Buprenorphine/naloxone sublingual film

Drug Profile

Buprenorphine/naloxone sublingual film

Alternative Names: Naloxone/buprenorphine; SCH 000484; Suboxone; Suboxone film

Latest Information Update: 15 Feb 2018

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At a glance

  • Originator Reckitt Benckiser Pharmaceuticals
  • Developer Aquestive Therapeutics; Indivior; Reckitt Benckiser Pharmaceuticals
  • Class Antidotes; Cyclopropanes; Drug withdrawal therapies; Morphinans; Opioid analgesics; Small molecules
  • Mechanism of Action Nociceptin receptor agonists; Opioid delta receptor antagonists; Opioid kappa receptor antagonists; Opioid mu receptor agonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • New Molecular Entity No

Highest Development Phases

  • Marketed Opioid abuse

Most Recent Events

  • 08 Feb 2018 Indivior initiates litigation against Dr. Reddy's, Actavis, Par, Alvogen and Teva over ANDA submission for buprenorphine/naloxone sublingual film in USA
  • 20 Nov 2017 Indivior initiates litigation against Dr Reddy's over ANDA submission for buprenorphine/naloxone sublingual film in USA
  • 25 Sep 2017 Indivior and Monosol Rx entered into a settlement agreement with Mylan for resolving patent litigation related to buprenorphine/naloxone sublingual film ANDA application by Mylan
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