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Viatris Clears US Symbicort Hurdle But Loses Key Patent Fight To AstraZeneca

Three US Patents Not Invalid Due To Obviousness; Appeal Planned

 
• By Dean Rudge

Viatris and partner Kindeva Drug Delivery are celebrating a first tentative nod for a generic to one of the most significant respiratory opportunities in the US, but cannot launch at present with the firms having failed to navigate key pieces of intellectual property.

Gavel
Viatris failed to demonstrate obviousness by clear and convincing evidence • Source: Shutterstock

Viatris has received a first tentative approval from the US Food and Drug Administration for a generic to AstraZeneca’s blockbuster Symbicort (budesonide/formoterol fumarate dihydrate) pressurized metered dose inhaler, although an unfavorable patent-litigation court decision handed down shortly beforehand has left the generics and biosimilars giant on the back foot.

Days before the tentative approval was announced, a court in West Virginia held as valid asserted claims in three patents shielding the branded treatment for asthma and chronic obstructive pulmonary disease, knocking

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