Impax Laboratories, Inc. (NASDAQ: IPXL) today confirms that it has initiated a challenge of a patent listed by Genzyme Corporation ("Genzyme") in connection with RENVELA® (sevelamer carbonate for suspension), 2.4 g and 0.8 g.
Impax filed its Abbreviated New Drug Application ("ANDA") containing a paragraph IV certification for a generic version of RENVELA® with the U.S. Food & Drug Administration ("FDA"). Following receipt of the notice from the FDA that Impax's ANDA had been accepted for filing, Impax notified the New Drug Application holder and patent owner of its paragraph IV certification.
On July 1, 2010, Genzyme filed suit for patent infringement against Impax in the United States District Court for the District of Maryland. This action formally initiates the patent challenge process under the Hatch-Waxman Act.
Once the ANDA is approved by FDA, Global Pharmaceuticals, Impax's generic division, will commercialize the products.
RENVELA® is indicated for the control of serum phosphorus in patients with Chronic Kidney Disease on dialysis. According to Wolters Kluwer Health, U.S. sales of RENVELA®, 2.4 g and 0.8 g (for suspension), were approximately $6.8 million for the past seven months ending April 2010.