Glycopyrronium Formoterol Aerosol Composition, Chiesi, EP3384898A1

The EPO published European Patent Application EP3384898A1 for a stable pressurised aerosol solution composition containing glycopyrronium bromide and formoterol, filed by Chiesi Farmaceutici S.p.A. The application claims priority across multiple therapeutic classifications including A61P 11/00 (respiratory system therapy), A61K 9/00 (medicinal preparations), and A61K 31/167 (amine amide compounds). The designated states cover the full EU territory plus several additional European countries.

For generic pharmaceutical manufacturers and respiratory drug developers, this publication establishes a patent barrier around a fixed-dose combination of glycopyrronium bromide and formoterol in a pressurised aerosol formulation. Parties developing competing respiratory fixed-dose combination products should assess whether their formulations could fall within the scope of these claims before proceeding to market. Freedom-to-operate analysis is advisable for any product in the same therapeutic category targeting the same patient population.