More than 30 states sue drug manufacturers for blocking Suboxone generic

Two pharmaceutical companies schemed to prevent a less expensive generic version of Suboxone from entering the market, according to a lawsuit filed by 35 states and the District of Columbia.

According to the lawsuit, conduct by the companies allegedly led to limited treatment and competition for patients who take Suboxone, which is a combination of buprenorphine and naloxone that helps treat opioid addiction.

The lawsuit alleges Indivior, previously known as Reckitt Benckiser Pharmaceuticals, and MonoSol Rx employed tactics such as “product hopping, unfounded allegations of safety issues with the tablet form of Suboxone, intentional delays involving the U.S. Food and Drug Administration’s requirement of a risk evaluation and mitigation strategy, and filing a sham citizen petition to delay would-be competitors.”

Several attorneys general released statements condemning the anticompetitive actions.

“My office will not permit drug companies to engage in anticompetitive conduct that unlawfully extends their monopolies — and their monopoly profits — on drugs,” Eric T. Schneiderman, New York Attorney General, said in a press release. “We will take decisive action against drug companies that engage in schemes to manipulate the cost and availability of treatment options to maximize corporate profits. Opioid abuse is a public health crisis, and opioid-dependent patients should have access to the most affordable addiction treatment options available.”

“Gaming the system to charge higher prices on needed medications is wrong,” Roy Cooper, North Carolina Attorney General, said in a press release. “Prescription drug abuse is a serious problem in North Carolina and those trying to recover from it suffer if artificially high costs make it harder for them to get treatment.”

As detailed in the lawsuit, Reckitt was granted a 7-year orphan drug status for Suboxone by the FDA, providing an exclusivity period to recover the costs of developing and marketing the drug. When that period approached expiration, the company teamed with MonoSol Rx, maker of PharmFilm, to develop a sublingual film form of Suboxone.

Reckitt claimed the film would reduce accidental exposure to children. The company then raised the price of the tablets above that of the film and allegedly used other tactics to encourage physicians to prescribe the film. By 2013, when the generic tablets had received FDA approval, 85% of prescriptions for Suboxone were for the film form, according to the lawsuit.

These actions were designed to delay approval of a cheaper generic version, the lawsuit states. The attorneys general are seeking “injunctive relief, penalties and disgorgement” of the profits the companies made due to their alleged illegal actions.

Indivior issued several press releases noting the company had been notified regarding the lawsuit and that it “intends to continue to vigorously defend its position.”

“[The] states released a redacted copy of this complaint, which alleges, among other things, that Indivior, along with other defendants, switched Suboxone treatment from a tablet to a film formulation in order to prevent or delay the introduction of generic alternatives,” Indivior said in a press release. “The company continues to take these allegations seriously, intends to defend this and other related actions, and will continue to cooperate with the relevant U.S. government agencies in their investigations of the company.”

MonoSol Rx also issued a release in response to the complaint.

“We believe that the allegations in the complaint are wholly without merit and the suit is both factually and legally deficient,” Keith Kendall, chief executive officer of MonoSol Rx, said in a press release. “As a small innovative company with research and development [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. 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.”