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Generated: April 29, 2017

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Methylphenidate - Generic Drug Details

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What are the generic sources for methylphenidate and what is the scope of freedom to operate?

is the generic ingredient in thirteen branded drugs marketed by Noven Pharms Inc, Nextwave Pharms, Mallinckrodt, Tris Pharma Inc, Ucb Inc, Novel Labs Inc, Able, Impax Labs Inc, Teva Pharms, Mallinckrodt Inc, Watson Labs, Sun Pharm Inds Inc, Ascent Pharms Inc, Actavis Labs Fl Inc, Janssen Pharms, Actavis Elizabeth, Mylan Pharms Inc, Novartis, Rhodes Pharms, Barr Labs Inc, Cnty Line Pharms, Nostrum Labs Inc, Tedor Pharma Inc, Mayne Pharma, Pfizer Inc, Abhai Llc, Vintage Pharms, and Kremers Urban Pharms, and is included in forty-nine NDAs. There are thirty-two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Methylphenidate has forty-three patent family members in twenty-eight countries.

There are thirty-one drug master file entries for methylphenidate. One supplier is listed for this compound. There are three tentative approvals for this compound.

Summary for Generic Name: methylphenidate

Drug Master File Entries: see list31
Suppliers / Packagers: see list1
Bulk Api Vendors: see list16
Clinical Trials: see list180
Patent Applications: see list8,789
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:methylphenidate at DailyMed

Pharmacology for Ingredient: methylphenidate

Tentative approvals for METHYLPHENIDATE

Applicant Application No. Form Dosage
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Noven Pharms Inc
FILM, EXTENDED RELEASE;TRANSDERMAL021514-001Apr 6, 2006RXYesNo8,632,802► SubscribeY ► Subscribe
Noven Pharms Inc
FILM, EXTENDED RELEASE;TRANSDERMAL021514-002Apr 6, 2006RXYesNo6,210,705► SubscribeY ► Subscribe
Sun Pharm Inds Inc
methylphenidate hydrochloride
TABLET;ORAL090710-002Mar 15, 2012ABRXNoNo► Subscribe► Subscribe
Pfizer Inc
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE, CHEWABLE;ORAL207960-001Dec 4, 2015RXYesNo► Subscribe► Subscribe
Rhodes Pharms
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL205831-002Apr 17, 2015RXYesNo► Subscribe► Subscribe
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