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*:
Constraining patent/regulatory exclusivity:
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 |
Pharmacology 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
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 | 212839-005 | 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 | ⤷ Sign Up | ||||
Sk Life | XCOPRI | cenobamate | TABLET;ORAL | 212839-005 | Mar 10, 2020 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Sk Life | XCOPRI | cenobamate | TABLET;ORAL | 212839-006 | 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
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
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Taiwan | I398249 | ⤷ Sign Up | |
South Korea | 20080005437 | NEUROTHERAPEUTIC AZOLE COMPOUNDS | ⤷ Sign Up |
China | 101228138 | Neurotherapeutic azole compounds | ⤷ Sign Up |
European Patent Office | 1879873 | COMPOSES AZOLE NEUROTHERAPEUTIQUES (NEUROTHERAPEUTIC AZOLE COMPOUNDS) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for cenobamate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1879873 | 301106 | Netherlands | ⤷ Sign Up | PRODUCT NAME: CENOBAMAAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/21/1530 20210330 |
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 | 132021000000101 | Italy | ⤷ Sign Up | PRODUCT NAME: CENOBAMATO(ONTOZRY); AUTHORISATION NUMBER(S) AND DATE(S): 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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