Generic Pulmicort Respules Launched by Sandoz

Sandoz has launched a generic version of AstraZeneca’s asthma drug Pulmicort Respules in the US market.

The generic budesonide inhalation suspension 1 mg is approved for the maintenance treatment of asthma and to serve as prophylactic therapy in children aged 12 months to 8 years. This inhaled corticosteroid is not a bronchodilator and thus should not be used to treat an acute asthma attack.

"Asthma is unfortunately becoming increasingly prevalent while few generic alternatives exist for the biggest and most expensive products,” stated Sandoz president Peter Goldschmidt. “As a leading US provider of affordable, high-quality medicines, we are pleased to be the first company to make high-quality generic budesonide inhalation suspension 1-mg strength available.”

Sandoz expects 180-day generic drug marketing exclusivity for this product.

US sales for budesonide inhalation suspension were about $242 million for 12 months ending in May 2015, according to IMS Health.

Sandoz noted an immediate increase in wheezing may occur after dosing. Some of the most common side effects associated with this treatment include respiratory infection, runny nose, cough, and ear infection.