Watson’s Sevelamer carbonate tablet is the generic version of Genzyme’s Renvela, a phosphate binder indicated for the control of serum phosphorus in patients with chronic kidney disease who are on dialysis.
Watson stated that Genzyme filed suit against the company on May 24, 2010 in the US District Court for the District of Maryland seeking to prevent Watson from commercialising its product prior to the expiration of US 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.