Impax Laboratories, Inc. (NASDAQ:IPXL) today confirms that it has initiated a challenge of the patents listed by Abbott Laboratories in connection with its TRICOR® (fenofibrate) tablets, 48 mg and 145 mg.
Impax filed its Abbreviated New Drug Application (“ANDA”) containing a Paragraph IV certification for a generic version of TRICOR® 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 owners of its Paragraph IV certification.
On October 29, 2009, Abbott Laboratories and Laboratoires Fournier S.A. 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.