Jefferson City, Mo. – Missouri Attorney General Chris Koster and 35 other attorneys general today filed an antitrust lawsuit against the makers of Suboxone, a prescription drug used to treat opioid addiction, alleging the companies engaged in a scheme to block generic competitors and caused purchasers to pay artificially high prices.
Reckitt Benckiser Pharmaceuticals, now known as Indivior, is accused of conspiring with MonoSol Rx to switch the form of Suboxone from a tablet to a film in order to prevent or delay generic alternatives and maintain monopoly profits.
The companies are accused of violating state and federal antitrust laws.
According to the lawsuit, when Reckitt introduced Suboxone in 2002 (in tablet form), it had exclusivity protection that lasted for seven years, meaning no generic version could enter the market during that time. Before that period ended, however, Reckitt worked with MonoSol to create a new version of Suboxone – a dissolvable film, similar 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 attorneys general allege that this conduct was illegal “product hopping,” where a company makes modest changes to its product to extend patent protections in order to keep other companies from entering the market and offering 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 in attempts to delay FDA approval of generic versions of Suboxone.
As a result, the attorneys general allege 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.
“As opioid addiction has skyrocketed, these companies schemed to preserve their monopoly of the addiction treatment,” Koster said. “This conduct violates laws that protect consumers, and must be punished.”
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