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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

Executive Summary

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.

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

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.”

AZ: US Federal Circuit 'Flagrantly Violated Precedent' On Symbicort

The US Court of Appeals for the Federal Circuit has “abandoned the basic principles of significant figures that have long been recognized by this court,” AstraZeneca argues, as part of its petition to have reheard a recent verdict favoring Mylan on the originator’s Symbicort IP.

Viatris CEO Talks Integration, Roadmap And Interchangeable Biosimilars

As CEO Michael Goettler provides an update on the progress made by Viatris in its first year as a combined company, he also offers Generics Bulletin hints as to the detailed strategy that will be unveiled at the firm’s upcoming investor day and explains how biosimilars – including interchangeable Semglee (insulin glargine) – and complex generics are important components of the firm’s future growth plans.

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