Kentucky Attorney General Andy Beshear has joined a multistate antitrust lawsuit against the makers of Suboxone, a prescription drug used to treat heroin and other opioid addiction by blocking cravings for the substances.
The suit alleges that Reckitt Benckiser Pharmaceuticals — now Indivior — switched Suboxone from a tablet to a mouth-dissolving film so that the Food and Drug Administration would grant the drug maker more years of exclusivity before generic alternatives could hit the market.
“Substance abuse is the single greatest threat to our Commonwealth,” Beshear said in a news release. “For these companies to allegedly try and monopolize the market on a treatment drug is beyond belief and borderlines on inhuman.”
Beshear said in order to win the battle over heroin in addiction in Kentucky, the state needs “every resource available and affordable.”
“In Kentucky, drugs are killing our children, destroying our families and scarring our neighborhoods,” he said. “It is also the single greatest threat to job growth.”
The Louisville area has a seen spike in heroin overdose deaths recently, and last year, Jefferson County led the state with nearly 270 fatal drug overdoses.
The companies are accused of violating state and federal antitrust competition laws in the handling of Suboxone. Reckitt originally had patent exclusivity until 2009. During that time, they developed a dissolving film form of the drug — similar to a breath freshening strip.
The FDA grants new exclusivity when the delivery mechanism is changed. The suit says Reckitt expressed “unfounded safety concerns about the tablet version and intentionally delayed FDA approval of generic versions of Suboxone.”
The suit also claims the company hiked prices for the dissolving film – annual sales of Suboxone have been more than $1 billion a year since the drug was converted from pill to dissolving film.
Suboxone is a mixture of naloxone — the opioid-reversal medication — and a less potent opioid called buprenorphine. It was developed in 2002 to stop drug users from taking buprenorphine to get high.
Kentucky joins 35 states in filing the suit, including Tennessee, Michigan, Virginia and Pennsylvania.