Adalvo is proud to announce the first-to-market launch of generic Brivaracetam film-coated tablets in Croatia, in partnership with one of Europe’s leading generic pharmaceutical companies.
This milestone marks the first generic launch of Brivaracetam anywhere in Europe, enabled by Adalvo’s dossier and delivered at a pivotal moment for the market. While additional generic entrants are expected in the coming weeks, this first-to-market launch reflects the strength of the partnership and the quality and precision of Adalvo’s development programme.
Brivaracetam is indicated as an adjunctive therapy in the treatment of partial-onset seizures, with or without secondary generalisation, in adults, adolescents, and children from two years of age with epilepsy. The product is a bioequivalent generic of the reference brand Briviact, developed by UCB Pharma.
Adalvo’s Brivaracetam dossier was submitted via the Decentralised Procedure (DCP) on Day-1 following expiry of the data exclusivity period, demonstrating the company’s commitment to first-to-market execution and its ability to move with speed and precision as exclusivity windows open.
Anil Okay, CEO of Adalvo, commented: “Reaching patients first is never an accident—it is the product of discipline, speed, and the right partnerships. Working with a partner who understands the value of moving decisively, we have achieved something meaningful for patients in Croatia living with epilepsy. Our European marketing authorisations have been granted, and upon expiry of the relevant patents we will roll out the product across Europe.”
This launch further demonstrates Adalvo’s broader CNS portfolio strategy and its ability to convert regulatory milestones into commercial outcomes for partners. Adalvo continues to expand its neurological offerings, providing differentiated, high-quality generics across key therapeutic areas.