AstraZeneca has filed patent infringement actions against seven generic drug manufacturers, which have submitted Abbreviated New Drug Applications (ANDA) for Crestor (rosuvastatin calcium), a cholesterol drug. Filed in the US District Court, District of Delaware, the patent infringement actions are against Aurobindo Pharma, Apotex, Cobalt Pharmaceuticals, Par Pharmaceuticals, Sandoz, Mylan Pharmaceuticals, and Sun Pharma. All companies notified AstraZeneca with a notice-letter that they had submitted an ANDA to the FDA seeking approval to market generic versions of Crestor tablets before the expiration of the US patents. Notice-letters were also received from Teva Pharmaceuticals and Glenmark Pharmaceuticals, but AstraZeneca is not filing patent infringement actions against these companies. They did not state they intended to market their generic versions prior to the expiration of patent US No. RE 37'314, which covers the active ingredient and expires in 2016. Novo Nordisk and Pfizer have settled a lawsuit which Novo Nordisk placed against the US drug giant claiming Pfizer's inhaled insulin product Exubera infringed patents owned by Novo Nordisk. The lawsuit was originally field in August 2006 in the US Federal Court in the Southern District of New York. The terms of the settlement were not disclosed. Pfizer dropped Exubera in October due to its underperformance in the market. Sun Pharma and Novartis have reached a settlement in regards to Sun Pharma's submission of an ANDA for a generic version of Exelon (rivastigmine tartrate) capsules. The agreement stipulates a dismissal of the lawsuits filed in the US against Sun Pharma. Under the terms of the agreement, Sun Pharma is not to market generic Exelon in the US until some time prior to the expiration of the patents covering Exelon. The drug is indicated for the treatment of symptoms associated with mild to moderate Alzheimer's disease. Sun Pharma's generic Exelon was approved by the US Food and Drug Administration earlier this year. Other terms of the agreement were not disclosed. Meanwhile, Watson Pharmaceuticals has reached a settlement with Novartis in regards to Watson's generic version of Exelon (rivastigmine tartrate) capsules. Under the terms of the agreement, Novartis has granted Watson a license to its Exelon US patents for a generic version of the drug. However, Watson will not commence marketing its generic equivalent product until sometime prior to the expiration of the patents covering Exelon, the agreement stipulated. Currently, Watson has tentative approval for its generic version from the US Food and Drug Administration. Other details concerning the settlement or launch of Watson's generic have not been disclosed. Also last week, Watson reached a settlement over another patent litigation - this time with Biovail Laboratories. The litigation was against Watson's subsidiary Andrx Pharmaceuticals and was in regards to Andrx's generic version of Cardizem LA (diltiazem extended-release tablets). Under the terms of the agreement, Biovail has granted Watson an exclusive license to its Cardizem LA US patents for a generic version of the drug, which is indicated for the treatment and prevention of angina and high blood pressure. Watson is not to commence marketing of the generic version until April 1, 2009. Other details concerning the settlement were not disclosed. A status conference was held last week relating to the patent infringement lawsuit by VNUS Medical Technologies against Diomed and its co-defendants, Angio-Dynamics and Vascular Solutions. The trial in regards to the lawsuit was originally scheduled to commence on October 29 but was delayed based on a conflict in the court's schedule. A further status conference has been set for January 11, at which time the judge may set a trial date or may defer doing so until later.
