Impax Initiates Patent Challenge Related To Tricor Tablets

Impax Laboratories (Impax) has initiated a challenge of the patents listed by Abbott Laboratories in connection with its Tricor (fenofibrate) tablets, 48mg and 145mg.

Tricor is indicated as adjunctive therapy to diet to reduce elevated LDL-C, Total-C, Triglycerides and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dislipidemia (Fredrickson Type IIa and IIb). Tricor is also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (Fredrickson Type IV and V hyperlipidemia).

Impax has filed its Abbreviated New Drug Application (ANDA) containing a Paragraph IV certification for a generic version of Tricor with the 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 owners of its Paragraph IV certification.

On October 29, 2009, Abbott Laboratories and Laboratoires Fournier have filed suit for patent infringement against Impax in the US District Court for the District of New Jersey. The action formally initiates the patent challenge process under the Hatch-Waxman Act.

The company said that once the ANDA is approved by FDA, Global Pharmaceuticals, Impax’s generic division, will commercialise the products.