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news.Actavis has announced that it will immediately re-launch its generic version of AstraZeneca's Pulmicort Respules (budesonide inhalation suspension) 0.25 and 0.5mg vials following a decision from the United States Court of Appeals for the Federal Circuit to uphold a lower court's ruling that United States Patent No. 7,524,834 is invalid.
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The Appeals court also dissolved the injunction preventing Actavis from further distribution of its generic version of Pulmicort Respules that was granted on March 12, 2015.
"We are pleased to be able to supply the market immediately with this product, and we are pleased that the Court of Appeals was able to work so swiftly to address this important matter," said Brent Saunders, CEO and President of Actavis.
Actavis’ Abbreviated New Drug Application ("ANDA") for its generic version of Pulmicort Respules received final approval from the U.S. Food and Drug Administration in August 2012.
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 December 31, 2014 total U.S. brand and generic sales of Pulmicort Respules were approximately $1.2 billion.