Sandoz introduces generic Pulmicort Respules

PRINCETON, N.J. — Sandoz on Tuesday announced the launch of a generic version of AstraZeneca’s Pulmicort Respules (budesonide inhalation suspension) in 1-mg strength. Sandoz expects to have 180-day generic drug marketing exclusivity for the 1-mg strength.

Sandoz’s new product is aimed for asthma treatment and as prophylactic therapy in children from 12 months to 8 years old. It is not intended for the relief of acute bronchospasm.

"Asthma is unfortunately becoming increasingly prevalent, while few generic alternatives exist for the biggest and most expensive products,” Peter Goldschmidt, president of Sandoz, said. “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.”

American sales for budesonide inhalation suspension amounted to approximately $242 million from May 2014 to May 2015, according to IMS Health.