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Last Updated: March 28, 2024

METHYLPHENIDATE Drug Patent Profile


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When do Methylphenidate patents expire, and when can generic versions of Methylphenidate launch?

Methylphenidate is a drug marketed by Mylan Tech Viatris, Actavis Elizabeth, Barr Labs Inc, Dr Reddys Labs Sa, Granules, Impax Labs Inc, Specgx Llc, Teva Pharms, Actavis Labs Fl Inc, Abhai Llc, Alkem Labs Ltd, Ascent Pharms Inc, Breckenridge, Chartwell Molecular, Novel Labs Inc, Patrin, Quagen, Tris Pharma Inc, Wes Pharma Inc, Nostrum Labs Inc, Rising, Able, Actavis Labs Fl, Alvogen, Amneal Pharms, Andor Pharms, Ani Pharms, Aurolife Pharma Llc, Dr Reddys, Heritage Pharma, Lannett Co Inc, Osmotica Pharm Us, Rhodes Pharms, Strides Pharma, Sun Pharm Inds Inc, Watson Labs, Abhai Inc, Accord Hlthcare, Bionpharma, Cediprof Inc, Mountain, Oxford Pharms, and Prinston Inc. and is included in seventy-one NDAs.

The generic ingredient in METHYLPHENIDATE is methylphenidate hydrochloride. There are thirty-two drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.

Drug patent expirations by year for METHYLPHENIDATE
Drug Prices for METHYLPHENIDATE

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Drug Sales Revenue Trends for METHYLPHENIDATE

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Recent Clinical Trials for METHYLPHENIDATE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Ralph H. Johnson VA Medical CenterPhase 2
University Hospital, Strasbourg, FrancePhase 3
Stéphanie BaggioPhase 3

See all METHYLPHENIDATE clinical trials

Pharmacology for METHYLPHENIDATE
Medical Subject Heading (MeSH) Categories for METHYLPHENIDATE
Paragraph IV (Patent) Challenges for METHYLPHENIDATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
COTEMPLA XR-ODT Extended-release Orally Disintegrating Tablets methylphenidate 8.6 mg, 17.3 mg and 25.9 mg 205489 1 2017-09-01
DAYTRANA Transdermal System methylphenidate 10 mg/9 hrs 15 mg/9 hrs 20 mg/9 hrs 30 mg/9 hrs 021514 1 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
Nostrum Labs Inc METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET, CHEWABLE;ORAL 204954-002 Jan 26, 2017 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amneal Pharms METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 207515-003 Feb 1, 2018 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva Pharms METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 077707-001 Jul 19, 2012 AB2 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Impax Labs Inc METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205105-004 Jul 28, 2016 AB2 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ascent Pharms Inc METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET;ORAL 207416-001 Sep 22, 2015 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Accord Hlthcare METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET;ORAL 213936-003 Oct 28, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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