As reported today, May 21, 2007, at Business Wire:
Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA) announces that on May 18, 2007 the U.S. Food and Drug Administration granted to Teva final approval of its amlodipine besylate/benazepril products in 2.5 mg/10 mg, 5 mg/10mg; 5 mg/20 mg and 10 mg/20 mg dosage strengths, AB rated to Novartis’ Lotrel® and Teva immediately commenced shipping the product. On May 19, 2007, the United States 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, 2007 at 11:00 am for further proceedings.
Annual sales of the brand product are approximately $1.5 billion in the U.S. based on IMS sales data. As the first company to file an Abbreviated New Drug Application (ANDA) with a Paragraph IV patent certification, Teva has been awarded 180 days marketing exclusivity for this product.
See the full release here.
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