Market Overview

Impax Laboratories Confirms Patent Challenge Relating to Generic GRALISE® 300 mg and 600 mg


Impax Laboratories, Inc. (NASDAQ: IPXL) today confirms that it has initiated a challenge of the patents listed in the Orange Book in connection with Gralise® (gabapentin tablets, 300 mg and 600 mg).

Impax filed its Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic version of Gralise® with the U.S. Food & Drug Administration (FDA). Following receipt of the notice from 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.

On April 10, 2012, Depomed, Inc. filed suit for patent infringement against Impax Laboratories, Inc. 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.

Posted-In: News FDA


Related Articles (IPXL)

View Comments and Join the Discussion!