Maker of Opiate Addiction Treatment Drug, Suboxone, Accused of Conspiring to Keep Monopoly Profits

Sep 23 2016

MADISON, WI – Wisconsin Attorney General Brad Schimel and a bipartisan group of 35 other attorneys general filed an antitrust lawsuit today against the makers of Suboxone, a prescription drug used to treat opiate addiction. The lawsuit, being led by Wisconsin, alleges 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 and maintain monopoly profits.


The companies are accused of violating state and federal antitrust laws.


Suboxone is a brand-name prescription drug used to treat heroin and opioid addictions by easing addiction cravings.


“Wisconsin and the nation are suffering hundreds and thousands of opiate-related deaths each year, and we cannot allow treatment barriers to exist for those suffering from addiction,” said Attorney General Schimel. “We have an obligation to prevent monopolies, like the one the makers of Suboxone engaged in, in order to have an even playing field for the rest of the industry and to prevent artificially increased costs to consumers.”


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 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 attorneys general allege 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, 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.


The lawsuit, filed in the U.S. District Court for the Eastern District 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 anticompetitive conduct, to restore competition, and to order appropriate relief for consumers and the states, plus costs and fees.


In addition to Wisconsin Attorney General Brad Schimel, attorneys general of the following jurisdictions joined in the lawsuit: Alabama, Alaska, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Hawaii, Illinois, 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, and Washington, D.C.


Wisconsin Assistant Attorney General Gwendolyn J. Cooley is coordinating the lawsuit.


A redacted version of the filed complaint will be available on the DOJ website later today. Redactions have been made pursuant to agreements with other state and federal parties to the litigation.