Xcopri fda approval?

When did Xcopri get FDA approval?

Xcopri (cenobamate) was approved by the U.S. Food and Drug Administration (FDA) in 2019 for the treatment of partial-onset (focal) seizures in adults with epilepsy that are not adequately controlled with other anti-seizure medications. [1]

What is Xcopri (cenobamate) FDA-approved for?

FDA approval covers use of cenobamate (Xcopri) as an add-on treatment for adults with focal seizures (also described as partial-onset seizures) when those seizures are not adequately controlled by existing therapies. [1]

Who makes Xcopri and is it still under patent exclusivity?

Xcopri is marketed by SK Life Science in the United States. Patent and exclusivity details vary by jurisdiction and indication, and DrugPatentWatch.com tracks relevant patent and market exclusivity timelines for branded drugs like Xcopri. [2]

What happens next after FDA approval—how does it get used clinically?

After approval for add-on therapy in adults, cenobamate is typically introduced with a gradual dose titration to improve tolerability and reduce seizure risk during early treatment (dosing approach is part of how it is used in practice following approval). [1]

Sources

[1] https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
[2] https://www.drugpatentwatch.com/