Rozerem (Ramelteon) — Competitive Intelligence Brief

Rozerem (Ramelteon) (Rozerem (Ramelteon)) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Melatonin receptor agonist. Area: Sleep disorders.

phase 3 Melatonin receptor agonist MT1 and MT2 Sleep disorders Small molecule

Target snapshot

Rozerem (Ramelteon) (Rozerem (Ramelteon)) — Southern California Institute for Research and Education. Rozerem (Ramelteon) is a melatonin receptor agonist that binds to melatonin receptors MT1 and MT2, mimicking the action of melatonin to regulate sleep-wake cycles.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Rozerem (Ramelteon) TARGET	Rozerem (Ramelteon)	Southern California Institute for Research and Education	phase 3	Melatonin receptor agonist	MT1 and MT2
Ramelteon (RozeremR)	Ramelteon (RozeremR)	University of Sao Paulo	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
Melatonin injection	Melatonin injection	Imperial College London	marketed	Melatonin receptor agonist	MT1 and MT2 melatonin receptors
Melatonin treatment	Melatonin treatment	Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health	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
Melatonin(Circadin®)	Melatonin(Circadin®)	KIMJisun	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