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Details for Generic Name: methylphenidate

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

This ingredient has forty-one patent family members in twenty-eight countries.

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

Tradenames:12
Patents:29
Applicants:22
NDAs:36
Drug Master File Entries: see list24
Suppliers / Packaging: see list4
Formulation / Manufacturing:see details

Pharmacology for Ingredient: methylphenidate

Tentative approvals for METHYLPHENIDATE

Applicant Application No. Form Dosage
<disabled><disabled>CAPSULE, EXTENDED RELEASE; ORAL10MG

Clinical Trials for: methylphenidate

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

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

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

Patient Controlled Administration of Methylphenidate for Cancer Related Fatigue - PRN Methylphenidate
Status: Recruiting Condition: Fatigue

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

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Status: Withdrawn Condition: Attention Deficit Hyperactivity Disorder

Courtesy of ClinicalTrials.org
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
Novartis
RITALIN LA
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021284-001Jun 5, 2002RXNo6,635,284<disabled>Y<disabled>
Noven Pharms Inc
DAYTRANA
methylphenidate
FILM, EXTENDED RELEASE;TRANSDERMAL021514-002Apr 6, 2006RXNo8,632,802<disabled>Y<disabled>
Rhodes Pharms
APTENSIO XR
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL205831-003Apr 17, 2015RXNo7,083,808<disabled>Y<disabled>
Noven Pharms Inc
DAYTRANA
methylphenidate
FILM, EXTENDED RELEASE;TRANSDERMAL021514-003Apr 6, 2006RXNo9,034,370<disabled>Y<disabled>
Janssen Pharms
CONCERTA
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-003Dec 8, 2000RXYes6,930,129*PED<disabled>Y<disabled>
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Non-Orange Book Patents for Generic Ingredient: methylphenidate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,916,191Device for transdermal administration of drugs including acrylic polymers<disabled in preview>
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International Patent Family for Ingredient: methylphenidate

Country Document Number Publication Date
Japan2002510600Apr 09, 2002
Poland341596Apr 23, 2001
Germany69822199Apr 08, 2004
Israel136760Jun 14, 2001
World Intellectual Property Organization (WIPO)9930694Aug 19, 1999
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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