US states sue Reckitt Benckiser, Indivior for allegedly trying to block Suboxone generics

Attorneys General from 36 US states launched an antitrust lawsuit Thursday against Reckitt Benckiser Pharmaceuticals and Indivior regarding the opioid addiction treatment Suboxone (buprenorphine/naloxone). The litigation, filed in the US District Court for the Eastern Division of Pennsylvania, accuses the companies of conspiring with MonoSol Rx to switch Suboxone from an oral version to a film formulation "in order to prevent or delay generic alternatives and maintain monopoly profits." 

Pennsylvania Attorney General Bruce Beemer said "the alleged scheme…denied consumers the choice of a generic version of Suboxone," adding that "this conduct forced consumers to pay more for Suboxone and severely limited their options for treating their opioid addictions." 

The lawsuit states that oral Subxone had been granted seven years of market exclusivity following its approval in 2002, but "before that period ended" Reckitt Benckiser teamed with MonoSol to introduce a dissolvable film formulation of the drug. "Over time, Reckitt Benckiser allegedly converted the market away from the tablet to the film through marketing, price adjustments and other methods," the Attorneys General claim, adding that the drugmaker eventually pulled oral Suboxone from the US market after most patients had been switched over.

According to the lawsuit, Suboxone Film "provided no real benefit" over the oral version, which was still available in other countries. The officials also alleged that the drugmaker "expressed unfounded safety concerns" about the oral drug and "intentionally delayed FDA approval of generic versions of Suboxone." Consequently, consumers and payers were charged artificially high prices for the treatment since late 2009, when generic alternatives might otherwise have reached the market, garnering annual sales that topped $1 billion, the lawsuit alleges.

Reckitt Benckiser launched Indivior in 2014 after having unveiled plans to spin off its pharmaceuticals business into a separate company. Meanwhile, a US district court sided with Indivior in June when it upheld two patents covering Suboxone Film, likely protecting the drug from generic competition until 2024. 

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