Mylan confirms first-to-file patent challenge over Vytorin generic

PITTSBURGH Schering-Plough and MSP Singapore Co. jointly filed a suit against a generic drug maker over an abbreviated new drug application for a cholesterol treatment.

Schering and MSP Singapore filed a lawsuit Dec. 16 in the U.S. District Court for the District of New Jersey, alleging patent infringement by Mylan.

Mylan said it expects to qualify for market exclusivity of ezetimibe and simvastatin tablets, 10-mg/10-mg, 10-mg/20-mg, 10-mg/40-mg and 10-mg/80-mg, once final approval is obtained from the Food and Drug Administration. The tablets are the generic equivalent of Vytorin.

Vytorin tablets had approximately $1.6 billion in sales for the same strengths for the 12 months ended Sept. 30, according to IMS Health data.