Disease: Opioid dependence
2018 U.S. sales: About $778 million
Generics launched: February
Used to treat patients with opioid addiction, Suboxone film has served as the cornerstone of Indivior’s business since the earlier tablet version fell to generic competition. Now, after some serious scrambling in court, it's Suboxone film's turn to face the copycat assault.
Indivior's latest—and perhaps last—legal battle to stall Suboxone film copies failed only days ago. Dr. Reddy’s Laboratories had launched its copies at risk, despite still-pending patent litigation, and Indivior won an injunction to stop the Indian drugmaker's rollout. But the U.S. Court of Appeals for the Federal Circuit tossed out that injunction, and then, in early February, denied the company’s request to reconsider.
Indivior now says it plans to petition the Supreme Court. But amid legal efforts, several generics makers launched, and Indivior rolled out its own authorized copycat.
U.K.-based Indivior reported $790 million in U.S. sales last year, most of which came from Suboxone film. Last year’s buprenorphine injection launch Sublocade—which Indivior says could grow to blockbuster levels—pulled in $12 million. That means Suboxone film, Indivior's only other drug to generate sales during the period, pulled in about $778 million or more in the U.S. in 2018.
With Suboxone film generics stealing share, Indivior has set up a “contingency plan” to deal with the sales loss. The company wants to focus its spending on launches for Sublocade and its new schizophrenia drug, Perseris, but it also has to maintain its cash levels at a minimum of $250 million to comply with debt agreements.
Under its plan, Indivior plans to lay off workers, reprioritize its R&D spending and more to save costs. The company also plans to launch an authorized generic of Suboxone film in hopes of hanging on to market share; it figures an authorized copy could bring in tens of millions of dollars in sales.
Even amid those struggles, Indivior faces a slew of other legal issues, including a Justice Department investigation; Indivior said it’s in “advanced discussions” about a potential settlement. The company also faces state subpoenas on numerous issues, an antitrust investigation by the Federal Trade Commission, and antitrust lawsuits from plaintiffs claiming the company illegally delayed generic versions of Suboxone tablets.