Specialty pharma business Impax Laboratories (NASDAQ: IPXL) confirmed Friday that Abbott Laboratories (NYSE:ABT) and an Abbott subsidiary filed suit against the company for patent infringement, in connection with a generic version of Simcor extended-release tablets, a drug used to reduce elevated cholesterol levels.
California-based Impax said it filed for an abbreviated new drug application (ANDA), containing a "paragraph IV certification", for a generic version of Simcor with the U.S. FDA.
Following receipt of notice from the FDA that it accepted the ANDA application, the company said it notified the new drug application holder and patent owner (Abbott) of its paragraph IV certification.
However, on Wednesday, Abbott and Abbott Respiratory filed suit against Impax in the United States District Court for the District of Delaware, an action that formally initiates the patent challenge process under the Hatch-Waxman Act, Impax said. The company, however, confirmed that once the ANDA is approved by FDA, Global Pharmaceuticals, Impax's generic division, will commercialize the product.
Simcor works to reduce elevated total levels of LDL (bad) cholesterol, and increase levels of HDL (good) cholesterol.
According to health information company Wolters Kluwer Health, U.S. sales of Simcor extended-release tablets were approximately $37 million for the twelve months ending September 30, 2010.