RELEXXII

Peak

methylphenidate hydrochloride

NDAORALTABLET, EXTENDED RELEASE
Approved
Jun 2022
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
10

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
Feb 3, 2037
132 months away
Patent Expiry
Feb 3, 2037

Patent Records (5)

Patent #ExpiryTypeUse Code
10265308
Feb 3, 2037
Product
U-4032
10695336
Feb 3, 2037
U-4032
9707217
Feb 3, 2037
Product
9827234
Feb 3, 2037
U-4032
9855258
Feb 3, 2037
Product
U-4032