Genzyme's suit stays final FDA approval of Watson's generic Renvela ANDA

May 26 2010

Watson Pharmaceuticals, Inc. (NYSE: WPI) today confirmed that its subsidiary, Watson Laboratories, Inc. filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market sevelamer carbonate 800mg tablets.  Watson's sevelamer carbonate tablet is the generic version of Genzyme's Renvela®.  Renvela ® is a phosphate binder indicated for the control of serum phosphorus in patients with chronic kidney disease who are on dialysis.

Genzyme Corporation filed suit against Watson on May 24, 2010 in the United States District Court for the District of Maryland seeking to prevent Watson from commercializing its product prior to the expiration of U.S. Patent No. 5,667,775.  Genzyme's suit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson's ANDA for up to 30 months or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.  

For the twelve months ending March 31, 2010, Renvela ® had total U.S. sales of approximately $200 million according to IMS Health data.