• Home
  • Symbicort Generic Approval on March 15, 2022
Workers' Comp

Symbicort Generic Approval on March 15, 2022

March 29, 2022

Recently the U.S. Food and Drug Administration (FDA) approved a generic formulation of Symbicort (budesonide and formoterol fumarate dihydrate) metered-dose inhaler for the treatment of asthma or chronic obstructive pulmonary disease (COPD). This is the first-time a generic combination agent of Symbicort has been approved.

The meter-dosed inhaler is available now in both strengths as the original brand name product, 160mcg/4.5 mcg and 80mcg/4.5mcg. The medication contains budesonide (an inhaled steroid to decrease inflammation) and formoterol (a long-acting beta-agonist that helps to open the airways by relaxing muscles). The inhaler is dosed the same for both COPD and asthma, two inhalations twice daily. The most common side effects are nose or throat irritation, increased risk of infection, stomach upset, and back pain.1 Patients should be aware that the medication should not be used as a rescue inhaler, they should rinse their mouth after use to decrease risk of thrush, and it may increase blood sugar levels. For full prescribing information please refer to the package insert for Symbicort.

According to the National Heart, Lung, and Blood Institute asthma affects more than 25 million Americans whereas COPD accounts for 16 million. Work-related lung diseases, including asthma, can result from a worker being exposed to harmful substances such as chemicals, fumes, or dust in the work environment. 

The Impact

Symbicort inhalers represent a small number of active prescriptions for Mitchell Pharmacy Solution clients, but this new generic approval currently shows around a 10% savings compared to the brand Average Wholesale Price (AWP) via Medispan.2 

For more information on the place in treatment or future impacts assessments, pricing information, or recommendations, please contact your Account Manager or Account Pharmacist.


1. Symbicort (budesonide/formoterol) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; July 2019.
2. Medi-Span®. Indianapolis (IN): Medi-Span®. Master Drug Data Base v2.5 (MDDB®); [cited 2022 MAR 20].Available from: http://www.medispan.com/master-drug-database.aspx