EAST BRUNSWICK, NJ - Savient Pharmaceuticals Inc. announced on Tuesday that it has filed a lawsuit in the US District Court for the District of New Jersey against Sandoz Pharmaceuticals, a Novartis Pharmaceuticals company, and Upsher-Smith Laboratories for infringement of Savient's US Patent Nos. 5,872,147 ("the '147' patent"); 6,090,799 ("the '799 patent"); 6,576,659 ("the '659 patent"); 6,670,351 ("the '351 patent"); and 6,828,313 ("the '313 patent").
According to a press release by the company, these patents relate to various methods of using Savient's product Oxandrin (oxandrolone tablets, USP) CIII. Oxandrin is Savient'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. Oxandrin can also be used to offset the protein catabolism associated with prolonged corticosteroid use.
The suit was brought following the US Food and Drug Administration's (FDA) decision late on December 1, 2006, to deny both Citizens Petitions filed by Savient, which had been pending since February 2004 and September 2005, and reliable information received by Savient indicating that Abbreviated New Drug Applications (ANDA) filed by both Sandoz and Upsher-Smith had also been approved by the FDA. 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.
Savient also announced that it is examining the impact of the FDA decisions and its agreement with Watson on its pending patent infringement lawsuit against Barr Laboratories, a wholly owned subsidiary of Barr Pharmaceuticals Inc.
"We are very pleased to announce our partnership with Watson, a leading marketer of prescription brand equivalent products," said President and Chief Executive Officer of Savient Christopher Clement.
"Despite the actions of the FDA on Friday, we remain determined to take the steps necessary to defend our patent rights. Since we recognize that generic 'equivalents' of our drug may have an equivalency range from 80 - 125% of our branded and authorized generic tablets, we want to make certain that both the brand and it's A-B rated authorized generic formulation would be available to the patients who depend on Oxandrin to manage involuntary weight loss, which is a debilitating and sometimes life-threatening condition associated with diseases such as AIDS and chronic obstructive pulmonary disease,” he added.
"Over the last three years, we have been awaiting action by the FDA with respect to our Citizens Petitions, and in advance of those determinations, have taken the steps necessary to ensure that if the decisions were ultimately not in our favor, that we, in collaboration with Watson, would be prepared. We remain resolute in that regard today and for the future," continued Clement.
"We have a strong balance sheet with nearly $200 million in cash. We continue to make steady progress with our Phase 3 clinical trial of Puricase for treatment failure gout, and do not expect these unrelated activities to affect those programs in any manner," concluded Clement.
