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Last Updated: November 21, 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, Anda Repository, Ascent Pharms Inc, Breckenridge, Chartwell Molecular, Novel Labs Inc, 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.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Methylphenidate

A generic version of METHYLPHENIDATE was approved as methylphenidate hydrochloride by SPECGX LLC on November 27^th, 1998.

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Summary for METHYLPHENIDATE

US Patents:	0
Applicants:	43
NDAs:	71
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	25
Clinical Trials:	418
Patent Applications:	5,230
Drug Prices:	Drug price information for METHYLPHENIDATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for METHYLPHENIDATE
What excipients (inactive ingredients) are in METHYLPHENIDATE?	METHYLPHENIDATE excipients list
DailyMed Link:	METHYLPHENIDATE at DailyMed

Drug patent expirations by year for METHYLPHENIDATE

Drug Prices for METHYLPHENIDATE

Recent Clinical Trials for METHYLPHENIDATE

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

Sponsor	Phase
University of Florida	Early Phase 1
Pediatric Center of the Central Clinical Hospital of the Medical University of Lodz	Phase 2
Institute of Medical Sciences of the University of Opole	Phase 2

See all METHYLPHENIDATE clinical trials

Pharmacology for METHYLPHENIDATE

Drug Class	Central Nervous System Stimulant
Physiological Effect	Central Nervous System Stimulation

Medical Subject Heading (MeSH) Categories for METHYLPHENIDATE

Central Nervous System Stimulants
Dopamine Uptake Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for METHYLPHENIDATE

N06BA	Centrally acting sympathomimetics
N06B	PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS
N06	PSYCHOANALEPTICS
N	Nervous system

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

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal Pharms	METHYLPHENIDATE HYDROCHLORIDE	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	207515-003	Feb 1, 2018		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms	METHYLPHENIDATE HYDROCHLORIDE	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	077707-001	Jul 19, 2012	AB2	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Impax Labs Inc	METHYLPHENIDATE HYDROCHLORIDE	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	205105-004	Jul 28, 2016	AB2	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ascent Pharms Inc	METHYLPHENIDATE HYDROCHLORIDE	methylphenidate hydrochloride	TABLET;ORAL	207416-001	Sep 22, 2015	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Accord Hlthcare	METHYLPHENIDATE HYDROCHLORIDE	methylphenidate hydrochloride	TABLET;ORAL	213936-003	Oct 28, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Actavis Labs Fl	METHYLPHENIDATE HYDROCHLORIDE	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	076655-001	Mar 21, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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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