Mylan sued over plans for Vytorin generic, and claims first-filer status
This article was originally published in Scrip
Executive Summary
Mylan has initiated a challenge to key US patents covering the hypolipaemic, Merck & Co's Vytorin (ezetimibe plus simvastatin), seeking to market a generic of the product before expiry of US patents. Following the submission of its ANDA with a paragraph IV challenge, the company said it was sued by Schering and MSP Singapore Company in the US District Court for the District of New Jersey. The suit triggers the 30-month stay of approval while the legal challenge is fought.