Unrestricted Fentanyl — Competitive Intelligence Brief

Unrestricted Fentanyl (Unrestricted Fentanyl) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Synthetic opioid agonist. Area: Pain management.

marketed Synthetic opioid agonist Mu-opioid receptor (OPRM1) Pain management Small molecule

Target snapshot

Unrestricted Fentanyl (Unrestricted Fentanyl) — Virginia Commonwealth University. Fentanyl is a synthetic opioid agonist that binds to mu-opioid receptors in the central nervous system to produce analgesia and sedation.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Unrestricted Fentanyl TARGET	Unrestricted Fentanyl	Virginia Commonwealth University	marketed	Synthetic opioid agonist	Mu-opioid receptor (OPRM1)
Methadone Maintenance Therapy	Methadone Maintenance Therapy	Oregon Health and Science University	marketed	Synthetic opioid agonist	Mu opioid receptor (μ-opioid receptor)
Duragesic reference fentanyl TDS	Duragesic reference fentanyl TDS	University of Maryland, Baltimore	marketed	Synthetic opioid agonist	Mu-opioid receptor (μ-OR)
Mylan generic fentanyl	Mylan generic fentanyl	University of Maryland, Baltimore	marketed	Synthetic opioid agonist	Mu-opioid receptor (OPRM1)
Normal dose of alfentanil hydrochloride	Normal dose of alfentanil hydrochloride	University Hospital, Ghent	marketed	Synthetic opioid agonist	Mu opioid receptor (μ-OR)
Fentanyl ev	Fentanyl ev	Azienda Sanitaria dell'Alto Adige	marketed	Synthetic opioid agonist	Mu-opioid receptor (OPRM1)
Ketamine + methadone	Ketamine + methadone	Cedars-Sinai Medical Center	marketed	NMDA receptor antagonist + synthetic opioid agonist combination	NMDA receptor (ketamine); mu opioid receptor (methadone)

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 (Synthetic opioid agonist class)

1. University of Maryland, Baltimore · 2 drugs in this class
2. Boston Medical Center · 1 drug in this class
3. L'Hospitalet de Llobregat · 1 drug in this class
4. Azienda Sanitaria dell'Alto Adige · 1 drug in this class
5. University Hospital, Ghent · 1 drug in this class
6. Virginia Commonwealth University · 1 drug in this class
7. Oregon Health and Science University · 1 drug in this class