Impax initiates challenge of patent listed by Shionogi Pharma concerning Fenoglide

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Impax Laboratories, Inc. (NASDAQ:IPXL) today confirms that it has initiated a challenge of a patent listed by Shionogi Pharma, Inc. in connection with its Fenoglide® (fenofibrate) tablets, 40 and 120 mg.

Impax filed its Abbreviated New Drug Application (ANDA) for a generic version of Fenoglide® 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 and the listing of the patent in the FDA Publication, Approved Drug Products with Therapeutic Equivalence Evaluations (commonly referred to as the "the Orange Book"), Impax submitted a paragraph IV certification to FDA and notified the New Drug Application holder and patent owner of its certification.

On April 28, 2010, Shionogi Pharma, Inc. and LifeCycle Pharma A/S 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. Based on the date of the paragraph IV certification, the Company believes that it is the first to file an ANDA with a paragraph IV certification and expects to be entitled to 180 days of market exclusivity.

Once the ANDA is approved by FDA, Global Pharmaceuticals, Impax's generic division, will commercialize the products.


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