FDA approves Teva's generic Famvir application
Teva Pharmaceuticals said today that the FDA has approved its generic version of Novartis' herpes treatment Famvir (famciclovir).
Famvir had annual sales of approximately $200 million in the United States for the twelve months ending June 30, 2007, based on IMS Health sales data.
Teva anticipates 180-days of market exclusivity for famciclovir based on the fact that it was the first company to file for a generic version of the drug.
Teva however still faces one legal obstacle before it can launch its generic Famvir version.
In 2005, Novartis sued Teva for patent infringement involving famciclovir. A hearing on the matter is scheduled for Sept. 5.
Teva has agreed not to launch its generic version until the hearing is concluded.
Famvir's main competition is GlaxoSmithKline's Valtrex, which generated global sales of approximately $1.3 billion in 2006. GSK's U.S. patent on Valtrex expires in 2009.