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Buprenorphine/naloxone - Orexo

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Drug Profile

Buprenorphine/naloxone - Orexo

Alternative Names: Naloxone/buprenorphine - Orexo; OX-219; PKX-219; Zubsolv

Latest Information Update: 16 Jan 2026

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At a glance

  • Originator PharmaKodex
  • Developer Orexo
  • Class Antidotes; Benzofurans; Cyclopropanes; Drug withdrawal therapies; Isoquinolines; Morphinans; Opioid analgesics; Small molecules
  • Mechanism of Action Nociceptin receptor agonists; Opioid delta receptor antagonists; Opioid kappa receptor antagonists; Opioid mu receptor agonists; Opioid mu receptor antagonists
  • Orphan Drug Status

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

    No
  • New Molecular Entity No

Highest Development Phases

  • Marketed Opioid-related disorders

Most Recent Events

  • 07 Jan 2026 Dexcel Pharma enteres into an asset purchase agreement with Orexo to acquire the US rights to Buprenorphine/naloxone
  • 24 Jul 2023 Sun Pharmaceutical Industries appealed the patent litigation decision issued by the US District Court for the District of New Jersey relating to Orexo's patents protecting ZUBSOLV® in the US
  • 01 Jul 2023 Orexo wins patent litigation against Sun Pharmaceuticals regarding buprenorphine/naloxone (ZUBSOLV®)submission in USA

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