Cenobamate - Generic Drug Details

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

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	Phase 1
SK Life Science, Inc.	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	212839-006	Mar 10, 2020		RX	Yes	No
Sk Life	XCOPRI	cenobamate	TABLET;ORAL	212839-005	Mar 10, 2020		RX	Yes	No
Sk Life	XCOPRI	cenobamate	TABLET;ORAL	212839-002	Mar 10, 2020		RX	Yes	No				Y

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
South Korea	101286499
Spain	2441765
Australia	2006237798	Neurotherapeutic azole compounds

Supplementary Protection Certificates for cenobamate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1879873	19/2021	Austria		PRODUCT NAME: CENOBAMAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1530 (MITTEILUNG) 20210330
1879873	2021C/524	Belgium		PRODUCT NAME: CENOBAMAAT; AUTHORISATION NUMBER AND DATE: EU/1/21/1530 20210330
1879873	C01879873/01	Switzerland		PRODUCT NAME: CENOBAMAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68051 19.05.2022