EAST BRUNSWICK, NJ - Savient Pharmaceuticals Inc. announced on Wednesday that it was granted a Temporary Restraining Order (TRO) enjoining all sales of generic oxandrolone tablets by Sandoz Pharmaceuticals, a Novartis Pharmaceuticals company, and Upsher-Smith Laboratories.
According to a press release by the company, the TRO was granted in the lawsuit filed by Savient against Sandoz and Upsher-Smith in the US District Court for the District of New Jersey 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). These patents relate to various methods of using Savient's product Oxandrin (oxandrolone tablets, USP) CIII.
Under the terms of the TRO, Savient will not launch sales of the A-B rated authorized generic of oxandrolone tablets, USP (C-III), an Oxandrin brand equivalent product, through Watson Pharmaceuticals Inc. while the TRO is in place, and Sandoz and Upsher-Smith have the right to move to vacate the TRO upon two days notice and the presentation of additional evidence. While the TRO is in place, Savient is permitted to and will continue to market and distribute the Oxandrin brand product.
President and Chief Executive Officer of Savient Pharmaceuticals Inc. Christopher Clement said, "We are very pleased with the action taken by the Court late yesterday and remain unwavering in our intention to take the actions necessary to defend our patent rights relating to the use of Oxandrin. We believe our patent position is strong and anticipate a favorable outcome."
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.
Savient Pharmaceuticals is a biopharmaceutical company engaged in developing and marketing pharmaceutical products that target unmet medical needs in both niche and broader markets.