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 is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.Cenobamate has twenty-three patent family members in nineteen countries.
One supplier is listed for this compound.
Summary for cenobamate
| International Patents: | 23 |
| US Patents: | 1 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 14 |
| Clinical Trials: | 11 |
| Patent Applications: | 72 |
| What excipients (inactive ingredients) are in cenobamate? | cenobamate excipients list |
| DailyMed Link: | cenobamate at DailyMed |
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 |
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 | 212839-002 | Mar 10, 2020 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| Sk Life | XCOPRI | cenobamate | TABLET;ORAL | 212839-001 | Mar 10, 2020 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| Sk Life | XCOPRI | cenobamate | TABLET;ORAL | 212839-004 | Mar 10, 2020 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| Sk Life | XCOPRI | cenobamate | TABLET;ORAL | 212839-004 | Mar 10, 2020 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| >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 |
|---|---|---|---|
| South Korea | 101286499 | See Plans and Pricing | |
| Russian Federation | 2007143073 | АЗОЛЬНЫЕ СОЕДИНЕНИЯ С НЕЙТРОТЕРАПЕВТИЧЕСКОЙ АКТИВНОСТЬЮ | See Plans and Pricing |
| Taiwan | 200722085 | Neurotherapeutic azole compounds | See Plans and Pricing |
| South Africa | 200709994 | Neurotherapeutic Azole Compounds | See Plans and Pricing |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for cenobamate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1879873 | CA 2021 00015 | Denmark | See Plans and Pricing | PRODUCT NAME: CENOBAMAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1530 20210330 |
| 1879873 | 301106 | Netherlands | See Plans and Pricing | PRODUCT NAME: CENOBAMAAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/21/1530 20210330 |
| 1879873 | 132021000000101 | Italy | See Plans and Pricing | PRODUCT NAME: CENOBAMATO(ONTOZRY); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/21/1530, 20210330 |
| 1879873 | 2190019-6 | Sweden | See Plans and Pricing | 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 |
