JERUSALEM, Israel--(BUSINESS WIRE)--Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA) announced today that further to its press release dated August 24, 2007, the U.S. District Court for the District of New Jersey has denied a motion filed by Novartis for a preliminary injunction related to Teva's Famciclovir Tablets, AB-rated to Novartis' Famvir®.
Teva's Abbreviated New Drug Application (ANDA) to market its Famciclovir Tablets, 125 mg, 250 mg and 500 mg has already been granted final approval by the U.S. Food and Drug Administration (FDA). 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, which will begin to run from the date of first commercial marketing.