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news.Watson Laboratories, subsidiary of Watson Pharmaceuticals, has filed an abbreviated new drug application (ANDA) with the FDA seeking approval to market Sevelamer carbonate for oral suspension, 0.8g and 2.4g per packet.
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Watson’s Sevelamer carbonate for oral suspension product is the generic version of Renvela for oral suspension from Genzyme.
Renvela is a phosphate binder indicated for the control of serum phosphorus in patients with chronic kidney disease who are on dialysis.
Watson said that Genzyme filed a suit against the company on July 9, 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.
The suit filed by Genzyme was 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.