(MONTGOMERY) –– Attorney General Luther Strange joined 35 other Attorneys General recently in filing an antitrust lawsuit against the makers of Suboxone, a prescription drug used to treat opioid addiction. The complaint alleges 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 and maintain monopoly profits.
The companies are accused of violating state laws and federal antitrust laws.
“Antitrust laws exist to protect consumers from unscrupulous trade practices that stifle fair competition,” said Attorney General Strange. “This lawsuit seeks to stop Indivior from doing so, and to provide relief for consumers who were harmed.”
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.
“The proliferation of opioid addictions is a tragedy in America and particularly in Alabama,” noted Attorney General Strange. “I have been committed as Attorney General to combat drug abuse through such programs as Prescription Drug Take Back and in Congress where I advocated a new law to expand prevention and education efforts throughout the nation. It is imperative that we make the best use of our resources to be effective in fighting this important battle. ”
According to yesterday’s 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 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, the Attorneys General allege, 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 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.
The Attorneys General of the following jurisdictions joined in the lawsuit: States of Wisconsin, Alabama, Alaska, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Hawaii, Illinois, Iowa, Kansas, Louisiana, Maine, Maryland, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New York, North Carolina, Ohio, Oklahoma, Rhode Island, South Carolina, Tennessee, Utah, Vermont, Washington, the Commonwealths of Kentucky, Massachusetts, Pennsylvania, and Virginia, and the District of Columbia.
