xcopri Drug Patent Profile
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Which patents cover Xcopri, and when can generic versions of Xcopri launch?
Xcopri is a drug marketed by Sk Life and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.
This drug has twenty-six patent family members in twenty countries.
The generic ingredient in XCOPRI is cenobamate. One supplier is listed for this compound. Additional details are available on the cenobamate profile page.
DrugPatentWatch® Generic Entry Outlook for Xcopri
Xcopri was eligible for patent challenges on March 10, 2024.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be October 30, 2032. This may change due to patent challenges or generic licensing.
There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.
Indicators of Generic Entry
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Questions you can ask:
- What is the 5 year forecast for xcopri?
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Summary for xcopri
International Patents: | 26 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 15 |
Clinical Trials: | 2 |
Patent Applications: | 55 |
Drug Prices: | Drug price information for xcopri |
What excipients (inactive ingredients) are in xcopri? | xcopri excipients list |
DailyMed Link: | xcopri at DailyMed |
![xcopri drug patent expirations Drug patent expirations by year for xcopri](/p/graph/s/t/xcopri-patent-expirations.png)
![Drug Prices for xcopri](/p/graph/drug-price/xcopri.png)
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for xcopri
Generic Entry Date for xcopri*:
Constraining patent/regulatory exclusivity:
NDA:
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 xcopri
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
SK Life Science, Inc. | Phase 3 |
SK Life Science, Inc. | Phase 1 |
Paragraph IV (Patent) Challenges for XCOPRI
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 xcopri
xcopri is protected by two US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of xcopri is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting xcopri
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: CO-ADMINISTRATION OF CENOBAMATE WITH PHENOBARBITAL AND/OR PHENYTOIN FOR THE TREATMENT OF PARTIAL ONSET SEIZURES
Neurotherapeutic azole compounds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting xcopri
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
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 | ⤷ 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 | ||||
Sk Life | XCOPRI | cenobamate | TABLET;ORAL | 212839-003 | Mar 10, 2020 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 | 212839-004 | 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 xcopri
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 xcopri
When does loss-of-exclusivity occur for xcopri?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 3065
Patent: COMPUESTOS AZOLICOS NEUROTERAPEUTICOS Y COMPOSICIONES FARMACEUTICAS QUE LOS CONTIENEN
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 06237798
Patent: Neurotherapeutic azole compounds
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0607529
Patent: compostos de azol neuroterapêuticos
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 06258
Patent: COMPOSES AZOLE NEUROTHERAPEUTIQUES (NEUROTHERAPEUTIC AZOLE COMPOUNDS)
Estimated Expiration: ⤷ Sign Up
China
Patent: 1228138
Patent: Neurotherapeutic azole compounds
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 79873
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 79873
Patent: COMPOSES AZOLE NEUROTHERAPEUTIQUES (NEUROTHERAPEUTIC AZOLE COMPOUNDS)
Estimated Expiration: ⤷ Sign Up
Finland
Patent: 0210018
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 35238
Estimated Expiration: ⤷ Sign Up
Patent: 08538557
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 8589
Patent: NEUROTHERAPEUTIC AZOLE COMPOUNDS
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 07013197
Patent: COMPUESTOS DE AZOL NEUROTERAPEUTICOS. (NEUROTHERAPEUTIC AZOLE COMPOUNDS.)
Estimated Expiration: ⤷ Sign Up
Netherlands
Patent: 1106
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 79873
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 79873
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 18792
Patent: АЗОЛЬНЫЕ СОЕДИНЕНИЯ С НЕЙТРОТЕРАПЕВТИЧЕСКОЙ АКТИВНОСТЬЮ (AZOLE COMPOUNDS WITH NEUTROTHERAPEUTIC ACTIVITY)
Estimated Expiration: ⤷ Sign Up
Patent: 07143073
Patent: АЗОЛЬНЫЕ СОЕДИНЕНИЯ С НЕЙТРОТЕРАПЕВТИЧЕСКОЙ АКТИВНОСТЬЮ
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 0709994
Patent: Neurotherapeutic Azole Compounds
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1286499
Estimated Expiration: ⤷ Sign Up
Patent: 080005437
Patent: NEUROTHERAPEUTIC AZOLE COMPOUNDS
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 41765
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 98249
Estimated Expiration: ⤷ Sign Up
Patent: 0722085
Patent: Neurotherapeutic azole compounds
Estimated Expiration: ⤷ Sign Up
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering xcopri around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 1879873 | COMPOSES AZOLE NEUROTHERAPEUTIQUES (NEUROTHERAPEUTIC AZOLE COMPOUNDS) | ⤷ Sign Up |
Malaysia | 148589 | NEUROTHERAPEUTIC AZOLE COMPOUNDS | ⤷ Sign Up |
Japan | 5035238 | ⤷ Sign Up | |
Brazil | PI0607529 | compostos de azol neuroterapêuticos | ⤷ Sign Up |
Taiwan | I398249 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for xcopri
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
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 | 122021000027 | Germany | ⤷ Sign Up | PRODUCT NAME: CENOBAMAT; REGISTRATION NO/DATE: EU/1/21/1530 20210326 |
1879873 | 2190019-6 | Sweden | ⤷ Sign Up | PRODUCT NAME: CENOBAMATE OR A PHARMACEUTICAL ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/21/1530 20210330 |
1879873 | 21C1027 | France | ⤷ Sign Up | PRODUCT NAME: CENOBAMATE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/21/1530 20210330 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |