Mylan Inc 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 US 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 US FDA approval is obtained. Schering and MSP Singapore filed a lawsuit December 16 in the US District Court for the District of New Jersey alleging patent infringement.
Vytorin Tablets had approximately US$ 1.6 billion in sales for the same strengths for the 12 months ending September 30, according to IMS Health. Currently, Mylan has 133 ANDAs pending US FDA approval representing US$ 85.6 billion in annual brand sales, according to IMS. Thirty-eight of these pending ANDAs are potential first-to-file opportunities, representing US$ 19.3 billion in annual brand sales, according to IMS.
Mylan ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 140 countries and territories.