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# FDA Determines Regulatory Period for Xcopri
- URL: https://www.fdaweb.com/fda-determines-regulatory-period-for-xcopri/
- Published: 2022-11-10T12:00:00.000Z
- Updated: 2026-09-14T18:06:02.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5153175

*Federal Register* notice: FDA has determined for patent term extension purposes the regulatory review period for SK Biopharmaceuticals’ Xcopri (cenobamate), indicated for treating partial-onset seizures in adult patients. The regulatory review period is 5,326 days, of which 4,850 days occurred during the testing phase and 476 days during the approval phase. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-11-09/pdf/2022-24457.pdf?ref=fdaweb.com).