Viatris Launches First Generic of Symbicort

Viatris and Kindeva Drug Delivery have launched Breyna (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol, the first generic version of AstraZeneca’s Symbicort. Breyna is a metered-dose inhaler (MDI), which contains both budesonide (a corticosteroid that reduces inflammation) and formoterol (a long-acting bronchodilator that relaxes muscles in the airways to improve breathing).

Breyna, a drug-device combination product, is indicated for certain patients with asthma or chronic obstructive pulmonary disease (COPD). It is indicated for patients with asthma 6 years of age and older, and as maintenance treatment of airflow obstruction and reducing exacerbations in patients with COPD, including chronic bronchitis and/or emphysema. Breyna is available in both 80 mcg/4.5 mcg and 160 mcg/4.5 mcg dosage strengths.

COPD is a chronic lung disease and affects more than 16 million Americans. Asthma causes swelling of the airways resulting in difficulty breathing, and about 25 million Americans have asthma.

Breyna is priced at a discount to Symbicort’s wholesale acquisition cost, according to a company spokesperson. For one inhaler, Breyna's cost is:

• $218.77 for the 80 mcg/4.5 mcg dosage strength
• $250.06 for the 160 mcg/4.5 mcg dosage strength

Viatris has established a Breyna copay program for commercially insured patients for $30 a month or up to $360 per year with 12 refills annually. Some patients may be eligible for a copay assistance of $20 per 30-day supply. The program will be available in August.

The wholesale acquisition cost of Symbicort is $390.47 but a spokesperson for AstraZeneca said the average out-of-pocket cost for Symbicort for a commercially insured patient is $56.20, when individual insurance plan design, formulary placement, provider access, assistance programs or savings offers are factored in.

The FDA approved Breyna in March 2022 but the launch was delayed because of litigation around the patent for Symbicort. In November 2022, Viatris announced that the U.S. District Court for the Northern District of West Virginia found one of AstraZeneca’s patent was invalid. AstraZeneca, however, filed a new complaint about other patents for Symbicort. Another patent expired In January 2023, and the pediatric exclusivity expired July 29, 2023.

This story has been updated to include information about wholesale acquisiton costs for both Breyna and Symbicort.