Actavis Inc. (ACT) announced that it has entered into an agreement with Purdue Pharma to settle all outstanding patent litigation related to Actavis' generic version of the currently marketed abuse-deterrent formulation of OxyContin.
As per the terms of the agreement, Actavis will be licensed to market a specified number of bottles of its generic OxyContin beginning on January 1, 2014. Launch of Actavis' product is contingent upon the Company receiving final approval from the U.S. Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for generic OxyContin.
Alternatively, if Actavis is unable to gain FDA approval of its generic OxyContin prior to September 1, 2014, the company will be permitted to launch a specified number of bottles of an authorized generic version of Purdue's abuse-deterrent product beginning in October 2014.
Actavis anticipates that the agreement will represent more than $100 million in combined gross profit in 2014 and 2015, more heavily weighted to 2014. The agreement is expected to result in a more modest contribution from 2016 through 2019. Other terms of the settlement were not disclosed.
OxyContin had U.S. sales of approximately $2.8 billion for the twelve month period ending January 31, 2013 according to IMS Health.
by RTT Staff Writer
For comments and feedback: email@example.com