Impax Laboratories, Inc. (NASDAQ: IPXL) today confirms that it has initiated a challenge of the patents listed in the Orange Book in connection with Fentora® (fentanyl buccal tablets, 100 mcg, 200 mcg, 400 mcg, 600 mcg and 800 mcg).
Impax filed its Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic version of Fentora® 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 November 18, 2011, Cephalon, Inc. and CIMA Labs, Inc. filed suit for patent infringement against Impax Laboratories, Inc. in the District of Delaware. 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, intends to commercialize the product.
Fentora® is used to treat "breakthrough" cancer pain that is not controlled by other medicines. According to Wolters Kluwer Health, U.S. sales of Fentora® were approximately $159 million for the twelve months ending September 2011.
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