Teva Pharmaceutical Industries Ltd. announced that the US Food and Drug Administration has granted final approval for the company's Abbreviated New Drug Application (ANDA) to market its generic version of Novartis' Famvir (Famciclovir) tablets, 125 mg, 250 mg and 500 mg.
The brand product had annual sales of approximately $200 million in the United States for the twelve months ended June 30, 2007, based on IMS sales data.
As the first company to file an ANDA containing a paragraph IV certification for this product, Teva has been awarded a 180-day period of marketing exclusivity, a company press release stated.
A patent infringement suit was brought against Teva in April 2005 involving Teva's paragraph IV certification to US Patent No. 5,246,937 related to Teva's Famciclovir products. A hearing is scheduled for September 5, 2007 in the US District Court for the District of New Jersey regarding Novartis' motion for a preliminary injunction in that action. Both parties have agreed not to launch a generic Famciclovir product until the conclusion of the hearing on September 5, 2007.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products.