The ruling follows the Monday launch of Actavis's product after the court found that Actavis's 0.25, 0.5 and 1 mg generic version of Pulmicort Respules didn't infringe on a patent, and another patent protecting the asthma drug in the U.S. 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 year ended Jan. 31, total U.S. brand and generic sales of Pulmicort Respules were about $1.2 billion, according to data cited by Actavis.
The restraining order, granted by the U.S. District Court for the District of New Jersey, prevents Actavis from selling the drug until April 12 to permit AstraZeneca an opportunity to seek injunctive relief with the U.S. Court of Appeals for the Federal Circuit.
AstraZeneca has said a new generic version of Pulmicort Respules would materially affect the royalties it receives on sales of a separate copy of Pulmicort Respules marketed by Teva Pharmaceutical Industries Ltd. (>> Teva Pharmaceutical Industries Limited). Teva has a generic version of the drug on the market following an earlier deal with AstraZeneca dating back to 2008. AstraZeneca said it had made around $260 million in royalties during 2012 from that royalty agreement.
Actavis, formerly known as Watson Pharmaceuticals Inc., acquired Actavis Group in October for roughly $5.72 billion, creating the world's third-largest generic pharmaceutical company by revenue. Actavis's sales have surged of late with the launch of new generic drugs and increased demand from health-care companies and consumers looking to reduce their spending.
In February, Actavis said its fourth-quarter earnings fell 70% as acquisition and other charges masked the generic-drug maker's stronger-than-expected revenue growth.
Shares of Actavis closed Tuesday at $96.68 and were inactive in recent premarket trading. The stock has risen 44% in the past 12 months.
Write to Saabira Chaudhuri at saabira.chaudhuri@dowjones.com
