(Reuters) – Specialty pharmaceutical company Aquestive Therapeutics Inc has escaped a lawsuit by a group of 42 states accusing it of helping Indivior Inc use illegal tactics to shield its opioid addiction treatment Suboxone from generic competition.
U.S. District Judge Mitchell Goldberg in Philadelphia ruled Wednesday that the states had not provided enough evidence that Aquestive, which partnered with Indivior to develop and manufacture a dissolvable film version of the drug, had any “conscious commitment” to Indivior’s alleged scheme.
The office of Wisconsin Attorney General Josh Kaul, which is leading the states’ case, and a lawyer for Aquestive did not immediately respond to requests for comment.
The states claim that in 2009, Indivior, at the time part of Reckitt Benckiser Group, extended its monopoly on Suboxone by pulling its pill version of the drug from the market and replacing it with the film version just as generic competitors were poised to launch their own versions of the pills.
Indivior persuaded the U.S. Food and Drug Administration to approve the film by raising concerns that the tablet version could accidentally be taken by children and urged the agency to block generic pills on those grounds as well, the states said.
Although the FDA decided to allow the generic pills in 2013, many patients had already switched to the film version by the time they reached the market, the states said. As a result of the scheme, they said, state health insurance programs overpayed for the drug.
Aquestive, then known as MonoSol LLC, partnered with Indivior to develop the Suboxone film beginning in 2006, and agreed in 2008 to manufacture it. The states claimed that Aquestive first suggested the strategy of pulling the pill from the market, which Aquestive has denied.
Goldberg said Wednesday that it did not matter because simply suggesting a strategy did not amount to joining an antitrust conspiracy. He said Aquestive had no actual power to withdraw the pill and that the states presented no evidence that it was involved in petitioning the FDA to block generic pills.
“At best, (Aquestive) worked diligently to do precisely what it contractually agreed to do,” the judge wrote. “Antitrust laws do not prohibit agreement to engage in such a lawful endeavor.”
The tablet version of Suboxone was first approved for sale in the United States in 2002. Although it did not have patent protection, the FDA gave the company seven years of exclusivity under the so-called orphan drug law, intended to help companies recoup costs of developing drugs that are unlikely to be profitable.
Indivior’s success in obtaining the protection has drawn scrutiny, as the drug did prove to be profitable for the company.
The case is State of Wisconsin v. Indivior Inc, U.S. District Court for the Eastern District of Pennsylvania, No. 2:16-cv-5073. It is part of the MDL In re: Suboxone Antitrust Litigation, No. 2:13-md-02445.
For the states: Wisconsin Assistant Attorney General Gwendolyn Cooley
For Aquestive: James Hibey of Steptoe & Johnson
For Indivior: Jonathan Berman of Jones Day
Read more:
Indivior must face states’ monopoly claim over opioid addiction drug
Indivior can’t reverse Suboxone antitrust class certification
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