COLUMBUS — Ohio Attorney General Mike DeWine and 35 other attorneys general filed an antitrust lawsuit last fall against the makers of Suboxone, a prescription drug used to treat opioid addiction, over allegations that the companies engaged in a scheme to block generic competitors and cause purchasers to pay artificially high prices.
Reckitt Benckiser Pharmaceuticals, now known as Indivior, is accused of conspiring with MonoSol Rx to switch Suboxone from a tablet version to a film (that dissolves in the mouth) in order to prevent or delay generic alternatives from coming onto the market and to maintain monopoly profits.
The companies are accused of violating state and federal antitrust laws.
“Some people rely on this prescription drug to treat heroin addiction,” Attorney General DeWine said. “They shouldn’t be forced to pay higher prices or deprived of options because drug makers circumvent the law to maximize their profits. People deserve the benefits of fair market competition. When the product involved is used to treat addiction, the implications are even more significant.”
Suboxone is a brand-name prescription drug used to treat opioid addictions by easing addiction cravings.
When Reckitt introduced Suboxone in 2002 (in tablet form), it had exclusive patent protection that lasted for seven years, meaning no generic version could enter the market during that time. The attorneys general allege, however, that before that period ended, Reckitt engaged in 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 lawsuit, Reckitt worked with MonoSol to create a new version of Suboxone – a dissolvable film, similar in size to a breath strip. Over time, Reckitt allegedly converted the market away from the tablet to the film through marketing, price adjustments, and other methods. Ultimately, after the majority of Suboxone prescriptions were written for the film, Reckitt removed the tablet from the U.S. market. The complaint alleges that this was done to keep generic alternatives to Suboxone off the market and deprive consumers of the option of substituting a lower-cost generic alternative. (Currently, no generic alternative of the film is available.)
The lawsuit alleges that the Suboxone film provided no real benefit over the tablet and that Reckitt continued to sell the tablets in other countries even after removing them from the U.S. market. Reckitt also allegedly expressed unproven safety concerns about the tablet version and intentionally delayed FDA approval of generic versions of Suboxone.
As a result, the attorneys general claim that consumers and purchasers have paid artificially high monopoly prices, potentially since October 2009, when generic alternatives of Suboxone might otherwise have become available. During that time, annual sales of Suboxone topped $1 billion.
The lawsuit, filed today 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 attorneys general ask the court to stop the companies from engaging in anti-competitive conduct, to restore competition, and to order appropriate relief for consumers and the states, plus costs and fees.
Ohio was one of the lead states in the multistate investigation that led to the action.
Information for this story was provided by the AG’s office.
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