Mylan files for approval of generic gout drug

PITTSBURGH — Mylan expects to be the first to market with a generic version of a drug for treating patients with gout, the company said Friday, though its filing has triggered a lawsuit from the makers of the branded version.

Mylan has filed with the Food and Drug Administration for approval of a generic version of Uloric (febuxostat) tablets in the 40-mg and 80-mg strengths, used for chronic treatment of hyperuricemia in patients with gout. Teijin owns the trademark for the drug and licenses it to Takeda, and both companies responded to the filing with a patent-infringement suit against Mylan in the U.S. District Court for the District of Delaware. The lawsuit was filed under the Hatch-Waxman Act of 1984 and places a stay of FDA approval on the generic drug for 30 months, or until the companies settle.

Uloric had sales of about $260.7 million during the 12-month period that ended in June, according to IMS Health. As the first company to win approval for a generic version of the drug, Mylan would have 180 days in which to compete exclusively against Teijin and Takeda.