HAYWARD, Calif. — Generic drug maker Impax Labs is challenging the patent covering a drug used to treat high cholesterol, the company said Friday.
Impax said it had filed an approval application with the Food and Drug Administration for niacin and simvastatin extended-release tablets in the 1,000 mg/20 mg strength. The drug is a generic version of Abbott Labs’ Simcor.
Impax’s application contained a paragraph IV certification, a legal assertion under the Hatch-Waxman Act of 1984 that the patent covering Simcor is invalid or unenforceable, or that Impax’s version won’t infringe upon it. Abbott responded last Wednesday by filing a patent infringement suit against Impax in the U.S. District Court for the District of Delaware.