Indivior, the manufacturer of the opioid addiction drug Suboxone, has settled with more than 40 states and Washington D.C. over claims that the company has unfairly extended its monopoly on the life-saving drug, according to Consumer Notice.
According to the lawsuit, Indivior undertook a series of actions that ensured that the company could maintain a monopoly of their drug Suboxone. Buprenorphine, known by its commercial name Suboxone, is an opioid agonist used in the treatment of individuals with opioid use disorder. An opioid agonist works to activate the opioid receptors of the brain, resulting in a reduction of withdrawal symptoms in patients recovering from opioid use disorder. Suboxone in particular is seen as a more long-term solution than its alternative naltrexone while being just as effective as methadone.
With such an important role in addiction therapies, ensuring that Suboxone is accessible and affordable is paramount. However, according to the lawsuit against it, Indivior schemed to keep generic forms of Suboxone, which was first approved in 1995, off the market. The lawsuit claims that in 2010, with competitors beginning to apply for approval to manufacture generic Suboxone tablets, Indivior undertook an initiative to extend their monopoly of the opioid use drug.
Using false claims about the risk of pediatric exposure, Indivior began forcing patients off of their tablets and onto their new dissolvable film versions of Suboxone. This claim has been soundly rejected by the FDA but still led to many patients transferring over to the new film form. Once this project began, Indivior also began raising the price of its Suboxone tablet. In 2013, Indivior stopped producing Suboxone tablets altogether.
In 2016, 41 states plus Washington D.C. filed suit against Indivior for these actions that unfairly increased the company’s monopoly on Suboxone. In June, Indivior offered $104.5 million to the plaintiffs to resolve the case. Several states would eventually settle for $157 million, but that amount would more than triple before all of the plaintiffs would agree to settle the case. This is not the first legal battle over Suboxone Indivior has faced. The company has already paid out approximately $900 million to state and federal authorities over the misleading safety statements Indivior used to convert tablet users to film users.
The settlement, which was reached shortly before the company was set to appear in court on October 30, would allocate $385 million to plaintiffs in exchange for dismissal of all charges without an admission of fault from Indivior.
In addition to claims of antitrust violations, Indivior also faces product liability claims from patients who used the film version of Suboxone and subsequently developed dental damage.
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