Impax Laboratories, Inc. confirms that it has initiated a challenge of patents listed by Takeda Pharmaceutical Company, Ltd. in connection with Dexilant (dexlansoprazole) delayed-release capsules, 30 mg and 60 mg.

Impax filed its Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic version of Dexilant with the US 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.

On April 1, Takeda Pharmaceuticals Co. LTD, Takeda Pharmaceuticals North America Inc., Takeda Pharmaceuticals LLC and Takeda Pharmaceuticals America Inc. filed suit for patent infringement against Impax in Northern District of California. This action formally initiates the patent challenge process under the Hatch-Waxman Act. Based on the filing date of the ANDA, the Company believes that it is the first to file an ANDA with a paragraph IV certification on the 30 mg capsule, 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.

Dexilant is used to treat gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and possible injury of the esophagus (the tube between the throat and stomach). It is used to treat the symptoms of GERD, allow the esophagus to heal, and prevent further damage to the esophagus. Dexilant is in a class of medications called proton pump inhibitors. It works by decreasing the amount of acid made in the stomach. According to Wolters Kluwer Health, US sales of Dexilant delayed-release capsules, 30 mg and 60 mg were approximately $20 million and $261 million, respectively, for the current 12 months ending January 2011.

Impax Laboratories, Inc. is a technology based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of branded products.