Long acting methylphenidate — Competitive Intelligence Brief

Long acting methylphenidate (Long acting methylphenidate) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Sympathomimetic amine; CNS stimulant. Area: Neurology; Psychiatry.

marketed Sympathomimetic amine; CNS stimulant Dopamine transporter (DAT); Norepinephrine transporter (NET) Neurology; Psychiatry Small molecule

Target snapshot

Long acting methylphenidate (Long acting methylphenidate) — University of California, Los Angeles. Long-acting methylphenidate is a sustained-release formulation of a central nervous system stimulant that increases dopamine and norepinephrine availability in the brain by inhibiting their reuptake.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Long acting methylphenidate TARGET	Long acting methylphenidate	University of California, Los Angeles	marketed	Sympathomimetic amine; CNS 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
Levophed	Norepinephrine Bitartrate	Pfizer Inc.	marketed	Catecholamine, sympathomimetic amine	Alpha-adrenergic 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)

• 2035-02-26 — Levophed · 10251848 · Formulation · US
• 2035-02-26 — Levophed · RE49422 · Formulation · US
• 2035-02-26 — Levophed · RE49443 · Formulation · US
• 2038-01-30 — Levophed · 10226436 · Formulation · US
• 2038-01-30 — Levophed · 10568850 · Formulation · US
• 2038-01-30 — Levophed · 12245996 · Formulation · US
• 2038-01-30 — Levophed · 10159657 · Formulation · US
• 2038-01-30 — Levophed · 11413259 · Formulation · US
• 2038-01-30 — Levophed · 10420735 · Formulation · US
• 2038-01-30 — Levophed · 11602508 · Formulation · US
• 2039-04-26 — Levophed · 10888534 · Formulation · US
• 2041-03-08 — Levophed · 12097170 · Formulation · US
• 2041-03-08 — Levophed · 12290494 · Formulation · US

Sponsor landscape (Sympathomimetic amine; CNS stimulant class)

1. Massachusetts General Hospital · 3 drugs in this class
2. NYU Langone Health · 2 drugs in this class
3. University of California, Los Angeles · 2 drugs in this class
4. University of Cincinnati · 2 drugs in this class
5. Assistance Publique - Hôpitaux de Paris · 1 drug in this class
6. Rush University Medical Center · 1 drug in this class
7. Seattle Children's Hospital · 1 drug in this class
8. University of California, Davis · 1 drug in this class
9. Rochester Center for Behavioral Medicine · 1 drug in this class
10. BRC Operations Pty. Ltd. · 1 drug in this class