Impax initiates patent challange for Simcor

Simcor is indicated to reduce 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 TG in patients with hypertriglyceridemia when treatment with simvastatin monotherapy or niacin extended-release monotherapy is considered inadequate.

Impax filed its abbreviated new drug application (ANDA) containing a paragraph IV certification for a generic version of Simcor with the US 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.

Impax said that, on 24 November 2010, Abbott Laboratories and Abbott Respiratory filed suit for patent infringement against the company in the US District Court for the District of Delaware.

Once the ANDA is approved by FDA, Global Pharmaceuticals, Impax’s generic division, is expected to commercialise the product.