AstraZeneca Files Suit Against Apotex for Pulmicort Respules Patent Infringement
AstraZeneca has filed a lawsuit against Apotex in the U.S. District Court for the District of New Jersey, seeking a declaration of patent infringement for its Pulmicort Respules. The action follows the FDA's approval of Apotex's generic version of the drug.
Wilmington, DE – AstraZeneca has initiated legal proceedings against Apotex, Inc. and Apotex Corp. in the U.S. District Court for the District of New Jersey. The lawsuit seeks a legal declaration that Apotex's actions infringe upon AstraZeneca's patents for its Pulmicort Respules product.
The legal challenge was filed after the U.S. Food and Drug Administration (FDA) granted approval on March 30, 2009, for Apotex to market a generic version of AstraZeneca's Pulmicort Respules (budesonide inhalation suspension). AstraZeneca's suit contends that Apotex intends to market this generic version prior to the expiration of AstraZeneca's relevant patents.
In conjunction with the lawsuit, AstraZeneca has also submitted a Motion for Interim Relief. This motion requests a court order to prohibit the sale of Apotex's generic product while the patent infringement case is ongoing. The court is scheduled to hear arguments on this motion on April 16, 2009.
AstraZeneca has stated it has strong confidence in its intellectual property rights for Pulmicort Respules and intends to defend them vigorously. The patents covering Pulmicort Respules are set to expire in 2018, with pediatric exclusivity extending to 2019. In 2008, Pulmicort achieved U.S. sales of $982 million, with approximately 90 percent attributed to Pulmicort Respules.