Teva fights off Novartis to market generic famciclovir tablets

Israeli-based Teva has received a favourable ruling from the US District Court for the District of New Jersey regarding a lawsuit filed by Swiss pharmaceutical company Novartis for a preliminary injunction related to Teva's famciclovir, a generic version of Novartis' Famvir treatment for genital herpes.

Teva's ANDA to market famciclovir tablets in 125 mg, 250 mg and 500 mg has already been granted final approval by the FDA.

Famvir had annual sales of approximately USD 200m in the US for the twelve months to 30 June 2007, based on IMS 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 from the date of first commercial marketing.

Teva is currently involved in patent litigation with Novartis concerning this product. A trial date has yet to be set.