QUILLICHEW ER

Peak

methylphenidate hydrochloride

NDAORALTABLET, EXTENDED RELEASE, CHEWABLE
Approved
Dec 2015
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
11

Clinical Trials (5)

NCT03580005Phase 4Withdrawn

A 6-week Study to Evaluate the Safety and Efficacy of Quillichew ERCT in 4-5 Year Old Children With ADHD.

Started Oct 2018
0
Attention Deficit Hyperactivity Disorder (ADHD)Attention Deficit Hyperactivity Disorder
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

Loss of Exclusivity

LOE Date
Aug 14, 2033
90 months away
Patent Expiry
Aug 14, 2033

Patent Records (5)

Patent #ExpiryTypeUse Code
8202537
Mar 15, 2027
Product
—
8287903
Feb 15, 2031
Product
—
11103495
Aug 14, 2033
Product
U-2993
11633389
Aug 14, 2033
Product
—
8999386
Aug 14, 2033
Product
—
External Resources
DailyMed
Full prescribing information
FDA Drugs@FDA
FDA approval history
RxNorm
Drug nomenclature & identifiers