Suboptimal Suboxone Conduct Costs Indivior $102.5 Million

Cozen O'Connor
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  • A group of 42 AGs settled with Indivior Inc. to resolve allegations that the pharmaceutical company violated the Sherman Act and state antitrust laws by engaging in anticompetitive activities to impede competition from generic equivalents of Suboxone, its brand-name opioid addiction treatment drug.
  • Indivior was originally granted seven years of exclusivity to sell the Suboxone tablet after receiving FDA approval. The AGs allege that upon the expiration of the exclusivity period, Indivior engaged in a “product-hopping” scheme, by which it falsely asserted safety issues as a reason to transition from tablet formulation to a sublingual film with the intent of undermining the market for generic tablet versions of the drug.
  • Under the terms of the settlement, Indivior must pay $102.5 million. In addition, the company must notify the states if it files an FDA Citizen Petition attempting to delay generic competition or if it undertakes any future reformulations (and the reasons for those), among other requirements.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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