Impax Laboratories, Inc. (NASDAQ: IPXL) today confirms that it has initiated a challenge of patents listed by MSP Singapore Co. LLC in connection with VYTORIN® (ezetimibe/simvastatin), 10 mg/80 mg.
Impax filed its Abbreviated New Drug Application ("ANDA") containing a paragraph IV certification for a generic version of VYTORIN® 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 August 19, 2010, Schering Corporation and MSP Singapore Co. LLC filed suit for patent infringement against Impax in the United States District Court for the District of New Jersey. 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.
VYTORIN® is indicated as adjunctive therapy to diet to reduce elevated total-C, LDL-C, Apo B, TG, and non-HDL-C, and to increase HDL-C in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia, as well as reduce elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH), as an adjunct to other lipidlowering treatments. According to Wolters Kluwer Health, U.S. sales of VYTORIN®, 10 mg/80 mg, were approximately $222 million for the twelve months ended June 30, 2010.
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