Salix Pharmaceuticals, Ltd. announced that Salix Pharmaceuticals, Inc. has filed a lawsuit in the United States District Court for the District of New Jersey against Novel Laboratories, Inc. for infringement of the patent protecting Osmoprep (sodium phosphate monobasic monohydrate, USP and sodium phosphate dibasic anhydrous, USP) tablets. Salix has an exclusive license to the patent protecting Osmoprep from CDC III, LLC (CDC) for commercialization of Osmoprep in the United States.
The lawsuit is in response to an Abbreviated New Drug Application (ANDA) filed by Novel with the US Food and Drug Administration regarding Novel's intent to market a generic version of Osmoprep in the United States prior to the May 18, 2013 expiration of US Patent No. 5,616,346.
Salix has full confidence in the intellectual property rights that protect Osmoprep. Moreover, Salix intends to use all reasonable means at its disposal to continue to vigorously defend and enforce the intellectual property rights protecting Osmoprep.
Salix Pharmaceuticals, Ltd., headquartered in Raleigh, North Carolina, develops and markets prescription pharmaceutical products for the treatment of gastrointestinal diseases. Salix's strategy is to in-license late-stage or marketed proprietary therapeutic drugs, complete any required development and regulatory submission of these products, and market them through the company's gastroenterology specialty sales and marketing team.