Indivior hit hard as generic Suboxone defence crumbles

Indivior has suffered a critical defeat in the US courts for opioid addiction product Suboxone Film, opening the door to generic competition and sparking a run on its shares. The UK company’s attempt to block a generic version of Suboxone Film (sublingual buprenorphine/naloxone) developed by India’s Dr. Reddy’s Laboratories has been rejected by an appeals court, upholding an earlier ruling of non-infringement of a key patent on the brand. Dr. Reddy’s said in a statement that it plans to resume the rollout of the generic, which was approved by the FDA in June, “as soon as permitted,” and its expected to hit the ground running now as the restraining did not prevent commercial manufacturing of the product. The injunction was formally lifted today, although Indivior said a launch would depend on the appeals court formally returning the verdict to the lower court.  The company lost no time in putting out a statement suggesting launch by Dr. Reddy’s would be ‘at risk’, as there is still outstanding patent litigation involving other patents on Suboxone.

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