December 22, 2009 – A drug manufacturer recently filed paperwork with the FDA to produce a generic version of the cholesterol-lowering medication Vytorin.
Mylan Pharmaceuticals Inc. said it filed an abbreviated new drug application (ANDA) with the FDA for Ezetimibe and Simvastatin tablets, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg. In response to the ANDA filing, Vytorin’s maker, Schering Corp. and MSP Singapore Co., filed a lawsuit against Mylan. The suit was filed Dec. 16 in the U.S. District Court for the District of New Jersey and accuses the company of patent infringement.
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 if final FDA approval is obtained.
Vytorin had approximately $1.6 billion in sales for the same strengths for the 12 months ending Sept. 30, according to IMS Health.
For more information: www.mylan.com