Mylan sued by Schering over generic Vytorin

Published: 23-Dec-2009

US generic drugmaker Mylan is being sued by Schering Corporation and MSP Singapore over plans to make a generic version of cholesterol drug Vytorin.


US generic drugmaker Mylan is being sued by Schering Corporation and MSP Singapore over plans to make a generic version of cholesterol drug Vytorin.

Mylan, based in Canonsburg, Pennsylvania, is seeking US Food and Drug Administration approval for Ezetimibe and Simvastatin tablets, which would infringe two of Schering's patents.

Mylan claims it is the first company to have filed a substantially complete Abbreviated New Drug Application (ANDA) for the product and expects to qualify for 180 days of sole marketing exclusivity once final FDA approval is obtained.

Schering and MSP Singapore have filed a lawsuit in the US District Court for the District of New Jersey alleging patent infringement.

US sales of Vytorin tablets were approximately US$1.6bn for the 12 months to 30 September.

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