Indivior settles FTC complaint that it blocked generic competition to Suboxone

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Patients recovering from opioid addiction are taking Suboxone, a prescription oral medication to reduce withdrawal symptoms.

The FTC said it will combine the $10 million and the $50 million settlements into a fund to provide payments to patients who bought Suboxone Oral Film. Patients who purchased the prescription oral medication from March, 2013, to February, 2019, can file a claim online. The deadline to file a claim is December 1, 2020.

In a statement, FTC Bureau of Competition Deputy Director Gail Levine said, “In the midst of the nation’s opioid crisis, a critical opioid-addiction treatment was about to become more affordable. But Indivior prevented that. It kept its drug prices high by unlawfully impeding generic manufacturers from competing effectively.”

Indivior’s regulatory exclusivity for Suboxone expired in 2009 and was expected to face competition from a lower-cost generic version of the drug.

The pharmaceutical distributor developed a dissolvable oral film version of Suboxone before the generic competitors became available in the market. The FTC alleged that Indivior filed a meritless citizen petition with the Food and Drug Administration (FDA) claiming that it stopped manufacturing and selling Suboxone Sublingual Tablet due to safety concerns and requested the agency to reject any generic tablet application.