pediatric, prolonged released melatonin — Competitive Intelligence Brief

pediatric, prolonged released melatonin (pediatric, prolonged released melatonin) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Melatonin receptor agonist. Area: Sleep disorders.

phase 3 Melatonin receptor agonist Melatonin receptor Sleep disorders Small molecule

Target snapshot

pediatric, prolonged released melatonin (pediatric, prolonged released melatonin) — University Hospital, Strasbourg, France. Melatonin is a hormone that regulates sleep-wake cycles, and prolonged release formulations aim to maintain therapeutic levels throughout the night.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
pediatric, prolonged released melatonin TARGET	pediatric, prolonged released melatonin	University Hospital, Strasbourg, France	phase 3	Melatonin receptor agonist	Melatonin receptor
Thymanax	AGOMELATINE	Les Laboratoires Servier	marketed	agomelatine	Melatonin receptor type 1A	2009-01-01
Melatol	MELATONIN	Rad Neurim Pharmaceuticals Eec Sarl	marketed	Adrenocorticotropic Hormone [EPC]	Melatonin receptor type 1B	2007-01-01
Rozerem	RAMELTEON	Takeda	marketed	Melatonin Receptor Agonist [EPC]	Melatonin receptor type 1A	2005-01-01
Ovide	MALATHION	Taro	marketed	Cholinesterase Inhibitor [EPC]	Melatonin receptor type 1A	1982-01-01
Sublingual Melatonin	Sublingual Melatonin	Al-Azhar University	marketed	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

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