FDA Gives Tentative OK to Viatris, Kindeva for Generic Symbicort

The US Food and Drug Administration (FDA) has granted tentative approval for a generic version of AstraZeneca’s blockbuster respiratory drug, Symbicort (budesonide/formoterol), to Viatris, the new company formed from the combination of Mylan and Upjohn, Pfizer’s off-patent branded and generic established medicines business, and Kindeva Drug Delivery, formerly 3M Drug Delivery Systems.

Symbicort is indicated for treating asthma or chronic obstructive pulmonary disease and is one of AstraZeneca’s top-selling drugs with 2020 sales of $2.7 billion. The FDA provided tentative approval at this time due to ongoing patent litigation over the drug.

Last week (March 2, 2021) the US District Court for the Northern District of West Virginia ruled in favor of AstraZeneca over Viatris’ and Kindeva’s asserted claims that certain of Symbicort patents are invalid. The district court ruled that the patents (US Patent Nos. 7,759,328, 8,143,239, and 8,575,137) are not invalid for obviousness. Viatris and Kindeva say they disagree with the district court decision. While the trial court decision prevents commercial launch at this time, the companies say they intend to file an appeal on the position that the patents are invalid. Viatris and Kindeva say they are committed to bringing a generic Symbicort to market as soon as possible.

Source: Viatris and Kindeva Drug Delivery

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