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Last Updated: August 10, 2020

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METHYLPHENIDATE HYDROCHLORIDE Drug Profile

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Which patents cover Methylphenidate Hydrochloride, and what generic alternatives are available?

Methylphenidate Hydrochloride is a drug marketed by Actavis Elizabeth, Barr Labs Inc, Granules Pharms, Impax Labs Inc, Mayne Pharma, Specgx Llc, Teva Pharms, Actavis Labs Fl Inc, Abhai Llc, Alkem Labs Ltd, Breckenridge, Novel Labs Inc, Novelgenix Theraps, Patrin Pharma Inc, Quagen, Tris Pharma Inc, Ascent Pharms Inc, Rising, Able, Actavis Labs Fl, Alvogen Pine Brook, Amneal Pharms, Andor Pharms, Ani Pharms Inc, Cnty Line Pharms, Heritage Pharma, Lannett Co Inc, 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 fifty-nine NDAs.

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

US ANDA Litigation and Generic Entry Outlook for Methylphenidate Hydrochloride

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

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Drug patent expirations by year for METHYLPHENIDATE HYDROCHLORIDE
Drug Prices for METHYLPHENIDATE HYDROCHLORIDE

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Recent Clinical Trials for METHYLPHENIDATE HYDROCHLORIDE

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

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

See all METHYLPHENIDATE HYDROCHLORIDE clinical trials

Pharmacology for METHYLPHENIDATE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for METHYLPHENIDATE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
QUILLICHEW ER TABLET, EXTENDED RELEASE, CHEWABLE;ORAL methylphenidate hydrochloride 207960 2016-04-25
APTENSIO XR CAPSULE, EXTENDED RELEASE;ORAL methylphenidate hydrochloride 205831 2016-03-28
APTENSIO XR CAPSULE, EXTENDED RELEASE;ORAL methylphenidate hydrochloride 205831 2015-12-24
APTENSIO XR CAPSULE, EXTENDED RELEASE;ORAL methylphenidate hydrochloride 205831 2015-12-23
QUILLIVANT XR FOR SUSPENSION, EXTENDED RELEASE;ORAL methylphenidate hydrochloride 202100 2013-08-02
METHYLIN SOLUTION;ORAL methylphenidate hydrochloride 021419 2010-04-13
RITALIN LA CAPSULE, EXTENDED RELEASE;ORAL methylphenidate hydrochloride 021284 2007-05-21
METADATE CD CAPSULE, EXTENDED RELEASE;ORAL methylphenidate hydrochloride 021259 2007-03-15
RITALIN LA CAPSULE, EXTENDED RELEASE;ORAL methylphenidate hydrochloride 021284 2006-08-21
CONCERTA TABLET, EXTENDED RELEASE;ORAL methylphenidate hydrochloride 021121 2005-07-19
METADATE CD CAPSULE, EXTENDED RELEASE;ORAL methylphenidate hydrochloride 021259 2005-05-13

US Patents and Regulatory Information for METHYLPHENIDATE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actavis Labs Fl METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 076772-001 Mar 22, 2018 DISCN No No   Start Trial   Start Trial   Start Trial
Lannett Co Inc METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 091695-001 Jul 9, 2013 BX RX No No   Start Trial   Start Trial   Start Trial
Abhai Llc METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride SOLUTION;ORAL 207485-001 Nov 18, 2016 AA RX No No   Start Trial   Start Trial   Start Trial
Specgx Llc METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 203583-005 Sep 29, 2015 AB2 RX No No   Start Trial   Start Trial   Start Trial
Watson Labs METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET;ORAL 040220-001 Aug 29, 1997 DISCN 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

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