AG Jepsen: Conn. Joins Antitrust Lawsuit over Allegations that Drug
Company Illegally Blocked Generic Opioid Treatment from Market
35 states and D.C. file antitrust, consumer protection lawsuit over alleged Suboxone "product hopping"
Connecticut, 34 other states and the District of Columbia filed a federal lawsuit yesterday afternoon against the makers of Suboxone, a prescription drug used to treat opioid addiction, alleging that the companies engaged in an illegal scheme to block generic competitors from entering the market and cause purchasers to pay artificially high prices, Attorney General George Jepsen said.
Reckitt Benckiser Pharmaceuticals, Inc. – now known as Indivior PLC – and MonoSol Rx are accused of conspiring to switch Suboxone from a tablet version to a film, which dissolves in the mouth, in order to prevent or delay generic alternatives and maintain artificially inflated profits. The states allege that the companies' behavior violates both state and federal laws.
Suboxone is a brand-name prescription drug used to treat heroin and other opioid addictions by easing addiction cravings. No generic alternative to Suboxone film is currently available.
"One of my highest priorities is determining if the dramatic increases in pharmaceutical prices over the last several years– for both brand and generic drugs – reflect violations of laws within my authority to enforce," said Attorney General Jepsen. "In this case, we have a brand-name pharmaceutical manufacturer that sought to protect its profits by preventing lower-priced generic alternatives from entering the prescription drug market. The circumstances alleged in this case are particularly egregious in that, in the midst of an epidemic of opioid abuse and addiction, Connecticut consumers and taxpayers have had to pay more for a drug that may help to mitigate some of the problem."
When Reckitt introduced tablet-form Suboxone in 2002, it had statutorily imposed exclusivity protection that lasted seven years, meaning that no generic version could enter the market during that time. The states allege that, before that exclusivity period ended, Reckitt worked with MonoSol to develop a new version of Suboxone – a dissolvable film, similar in size to a breath strip.
Over time, the states allege that Reckitt 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 states allege that this conduct was illegal "product hopping" – where a company makes modest changes to a product to extend its patent protections so that other companies cannot enter the market and offer less-expensive generic alternatives. According to the complaint, the Suboxone film provided no real benefit over the tablet, and Reckitt continued to sell the tablets in other countries. Reckitt also allegedly expressed unfounded safety concerns about the tablet version.
As a result, the states allege that federal and state healthcare programs, including Medicaid, as well as consumers and other 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 and, since then, rates of opioid abuse in Connecticut and across the country have increased significantly.
The lawsuit, filed under seal in the U.S. District Court for the Eastern District of Pennsylvania, accuses the companies of conspiracy to monopolize and illegal restraint of trade in violation of the federal Sherman Act, the Connecticut Antitrust Act, the Connecticut Unfair Trade Practices Act (CUTPA) and various other state laws. The states 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.
In addition to Connecticut, and led by the Wisconsin Attorney General, other states joining this lawsuit include Alabama, Alaska, Arkansas, California, Colorado, Delaware, Florida, Hawaii, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Minnesota, Mississippi, Missouri, Montana, Nebraska, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Utah, Vermont, Virginia and Washington and the District of Columbia.
Assistant Attorneys General Gary Becker and Michael Cole, chief of the Antitrust and Government Program Fraud Department, are assisting the Attorney General with this matter.