On May 18, 2007 the FDA granted final approval to Teva of its amlodipine besylate/benazepril products in 2.5mg/10mg, 5mg/10mg; 5mg/20mg and 10mg/20mg dosage strengths, AB rated to Novartis’ Lotrel, and Teva immediately commenced shipping the product.
On May 19, 2007, the US District Court for the District of New Jersey granted, in connection with Novartis’ pending patent infringement action, an emergency request for a temporary order restraining Teva’s launch and scheduled a hearing for May 21, for further proceedings.
Annual sales of the brand product are approximately $1.5 billion in the US based on IMS sales data. As the first company to file an Abbreviated New Drug Application with a paragraph IV patent certification, Teva has been awarded 180 days marketing exclusivity for this product.