Generics Bulletin

Viatris Wins First US Symbicort Generic – Will It Launch At Risk?

Federal Circuit Recently Told AstraZeneca It Would Not Review Viatris Win

16 Mar 2022

In the wake of a favorable US Court of Appeals for the Federal Circuit decision, Viatris has won FDA approval for the first generic Symbicort product. The ANDA sponsor’s management had recently declared itself “ready to launch if the opportunity presents itself in 2022.”

Neon Light Sign Lungs Icon — The FDA had published guidance in June 2015 • Source: Shutterstock

Viatris had declared only days ago that it was not anticipating introducing its proposed generic version of AstraZeneca’s Symbicort (budesonide/formoterol fumarate dihydrate) pressurized metered dose inhaler until 2023.

This may change, however, after the company on 15 March scooped the first US Food and Drug Administration approval for...