Court Grants AstraZeneca Temporary Restraining Order Against Apotex in Pulmicort Respules Patent Litigation
A U.S. court has granted AstraZeneca a temporary restraining order, preventing Apotex from launching a generic version of its Pulmicort Respules medication.
On April 16, 2009, the U.S. District Court for the District of New Jersey issued a temporary restraining order against Apotex, Inc. and Apotex Corp. This order bars the companies from launching a generic version of AstraZeneca’s PULMICORT RESPULES until further court order. A hearing is scheduled for April 27, 2009, to determine if the injunction should be continued.
The legal action followed the U.S. Food and Drug Administration’s (FDA) approval on March 30, 2009, of a generic version of AstraZeneca’s PULMICORT RESPULES (budesonide inhalation suspension) for Apotex. AstraZeneca filed suit after Apotex indicated its intent to market the generic product in the U.S. prior to the expiration of AstraZeneca’s patents.
AstraZeneca stated its full confidence in the strength of its intellectual property protecting PULMICORT RESPULES and its commitment to vigorously defending and enforcing these rights. The patents covering PULMICORT RESPULES are set to expire in 2018, with pediatric exclusivity extending to 2019.
PULMICORT RESPULES is a preventive and maintenance medicine for asthma, indicated for use in children aged 12 months to 8 years in the United States. In 2008, U.S. sales for PULMICORT totaled $982 million, with approximately 90 percent attributed to PULMICORT RESPULES.