FDA approves first generic of Symbicort for asthma and COPD

First approved in 2006 as an asthma treatment, AstraZeneca’s (LON:AZN) Symbicort (budesonide/formoterol) has also won an indication related to chronic obstructive pulmonary disease (COPD).

Now, FDA has approved the first generic of Symbicort for both indications.

Viatris (Nasdaq:VTRS) partnered with Kindeva Drug Delivery (St. Paul, Minnesota) to manufacture the generic version.

Last week, the companies announced that FDA had tentatively approved the Symbicort generic as a result of patent litigation related to the drug in the U.S. District Court for the Northern District of West Virginia related to AstraZeneca’s Symbicort patents, U.S. Patent Nos. 7,759,328, 8,143,239, and 8,575,137.

Symbicort and its generic are drug-device combination products, consisting of a metered-dose inhaler with the corticosteroid budesonide and the bronchodilator beta2-agonist formoterol.

“Today’s approval of the first generic for one of the most commonly pr…

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