As the first company to file an abbreviated new drug application for the 5mg, 10mg, 20mg and 40mg strengths, Teva has been awarded 180 days of marketing exclusivity. Meanwhile, Indian drug maker, Ranbaxy, has received approval and 180-day exclusivity on the rarely prescribed 80mg strength of the drug.
According to a source sited by Teva, annual sales in the US of the 5mg, 10mg, 20mg and 40mg strengths of Zocor were approximately $4.1 billion for the 12 months ended March 2006.
“Teva is proud to lead the largest generic launch in history. The addition of generic Zocor complements Teva’s long term strategy for providing high-quality and low-cost drug alternatives to the American public,” said Israel Makov, president and CEO of Teva.
The approval comes after a US district court rejected Novartis’ motion seeking a temporary restraining order to stop Teva and Ranbaxy from commercializing their versions of the drug. The motion was brought by Novartis’ generics unit Sandoz, which is itself seeking approval to sell its version of the drug.