Pricing

Patent: 080005437
Estimated Expiration: See Plans and Pricing

Spain

Patent: 41765
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 98249
Estimated Expiration: See Plans and Pricing

Patent: 0722085
Estimated Expiration: See Plans and Pricing

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

See the table below for additional patents covering XCOPRI around the world.

Country Patent Number Title Estimated Expiration
Poland 1879873 See Plans and Pricing
Portugal 1879873 See Plans and Pricing
China 101228138 Neurotherapeutic azole compounds See Plans and Pricing
Brazil PI0607529 compostos de azol neuroterapêuticos See Plans and Pricing
Russian Federation 2007143073 АЗОЛЬНЫЕ СОЕДИНЕНИЯ С НЕЙТРОТЕРАПЕВТИЧЕСКОЙ АКТИВНОСТЬЮ See Plans and Pricing
World Intellectual Property Organization (WIPO) 2006112685 See Plans and Pricing
Taiwan I398249 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for XCOPRI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1879873 21C1027 France See Plans and Pricing PRODUCT NAME: CENOBAMATE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/21/1530 20210330
1879873 2021C/524 Belgium See Plans and Pricing PRODUCT NAME: CENOBAMAAT; AUTHORISATION NUMBER AND 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 122021000027 Germany See Plans and Pricing PRODUCT NAME: CENOBAMAT; REGISTRATION NO/DATE: EU/1/21/1530 20210326
1879873 C202130027 Spain See Plans and Pricing 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 19/2021 Austria See Plans and Pricing PRODUCT NAME: CENOBAMAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1530 (MITTEILUNG) 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
>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.