Indivior lied and cheated its way to billions of dollars in Suboxone sales, according to a new federal indictment that details a yearslong marketing scheme to pump up sales.
Prosecutors are eyeing a $3 billion judgment in the case, which alleges that Indivior exaggerated the benefits of Suboxone Film, a new version of its older opioid dependence pill. The drugmaker generated billions of dollars by “deceiving" doctors into "believing that Suboxone Film is safer and less susceptible to diversion and abuse than other, similar drugs,” the indictment states.
Indivior also used underhanded tactics to move patients to the film formulation, the indictment states. The company developed Suboxone Film around 2007 as its patent protections for the original tablet were running out, and then, without any evidence to support its claims, marketed Suboxone Film as safer and less prone to child exposure, the government alleges.
Next, to delay generic versions of the tablet and switch patients to the film, Indivior withdrew the pill on false concerns of exposure to children, the indictment says.
The company also set up an internet and telephone program for patients to connect with doctors about their opioid dependence, the government says. Indivior intentionally matched those patients with doctors who were prescribing Suboxone in a “careless and clinically unwarranted manner," the indictment alleges.
Authorities are demanding $3 billion for the company’s alleged illicit marketing, plus forfeiture of Indivior assets such as bank accounts and patents. The government alleges health care fraud, wire fraud and mail fraud, along with conspiracy to commit each of those crimes.
Indivior responded in a statement that it's “extremely disappointed” by the indictment, arguing the allegations are “wholly unsupported by either the facts or the law.”
“The department has apparently decided it would rather pursue self-serving headlines on a matter of national significance than achieve an appropriate resolution, but we will contest this case vigorously and we look forward to the full facts coming out in court,” the company said.
And in an open letter, Indivior Chairman Howard Pien wrote that the company "never deliberately diverted" its drug. He said governmental agencies have concluded that Suboxone Film's unit-dose packaging are less susceptible to child exposure.
"I couldn’t be prouder of the work Indivior does to fight the opioid crisis," Pien added. "The company conducts more research into opioid addiction than any other company, and the products it has brought to market have helped millions of people struggling with opioid addiction."
The indictment comes only months after Indivior lost U.S. market exclusivity for Suboxone Film. The company has a contingency plan and hopes to bolster its newer launches buprenorphine injection Sublocade and schizophrenia med Perseris while cutting costs.
Still, the Suboxone sales erosion paired with a federal indictment could prove a serious challenge for the drugmaker. Sublocade sales only came in at $12 million last year, while Perseris just launched in February. Last year, Indivior generated just over $1 billion in global sales for all its meds.
Aside from the Department of Justice investigation and patent challenges with Suboxone, Indivior has faced a number of legal issues in recent years. The Federal Trade Commission is still investigating the drugmaker, according to its annual report. In addition, numerous plaintiffs have sued, claiming the company illegally blocked generic versions of Suboxone tablets. Connecticut and California have each subpoenaed the company, and Indivior is part of a national opioid class action lawsuit.