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Reckitt Benckiser, the company that brought Suboxone to market, settled allegations that the company wrongly marketed and promoted Suboxone, resulting in the improper expense to state Medicaid funds. Reckitt will pay $700 million to settle the allegations. New York State Attorney General, Letitia James, said in a release dated October 23, 2019, that no company is above the law: “Reckitt misled the public about the real impacts of Suboxone and encouraged physicians to wrongly prescribe it, while cheating New York out of tens of millions of dollars in the process.” FiercePharma reported that would bring Reckitt total settlements this year to just over $2 billion, putting its Suboxone marketing investigations behind it, once and for all.
On April 9th 2019, a federal grand jury indicted Indivior, formerly part of Reckitt Benckiser Pharmaceuticals Inc., for allegedly engaging in an illicit nationwide scheme to promote Suboxone. Reckitt Benkiser had spun off Indivior Inc., meaning the two became separate companies in December of 2014. The U.S.’s criminal trial against Indivior is scheduled to begin on May 11, 2020. Then the U.S. Department of Justice announced on July 11, 2019 that Reckitt Benckiser agreed to pay $1.4 billion to resolve potential criminal and civil liability related to a federal investigation of the marketing of Suboxone.
After the April 9, 2019 indictment against Indivior, FiercePharma reported the company said the allegations were “wholly unsupported by either the facts or the law.” Indivior’s Chairman said the company “never deliberately diverted its product.” In an open letter he claimed the company went beyond what the law required in its education campaign to doctors and by reporting multiple physicians to the appropriate authorities. He further claimed the DOJ indictment can’t be justified on any fair reading of the facts or the law. “But we will contest these charges vigorously and we are confident in our position.”
It is not clear if Indivior is as confident in its position following the DOJ announcement. “RB Group has agreed to cooperate fully with all investigations and prosecutions by the Department of Justice related, in any way, to Suboxone.” Indivior may find it is fighting against the interests of its former parent company, Reckitt Benckiser. The DOJ said:
According to the indictment, Indivior—including during the time when it was a subsidiary of RB Group—promoted the film version of Suboxone (Suboxone Film) to physicians, pharmacists, Medicaid administrators, and others across the country as less-divertible and less-abusable and safer around children, families, and communities than other buprenorphine drugs, even though such claims have never been established.The indictment further alleges that Indivior touted its “Here to Help” internet and telephone program as a resource for opioid-addicted patients. Instead, however, Indivior used the program, in part, to connect patients to doctors it knew were prescribing Suboxone and other opioids to more patients than allowed by federal law, at high doses, and in a careless and clinically unwarranted manner.The indictment also alleges that, to further its scheme, Indivior announced a “discontinuance” of its tablet form of Suboxone based on supposed “concerns regarding pediatric exposure” to tablets, despite Indivior executives’ knowledge that the primary reason for the discontinuance was to delay the Food and Drug Administration’s approval of generic tablet forms of the drug.The indictment alleges Indivior’s scheme was highly successful, fraudulently converting thousands of opioid-addicted patients over to Suboxone Film and causing state Medicaid programs to expand and maintain coverage of Suboxone Film at substantial cost to the government.
Meanwhile, as alluded to above in the above news release from the DOJ, Indivior has been fighting a legal battle to delay generic approval for Suboxone. On June 14, 2018, the FDA approved Mylan Technologies Inc. and Dr. Reddy’s Laboratories SA to market the first generic versions of buprenorphine and naloxone sublingual film (Suboxone). Then on June 15th, the U.S. District Court of New Jersey granted Indivior a temporary injunction against Dr Reddy’s, compelling it to immediately stop its launch activities with Suboxone film. According to FiercePharma, Indivior has filed patent infringement lawsuits against both Mylan and Dr Reddy’s. Indivior will have to pay Dr Reddy’s $18 million to satisfy losses or damages incurred during the temporary restraining order if the generics company is successful in its legal defense.
When the U.S. Court of Appeals found that Indivior was not likely to succeed on the claimed patent infringement and ruled the lower court’s preliminary injunction be lifted, Indivior then tried blocking the appeals court ruling by taking the issue to the Supreme Court. Chief Justice John Roberts denied Indivior’s motion to stay the appeals court mandate on February 19th, 2019, clearing the way for Dr Reddy’s to market its generic version of Suboxone as the litigation continues. Dr Reddy’s immediately began shipping its generic version, as the original injunction did not stop it from manufacturing the drug. Indivior then announced it would launch its own generic version of Suboxone in the U.S. on February 20th. Mylan, which had made a deal with Indivior, announced it will launch its generic version on February 22nd.
Then on July 12, 2019, the U.S. Federal Circuit Court of Appeals in Washington upheld lower court rulings that “Dr. Reddy’s did not infringe two Indivior patents related to Suboxone.” Two other companies, Teva and Alvogen were also found to not have infringed on Indivior patents. Writing for the majority, Circuit Judge Alan Lourie said that while Indivior’s patents should not be voided, it failed to show that they covered Dr. Reddy’s and Alvogen’s drying processes for their products. This was the day after Reckitt Benckiser agreed to pay $1.4 billion to settle a federal investigation of the marketing of Suboxone noted above. Indivior said the settlement was separate from its own case.
The above consequences have been coming for several years. And Reckitt Benckiser and Indivior are complicit in the actions taken by both companies to position themselves as the primary service provider for buprenorphine-based MAT in the U.S. But their actions to delay generic buprenorphine/naloxone didn’t just begin during the time period described above.
Reckitt Benckiser (RB) knew it only had patent exclusivity for their buprenorphine products (Suboxone and Subutex tablets) until 2009, but they had a strategy to circumvent the pending loss. First, they acquired the rights for the sublingual film version of Suboxone in 2008. Then in October of 2008 they submitted a New Drug Application to the FDA for the film version of Suboxone, which was approved by the FDA in August of 2010.
In its 2011 annual report, Reckitt Benckiser thought generic versions of Suboxone could take up 80% of the revenue and profit from the U.S. Suboxone market. However, they expected Suboxone film would help “to mitigate the impact.” Then in September of 2012 RB announced that they were voluntarily withdrawing Suboxone tablets from the market because of data they had received from the U.S. Poison Control Centers suggesting there were higher rates of pediatric overdose on the tablet formulation than the film version. The FDA thought the study Reckitt Benckiser cited (and paid for) did not demonstrate any difference in its safety profile of abuse formulations between Suboxone tablets and film.
Public Citizen said that few, if any, companies went as far as RB to pre-emptively withdraw an off-patent drug from the market (Suboxone tablets) to make room for a newly patented successor (Suboxone film). A year before the withdrawal of the tablets from the market, RB stated in its 2011 report that its goal was to convert as many tablet users as possible to the film version.
To this end, the company initiated a marketing campaign to persuade physicians to switch patients from the tablet to film form. It also employed more direct tactics to complement the marketing push, raising the price of the tablets to levels higher than the film versions. As a result of these efforts, tablet sales fell 19 percent between August 2011 and August 2012, while sales of Suboxone film doubled during the same period. By September 2012, the film version had captured 70 percent of the Suboxone market, clearing the way for the announcement of the withdrawal of the tablets that month. See “The Opioid Buzzard” for more on this.
Whether you look at Reckitt Benckiser or Indivior you can see a pattern of systematic steps to maintain a monopoly on the buprenorphine-naloxone end of the MAT, medical-assisted treatment, market. This resulted in 2019 with over $2 billion in settlements for improper, illegal marketing tactics with Suboxone for Reckitt Benckiser. Indivior is next, as the federal government indicted it for an illicit scheme to market Suboxone. Yet Indivior still projects a rosy future for its products. It has a new buprenorphine product, monthly depot shot of buprenorphine called Sublocade, and Perseris, which is an extended release injectable of risperidone for schizophrenia that launched in February of 2019. But there are additional changes in the MAT market that contribute to Indivior’s optimism.
The first quarter financial report by Indivior for 2019 reported that U.S. net revenue grew 2% as Suboxone Film share loss was more than offset by “underlying market growth, strong initial sell-in of the Group’s authorized generic film product and net revenue from SUBLOCADE™.” Operating Highlights for the first quarter included continued growth of the U.S. buprenorphine market, driven primarily by Government channels. The share erosion since the “at risk” launch of generic buprenorphine/naloxone film products in February 2019 was lower than anticipated. Suboxone Film market share ended the quarter with a 53% market share. “Sandoz Inc. launched an Indivior authorized generic buprenorphine/naloxone film and captured the leading position among allgeneric film products” by the end of the first quarter. Shaun Thaxter, the CEO of Indivior, said their first quarter performance only strengthened their confidence that they are “putting the building blocks in place for a return to sustained growth” with Sublocade and Perseris. He looked forward to reporting progress throughout the year.
His optimism seems to rest on how the market for buprenorphine products continues to grow, benefitting from legislative changes that have expanded opioid use disorder (OUD) treatment funding and treatment capacity. This was accomplished by increasing the number of patients that physicians could treat from 100 to 275.
Recognising the foregoing factors, we are introducing FY 2019 financial guidance. A key element of guidance is of course the performance of SUBLOCADE™, our new monthly buprenorphine extended-release injection, and here we made good progress in executing our plans: Q1 net revenue of $11m puts us on track to meet our FY 2019 guidance for net revenue of $50m-$70m. We continue to believe SUBLOCADE™ to be a transformational treatment for opioid dependence and we will not be distracted in our efforts to bring this important new option to patients in the US. Separately, while not a material contributor to our full-year guidance, we are nonetheless encouraged by the initial market reception to PERSERIS™, our monthly risperidone injection for schizophrenia, which we launched towards the end of the first quarter.
Thaxter said Indivior remained “undaunted in the pursuit of our Vision to improve the lives of patients suffering from addiction and its co-occurring disorders.” Yet the above story seems to point to another Vision—sustained growth and profitability—that blinds them from seeing where they are potentially taking us. Is this self-described “leader and innovator” in OUD treatment leading towards a “treatment” strategy that increases rather than decreases the number of those who are chained to an opioid? Like in the story of the Pied Piper, are we dancing to the tune of Indivior, unaware we are being led into the river of OUD instead of being saved from it?
For more on Indivior and Sublocade, see “Opioid Epidemic Price Gouging.” For further information on Reckitt Benckiser and its attempts to prolong a market for Suboxone, see “A Double-Edged Drug.”