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Details for Generic Name: methylphenidate

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Methylphenidate is the generic ingredient in eleven branded drugs marketed by Noven Pharms Inc, Ucb Inc, Barr Labs Inc, Teva Pharms, Watson Labs Inc, Novartis, Nextwave Pharms, Mallinckrodt, Sun Pharm Inds Inc, Tris Pharma Inc, Janssen Pharms, Mallinckrodt Inc, Able, Actavis Elizabeth, Kudco Ireland, Watson Labs, Actavis Labs Fl Inc, Corepharma, and Vintage Pharms, and is included in thirty-three NDAs. There are eighteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are twenty-four drug master file entries for methylphenidate. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: methylphenidate

Drug Master File Entries: see list24
Suppliers: see list1

Pharmacology for Ingredient: methylphenidate

Tentative approvals for METHYLPHENIDATE

Applicant Application No. Form Dosage

Clinical Trials for: methylphenidate

Methylphenidate Study in Breast or Gastrointestinal Cancer Patients
Status: Terminated Condition: Breast Cancer; Fatigue; Gastrointestinal Cancer

A Study Comparing Long-acting Methylphenidate (ConcertaTM) vs. Placebo in the Treatment of Memory Loss Due to HIV
Status: Recruiting Condition: HIV Dementia

The Effect of Methylphenidate on Non-motor Symptoms and Postural Control in Parkinson's Disease.
Status: Terminated Condition: Parkinson's Disease

Study of the Effect of Individualizing Daytrana Wear-times on Sleep in Children With ADHD
Status: Completed Condition: Attention Deficit Hyperactivity Disorder; INSOMNIA

Effect of Methylphenidate on Connectivity
Status: Withdrawn Condition: Attention Deficit Hyperactivity Disorder

Efficacy and Effectiveness of Methylphenidate in Swedish Male Prison Inmates With Attention-deficit Hyperactivity Disorder (ADHD)
Status: Completed Condition: Attention Deficit Hyperactivity Disorder

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ucb Inc
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021259Feb 19, 2006RXNo<disabled><disabled>
Kudco Ireland
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL091695Sep 23, 2013RXNo<disabled><disabled>
Ucb Inc
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021259Feb 19, 2006RXNo6,344,215<disabled>Y<disabled>
Nextwave Pharms
methylphenidate hydrochloride
FOR SUSPENSION, EXTENDED RELEASE;ORAL202100Sep 27, 2012RXYes8,465,765<disabled>Y<disabled>
Janssen Pharms
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121Dec 8, 2000RXYes8,629,179*PED<disabled>Y<disabled>
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