XCOPRI Drug Patent Profile

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 are two patents protecting this drug.

This drug has twenty-six patent family members in twenty countries.

The generic ingredient in XCOPRI is cenobamate. One supplier is listed for this compound. 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

Summary for XCOPRI

International Patents:	26
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	15
Clinical Trials:	2
Patent Applications:	56
Drug Prices:	Drug price information for XCOPRI
What excipients (inactive ingredients) are in XCOPRI?	XCOPRI excipients list
DailyMed Link:	XCOPRI at DailyMed

See drug prices for XCOPRI

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for XCOPRI

NDA:

212839

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

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

See all XCOPRI clinical trials

Pharmacology for XCOPRI

Mechanism of Action

Cytochrome P450 2B6 Inducers Cytochrome P450 2B6 Inhibitors Cytochrome P450 2C19 Inhibitors Cytochrome P450 2C8 Inducers Cytochrome P450 3A Inhibitors Cytochrome P450 3A4 Inducers GABA A Receptor Positive Modulators Sodium Channel Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for XCOPRI

N03AX	Other antiepileptics
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

US Patents and Regulatory Information for XCOPRI

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

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

FDA Regulatory Exclusivity protecting XCOPRI

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
Sk Life	XCOPRI	cenobamate	TABLET;ORAL	212839-006	Mar 10, 2020		RX	Yes	No
Sk Life	XCOPRI	cenobamate	TABLET;ORAL	212839-003	Mar 10, 2020		RX	Yes	No
Sk Life	XCOPRI	cenobamate	TABLET;ORAL	212839-002	Mar 10, 2020		RX	Yes	No
Sk Life	XCOPRI	cenobamate	TABLET;ORAL	212839-004	Mar 10, 2020		RX	Yes	No

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

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

Australia

Brazil

Canada

China

Denmark

European Patent Office

Finland

Japan

Malaysia

Mexico

Netherlands

Poland

Portugal

Russian Federation

South Africa

South Korea

Spain

Taiwan

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
Taiwan	200722085	Neurotherapeutic azole compounds
Taiwan	I398249
Canada	2606258	COMPOSES AZOLE NEUROTHERAPEUTIQUES (NEUROTHERAPEUTIC AZOLE COMPOUNDS)
Japan	5035238
South Africa	200709994	Neurotherapeutic Azole Compounds

Supplementary Protection Certificates for XCOPRI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1879873	2190019-6	Sweden		PRODUCT NAME: CENOBAMATE OR A PHARMACEUTICAL ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/21/1530 20210330
1879873	C01879873/01	Switzerland		PRODUCT NAME: CENOBAMAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68051 19.05.2022
1879873	C202130027	Spain		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	122021000027	Germany		PRODUCT NAME: CENOBAMAT; REGISTRATION NO/DATE: EU/1/21/1530 20210326
1879873	2021C/524	Belgium		PRODUCT NAME: CENOBAMAAT; AUTHORISATION NUMBER AND DATE: EU/1/21/1530 20210330