Savient files patent suit against Sandoz

New Jersey, USA-based Savient Pharmaceuticals says that it has filed a law suit in the US District Court for the District of New Jersey against Sandoz Pharmaceuticals, the generics unit of Swiss drug major Novartis, and Upsher-Smith Laboratories for infringement of Savient's US Patent Nos 5,872,147; 6,090,799; 6,576,659; 6,670,351; and 6,828,313. These patents relate to various methods of using Savient's product Oxandrin (oxandrolone tablets, USP) CIII, the firm's oral anabolic agent indicated as adjunctive therapy to promote weight gain after weight loss following extensive surgery, chronic infection, or severe trauma. Oxandrin is also indicated for patients who, without definite pathophysiologic reason, fail to gain or maintain normal weight, and can be used to offset the protein catabolism associated with prolonged corticosteroid use.

The suit was brought following the Food and Drug Administration's decision late on December 1, to deny both Citizens Petitions filed by Savient, which had been pending since February 2004 and September 2005, and reliable information received by the company indicating that Abbreviated New Drug Applications filed by both Sandoz and Upsher-Smith had also been approved by the agency. Savient has also filed a motion seeking a temporary restraining order and preliminary injunction to stop Sandoz and Upsher-Smith from marketing and selling their generic formulations of Oxandrin, which was granted late on December 4.

Additionally, Savient said that it is examining the impact of the FDA decisions and its agreement with Watson Pharmaceuticals on its pending patent infringement law suit against Barr Laboratories. Savient acknowledged that, in anticipation of these developments, it had previously entered into a supply and distribution agreement with Watson granting it exclusive US distribution rights to its A-B rated authorized generic of oxandrolone tablets, USP (C-III).