ORADUR®-Methylphenidate — Competitive Intelligence Brief

ORADUR®-Methylphenidate (ORADUR®-Methylphenidate) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Sympathomimetic amine; central nervous system stimulant. Area: Neurology / Psychiatry.

phase 3 Sympathomimetic amine; central nervous system stimulant Dopamine transporter (DAT); Norepinephrine transporter (NET) Neurology / Psychiatry Small molecule

Target snapshot

ORADUR®-Methylphenidate (ORADUR®-Methylphenidate) — Orient Pharma Co., Ltd.. ORADUR-Methylphenidate is an extended-release formulation of methylphenidate that inhibits the reuptake of dopamine and norepinephrine in the central nervous system.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
ORADUR®-Methylphenidate TARGET	ORADUR®-Methylphenidate	Orient Pharma Co., Ltd.	phase 3	Sympathomimetic amine; central nervous system stimulant	Dopamine transporter (DAT); Norepinephrine transporter (NET)
Propadrine	PHENYLPROPANOLAMINE	Alpharma Us Pharms	marketed	Indirectly Acting Sympathomimetic Amines	Sodium-dependent noradrenaline transporter	2000-01-01
Didrex	BENZPHETAMINE	Pfizer	marketed	Sympathomimetic Amine Anorectic	Alpha-1A adrenergic receptor	1960-01-01
Tenuate	DIETHYLPROPION	ANI Pharmaceuticals	marketed	Sympathomimetic Amine Anorectic	Sodium-dependent dopamine transporter	1959-01-01
Aramine	METARAMINOL		marketed	Indirectly Acting Sympathomimetic Amines	Macrophage migration inhibitory factor	1954-01-01
Vialin	MEPHENTERMINE	Baxter	marketed	Indirectly Acting Sympathomimetic Amines	Alpha-1A adrenergic receptor	1951-01-01
Ephedrine, continuous infusion	Ephedrine, continuous infusion	University of Parma	marketed	Sympathomimetic amine	Alpha and beta-adrenergic 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 (Sympathomimetic amine; central nervous system stimulant class)

1. Children's Hospital Medical Center, Cincinnati · 1 drug in this class
2. Hospital de Clinicas de Porto Alegre · 1 drug in this class
3. Oregon Health and Science University · 1 drug in this class
4. Orient Pharma Co., Ltd. · 1 drug in this class
5. Pfizer · 1 drug in this class
6. St. Louis University · 1 drug in this class
7. The Royal Ottawa Mental Health Centre · 1 drug in this class
8. UCB Pharma · 1 drug in this class
9. University of California, San Francisco · 1 drug in this class
10. University of Utah · 1 drug in this class