1. Generics Bulletin

As US Court Chops Another Symbicort Patent, Will Viatris Make Its Move?

AstraZeneca Tells Generics Bulletin It May Appeal Invalidity Ruling

 
• By Dean Rudge

Viatris has persuaded a US district court that a further patent shielding AstraZeneca’s Symbicort pressurized metered dose inhaler is invalid. The ANDA sponsor, holding the only US FDA approval for a generic version of the blockbuster, has the potential to launch – although a further trial is planned in December.

COPD awareness frame poster with lungs filled with air bubbles on red background. Chronic obstructive pulmonary disease symbol. Medical template for clinics and centers. Vector illustration.
Viatris is looking to break AZ's 16 year monopoly • Source: Shutterstock

Viatris has removed another significant legal hurdle to launching its Breyna US generic version of AstraZeneca’s Symbicort (budesonide/formoterol fumarate dihydrate) pressurized metered dose inhaler – but a potential timeline to launching what would be the country’s first generic Symbicort product remains unclear.

A US District Court for the Northern District of West Virginia judge has ruled that asserted claims of AstraZeneca’s US...

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