Indivior, Inc. has agreed to pay $10 million to settle Federal Trade Commission charges that it violated antitrust laws through a deceptive scheme to thwart lower priced generic competition with its branded opioid replacement therapy drug Suboxone. The proposed stipulated order for a permanent injunction and equitable monetary relief also bars Indivior from similar future conduct.
A prescription oral medication, Suboxone is used to minimize withdrawal symptoms in patients recovering from opioid addiction. This settlement follows the FTC’s 2019 settlement with Indivior’s former parent company, Reckitt Benckiser Group plc.
“In the midst of the nation’s opioid crisis, a critical opioid-addiction treatment was about to become more affordable,” said Gail Levine, a Deputy Director of the FTC’s Bureau of Competition. “But Indivior prevented that. It kept its drug prices high by unlawfully impeding generic manufacturers from competing effectively.”
The $10 million from this settlement will be combined with the $50 million from the Reckitt Benckiser Group plc settlement into a fund that will be used to provide payments to people who purchased Suboxone Oral Film. Starting today, anyone who was prescribed Suboxone film in the United States between March 1, 2013 and Feb. 28, 2019 can file a claim online at www.ftc.gov/suboxone.
Introduced in 2002, Suboxone quickly became a mainstay of opioid addiction treatment, according to the FTC’s complaint against Indivior. But in 2009, Indivior’s regulatory exclusivity for Suboxone was set to expire, and the company expected to face competition from lower-cost generics. According to the complaint, before the generic versions of Suboxone tablets became available, Indivior developed a dissolvable oral film version of Suboxone and worked to shift prescriptions to this patent-protected film. The complaint also alleged that to buy more time to move patients to the film version of Suboxone, Indivior filed a meritless citizen petition with the FDA reciting the same unsupported safety claims and requesting that the agency reject any generic tablet application.
The fencing-in relief in the stipulated order is specific to this case and appropriate given the egregiousness of Indivior’s alleged conduct.
The proposed FTC settlement is also part of a broader government settlement with Indivior, which resolves criminal and civil fraud claims by the U.S. Attorney’s Office for the Western District of Virginia and the U.S. Department of Justice. The FTC is grateful to the U.S. Attorney’s Office and DOJ for their cooperation and for their vigorous prosecution in this important area.
The Commission vote authorizing the staff to file the complaint and the proposed stipulated order was 3-0-2, with Commissioner Rebecca Kelly Slaughter not participating and Commissioner Christine S. Wilson recused. The complaint was filed on July 24, 2020, in the U.S. District Court for the Western District of Virginia.
NOTE: Stipulated final orders have the force of law when signed and entered by a District Court judge.