Impax confirms that Warner Chilcott and Mayne Pharma filed suit for patent infringement in connection with Doryx®

Impax Laboratories, Inc. today confirms that Warner Chilcott Laboratories Ireland Limited, Warner Chilcott Company, Inc., Warner Chilcott (US), LLC, and Mayne Pharma International Pty. Ltd. filed suit for patent infringement against Impax in the United States District Court for the District of New Jersey in response to Impax’s challenge of the patent listed in connection with Doryx® (doxycycline hyclate) delayed-release tablets, 150 mg.

Impax filed its Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic version of Doryx® 150 mg 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. Based on the filing date of the ANDA, the Company expects to be entitled to 180-day market exclusivity. Global Pharmaceuticals, Impax’s generic division, will commercialize the products.

For more information, please visit the Company’s Web site at: www.impaxlabs.com

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