Savient Pharmaceuticals Inc. has filed a patent infringement lawsuit in the U.S. District Court for the District of New Jersey against Sandoz Pharmaceuticals and Upsher-Smith Laboratories alleging infringement of five methods of using Oxandrin, generically known as Oxandrolone. Savient has also filed a motion seeking a temporary restraining order and preliminary injunction to restrain Sandoz and Upsher-Smith from marketing and selling their generic formulations of Oxandrin.
The lawsuit was result of decision by the Food and Drug Administration denying two Citizens Petitions filed in 2004 and 2005 attempting to stop the approval of a generic version of Oxandrin made by Sandoz and Upsher-Smith. Savient also added it is examining the impact of the FDA decisions and its agreement with Watson on its pending patent-infringement lawsuit against Barr Laboratories, which also seeks to market a generic version of Oxandrin. Savient further added that it signed a supply and distribution deal with Watson granting it exclusive U.S. distribution rights to the authorized generic version of Oxandrin tablets.
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