Agreement Continues AG James’ Efforts to Combat the Opioid Crisis
New York Attorney General Letitia James, together with 41 other attorneys general, reached a $102.5 million settlement with Indivior Inc. (Indivior), the manufacturer of an opioid addiction treatment drug, for monopolistic practices that suppressed the market for generic versions of the drug, Suboxone. The agreement, which was submitted to the court in the Eastern District of Pennsylvania for approval, requires Indivior to pay the states $102.5 million, of which New York will receive approximately $5.7 million. Indivior is also required to inform the states of all Citizen Petitions it submits to the U.S. Food and Drug Administration (FDA) and provide notice about new products and/or a change in corporate control to help ensure that Indivior doesn’t repeat their monopolistic actions.
“As the opioid crisis was raging across the country, Indivior selfishly maneuvered to keep less expensive versions of a lifesaving drug out of the hands of millions of Americans,” said Attorney General James. “Indivior’s drug was supposed to help many, but its monopolistic practices helped fuel the opioid epidemic and impede efforts to confront it. This agreement continues our efforts to address the opioid crisis and hold all the companies that contributed to this crisis accountable.”
This agreement resolves a lawsuit filed by the Office of the Attorney General (OAG) and the other states against Indivior for anticompetitive practices. The 2016 lawsuit alleged that Indivior used illegal means to switch patients from Suboxone tablets to its new, patented Suboxone film while attempting to destroy the market for tablets, in order to preserve its drug monopoly.
Suboxone is used to treat people addicted to opioids and is intended to prevent abuse. Suboxone tablets were first approved for sale in the U.S. in 2002. Although Suboxone tablets lacked any patent protection, the FDA designated Suboxone as an “orphan drug,” meaning that it could have no competitors for seven years, because the company was not expected to recoup its research and development costs. Because Indivior’s exclusive right to sell and market the drug in tablet form was set to expire in 2009, Indivior sought to prevent lower cost generic competition and maintain its monopoly by engaging in a range of anticompetitive conduct from 2008 until generic entry occurred in 2013.
First, to thwart the entry of a generic version of Suboxone, Indivior informed the FDA in 2007 that it planned to introduce a new version of Suboxone that was a sublingual film, or a dissolvable oral strip. Because the new version of Suboxone would not be the pharmaceutical equivalent of the original tablet form, pharmacists would not be able to substitute a generic manufacturer’s tablet version for the film version. To persuade the FDA to approve Suboxone film, Indivior claimed that the tablet version — which Indivior itself had marketed in the U.S. for nearly ten years — was unsafe because it presented a high exposure risk to children. The FDA approved Indivior’s patented film version of Suboxone in August 2010.
In early 2012, the FDA ordered Indivior and potential generic manufacturers of the tablet version to participate in a shared Risk Evaluation and Mitigation Strategy to reduce the risk of pediatric exposure to the tablets, but Indivior did not cooperate in this process. Instead, in September 2012, it filed a Citizen’s Petition with the FDA requesting that the agency withhold approval of the tablet version — which Indivior had itself been marketing since 2002 — unless generic manufacturers could satisfy certain procedures to minimize pediatric exposure risks. This petition was ultimately rejected by the FDA, but by the time generics were finally able to enter the market, Indivior had pulled its tablet version from the market and converted the vast majority of the market to the film version for which there was no generic substitute.
This agreement requires Indivior to pay $102.5 million to the states, an estimated $5.7 million will be earmarked for New York. The agreement continues Attorney General James’ efforts to combat the opioid crisis and keep New Yorkers safe. In March 2019, Attorney General James filed a historic lawsuit to hold various opioid manufacturers and distributors responsible for their roles in the crisis. Attorney General James has recovered more than $2.6 billion to support New York opioid abatement, treatment, and prevention efforts from companies including Teva Pharmaceuticals, Mallinckrodt, Allergan, Endo, McKesson, Cardinal Health, and Amerisource Bergen. Attorney General James has also led multistate coalitions in reaching settlements for billions of dollars with CVS, Walgreens, and Walmart for their role in failing to properly regulate opioid prescriptions. Additionally, Attorney General James has also cracked down on dozens of drug trafficking rings, taken action against drug peddlers, and removed dangerous drugs out of New York communities.
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