Viatris : FDA Grants Tentative Approval Of Budesonide/formoterol Fumarate Dihydrate Products

(RTTNews) - Viatris Inc. (VTRS) and Kindeva Drug Delivery L.P. said that the U.S. Food and Drug Administration granted tentative approval of budesonide/formoterol fumarate dihydrate products. It is the first generic version of Symbicort based on an Abbreviated New Drug Application or ANDA.

Symbicort is indicated for certain patients with asthma or chronic obstructive pulmonary disease (COPD).

The FDA provided tentative approval at this time due to ongoing patent litigation.

On March 2, 2021, the U.S. District Court for the Northern District of West Virginia found that the asserted claims of AstraZeneca's Symbicort patents, U.S. Patent Nos. 7,759,328, 8,143,239, and 8,575,137, are not invalid for obviousness.

Viatris and Kindeva noted that the trial court decision prevents commercial launch at this time. But, they intend to file an appeal to continue vigorously defending their position that the patents are invalid. They are committed to bringing a generic Symbicort to market as soon as possible.

Viatris said it has not planned any revenue for 2021 from generic Symbicort, and the product's potential launch revenue was not included in the company's recently announced 2021 financial guidance.

Symbicort had U.S. branded sales of $3.5 billion for the 12 months ending January 2021, according to IQVIA.