Mylan Inc.
Mylan Confirms First-to-File Patent Challenge Relating to Vytorin Cholesterol Medication
Published in Medical Letter on the CDC and FDA, January 10th, 2010
Mylan Inc. (NASDAQ:MYL) 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...
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