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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, Mallinckrodt Inc, Teva Pharms, Watson Labs Inc, Novartis, Nextwave Pharms, Mallinckrodt, Novel Labs Inc, Sun Pharm Inds Inc, Tris Pharma Inc, Janssen Pharms, Abhai, Able, Actavis Elizabeth, Kudco Ireland, Watson Labs, Actavis Labs Fl Inc, Ascent Pharms Inc, Corepharma, and Vintage Pharms, and is included in thirty-nine NDAs. There are thirty 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

Drug Master File Entries: see list24
Suppliers / Packaging: see list4

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

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

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Status: Withdrawn Condition: Attention Deficit Hyperactivity Disorder

Methylphenidate for Depressed Cancer Patients Receiving Palliative Care
Status: Completed Condition: Depression; Palliative Care; Cancer; Mental 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
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021284-003Jun 5, 2002RXNo6,635,284<disabled>Y <disabled>
Mallinckrodt Inc
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL202608-001Dec 28, 2012RXNo<disabled><disabled>
methylphenidate hydrochloride
TABLET;ORAL091159-001Mar 12, 2014RXNo<disabled><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
Japan4316800Aug 19, 2009
Slovenia20360Apr 30, 2001
Peru01202000Feb 19, 2000
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

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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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