Dexmedetomidine (DEX) — Competitive Intelligence Brief

Dexmedetomidine (DEX) (Dexmedetomidine (DEX)) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Alpha-2 adrenergic receptor agonist. Area: Anesthesia and Critical Care.

marketed Alpha-2 adrenergic receptor agonist Alpha-2 adrenergic receptor Anesthesia and Critical Care Small molecule

Target snapshot

Dexmedetomidine (DEX) (Dexmedetomidine (DEX)) — Ain Shams University. Dexmedetomidine is a selective alpha-2 adrenergic receptor agonist that produces sedation, analgesia, and anxiolysis by activating presynaptic and postsynaptic alpha-2 receptors in the central nervous system.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Dexmedetomidine (DEX) TARGET	Dexmedetomidine (DEX)	Ain Shams University	marketed	Alpha-2 adrenergic receptor agonist	Alpha-2 adrenergic receptor
oxymetazoline-fluticasone propionate	oxymetazoline-fluticasone propionate	Brian J Lipworth	marketed	Nasal decongestant/corticosteroid combination	Alpha-2 adrenergic receptor; glucocorticoid receptor
Nebulized lidocaine and dexmedetomidine	Nebulized lidocaine and dexmedetomidine	Ain Shams University	marketed	Local anesthetic and sedative-analgesic combination	Voltage-gated sodium channels (lidocaine); alpha-2 adrenergic receptors (dexmedetomidine)
Venlafaxine XR + Mirtazapine	Venlafaxine XR + Mirtazapine	National Institute of Mental Health (NIMH)	marketed	Antidepressant combination (SNRI + NaSSA)	Serotonin transporter, norepinephrine transporter, alpha-2 adrenergic receptors, 5-HT2 receptors, 5-HT3 receptors
IV acetaminophen & IV dexmedetomidine	IV acetaminophen & IV dexmedetomidine	Beth Israel Deaconess Medical Center	marketed	Analgesic/sedative combination	COX enzymes (acetaminophen); alpha-2 adrenergic receptors (dexmedetomidine)
dexmedetomidine 1 µg/kg IV	dexmedetomidine 1 µg/kg IV	American University of Beirut Medical Center	marketed	Alpha-2 adrenergic agonist	Alpha-2 adrenergic receptor
Clonidine Oral Liquid Product	Clonidine Oral Liquid Product	Region Örebro County	marketed	Alpha-2 adrenergic agonist	Alpha-2 adrenergic receptor

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 (Alpha-2 adrenergic receptor agonist class)

1. Allergan · 3 drugs in this class
2. Eye & ENT Hospital of Fudan University · 2 drugs in this class
3. National Cancer Institute, Egypt · 2 drugs in this class
4. The University of Hong Kong · 2 drugs in this class
5. Sindh Institute of Urology and Transplantation · 2 drugs in this class
6. Fayoum University Hospital · 1 drug in this class
7. First Affiliated Hospital of Chongqing Medical University · 1 drug in this class
8. Guangzhou General Hospital of Guangzhou Military Command · 1 drug in this class
9. Icahn School of Medicine at Mount Sinai · 1 drug in this class
10. KAT General Hospital · 1 drug in this class