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news.Impax Laboratories has confirmed that Genzyme has filed patent infringement over Renvela (sevelamer carbonate for suspension), 2.4g and 0.8g in a US Court for the District of Maryland. The action formally initiates the patent challenge process under the Hatch-Waxman Act.
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Renvela is indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis.
Impax has filed abbreviated new drug application (ANDA) with the FDA containing a paragraph IV certification for a generic version of Renvela.
Impax notified the new drug application holder and patent owner of its paragraph IV certification, after receiving acceptance notice for filing, from the FDA, regarding its ANDA.
Impax stated that following the approval of ANDA by FDA, Global Pharmaceuticals, generic division of Impax, is expected to commercialise the products.