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September 22, 2016

MADIGAN FILES LAWSUIT AGAINST MAKERS OF OPIOID ADDICTION TREATMENT DRUG SUBOXONE

Madigan & 35 Attorneys General Accuse Company of Conspiring to Keep Monopoly Profits

Chicago — Attorney General Lisa Madigan and 35 other attorneys general today filed an antitrust lawsuit 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, which forced people to pay artificially high prices during a time when the companies reaped more than $3 billion in profits.

The lawsuit alleges that Reckitt Benckiser Pharmaceuticals, now known as Indivior, conspired 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 and maintain monopoly profits. The companies are accused of violating state and federal antitrust laws.

“These companies rigged a system to ensure they profited at the expense of the people who depended on this drug to treat and recover from addiction,” Madigan said.

Suboxone is a brand-name prescription drug used to treat heroin addiction and other opioid addictions by easing addiction cravings. No generic alternative is currently available.

According to the lawsuit, when Reckitt introduced Suboxone in 2002 in tablet form, it had exclusivity protection that lasted seven years, which meant 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, which is 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.

Madigan and the other attorneys general allege 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 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, the lawsuit alleges 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, Madigan and the other 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 pay the states’ costs and fees.

Joining Madigan in the lawsuit are attorneys general from: Alabama, Alaska, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Hawaii, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Utah, Vermont, Virginia, Washington, Wisconsin and the District of Columbia.

Assistant Attorney General Chad Brooker is handling the case for Madigan’s Antitrust Bureau.

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