Maine and 35 other states on Friday sued the maker of the opioid addiction treatment medication Suboxone.
The antitrust suit alleges that Reckitt Benckiser Pharmaceuticals, now known as Indivior, conspired with another company, MonoSol Rx, to block generic competitors for Suboxone.
The companies switched the form of the prescription drug, from a tablet to a film that dissolves in the mouth, thereby extending its patent protections and preventing other companies from producing cheaper alternatives, according to the suit.
That’s called “product hopping,” and it’s illegal, a news release from the Maine attorney general’s office states.
The scheme allowed the companies to maintain a monopoly and artificially inflate prices, the suit alleges.
Maine Attorney General Janet Mills did not mince words in describing the consequences of Reckitt’s alleged actions here, where drug overdose deaths are up 50 percent over the same time last year. Opioids including fentanyl, heroin and prescription painkillers are a factor in most of those deaths.
“It is difficult to overstate the effects of artificially inflating the cost of a drug that could ease Maine’s opiate addiction epidemic,” Mills said in a news release. “People will quite literally die because they cannot afford an effective form of treatment. It is unconscionable that in the midst of an epidemic this would be happening.”
In Maine and elsewhere, Suboxone is a major tool in the fight to treat people with opiate addiction. The state has struggled to convince more doctors to prescribe Suboxone, even as Gov. Paul LePage’s administration pushed for it as an alternative to methadone. Unlike methadone, it does not provide a high. Substance abuse experts say people battling addiction should have access to both medications.
Suboxone contains buprenorphine, a medication that eases cravings and symptoms of withdrawal from heroin and other opioids. It also contains naloxone, the medication in the overdose antidote Narcan.
In Suboxone, however, naloxone serves a different purpose — to prevent misuse. If patients inject Suboxone in an attempt to get high, the naloxone leads to the painful process of withdrawal.
There is no generic alternative to the film version of Suboxone, which is similar to a breath strip. The suit alleges that it provides no benefit over the tablet.
Reckitt introduced Suboxone in 2002 under a patent that prevented other companies from developing a generic for seven years, the suit states. Before the clock wound down on that period, the company worked with MonoSol to create the dissolvable film.
Over time, Reckitt shifted the market away from the tablet and toward the film, through marketing, price adjustments and other methods, the suit alleges. Then when most doctors were writing Suboxone prescriptions for the film version, Reckitt pulled the tablet from the market in the U.S. (but kept selling it in other countries).
Reckitt also raised unfounded safety concerns about the tablet version and intentionally delayed government approval of generic alternatives, the suit alleges.
Consumers and other purchasers of Suboxone have paid artificially high prices for the drug since 2009, when a generic might otherwise have hit the market, according to the suit. During that period, annual sales of the drug totaled more than $1 billion.
The attorneys general want a judge to order the companies to restore competition and compensate consumers and the states. That would surely be a blow, but more profits appear to be on their way thanks to a move by the federal government this summer.
The suit comes just months after President Barack Obama’s administration passed rules that made Suboxone’s potential customer base significantly larger. In July, the U.S. Department of Health and Human Services eased restrictions on doctors who prescribe the medication, in an effort to help alleviate the opioid addiction epidemic plaguing the nation. Now, those with a special license can treat up to 275 patients per year, nearly triple the previous cap of 100. The Department of Health and Human Services estimated that up to 70,000 more people would have access to the drug as a result.
Indivior, unsurprisingly, applauded the decision.
It did not immediately issue a response to the lawsuit.
Monosol Rx has denied any wrongdoing.
“We believe that the allegations in the complaint are wholly without merit and the suit is both factually and legally deficient. … Suboxone sublingual film is a product which has saved countless lives since its approval by the FDA in 2010,” CEO Keith Kendall said in a statement.