The share price of Impax Laboratories, Inc. (IPXL) has been on a steady rise since the company reported impressive third quarter results on Nov 4, 2013, aided by positive estimate revisions.
Impax recently received further boost when it entered into an agreement with privately-held Purdue Pharma to settle all of its pending patent litigation.
The litigation is related to Impax’s generic version of the currently marketed, reformulated OxyContin. The litigation dates back to Apr 2011 when Purdue Pharma filed suit against Impax alleging patent infringement based on latter’s Abbreviated New Drug Application (ANDA) relating to OxyContin.
In addition, Purdue Pharma filed a separate lawsuit against Impax involving the same product and ANDA, asserting infringement of two newly issued patents in Feb 2013.
As per the settlement agreement, Impax will have the right to market a specified number of bottles of its generic OxyContin. This marketing right is contingent upon Impax receiving final approval from the U.S. Food and Drug Administration (:FDA) on its ANDA for generic OxyContin. However, if Impax’s final ANDA does not get approved, it will have the right to launch a specified number of bottles of an authorized generic version of OxyContin beginning Jan1, 2016.
We note that 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.
As per IMS, sales of OxyContin were approximately $2.6 billion in the trailing twelve months ended Sep 2013.
We note that Global Pharmaceuticals, the generic unit of Impax, performed impressively in the third quarter of 2013. Segmental revenues climbed 15.3% to $115.7 million during the quarter aided by the sales of new generic products launched this year. Growth was partially offset by lower sales of Impax’s authorized generic version of Shire’s (SHPG) attention deficit hyperactivity disorder (ADHD) drug, Adderall XR.