Teva Files Paragraph IV ANDA For Avapro

Law360, New York (July 20, 2004, 12:00 AM EDT) -- Israeli drug maker Teva Pharmaceuticals has filed an application to make a generic version of Sanofi-Synthelabo’s hypertension drug Avapro.

Teva filed an Abbreviated New Drug Application (ANDA) with a Paragraph IV certification with the U.S. Food and Drug Administration for the marketing in the U.S.of a generic version of the drug Sanofi-Synthelabo said.

The filing does not challenge Sanofi-Synthelabo’s basic product patent that expires in 2011, but alleges only that the Teva formulation does not infringe the pharmaceutical formulation patent expiring in 2015, Sanofi-Synthelabo said....
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