Impax Laboratories, Inc. (NASDAQ: IPXL) today confirms that it has initiated a challenge of patents listed in connection with SIMCOR® (niacin/simvastatin) extended-release tablets, 1000/20 mg.
Impax filed its Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic version of SIMCOR® 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 November 24, 2010, Abbott Laboratories and Abbott Respiratory LLC filed suit for patent infringement against Impax in the United States District Court for the District of Delaware. 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 product.
SIMCOR® is indicated to reduce (1) elevated total-C, LDL-C, Apo B, non-HDL-C, TG, or to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia when treatment with simvastatin monotherapy or niacin extended-release monotherapy is considered inadequate, and (2) TG in patients with hypertriglyceridemia when treatment with simvastatin monotherapy or niacin extended-release monotherapy is considered inadequate.
According to Wolters Kluwer Health, U.S. sales of SIMCOR® extended-release tablets, 1000/20 mg, were approximately $37 million for the twelve months ended September 30, 2010.
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