In another case revolving around drug pricing, 36 states have joined a lawsuit against Indivior, the manufacturer of the branded drug Suboxone. Suboxone is a prime treatment for patients addicted to heroin and other drugs, including painkillers.
Included as a defendant is MonoSolRX , the company that licensed its sublingual film technology to Indivior.
Among the charges in the complaint, the states say Indivior tried to force patients to stop using a tablet and begin using a dissolvable oral strip version of Suboxone. It also alleges other anti-competitive behavior.
“My office will not permit drug companies to engage in anticompetitive conduct that unlawfully extends their monopolies – and their monopoly profits – on drugs,” said New York Attorney General Eric Schneiderman. “Opioid abuse is a public health crisis, and opioid-dependent patients should have access to the most affordable addiction treatment options available.”
Orphan drug monopoly
Suboxone tablets have been an approved form of treatment since 2002. The tablet form of the drug lacked patent protection, but the FDA gave Indivior a seven-year “orphan drug” monopoly on Suboxone sales because the company was not expected to recoup its research and development costs.
However, Schneiderman says the drug generated $2 billion in U.S. sales for Indivior by 2010. The complaint claims that when Individor's exclusivity was set to expire seven years ago, it tried to prevent lower cost generic competition by initiating anti-competitive activities.
“The defendants in this case have preyed on a vulnerable population – men and women trying overcome the scourge of opioid addiction,” said Maryland Attorney General Brian Frosh. “Free and fair competition is necessary to keep drug prices affordable and to keep much-needed prescription drugs accessible to those who rely on them for treatment.”
The suit seeks unspecified damages based on the amount of estimated profits the company earned on its alleged anti-competitive activity.
Opioid addiction is a growing problem in the U.S., increasing the demand for the opioid treatment drug. A new report by researchers at the National Center for Injury Prevention and Control, the cost of prescription opioid overdose, abuse, and dependence in the U.S. is an estimated $78.5 billion a year.
"More than 40 Americans die each day from overdoses involving prescription opioids,” said Dr. Tom Frieden, Director of the Centers for Disease Control and Prevention. "The rising cost of the epidemic is also a tremendous burden for the health care system."
The study shows that health care costs make up about one-third of costs linked to the prescription opioid epidemic, and about a quarter of the costs are borne by state and federal governments.