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Last Updated: October 18, 2021

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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, Impax Labs Inc, Mayne Pharma, Specgx Llc, Teva Pharms, Novartis, Actavis Labs Fl Inc, Nextwave, Abhai Llc, Alkem Labs Ltd, Anda Repository, Ascent Pharms Inc, Breckenridge, Eywa, Novel Labs Inc, Quagen, Tris Pharma Inc, Nostrum Labs Inc, Rising, Nextwave Pharms, Janssen Pharms, Able, Actavis Labs Fl, Alvogen, Amneal Pharms, Andor Pharms, Ani Pharms, Dr Reddys, Heritage Pharma, Mylan, Osmotica, Par Pharm, Sun Pharm Inds Inc, Watson Labs, Abhai Inc, Accord Hlthcare, Aurolife Pharma Llc, Cediprof Inc, Mountain, Oxford Pharms, Prinston Inc, and Uspharma, and is included in eighty-one NDAs. There are forty-one 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 seven patent family members in twenty-two countries.

There are thirty-two drug master file entries for methylphenidate hydrochloride. Forty-six 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
VA New York Harbor Healthcare SystemPhase 4
VA Office of Research and DevelopmentPhase 2

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
Ironshore Pharms JORNAY PM methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 209311-003 Aug 8, 2018 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Actavis Elizabeth METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 208861-002 Dec 13, 2018 AB3 RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Quagen METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride SOLUTION;ORAL 213567-001 Jun 4, 2020 AA RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Specgx Llc METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET;ORAL 040300-001 Nov 27, 1998 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Purdue Pharma Lp ADHANSIA XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 212038-005 Feb 27, 2019 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever 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 021121-002 Aug 1, 2000 ⤷  Free Forever Trial ⤷  Free Forever Trial
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-001 Aug 1, 2000 ⤷  Free Forever Trial ⤷  Free Forever Trial
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-002 Aug 1, 2000 ⤷  Free Forever Trial ⤷  Free Forever Trial
Rhodes Pharms APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831-005 Apr 17, 2015 ⤷  Free Forever Trial ⤷  Free Forever Trial
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-001 Aug 1, 2000 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Medtronic
Express Scripts
Boehringer Ingelheim
Harvard Business School
Moodys
McKinsey

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.