Oral Melatonin (4 mg) — Competitive Intelligence Brief

Oral Melatonin (4 mg) (Oral Melatonin (4 mg)) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Melatonin receptor agonist. Area: Neurology / Sleep Medicine.

phase 3 Melatonin receptor agonist MT1 and MT2 melatonin receptors Neurology / Sleep Medicine Small molecule

Target snapshot

Oral Melatonin (4 mg) (Oral Melatonin (4 mg)) — Woolcock Institute of Medical Research. Melatonin binds to melatonin receptors (MT1 and MT2) to regulate circadian rhythm and promote sleep.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Oral Melatonin (4 mg) TARGET	Oral Melatonin (4 mg)	Woolcock Institute of Medical Research	phase 3	Melatonin receptor agonist	MT1 and MT2 melatonin receptors
Oral Bedtime Melatonin	Oral Bedtime Melatonin	Hospital San Carlos, Madrid	marketed	Melatonin receptor agonist	MT1 and MT2 melatonin receptors
Melatonin PR	Melatonin PR	Seoul National University Hospital	marketed	Melatonin receptor agonist	MT1 and MT2 melatonin receptors
melatonin in children premedication	melatonin in children premedication	Azienda Ospedaliera Universitaria Policlinico "G. Martino"	marketed	Melatonin receptor agonist	MT1 and MT2 melatonin receptors
transdermal therapeutic system- melatonin.	transdermal therapeutic system- melatonin.	Ain Shams University	marketed	Melatonin receptor agonist	MT1 and MT2 melatonin receptors
Sublingual Melatonin	Sublingual Melatonin	Al-Azhar University	marketed	Melatonin receptor agonist	MT1 and MT2 melatonin receptors
Melatonin Patches	Melatonin Patches	Ain Shams University	marketed	Melatonin receptor agonist	MT1 and MT2 melatonin receptors

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 (Melatonin receptor agonist class)

1. Ain Shams University · 2 drugs in this class
2. Al-Azhar University · 1 drug in this class
3. Azienda Ospedaliera Universitaria Policlinico "G. Martino" · 1 drug in this class
4. B.P. Koirala Institute of Health Sciences · 1 drug in this class
5. Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health · 1 drug in this class
6. Hospital San Carlos, Madrid · 1 drug in this class
7. Imperial College London · 1 drug in this class
8. KIMJisun · 1 drug in this class
9. Rush University Medical Center · 1 drug in this class
10. Seoul National University Hospital · 1 drug in this class