Federal Grand Jury Validates Allegations in In re: Suboxone (Buprenorphine Hydrochloride and Naloxone) Antitrust Litigation

A federal grand jury indicted Indivior Inc. and Indivior PLC for fraudulently marketing its blockbuster drug, Suboxone. The indictment echoed the same allegations made by plaintiffs in In re: Suboxone (Buprenorphine Hydrochloride and Naloxone) Antitrust Litigation, No. 2:13-md-02445, a civil case that plaintiffs have been litigating in the Eastern District of Pennsylvania since 2013.  Faruqi & Faruqi represents the direct purchaser plaintiffs in In re: Suboxone (Buprenorphine Hydrochloride and Naloxone) Antitrust Litigation.

Plaintiffs in In re: Suboxone (Buprenorphine Hydrochloride and Naloxone) Antitrust Litigation allege that Indivior forecasted a significant loss of revenue to generic competitors after the FDA-granted exclusivity period on its original tablet form of Suboxone expired in 2009. To protect itself from competition, Indivior developed a patent-protected Suboxone film, and engaged in what is known as a “product hop.” Although the film and the tablet were medically equivalent, the differences in dosage form prohibit pharmacists from providing the lower priced generic tablet to patients with Suboxone film prescriptions. To ensure that doctors prescribed Suboxone film instead of Suboxone tablets, which would be subject to substitution by pharmacists upon generic entry, Indivior dismantled the market for Suboxone tablets by raising the tablets’ price and launching a fraudulent marketing campaign advising health care providers that the film form of Suboxone was safer and more effective than the tablet form. By the time that a generic tablet form entered the market, Indivior had successfully caused most physicians to change their prescribing habits to favor the film form of the drug. Indivior ultimately removed the tablet from the market, citing its false safety concerns, so that a pharmacist could only provide generic tablets to patients with prescriptions for the generic tablet – a much less frequent event in the wake of Indivior’s disparagement of tablets. Through its anticompetitive and fraudulent conduct, Indivior was able to maintain its monopoly over opioid dependent patients.

In a 47-page, 28-count, indictment, a grand jury found probable cause based on these same facts. The Department of Justice detailed allegations evidencing that Indivior knowingly fabricated safety and efficacy claims solely for the purpose of preventing competition and allowing Indivior to maintain monopoly prices on its potentially life-saving drug.