CRESTOR US patent upheld by Court of Appeals for the Federal Circuit AstraZeneca announced today that the Court of Appeals for the Federal Circuit has upheld the decision of the District Court, District of Delaware, finding that the US substance patent protecting CRESTOR (rosuvastatin calcium) (RE37,314 – the ‘314 patent) is valid and enforceable. The defendants may seek a rehearing and/or review by the U.S. Supreme Court. Absent a reversal of this decision, none of the Abbreviated New Drug Applications (ANDAs) filed by Apotex, Aurobindo, Cobalt, Glenmark, Mylan, Par, Sandoz, Sun, Teva and Torrent may be approved by the FDA prior to expiration of the ‘314 patent. The ‘314 patent, which expires in 2016, covers rosuvastatin calcium, the active ingredient in CRESTOR.
FORXIGA™ (dapagliflozin) now approved in European Union for treatment of type 2 diabetes AstraZeneca and Bristol-Myers Squibb Company today announced that the European Commission has approved FORXIGA™ (dapagliflozin) tablets for the treatment of type 2 diabetes in the European Union (EU). FORXIGA is a selective and reversible inhibitor of sodium-glucose cotransporter 2 (SGLT2) that works independently of insulin to help remove excess glucose from the body, a unique mode of action not seen in any other currently available treatments for type 2 diabetes. This is the first medicine in the new SGLT2 class to gain regulatory approval for the treatment of type 2 diabetes, a disease in which high unmet medical need exists.
Tuesday, 13 November 2012
Court in Germany finds SEROQUEL XR® formulation patent invalid AstraZeneca today announced that the Federal Patent Court in Germany has found the formulation patent protecting SEROQUEL XR® (quetiapine fumarate) prolonged-release tablets – marketed as SEROQUEL Prolong in Germany – to be invalid. The patent was challenged by Accord Healthcare Limited, Hexal AG and TEVA Deutschland GmbH.
AstraZeneca PLC Third quarter and nine months results 2012 As expected, the revenue decline in the third quarter reflected the ongoing effect from the loss of exclusivity on several brands. Continued disciplined management of operating expenses and proceeds from the sale of Nexium OTC rights mitigated the impact of the revenue decline on Core operating profit. Financial targets for full year unchanged.
This website is intended for people seeking information on AstraZeneca's International business. We also have national business sites; links to these are under 'Other AZ websites' at the top of the page.