Back when Indivior was still a part of Reckitt Benckiser, some industry watchers found it odd when the company pushed to a sublingual film version of Suboxone and discontinued the tablets due to a public health concern that children could take them. Now, 35 U.S. states and the District of Columbia have filed suit against those actions, calling the moves anticompetitive and seeking to “disgorge” Indivior’s “ill-gotten” gains.
Used to treat patients addicted to heroin and painkillers, Suboxone was approved in 2002 as a tablet. According to the suit, before the drug’s patent protection ended 2009, Indivior introduced a film version that it said would pose less risks for children. Then, as generics neared, the company pushed its “unfounded pediatric safety concerns," petitioning the FDA to set strict packaging requirements on would-be competitors, the suit alleges.
During the period, in a move to protect profits, the company sought to switch patients to the sublingual film, the states claim.
If it weren't for the Suboxone "product hop," a majority of patients would have been on generics, according to a statement by New York Attorney General Eric Schneiderman. And in approving the new version, the FDA "acknowledged that the film version may actually present more of a threat to children in the case of accidental exposure," the AG's statement said.
Indivior, for its part, said it will “continue to vigorously defend its position.”
Suboxone reached $2 billion in 2010 sales, despite being awarded seven years of “orphan drug” protection by the FDA because of expectations it wouldn’t recoup R&D expenses, according to the New York AG.
Regular pharma-watchers will recognize the patient switching approach Indivior is alleged to have taken, as companies routinely seek to delay generic competition with “life-cycle management,” according to a recent Journal of the American Medical Association study. Drugmakers use lawsuits, add-on patents, patient switching and “pay-for-delay” schemes to delay competition, the authors found; such moves were cited as one cause for growing pharma costs.
Patient switching is a tactic that Schneiderman has worked to control before, as he took Actavis to task in 2014 for discontinuing Namenda IR--which was losing patent protection--in favor of a newer version. As part of an agreement, Actavis said it'd produce the old drug for two months.
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