AstraZeneca files patent infringement case against Apotex

Anglo-Swedish drug major AstraZeneca has filed a law suit in the US District Court for the District of New Jersey against Apotex, seeking a  declaration of patent infringement. On March 30, the US Food and Drug  Administration granted approval for a generic version of AstraZeneca's  Pulmicort Respules (budesonide inhalation suspension) to Apotex. The  suit follows Apotex' indication of intent to market a generic version of  the product in the USA prior to the expiration of the UK-based firm's  patents.

Additionally, AstraZeneca has filed a motion for interim relief seeking  to prohibit sales of Apotex' generic product until the patent  infringement case has concluded. The Court has indicated that it will  hear oral arguments regarding the motion on April 16.

AstraZeneca says it has full confidence in the strength of its  intellectual property rights protecting the drug and will continue to  vigorously defend and enforce these.  Patents covering Pulmicort  Respules expire in 2018 with pediatric exclusivity extending to 2019,  the firm maintains.