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.
FDA approves two Novo Nordisk insulin pens
PLAINSBORO, N.J. — The Food and Drug Administration has approved two new insulin pens made by Novo Nordisk, the Danish drug maker said Friday.
Novo Nordisk announced the FDA approval of Novolog FlexTouch (insulin aspart [rDNA origin]) and Levemir FlexTouch (insulin detemir [rDNA origin]).
FlexTouch is a new profiled insulin delivery system that allows patients to administer insulin by pressing a low-dose-force button. In traditional insulin pens, a push button extends when a dose is dialed, which can present challenges for a patient at higher doses, the company said.
Dr. Reddy’s sales increase by 17%
HYDERABAD, India — Indian drug maker Dr. Reddy’s Labs had sales of $536 million in second-quarter 2014 and profits of $110 million, the company said.
Those figures represented sales growth of 17% and a 76% growth in profits over second quarter 2013. Seventy-nine percent of the company’s sales came from generic drugs, including 50% from sales in North America; sales of generics grew by 32% over last year.
During the quarter, the company filed four applications for new generics with the Food and Drug Administration, and it currently has 62 applications pending, of which 39 contain challenges to branded drug patents, and nine are potential "first-to-file" drugs for which the company would get 180 days in which to compete exclusively against the branded versions of the drugs upon FDA approval.