The first generic version of the topiramate-based extended-release epilepsy treatment ‘Qudexy XR Cap’ has been approved in Korea.

The Ministry of Food and Drug Safety granted marketing authorization for Intrio Biopharma’s ‘Topimed XR Tab. 50mg’ on the 23rd.

Unlike ‘Qudexy XR Cap’ which is an oblong hard capsule formulation, Topimed XR Tab was developed as a circular extended-release film-coated tablet.

Intrio Biopharma has been developing Topimed XR Tab since 2022.

The original epilepsy drug that contains topiramate was Janssen's ‘Topamax Tab,’ but in 2014, the U.S. generic company Upsher-Smith developed and received U.S. FDA approval for Qudexy XR