Impax Laboratories Files for Generic Oxycontin

Impax Laboratories, Inc announced today that it has filed an application for a generic version of Purdue Pharma's Oxycontin (oxycodone hydrochloride) 10, 15, 20, 30, 40, 60, and 80 mg controlled-release tablets.

Impax filed its Abbreviated New Drug Application (ANDA) with the FDA and it has been accepted for filing.

Purdue Pharma responded by filing suit for patent infringement against Impax Laboratories. This action formally initiates the patent challenge process under the Hatch-Waxman Act.

Once the FDA has approved the ANDA, Global Pharmaceuticals, Impax's generic division, will commercialize the drugs.

Oxycontin is indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

According to Wolters Kluwer Health, the drug saw sales approximately $2.8 billion for the twelve months ending January, 2011.