Drug makers file suit against Mylan over generic Vivelle-Dot

PITTSBURGH — A group of drug makers have sued Mylan over its attempt to gain Food and Drug Administration approval for a generic menopause drug, Mylan said Tuesday.

The generic drug maker said that Novartis, Noven Pharmaceuticals and Vivelle Ventures had sued it in the U.S. District Court for the Southern District of New York and the U.S. District Court for the District of Vermont for its filing of a regulatory approval application for estradiol transdermal system, a generic version of Vivelle-Dot. Mylan’s application contained a paragraph IV certification, a legal assertion that the patent covering Vivelle-Dot is invalid, unenforceable or won’t be infringed, thus prompting the lawsuit.

The drug is used to treat menopause and hypoestrogenism and prevent postmenopausal osteoporosis. Sales of Vivelle-Dot were $215 million in 2010, according to IMS Health. Mylan was the first company to file for approval of a generic version and thus is entitled to 180 days of market exclusivity in which to compete directly with the branded version should it win final FDA approval.