Schering and MSP Singapore sue Mylan over generic Vytorin ANDA

Mylan Inc. (Nasdaq: MYL) today confirmed that the company and its subsidiary Mylan Pharmaceuticals Inc. have been sued by Schering Corporation and MSP Singapore Company in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Ezetimibe and Simvastatin Tablets, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg. This product is the generic version of Vytorin® Tablets, a cholesterol treatment.

Mylan believes it is the first company to have filed a substantially complete ANDA containing a Paragraph IV certification for the product and expects to qualify for 180 days of sole marketing exclusivity once final FDA approval is obtained. Schering and MSP Singapore filed a lawsuit Dec. 16 in the U.S. District Court for the District of New Jersey alleging patent infringement.

Vytorin Tablets had approximately $1.6 billion in sales for the same strengths for the 12 months ending Sept. 30, according to IMS Health. Currently, Mylan has 133 ANDAs pending FDA approval representing $85.6 billion in annual brand sales, according to IMS. Thirty-eight of these pending ANDAs are potential first-to-file opportunities, representing $19.3 billion in annual brand sales, according to IMS.