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Last Updated: July 12, 2020

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Methylphenidate - Generic Drug Details

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What are the generic drug sources for methylphenidate and what is the scope of patent protection?

Methylphenidate is the generic ingredient in sixteen branded drugs marketed by Noven Pharms Inc, Neos Theraps Inc, Purdue Pharma Lp, Rhodes Pharms, Ironshore Pharms, Lannett Co Inc, Actavis Elizabeth, Barr Labs Inc, Granules Pharms, Impax Labs Inc, Mayne Pharma, Specgx Llc, Teva Pharms, Novartis, Actavis Labs Fl Inc, Nextwave, Abhai Llc, Alkem Labs Ltd, Breckenridge, Novel Labs Inc, Novelgenix Theraps, Patrin Pharma Inc, Tris Pharma Inc, Ascent Pharms Inc, Rising, Nextwave Pharms, Janssen Pharms, Able, Actavis Labs Fl, Alvogen Pine Brook, Amneal Pharms, Andor Pharms, Ani Pharms Inc, Cnty Line Pharms, Heritage Pharma, Mylan, Osmotica, Par Pharm, Watson Labs, Abhai Inc, Aurolife Pharma Llc, Bionpharma Inc, Cediprof Inc, Mountain, Oxford Pharms, and Sun Pharm Inds Inc, and is included in seventy-five NDAs. There are forty-nine patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Methylphenidate has three patent family members in two countries.

There are thirty-two drug master file entries for methylphenidate. Two suppliers are listed for this compound.

Drug Prices for methylphenidate

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Drug Sales Revenue Trends for methylphenidate

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Recent Clinical Trials for methylphenidate

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SponsorPhase
VA New York Harbor Healthcare SystemPhase 4
Miami VA Healthcare SystemPhase 4
Portland VA Medical CenterPhase 4

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Pharmacology for methylphenidate
Medical Subject Heading (MeSH) Categories for methylphenidate
Paragraph IV (Patent) Challenges for METHYLPHENIDATE
Tradename Dosage Ingredient NDA Submissiondate
COTEMPLA XR-ODT TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL methylphenidate 205489 2017-09-01
DAYTRANA FILM, EXTENDED RELEASE;TRANSDERMAL methylphenidate 021514 2011-04-13

US Patents and Regulatory Information for methylphenidate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Rhodes Pharms APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831-007 Apr 17, 2015 AB3 RX Yes Yes   Start Trial   Start Trial   Start Trial
Cnty Line Pharms METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET;ORAL 206840-001 Sep 15, 2016 DISCN No No   Start Trial   Start Trial   Start Trial
Ironshore Pharms JORNAY PM methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 209311-005 Aug 8, 2018 RX Yes No   Start Trial   Start Trial   Start Trial
Osmotica METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 205327-004 Jul 28, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for methylphenidate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Noven Pharms Inc DAYTRANA methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514-001 Apr 6, 2006   Start Trial   Start Trial
Noven Pharms Inc DAYTRANA methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514-002 Apr 6, 2006   Start Trial   Start Trial
Noven Pharms Inc DAYTRANA methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514-003 Apr 6, 2006   Start Trial   Start Trial
Noven Pharms Inc DAYTRANA methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514-002 Apr 6, 2006   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
AstraZeneca
McKesson
Merck
Boehringer Ingelheim
Baxter

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.