A lawsuit filed by 35 states and the District of Columbia alleges that drugmaker Indivior violated antitrust laws by trying to extend its monopoly over Suboxone, New York’s attorney general announced Thursday. Suboxone is a prescription drug used to treat patients addicted to heroin, painkillers and other opioid drugs.
The company’s actions drove up prices, depriving consumers and the states of lower costs, according to California’s attorney general.
The states want Indivior to pay back the billions of dollars in profits earned as a result of its alleged practices.
The company and MonoSol Rx conspired to block generic competitors for Suboxone by switching the drug from a tablet to a dissolving film, the lawsuit claims. As a result, consumers have been paying artificially high prices for Suboxone since 2009, when a generic alternative might otherwise have become available.
“The company intends to continue to vigorously defend its position,” said a brief statement on Indivior’s website. The company did not respond to a request for more information.
The Food and Drug Administration first approved the sale of Suboxone tablets, a mixture of buprenorphine and naloxone made by Indivior, in 2002. At that time, the FDA granted the British drugmaker, then known as Reckitt Benckiser, a seven-year “orphan drug” monopoly on Suboxone sales.
Before the exclusive rights expired, Indivior manipulated FDA regulations to delay the entry of generic Suboxone onto the market, the lawsuit claims. New Jersey-based MonoSol Rx was also named in the suit for working with Indivior to create a dissolvable strip of the medication.
The states’ attorneys described Indivior’s scheme as “product-hopping,” a term used when slight reformulations that don’t offer any real advantages are made to a drug.
The scheme began two years before the exclusive rights expired in 2007; at that time, the British company told the FDA it planned to introduce a dissolvable oral strip version of Suboxone, which was not the exact pharmaceutical equivalent of the tablet form. Before any generic pills could begin competing, Invidior fabricated safety concerns about Suboxone tablets — that tablets presented a high exposure risk to children — and even removed its own tablets from the market, the lawsuit claims.
Then, Invidior and MonoSol Rx, the dissolvable strip company, marketed their new Suboxone strip as safer than the original pills. Acknowledging that the film version may actually present more of a threat to children, the FDA nevertheless approved Indivior’s patented film version of Suboxone in August 2010.
By the time generics entered the market, the attorneys general say, Indivior had converted the vast majority of doctors prescribing Suboxone to the film version, which has no generic substitute.
“My office will not permit drug companies to engage in anticompetitive conduct that unlawfully extends their monopolies — and their monopoly profits — on drugs,” New York Attorney General Eric T. Schneiderman said in a statement.
“We believe that the allegations in the complaint are wholly without merit and the suit is both factually and legally deficient,” MonoSol Rx CEO Keith Kendall said in a statement. “I think it is important to add that Suboxone sublingual film is a product which has saved countless lives since its approval by the FDA in 2010.”