Maryland among 36 states suing makers of heroin addiction treatment drug Suboxone for antitrust violations

Maryland among 36 states suing makers of heroin addiction treatment drug Suboxone.

Maryland and 35 other states filed an antitrust lawsuit Thursday against the makers of the opioid addiction treatment drug Suboxone.

The lawsuit, filed in U.S. District Court for the Eastern Division of Pennsylvania, alleges that Reckitt Benckiser, now known as Indivior, and MonoSol Rx conspired to block generic competitors for Suboxone by switching the drug from a tablet to a dissolving film. As a result, consumers have been paying artificially high prices for Suboxone since 2009, when a generic alternative might otherwise have become available.

"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 E. Frosh in a statement. "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."

Reckitt could not be reached for comment late Thursday.

In a statement released Friday, MonoSol Rx denied any wrongdoing.

"We believe that the allegations in the complaint are wholly without merit and the suit is both factually and legally deficient. As a small innovative company with R&D in New Jersey and manufacturing in Indiana, we are proud of our patented technology and the value it has brought to patients and caregivers" Keith Kendall, CEO of MonoSol Rx, 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."

Reckitt debuted Suboxone as a tablet in 2002 under a patent that prevented any other company from developing a generic for seven years, according to the lawsuit.

The lawsuit alleges that before the patent for the Suboxone tablet expired, Reckitt and MonoSol worked together to create a new version of Suboxone — a film the size of a breath strip that dissolves on the tongue — then shifted the market away from the tablet to the film. Once most customers had shifted to the film, Reckitt took the tablet off the market, according to the lawsuit.

The suit alleges that this was illegal "product hopping," which is when a company makes changes to a product in order to extend its patent and prevent other companies from making a cheaper generic alternative.

Reckitt also allegedly delayed FDA approval of generic Suboxone tablets by raising unfounded safety concerns about the tablet, according to the lawsuit.

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