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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, 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-four 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
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
methylphenidate hydrochloride
TABLET;ORAL040300-001Nov 27, 1998RXNo<disabled><disabled>
Teva Pharms
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL077707-002Jul 19, 2012RXNo<disabled><disabled>
Janssen Pharms
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL021121-001Aug 1, 2000RXNo6,930,129*PED<disabled>Y<disabled>
Mallinckrodt Inc
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL075629-001May 9, 2000RXNo<disabled><disabled>
Barr Labs Inc
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL079031-002Jul 13, 2012RXNo<disabled><disabled>
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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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