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Last Updated: August 3, 2020

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METHYLPHENIDATE HYDROCHLORIDE - Generic Drug Details

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

Methylphenidate hydrochloride is the generic ingredient in fourteen branded drugs marketed by 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-three NDAs. There are forty-three patents protecting this compound and twelve Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Methylphenidate hydrochloride has one hundred and fifty-four patent family members in twenty-nine countries.

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

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
Mylan METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 206726-002 Oct 21, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Novartis RITALIN LA methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021284-001 Jun 5, 2002 AB1 RX Yes No   Start Trial   Start Trial   Start Trial
Osmotica METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 205327-003 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 HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-003 Dec 8, 2000   Start Trial   Start Trial
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-001 Aug 1, 2000   Start Trial   Start Trial
Novartis RITALIN LA methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021284-003 Jun 5, 2002   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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