PARSIPPANY, N.J. — A court has ruled in favor of generic drug maker Actavis concerning its generic version of a drug to treat asthma in children, the company said.
Actavis said the U.S. District Court for the District of New Jersey had ruled Actavis' generic version of AstraZeneca's Pulmicort Respules (budesonide inhalation suspension) in the 0.25-mg, 0.5-mg and 1-mg strengths did not infringe one of AstraZeneca's patents on the drug, while another patent covering the drug was invalid. Actavis' generic versions of the first two strengths for the drug received Food and Drug Administration approval in August 2012, while the 1-mg strength is still awaiting approval.
Pulmicort Respules is used as a maintenance medicine to control and prevent asthma symptoms in children ages 12 months to 8 years. Various versions of the drug had sales of about $1.2 billion during the 12-month period that ended in January, Actavis said.