Mylan has been sued by Schering and MSP Singapore Company in the US District Court for the District of New Jersey alleging patent infringement for filing an ANDA with the USFDA 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. Mylan says that 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. 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.
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