Methylphenidate Patent Expiration

Methylphenidate is Used for treating Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients. It was first introduced by Noven Pharmaceuticals Inc in its drug Daytrana on Apr 6, 2006. Another drug containing Methylphenidate is Cotempla Xr-Odt. 4 different companies have introduced drugs containing Methylphenidate.


Methylphenidate Patents

Given below is the list of patents protecting Methylphenidate, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Cotempla Xr-odt US11166947 Effective dosing of a child for the treatment of ADHD with methylphenidate Jan 25, 2038 Neos Theraps Inc
Cotempla Xr-odt US9072680 Compositions comprising methylphenidate complexed with ion-exchange resin particles Jun 28, 2032 Neos Theraps Inc
Cotempla Xr-odt US9089496 Compositions comprising methylphenidate complexed with ion-exchange resin particles Jun 28, 2032 Neos Theraps Inc
Cotempla Xr-odt US8840924 Compositions and methods of making rapidly dissolving ionically masked formulations Jun 05, 2026

(Expired)

Neos Theraps Inc
Daytrana US8632802 Device for transdermal administration of drugs including acrylic polymers Oct 07, 2025

(Expired)

Noven Pharms Inc
Daytrana US9034370 Device for transdermal administration of drugs including acrylic polymers Oct 07, 2025

(Expired)

Noven Pharms Inc
Daytrana US9668981 Device for transdermal administration of drugs including acrylic based polymers Oct 07, 2025

(Expired)

Noven Pharms Inc
Daytrana US6210705 Compositions and methods for treatment of attention deficit disorder and attention deficit/hyperactivity disorder with methylphenidate Sep 30, 2018

(Expired)

Noven Pharms Inc
Daytrana US6348211 Compositions and methods for treatment of attention deficit disorder and attention deficit/hyperactivity disorder with methylphenidate Sep 30, 2018

(Expired)

Noven Pharms Inc
Daytrana US5958446 Solubility parameter based drug delivery system and method for altering drug saturation concentration Dec 12, 2012

(Expired)

Noven Pharms Inc



Methylphenidate's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Methylphenidate:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Multimodal Therapy for the Treatment of Fatigue in Patients With Prostate Cancer Receiving Radiotherapy With Androgen Deprivation Therapy M.D. Anderson Cancer Center NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
Benefits of ADHD Treatment in Detained People Stéphanie Baggio NA RECRUITING
(Sep 1, 2026)
PHASE3
Psilocybin in Chronic Low Back Pain and Depression Johns Hopkins University NA RECRUITING
(Sep 1, 2026)
PHASE1
Methylphenidate to Address Attention and Executive Deficits Among Children With Sickle Cell Disease St. Jude Children's Research Hospital NA RECRUITING
(Sep 1, 2026)
PHASE1
Efficacy of Reboxetine and Methylphenidate Treatment on Attentional, Sensory and Emotional Dysregulation in Adults With PTSD University of Haifa NA RECRUITING
(Aug 1, 2026)
PHASE2
Adjunctive Methylphenidate ER in Patients With Schizophrenia to Improve Functional and Cognitive Outcomes The Royal Ottawa Mental Health Centre NA COMPLETED
(Aug 1, 2026)
PHASE2
EEG-MRI Imaging of Methylphenidate Effects in Adult ADHD and Attentional Symptoms in Mood Disorders University Hospital, Strasbourg, France NA RECRUITING
(Aug 1, 2026)
PHASE3
A Multimodal Imaging Study of Dopamine in Early Psychosis New York State Psychiatric Institute NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE1
Phase 3 Efficacy and Safety Study in Adults With ADHD Using CTx-1301. Cingulate Therapeutics NA COMPLETED
(Jun 1, 2026)
PHASE3
Methylphenidate in Pediatric Brain Tumor Survivors With Cancer-related Fatigue Odense University Hospital NA RECRUITING
(Jun 1, 2026)
PHASE3
Cognitive Behavioral Therapy and Multimodal Therapy in Treating Sleep Disturbance in Patients With Cancer M.D. Anderson Cancer Center NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE2
Behavioral Effects of Drugs: Inpatient (36) (Alcohol, Duloxetine, and Methylphenidate) Craig Rush NA COMPLETED
(May 1, 2026)
PHASE1
A Study of Cancer Related Fatigue in Patients With Metastatic Cancer Receiving Anti-PD1 Immunotherapy M.D. Anderson Cancer Center NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE3
Methylphenidate and Exercise in Reducing Cancer-Related Fatigue in Patients With Prostate Cancer M.D. Anderson Cancer Center NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2, PHASE3
A Trial to Assess How Centanafadine Interacts With Stimulants in the Body Otsuka Pharmaceutical Development & Commercialization, Inc. NA COMPLETED
(Apr 1, 2026)
PHASE1


Methylphenidate Generic API Manufacturers

Several generic applications have been filed for Methylphenidate. The first generic version for Methylphenidate was by Actavis Elizabeth Llc An Indirect Wholly Owned Sub Of Teva Pharmaceuticals Usa Inc and was approved on Jun 19, 2020. And the latest generic version is by Mylan Technologies Inc A Viatris Co and was approved on Mar 14, 2022.

Given below is the list of companies who have filed for Methylphenidate generic, along with the locations of their manufacturing plants worldwide.