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.
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||Type||RLD||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|CAPSULE, EXTENDED RELEASE;ORAL||021259||Feb 19, 2006||RX||No||<disabled>||<disabled>|
|TABLET, EXTENDED RELEASE;ORAL||091695||Sep 23, 2013||RX||No||<disabled>||<disabled>|
|CAPSULE, EXTENDED RELEASE;ORAL||021259||Feb 19, 2006||RX||No||6,344,215||<disabled>||Y||<disabled>|
|FOR SUSPENSION, EXTENDED RELEASE;ORAL||202100||Sep 27, 2012||RX||Yes||8,465,765||<disabled>||Y||<disabled>|
|TABLET, EXTENDED RELEASE;ORAL||021121||Dec 8, 2000||RX||Yes||8,629,179*PED||<disabled>||Y||<disabled>|
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