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 prescribed complex drug-device combination products to treat asthma and COPD is another step forward in our commitment to bring generic copies of complex drugs to the market, which can improve quality of life and help reduce the cost of treatment,” said Sally Choe, director of the Office of Generic Drugs in the FDA Center for Drug Evaluation and Research, in a statement.
In AstraZeneca’s annual report, the company referred to Symbicort as one of its “key growth drivers.”
The drug brought in $2.7 million in revenue in 2021.
AstraZeneca has noted that it anticipated pricing pressure for Symbicort in mature markets such as the U.S., European Union, China and Japan.
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