Exclusive Summary

• 1) First approved in 2016 (US/EU), expanded to ≥1 month in the US in 2021; US generics began entering from 2023, while EU is expected to open from 2026 under 8+2 protection, leaving registration white space in many emerging markets. 2) The 10 mg/mL oral solution targets children and dysphagia patients, addressing focal-onset epilepsy (≈60% of 50 million globally) and ≈30% who need add-on therapy. 3) Compared with levetiracetam, it shows fewer behavioral adverse effects, minimal interactions and rapid full-dose initiation, fitting guideline use as an alternative/second-line add-on for focal seizures. 4) Tablet generics are crowded but oral solution competitors are fewer; leading with the liquid formulation creates differentiation in pediatric and hospital channels. 5) An ICH/CTD dossier with BE/stability data eases multi-country registrations, and typical 30–70% price discounts versus originator support access and tenders.