Watson Pharmaceuticals, Inc. today announced that its subsidiary Watson Laboratories, Inc., has received approval from the FDA for its Abbreviated New Drug Application (ANDA) for Budesonide Inhalation Suspension 0.25mg/2mL and 0.5mg/2mL Unit-dose ampules, the generic equivalent to AstraZeneca’s Pulmicort RESPULES. Watson is currently involved in patent litigation with AstraZeneca concerning this product. Watson plans to launch the product in 2012 subject to obtaining a favorable outcome on an anticipated motion for a preliminary injunction in the pending litigation.
For the twelve months ending May 31, 2012, Pulmicort RESPULES had total U.S. sales of approximately $1.1 billion according to IMS Health data. Pulmicort RESPULES is a maintenance medicine used to control and prevent asthma symptoms in children ages 12 months to 8 years.