Actavis, Inc., one of the world's largest generics prescription drug manufacturers, has confirmed that the United States District Court for the District of New Jersey has granted a motion by AstraZeneca seeking a temporary restraining order (TRO) to prevent Actavis from further distribution of its generic version of AstraZeneca's Pulmicort Respules (budesonide inhalation suspension) 0.25, 0.5 mg products. Actavis' sales of generic Pulmicort Respules have been enjoined until April 12, 2013 to permit AstraZeneca an opportunity to seek injunctive relief with the US Court of Appeals for the Federal Circuit.

The District Court ruling followed the April 1, 2013 launch of Actavis' product after the District Court found that Actavis' 0.25, 0.5  and 1 mg generic version of Pulmicort Respules did not infringe United States Patent No. 7,524,834 (the '834 Patent) and that United States Patent No. 6,598,603 (the '603 Patent) was invalid.

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 US brand and generic sales of Pulmicort Respules were approximately $1.2 billion.

Actavis, Inc. is the world's third-largest generics prescription drug manufacturer and a global, integrated specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products.