Sanofi-Synthelabo confirms the filing by Teva Pharmaceuticals USA Inc of an ANDA -Abbreviated New Drug Application -with a Paragraph IV certification for the marketing in the United States of a generic version of Avapro (Irbesartan).
Such filing does not challenge the basic product patent that expires in 2011, but alleges only that the Teva formulation does not infringe the pharmaceutical formulation patent (the '247 patent) expiring in 2015.
Sanofi-Synthelabo and its alliance partner Bristol-Myers Squibb shall examine Teva's Paragraph IV notice and the companies will respond accordingly, a release from Sanofi said.