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HAYWARD, Calif. — Generic drug maker Impax Labs has settled with a subsidiary of Sanofi regarding generic versions of two drugs for dialysis patients, Impax said Tuesday.
Impax announced a settlement with Genzyme concerning generic versions of Renvela (sevelamer carbonate) 800 mg tablets and 2.4 g and 0.8 g oral suspension and Renagel (sevelamer hydrochloride) tablets in the 400 mg and 800 mg strengths.
Under the settlement, Impax will have a license to sell its generic versions of the drugs on Sept. 16, 2014, or possibly earlier. Impax said it was likely the first company to file a complete regulatory approval application with the Food and Drug Administration for versions of both drugs, which are used to control serum phosphorus in patients with chronic kidney disease on dialysis. If it is, then it would be entitled to 180 days of market exclusivity in which to compete directly with the branded versions upon receiving FDA approval.
Renagel and Renvela had sales of $512 million between April 1, 2011 and the end of 2011 and $392 million in the first half of 2012, according to Sanofi.