COLUMBUS – Ohio has joined 34 other states and the District of Columbia that filed a lawsuit Thursday alleging that opioid drugmaker Indivior tried to keep generic versions of Suboxone off the market.
People deserve the benefits of fair market competition.”
-Ohio Attorney General Mike DeWine.
The British company previously known as Reckitt Benckiser Pharmaceuticals was granted FDA approval in 2002 for Suboxone tablets, which are used to treat patients addicted to heroin and other painkillers.
“Some people rely on this prescription drug to treat heroin addiction. They shouldn’t be forced to pay higher prices or deprived of options because drug makers circumvent the law to maximize their profits. People deserve the benefits of fair market competition,” said Ohio Attorney General Mike DeWine.
The complaint filed in the U.S. District Court for the Eastern District of Pennsylvania also names New Jersey’s MonoSol Rx, which makes pharmaceutical dissolving films.
The complaint says that when its exclusive rights to sell the drug expired in 2009, Indivior conspired with MonoSol Rx to make an oral strip form of the drug that they then marketed as safer than tablets, a practice dubbed “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.
The dissolvable film was similar in size to a breath strip. The complaint alleges that, over time, Indivior converted the market away from the tablet to the film through marketing, price adjustments, and other methods until, ultimately, the majority of Suboxone prescriptions were written for the film and the company removed the tablet from the U.S. market.
The lawsuit alleges that the Suboxone film provided no real benefit over the tablet , that Indivior expressed unproven safety concerns about the tablet and intentionally delayed FDA approval of generic versions of Suboxone.
Representatives of the two companies were not immediately available for comment.