Indivior must face states' monopoly claim over opioid addiction drug

Pharmacist Jim Pearce fills a Suboxone prescription at Boston Healthcare for the Homeless Program in Boston
Pharmacist Jim Pearce fills a Suboxone prescription at Boston Healthcare for the Homeless Program in Boston, Massachusetts January 14, 2013. REUTERS/Brian Snyder
  • States' case is part of MDL over alleged "product hop" from pill to dissolvable film
  • Judge rejects Indivior's claim that benefit to consumers outweighed any harm

(Reuters) - Drugmaker Indivior Inc must face a lawsuit by 42 state attorneys general accusing it of using illegal tactics to shield its opioid addiction treatment Suboxone from generic competition, a federal judge has ruled.

U.S. District Judge Mitchell Goldberg in Philadelphia found Monday that a reasonable jury could find that Indivior's switch from a pill to an oral film form of the drug in 2009 was intended to extend its monopoly just as generic manufacturers were poised to begin selling their own pills, a strategy known as product hopping. He denied the Virginia-based company's motion for a judgment in its favor.

States have said that the company's conduct forced consumers to pay inflated prices for the treatment amid an epidemic of opioid addiction.

"The cost of critical medication must not be inflated through anticompetitive tactics," Wisconsin Attorney General Josh Kaul, who is leading the multistate coalition, said in a statement.

Nina DeLorenzo, Indivior's chief global impact officer, said in a statement that "we take our role as a responsible steward of these medications extremely seriously."

The tablet version of Suboxone was first approved for sale in the United States in 2002. Although it did not have patent protection, the U.S. Food and Drug Administration gave the company seven years of exclusivity under the so-called orphan drug law, intended to help companies recoup costs of developing drugs that are unlikely to be profitable.

Indivior's success in obtaining the protection has drawn scrutiny, as the drug did prove to be profitable for the company.

In their 2016 lawsuit, the states said that shortly before the orphan drug period was set to expire in 2009, Indivior told the FDA that it planned to replace the pill with a film that dissolves under a patient's tongue. Since the film was not equivalent to the pill, pharmacists would be prevented from automatically prescribing a cheaper generic alternative to patients.

Furthermore, the states said, Indivior persuaded the FDA to approve the film by raising concerns that the tablet version could accidentally be taken by children and urged the agency to block generic pills on those grounds as well.

Although the FDA decided to allow the generic pills in 2013, many patients had already switched to the film version by the time they reached the market, the states said. They claimed Indivior's strategy violated federal and state antitrust laws against maintaining an illegal monopoly.

In seeking summary judgment, Indivior argued that any anticompetitive effect of its strategy was outweighed by the benefit of expanding the choices available to consumers.

Goldberg, however, said that the plaintiffs had "produced evidence that, if accepted, could establish that [Indivior's] conduct harmed consumer welfare," allowing the case to go forward.

The states' case is part of a larger multidistrict litigation before Goldberg that also includes antitrust claims over Suboxone from wholesalers and insurers.

The case is State of Wisconsin v. Indivior Inc , U.S. District Court for the Eastern District of Pennsylvania, No. 2:16-cv-5073. It is part of the MDL In re: Suboxone Antitrust Litigation, No. 2:13-md-02445.

For the states: Wisconsin Assistant Attorney General Gwendolyn Cooley

For Indivior: Jonathan Berman of Jones Day

(NOTE: This story has been updated with a comment from Indivior.)

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Indivior can't reverse Suboxone antitrust class certification

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Brendan Pierson reports on product liability litigation and on all areas of health care law. He can be reached at