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DFN-15 Active — Competitive Intelligence Brief

DFN-15 Active (DFN-15 Active) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Partial mu-opioid receptor agonist. Area: Pain Management.

phase 3 Partial mu-opioid receptor agonist Mu-opioid receptor (μ-OR) Pain Management Small molecule Live · refreshed every 30 min

Target snapshot

DFN-15 Active (DFN-15 Active) — BioDelivery Sciences International. DFN-15 is a buprenorphine sublingual tablet formulation designed to provide rapid onset and consistent opioid receptor agonism for pain management.

Comparator set (6 drugs)

Auto-detected by same drug class / molecular target / therapeutic area, ranked by phase + recency. Override with ?vs=slug1,slug2,….

DrugGenericSponsorPhaseClassTargetApproval / PDUFA
DFN-15 Active TARGET DFN-15 Active BioDelivery Sciences International phase 3 Partial mu-opioid receptor agonist Mu-opioid receptor (μ-OR)
Subutex, Buprenorphine Hydrochloride, SCH 28444 Subutex, Buprenorphine Hydrochloride, SCH 28444 Indivior Inc. marketed Partial mu-opioid receptor agonist Mu-opioid receptor (μ-OR)
Buprenorphine (Experimental) Buprenorphine (Experimental) University of Alabama at Birmingham marketed Partial mu-opioid receptor agonist Mu-opioid receptor (μ-OR)
Buprenorphine Buccal Film [Belbuca] Buprenorphine Buccal Film [Belbuca] Carolinas Pain Institute marketed Partial mu-opioid receptor agonist Mu-opioid receptor (μ-OR)
Use of buprenorphine with FAO > 30 OME Use of buprenorphine with FAO > 30 OME Fox Chase Cancer Center marketed Partial mu-opioid receptor agonist Mu-opioid receptor (μ-OR)
Buprenorphine SL Buprenorphine SL New York State Psychiatric Institute marketed Partial mu-opioid receptor agonist Mu-opioid receptor (μ-OR)
Immediate Release Sublingual Buprenorphine Immediate Release Sublingual Buprenorphine Royal Victoria Hospital, Canada marketed Partial mu-opioid receptor agonist Mu-opioid receptor (μ-OR)

Recent regulatory actions (last 90 days)

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

Upcoming PDUFA dates (next 180 days)

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

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Partial mu-opioid receptor agonist class)

  1. Indivior Inc. · 3 drugs in this class
  2. New York State Psychiatric Institute · 3 drugs in this class
  3. Orexo AB · 2 drugs in this class
  4. BioDelivery Sciences International · 2 drugs in this class
  5. King's College London · 1 drug in this class
  6. Merck Sharp & Dohme LLC · 1 drug in this class
  7. Mundipharma (China) Pharmaceutical Co. Ltd · 1 drug in this class
  8. NYU Langone Health · 1 drug in this class
  9. National Institute on Drug Abuse (NIDA) · 1 drug in this class
  10. Purdue Pharma LP · 1 drug in this class

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Cite this brief

Drug Landscape (2026). DFN-15 Active — Competitive Intelligence Brief. https://druglandscape.com/ci/dfn-15-active. Accessed 2026-05-13.

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