JORNAY PM

Peak

methylphenidate hydrochloride

NDAORALCAPSULE, EXTENDED RELEASE
Approved
Aug 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
10

Mechanism of Action

(CNS) stimulant. The exact mode of therapeutic action in ADHD is not known.

Indications (2)

Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 yearsolder

Clinical Trials (5)

NCT01338818Phase 3Completed

Open-label Extension Evaluating Methylphenidate Hydrochloride Extended Release in Adults With Attention Deficit/Hyperactivity Disorder

Started Apr 2011
299 enrolled
Attention Deficit/Hyperactivity Disorder
NCT01259492Phase 3Completed

Efficacy and Safety Study of Methylphenidate Hydrochloride Extended Release in Adults With Childhood-onset Attention Deficit/Hyperactivity Disorder (ADHD)

Started Nov 2010
725 enrolled
Attention Deficit/Hyperactivity Disorder
NCT00937040Phase 4Completed

Adult Study / OROS Methylphenidate Hydrochloride (HCL) (OROS MPH) in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

Started Jul 2009
357 enrolled
Attention Deficit Disorder With Hyperactivity
NCT00593853Phase 2Terminated

Efficacy Study of Methylphenidate Hydrochloride to Reduce Fatigue in Prostate Cancer Patients Receiving Hormone Therapy

Started Jan 2008
33 enrolled
Prostatic NeoplasmsFatigue
NCT00302458Phase 4Completed

A Study of Repeat Dosing of OROS® Methylphenidate Hydrochloride (CONCERTA®) and Immediate Release Methylphenidate Hydrochloride in Healthy Adults

Started Jan 2006
44 enrolled
Healthy

Loss of Exclusivity

LOE Date
Mar 23, 2032
73 months away
Patent Expiry
Mar 23, 2032

Patent Records (5)

Patent #ExpiryTypeUse Code
10182995
Mar 23, 2032
Product
—
10292937
Mar 23, 2032
U-2357
10617651
Mar 23, 2032
U-2357
10881618
Mar 23, 2032
U-2357
10905652
Mar 23, 2032
Product
—
External Resources
DailyMed
Full prescribing information
FDA Drugs@FDA
FDA approval history
RxNorm
Drug nomenclature & identifiers