FOSTER CITY, Calif. Indian generic drug maker Lupin is challenging a Gilead Sciences patent for a drug that treats chronic angina, Gilead said.
Gilead said it received a notice that Lupin had filed an approval application with the Food and Drug Administration for a generic version of Ranexa (ranolazine) extended-release tablets. Lupin’s application contained a Paragraph IV certification, a legal assertion under the Hatch-Waxman Act of 1984 that Gilead’s patents covering Ranexa are invalid, unenforceable or won’t be infringed by Lupin’s version.
Under the Hatch-Waxman Act, Gilead has 45 days from the receipt of the letter to file a patent infringement lawsuit against Lupin. Such a suit would prohibit the FDA from approving Lupin’s version of the drug for two and a half years or until the court rules against Gilead. The patents covering Ranexa are set to expire in 2019, according to FDA records.