The Novartis subsidiary said Tuesday that it will market its budesonide inhalation suspension in 1-mg strength, and it expects 180-day generic drug marketing exclusivity for that dosage. The product is a a generic version of Pulmicort Respules inhalation suspension (1 mg) from AstraZeneca.
Sandoz’s budesonide inhalation suspension is indicated for maintenance treatment of asthma and as prophylactic therapy in children ages 12 months to 8 years. The product is not indicated for the relief of acute bronchospasm.
“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 U.S. 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.”
Budesonide inhalation suspension totaled U.S. sales of about $242 million for the 12 months ended in May 2015, according to IMS Health data reported by Sandoz.