A slew of states have accused the maker of a top opioid addiction treatment of violating state and federal antitrust laws in an attempt to preserve their monopoly of the industry and score billions of dollars in ill-gotten sales.
The District of Columbia and 35 states sued Indivior, its former parent company Reckitt Benckiser Pharmaceuticals and MonoSol in Pennsylvania federal court for attempting to coerce patients to switch from a tablet version of Suboxone to dissolvable oral strips and inappropriately lengthening their hold of the market from 2008 until 2013.
Suboxone is a combination of buprenorphine – an opioid used for addiction medications – and naloxone, which gives patients severe withdrawal symptoms and is used to curb abuse of the treatment.
The alleged anticompetitive conduct is wide-ranging; the attorneys general claim Indivior tried to block generic drugmakers from gaining a foothold in the opioid addiction treatment market through illegal “product hopping,” or making small changes to extend patent or other market protections for a brand name drug.
Although the original Suboxone tablets weren't subject to any patent protections, Indivior wrested hold of the market by scoring “orphan drug” status from the U.S. Food and Drug Administration in 2002, giving it sole control of the pills until 2009. Indivior sold $2 billion worth of Suboxone tablets through 2010, according to the lawsuit. The states allege Indivior had annual sales of $1 billion per year from 2009 on, when there should have been a generic drug on the market lowering costs for patients, providers and insurers.
"The alleged scheme the defendants utilized denied consumers the choice of a generic version of Suboxone," Pennsylvania Attorney General Bruce Beemer said. "This conduct forced consumers to pay more for Suboxone and severely limited their options for treating their opioid addictions."
As the orphan drug protection came to an end, the states allege Indivior – which was spun out of Reckitt Benckiser in 2014 – licensed patented sublingual film technology from MonoSol and planned to keep their control of the market by persuading the FDA and providers that the original tablets were unsafe and posed a risk for children. FDA approved the film version of the drug in 2012, but noted that the new delivery model might have an even bigger unintended exposure risk.
Thanks to Indivior's campaign, FDA in 2012 required prospective generic manufacturers of Suboxone tablets to conduct risk analyses. When generic tablets started hitting the market in 2012, Indivior pulled its Suboxone tablets and most of the market switched to their film product.
The states allege that MonoSol conspired with Reckitt Benckiser and Indivior in the scheme. The companies are accused of violating the Sherman Act as well as numerous state antitrust laws and common law.
