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 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

Generic Entry Date for cenobamate^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

Anatomical Therapeutic Chemical (ATC) Classes for cenobamate

N03AX	Other antiepileptics
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for CENOBAMATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
XCOPRI	Tablets	cenobamate	12.5 mg, 25 mg, 50 mg, 100 mg, 150 mg and 200 mg	212839	2	2024-03-11

US Patents and Regulatory Information for cenobamate

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Glossary

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

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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

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Country	Patent Number	Title	Estimated Expiration
Canada	2606258	COMPOSES AZOLE NEUROTHERAPEUTIQUES (NEUROTHERAPEUTIC AZOLE COMPOUNDS)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2006112685		⤷ Sign Up
South Korea	20080005437	NEUROTHERAPEUTIC AZOLE COMPOUNDS	⤷ Sign Up
Mexico	2007013197	COMPUESTOS DE AZOL NEUROTERAPEUTICOS. (NEUROTHERAPEUTIC AZOLE COMPOUNDS.)	⤷ Sign Up
China	101228138	Neurotherapeutic azole compounds	⤷ Sign Up
Malaysia	148589	NEUROTHERAPEUTIC AZOLE COMPOUNDS	⤷ Sign Up
South Africa	200709994	Neurotherapeutic Azole Compounds	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for cenobamate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1879873	C01879873/01	Switzerland	⤷ Sign Up	PRODUCT NAME: CENOBAMAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68051 19.05.2022
1879873	CR 2021 00015	Denmark	⤷ Sign Up	PRODUCT NAME: CENOBAMAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1530 20210330
1879873	2190019-6	Sweden	⤷ Sign Up	PRODUCT NAME: CENOBAMATE OR A PHARMACEUTICAL ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/21/1530 20210330
1879873	2021C/524	Belgium	⤷ Sign Up	PRODUCT NAME: CENOBAMAAT; AUTHORISATION NUMBER AND DATE: EU/1/21/1530 20210330
1879873	132021000000101	Italy	⤷ Sign Up	PRODUCT NAME: CENOBAMATO(ONTOZRY); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/21/1530, 20210330
1879873	19/2021	Austria	⤷ Sign Up	PRODUCT NAME: CENOBAMAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1530 (MITTEILUNG) 20210330
1879873	122021000027	Germany	⤷ Sign Up	PRODUCT NAME: CENOBAMAT; REGISTRATION NO/DATE: EU/1/21/1530 20210326
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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