AstraZeneca has filed a lawsuit in the US District Court for the District of New Jersey against Apotex (Apotex, Inc and Apotex Corp) seeking a declaration of patent infringement. On 30 March 2009, the US FDA granted approval for a generic version of AstraZeneca's Pulmicort Respules (budesonide inhalation suspension) to Apotex. The lawsuit follows Apotex's indication of intent to market a generic version of AstraZeneca's Pulmicort Respules in the US prior to the expiration of AstraZeneca's patents.
Additionally, AstraZeneca has filed a Motion for Interim Relief seeking to prohibit sales of Apotex's generic product until the patent infringement case has concluded. The Court has indicated that it will hear oral arguments regarding the motion on 16 April 2009.
AstraZeneca has full confidence in the strength of its intellectual property rights protecting Pulmicort Respules and will continue to vigorously defend and enforce its intellectual property.
Patents covering Pulmicort Respules expire in 2018 with paediatric exclusivity extending to 2019.
Pulmicort Respules is a preventive, maintenance asthma medicine indicated for use in children 12 months to eight years of age in the United States. Full-year US sales for Pulmicort in 2008 totalled $982 million, about 90 per cent of which is accounted for by Pulmicort Respules.