Thursday, March 22, 2007

Sanofi filed patent infringement complaint against Synthon

World third-largest pharmaceutical company Sanofi-Aventis has filed a patent infringement complaint against Snython in the US District Court for the Middle District of North California in response to Synthon’s submission of abbreviated new drug application (ANDA) No. 78-483 with US FDA to obtain marketing approval of Zolpidem tartrate extended release tablets in 6.25mg and 12.5mg dosage strengths, generic version of Sanofi’s Ambien CR before expiry of the US Patent No. 6,514,531 (the ‘531 patent). Synthon has made Para IV certification with respect to the ‘531 patent.

1 comment:

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