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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, Able, Actavis Elizabeth, Kudco Ireland, Watson Labs, Actavis Labs Fl Inc, Corepharma, and Vintage Pharms, and is included in thirty-five NDAs. There are twenty 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: see list1
Formulation / Manufacturing:see details

Pharmacology for Ingredient: methylphenidate

Tentative approvals for METHYLPHENIDATE

Applicant Application No. Form Dosage

Clinical Trials for: methylphenidate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Rhodes Pharms
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL205831-001Apr 17, 2015RXNo<disabled><disabled>
Noven Pharms Inc
FILM, EXTENDED RELEASE;TRANSDERMAL021514-002Apr 6, 2006RXNo6,348,211<disabled>Y<disabled>
Janssen Pharms
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-004Apr 1, 2002RXNo8,629,179*PED<disabled>Y<disabled>
Barr Labs Inc
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL079031-003Jul 13, 2012RXNo<disabled><disabled>
Ucb Inc
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL040306-001Oct 20, 1999DISCNNo<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
Poland195315Aug 31, 2007
World Intellectual Property Organization (WIPO)9930694Aug 19, 1999
Norway329974Jan 31, 2011
South Africa9811429Jul 22, 1999
Slovenia20360Apr 30, 2001
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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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