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22 August 2023Big PharmaMarisa Woutersen

Indivior parts with $30m in Suboxone dispute

The pharmaceutical company agreed to pay millions to resolve a multi-district antitrust suit brought by more than 40 US state attorneys | Company sued over alleged actions aimed at preserving the monopoly of anti-addiction drug.

Indivior has agreed to settle claims in an antitrust multidistrict litigation over the drug Suboxone, which is used to treat opioid addiction.

The company confirmed the development in a statement released on Monday, August 21.

Indivior has agreed to pay $30 million to the end payor claimants as part of the settlement, from the company’s existing provision of $188 million allocated for the multidistrict litigation.

The agreement is subject to initial approval by the US District Court for the Eastern District of Pennsylvania, a notice period, participation by an appropriate number of end payors and final approval of the court.

Case background

The origins of the case trace back to 2016, when a number of states accused Indivior of switching from a tablet version to an oral film version of Suboxone.

Such actions were allegedly aimed at preserving its monopoly and thwarting generic drug manufacturers' plans to release a more cost-effective tablet version of the treatment.

Mark Crossley, the CEO of Indivior, said: “We remain focused on helping those suffering from substance use disorders and mental illness.

“Resolving these legacy legal matters at the right value helps us further our mission for patients and creates greater certainty for our stakeholders.”

In June, the company agreed to pay $102.5 million to resolve a multi-district antitrust suit brought by more than 40 US states' attorneys.

As part of the settlement agreement announced this week, the claimants have opted to abandon all claims linked to the litigation.

Meanwhile, Indivior has committed to certain notification provisions and restrictions.

These include mandated disclosures and notifications to the claimants, ongoing compliance reports with the agreement, and notifications of US Food and Drug Administration (FDA) related activities such as filing a citizen petition and any filing of an Abbreviated New Drug Application (ANDA) for a follow-on drug product.

In November 2020, Indivior entered into an agreement to comply with a 10-year stipulated order issued by the Federal Trade Commission (FTC), which obligated the company to implement comparable measures.

The company continues to prepare for trial on October 30, in relation to the remaining claims of the direct purchaser class while at the same time exploring the possibility of settlement at the right value with this class, outlined in the company’s half-year report on July 27.

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