Actavis, Inc. today confirmed that the United States District Court for the District of New Jersey has ruled that Actavis' generic version of AstraZeneca's Pulmicort RESPULES (budesonide inhalation suspension) 0.25, 0.5 mg, and 1 mg vials do not infringe United States Patent No. 7,524,834 (the '834 Patent) and that United States Patent No. 6,598,603 (the '603 Patent) is invalid. Actavis intends to launch the 0.25 and 0.5 mg products immediately.
Actavis' Abbreviated New Drug Application ("ANDA") for its generic version of Pulmicort RESPULES in the 0.25 and 0.5 mg strengths received final approval from the U.S. Food and Drug Administration in August 2012. Actavis' ANDA for the 1 mg strength is still pending.
Pulmicort RESPULES is a maintenance medicine used to control and prevent asthma symptoms in children ages 12 months to 8 years. For the 12 months ended January 31, 2013, total U.S. brand and generic sales of Pulmicort RESPULES were approximately $1.