CENOBAMATE - Generic Drug Details

What are the generic drug 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

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

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

See all CENOBAMATE clinical trials

Pharmacology for CENOBAMATE

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

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	212839-001	Mar 10, 2020		RX	Yes	Yes
Sk Life	XCOPRI	cenobamate	TABLET;ORAL	212839-004	Mar 10, 2020		RX	Yes	No
Sk Life	XCOPRI	cenobamate	TABLET;ORAL	212839-005	Mar 10, 2020		RX	Yes	No				Y
Sk Life	XCOPRI	cenobamate	TABLET;ORAL	212839-005	Mar 10, 2020		RX	Yes	No
Sk Life	XCOPRI	cenobamate	TABLET;ORAL	212839-006	Mar 10, 2020		RX	Yes	No

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

International Patents for CENOBAMATE

Country	Patent Number	Title	Estimated Expiration
Poland	1879873
European Patent Office	3768257	UTILISATION DE CARBAMATE DE [(1R)-1-(2-CHLOROPHÉNYL)-2-(TÉTRAZOL-2-YL)ÉTHYL] EN POLYTHÉRAPIE (USE OF [(1R)-1-(2-CHLOROPHENYL)-2-(TETRAZOL-2-YL)ETHYL] CARBAMATE IN COMBINATION THERAPY)
China	101228138	Neurotherapeutic azole compounds
Japan	2008538557
Denmark	1879873

Supplementary Protection Certificates for CENOBAMATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1879873	301106	Netherlands		PRODUCT NAME: CENOBAMAAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/21/1530 20210330
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	19/2021	Austria		PRODUCT NAME: CENOBAMAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1530 (MITTEILUNG) 20210330
1879873	CR 2021 00015	Denmark		PRODUCT NAME: CENOBAMAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1530 20210330
1879873	2190019-6	Sweden		PRODUCT NAME: CENOBAMATE OR A PHARMACEUTICAL ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/21/1530 20210330