Suboxone is used to treat heroin, other opioid addictions
FRANKFORT, Ky. (Sept. 23, 2016) – Attorney General Andy Beshear has joined a multistate antitrust lawsuit against the makers of Suboxone over allegations the companies blocked generic competitors and sold the drug at artificially high prices.
The suit claims Reckitt Benckiser Pharmaceuticals, now known as Indivior, conspired with MonoSol Rx to switch Suboxone from a tablet version to a mouth-dissolving film to prevent or delay generic alternatives and to maintain monopoly profits.
The companies are accused of violating state and federal antitrust laws in the handling of the drug used to treat opioid addiction.
“Substance abuse is the single greatest threat to our Commonwealth,” Beshear said. “For these companies to allegedly try and monopolize the market on a treatment drug is beyond belief and borderlines on inhuman. In Kentucky, drugs are killing our children, destroying our families and scarring our neighborhoods. It is also the single greatest threat to job growth. We need every resource available and affordable if we are going to win this battle.”
Suboxone is a brand-name prescription drug used to treat heroin addiction and other opioid addictions by easing addiction cravings. No generic alternative of the film version is currently available.
In 2002, when Reckitt introduced Suboxone in tablet form, it had exclusivity protection that lasted for seven years, meaning no generic version could enter the market during that time, according to the lawsuit.
During the seven-year timeframe, however, Reckitt worked with MonoSol to create a new version of Suboxone – a dissolvable film, similar in size to a breath-freshening strip.
Over time, Reckitt allegedly converted the market away from the tablet to the film through marketing and price adjustments. Ultimately, after the majority of Suboxone prescriptions were written for the film, Reckitt removed the tablet from the U.S. market.
The lawsuit alleges that this conduct was illegal “product hopping,” where a company makes modest changes to its product to extend patent protections so other companies can’t enter the market and offer cheaper generic alternatives.
According to the suit, the Suboxone film provided no real benefit over the tablet, and Reckitt continued to sell the tablets in other countries even after removing them from the U.S. market.
Reckitt also allegedly expressed unfounded safety concerns about the tablet version and intentionally delayed FDA approval of generic versions of Suboxone.
As a result, Beshear said it is alleged that consumers and purchasers have paid artificially high monopoly prices since late 2009, when generic alternatives of Suboxone might otherwise have become available.
During that time, annual sales of Suboxone topped $1 billion.
The lawsuit, filed in the U.S. District Court for the Eastern Division of Pennsylvania, accuses the companies of violating the federal Sherman Act and state laws.
Counts include conspiracy to monopolize and illegal restraint of trade. In the suit, the 36 attorneys general ask the court to stop the companies from engaging in anticompetitive conduct, to restore competition, and to order appropriate relief for consumers and the states, plus costs and fees.