Opioid Maker Indivior pays $102.5M to settle opioid antitrust claims

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Opioid Maker Indivior pays $102.5M to settle opioid antitrust claims’ antitrust claims involving treatment for opioid addiction in litigation brought by more than 42 state attorneys general.

Regulators said that Indivior’s practices suppressed the market for generic versions of the drug, Suboxone.

“As the opioid crisis was raging across the country, Indivior selfishly maneuvered to keep less expensive versions of a lifesaving drug out of the hands of millions of Americans,” New York Attorney General Letitia James said in a statement. “Indivior’s drug was supposed to help many, but its monopolistic practices helped fuel the opioid epidemic and impede efforts to confront it. This agreement continues our efforts to address the opioid crisis and hold all the companies that contributed to this crisis accountable.”

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New York is expected to retain roughly $5.7 million of that amount, James said.

Under the terms of the deal, Indivior must also inform the AGs of all citizen petitions it submits to the Food and Drug Administration (FDA). The company also has to provide notice about new products and corporate changes to help prevent future monopolistic practices.

The settlement finalized and announced on Friday puts an end to roughly seven years of legal wrangling.

In 2016, then-New York Attorney General Eric Schneiderman brought the lawsuit against Indivior together with 34 other states. The case would continue through the tenures of two other Empire State AGs — Barbara Underwood and James — and other states would join onto the effort before its resolution.

First approved for sale in the United States in 2002, Suboxone is meant to treat opioid addiction and prevent abuse. The tablets lacked patent protection, and the FDA designated it an “orphan drug,” leaving it without competitors for seven years.

“Because Indivior’s exclusive right to sell and market the drug in tablet form was set to expire in 2009, Indivior sought to prevent lower cost generic competition and maintain its monopoly by engaging in a range of anticompetitive conduct from 2008 until generic entry occurred in 2013,” the AG’s office said.

In 2007, Indivior informed the FDA about plans to manufacture Suboxone as a sublingual film, or dissolvable oral strip — and claimed that the long-used tablets were unsafe because they presented a high exposure risk to children, according to the AG.

Indivior CEO Mark Crossley said the company is “focused on helping those who suffer from substance use disorders.”

“We take our role as a responsible steward of medications for addiction and rescue extremely seriously,” Crossley said in a statement. “Resolving these legacy matters at the right value allows us to further this mission for patients.”

Throughout her tenure as attorney general, James has announced clampdowns on opioid manufacturers and distributors. She joined 14 other AGs in a $4.5 billion deal that banned the Sackler family from the opioid business. She joined 48 attorneys general in making consulting giant McKinsey & Company pay $573 million for what regulators described as “cynical and calculated marketing tactics” responsible for “turbocharging” the opioid crisis. She brought a separate case against Teva Pharmaceuticals to a jury, which laid down a $1.5 billion dollar hammer on the Israeli company.

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