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Orexo AB — Portfolio Competitive Intelligence Brief

Orexo AB pipeline: 2 marketed, 0 filed, 3 Phase 3, 0 Phase 2. Recent regulatory actions, upcoming PDUFA, patent timeline, top competitor overlap.

2 marketed 0 filed 3 Phase 3 0 Phase 2 0 Phase 1 Live · 30-min refresh

Portfolio leaders (marketed + Phase 3 / filed)

DrugGenericPhaseClassTargetAreaFirst approval
SL fentanyl SL fentanyl marketed
Higher bioavailability BNX sublingual tablets Higher bioavailability BNX sublingual tablets marketed Opioid partial agonist Mu-opioid receptor (μ-OR) Pain management; Opioid use disorder
Buprenorphine/naloxone sublingual tablets Buprenorphine/naloxone sublingual tablets phase 3 Opioid agonist-antagonist combination Mu-opioid receptor (buprenorphine partial agonist; naloxone antagonist) Psychiatry / Addiction Medicine
BNX sublingual tablets BNX sublingual tablets phase 3 Partial mu-opioid receptor agonist Mu-opioid receptor (OPRM1) Pain Management / Addiction Medicine
BNX sublingual film BNX sublingual film phase 3 Partial mu-opioid receptor agonist Mu-opioid receptor (μ-OR) Pain Management / Addiction Medicine

Therapeutic area mix

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this portfolio.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this portfolio.

Patent timeline (forward window)

No upcoming patent expiries for this portfolio.

Competitive overlap (companies sharing drug classes)

  1. Rutgers, The State University of New Jersey · 2 shared drug classes
  2. Indivior Inc. · 2 shared drug classes
  3. Merck Sharp & Dohme LLC · 2 shared drug classes
  4. New York State Psychiatric Institute · 2 shared drug classes
  5. Fox Chase Cancer Center · 1 shared drug class
  6. Friends Research Institute, Inc. · 1 shared drug class
  7. Brigham and Women's Hospital · 1 shared drug class
  8. Elite Laboratories, Inc · 1 shared drug class

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Cite this brief

Drug Landscape (2026). Orexo AB — Portfolio Competitive Intelligence Brief. https://druglandscape.com/ci/company/orexo-ab. Accessed 2026-05-14.

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