Watson Laboratories files ANDA with FDA for generic Renvela for oral suspension

Jul 13 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 for oral suspension, 0.8g and 2.4g per packet.  Watson's sevelamer carbonate for oral suspension product is the generic version of Genzyme's Renvela® for Oral Suspension.  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 July 9, 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.  Based on available information, Watson believes it may be a first applicant to file an ANDA requesting approval of a generic version of Renvela®  for oral suspension, and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity for this dosage form.