On Friday, Arkansas Attorney General Leslie Rutledge and 35 other attorneys general filed an antitrust lawsuit against the makers of Suboxone, a prescription drug used to treat opioid addition, over allegations that the company engaged in practices to block generic competitors from joining the market and caused 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 in order to delay generic alternatives and maintain monopoly profits. The companies are accused of violating Arkansas and federal antitrust laws, according to Rutledge.
“With a growing prescription drug abuse epidemic across this country, it is appalling that companies would take actions to prevent cheaper, generic treatments from entering the marketplace,” said Attorney General Rutledge. “Antitrust laws seek to ensure fair and equal competition and when those laws are violated, it is my duty to hold companies accountable.”
Suboxone is a brand-name prescription drug used to treat heroin addiction and other opioid addictions by easing addiction cravings. No generic alternative of the film is currently available.
According to the lawsuit, when Reckitt introduced Suboxone in 2002, it had exclusivity protection that lasted for seven years. 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. 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, known as product hopping, was illegal. Product hopping is when a company makes modest changes to its product to extend patent protections so other companies cannot 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.
As a result, the attorneys general allege that consumers 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.
Rutledge was joined in Friday’s filing by attorneys general in Alabama, Alaska, California, Colorado, District of Columbia, 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 Wisconsin.