You’re using a public version of DrugPatentWatch with 1 free search available | Register to unlock more free searches. CREATE FREE ACCOUNT

Serving leading biopharmaceutical companies globally:

Moodys
Medtronic
McKesson
Baxter
Colorcon
Harvard Business School

Last Updated: September 27, 2023

Methylphenidate hydrochloride - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic sources for methylphenidate hydrochloride and what is the scope of freedom to operate?

Methylphenidate hydrochloride is the generic ingredient in fifteen branded drugs marketed by Purdue Pharma Lp, Rhodes Pharms, Ironshore Pharms, Aytu Biopharma, Actavis Elizabeth, Barr Labs Inc, Dr Reddys Labs Sa, Granules, Impax Labs Inc, Specgx Llc, Teva Pharms, Novartis, Actavis Labs Fl Inc, Nextwave, Abhai Llc, Alkem Labs Ltd, Anda Repository, Ascent Pharms Inc, Breckenridge, Chartwell Molecular, Eywa, Novel Labs Inc, Quagen, Tris Pharma Inc, Nostrum Labs Inc, Rising, Nextwave Pharms, Janssen Pharms, Lannett Co Inc, Able, Actavis Labs Fl, Alvogen, Amneal Pharms, Andor Pharms, Ani Pharms, Aurolife Pharma Llc, Dr Reddys, Heritage Pharma, Osmotica, Strides Pharma, Sun Pharm Inds Inc, Watson Labs, Osmotica Pharm Us, Abhai Inc, Accord Hlthcare, Bionpharma, Cediprof Inc, Mountain, Oxford Pharms, and Prinston Inc, and is included in eighty-four NDAs. There are forty-four 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 fifteen patent family members in twenty-two countries.

There are twenty-three drug master file entries for methylphenidate hydrochloride. Forty-seven suppliers are listed for this compound. There are two tentative approvals for this compound.

Drug Prices for methylphenidate hydrochloride

See drug prices for methylphenidate hydrochloride

Recent Clinical Trials for methylphenidate hydrochloride

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

SponsorPhase
Ralph H. Johnson VA Medical CenterPhase 2
University Hospital, Strasbourg, FrancePhase 3
University of Geneva, SwitzerlandPhase 3

See all methylphenidate hydrochloride clinical trials

Generic filers with tentative approvals for METHYLPHENIDATE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial30MGTABLET, EXTENDED RELEASE, CHEWABLE;ORAL
⤷  Try a Trial⤷  Try a Trial20MGTABLET, EXTENDED RELEASE, CHEWABLE;ORAL
⤷  Try a Trial⤷  Try a Trial40MGTABLET, EXTENDED RELEASE, CHEWABLE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for methylphenidate hydrochloride
Anatomical Therapeutic Chemical (ATC) Classes for methylphenidate hydrochloride
Paragraph IV (Patent) Challenges for METHYLPHENIDATE HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
QUILLICHEW ER Extended-release Chewable Tablets methylphenidate hydrochloride 20 mg, 30 mg and 40 mg 207960 1 2016-04-25
APTENSIO XR Extended-release Capsules methylphenidate hydrochloride 30 mg 205831 1 2016-03-28
APTENSIO XR Extended-release Capsules methylphenidate hydrochloride 15 mg, 20 mg, 40 mg and 50 mg 205831 1 2015-12-28
APTENSIO XR Extended-release Capsules methylphenidate hydrochloride 10 mg 205831 1 2015-12-24
APTENSIO XR Extended-release Capsules methylphenidate hydrochloride 60 mg 205831 1 2015-12-23
QUILLIVANT XR Extended-release Oral Suspension methylphenidate hydrochloride 5 mg/mL 202100 2013-08-02
METHYLIN Oral Solution methylphenidate hydrochloride 5 mg/5 mL 10 mg/5 mL 021419 1 2010-04-13
RITALIN LA Extended-release Capsules methylphenidate hydrochloride 10 mg 021284 1 2007-05-21
METADATE CD Extended-release Capsules methylphenidate hydrochloride 40 mg 021259 1 2007-03-15
RITALIN LA Extended-release Capsules methylphenidate hydrochloride 20 mg, 30 mg and 40 mg 021284 2006-08-21
CONCERTA Extended-release Tablets methylphenidate hydrochloride 18 mg*, 27 mg, 36 mg and 54 mg 021121 2005-07-19
METADATE CD Extended-release Capsules methylphenidate hydrochloride 10 mg, 20 mg and 30 mg 021259 1 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 209311-005 Aug 8, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Dr Reddys Labs Sa METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 078458-003 Dec 1, 2011 AB1 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Purdue Pharma Lp ADHANSIA XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 212038-005 Feb 27, 2019 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Alvogen METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 204772-002 Feb 29, 2016 DISCN 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

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 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-003 Dec 8, 2000 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-004 Apr 1, 2002 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-004 Apr 1, 2002 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for methylphenidate hydrochloride

Country Patent Number Title Estimated Expiration
Canada 2880456 COMPRIME A CROQUER DE METHYLPHENIDATE A LIBERATION MODIFIEE (METHYLPHENIDATE EXTENDED RELEASE CHEWABLE TABLET) ⤷  Try a Trial
Japan 2016117767 注意欠陥障害の処置のための方法および組成物 (METHODS AND COMPOSITIONS FOR TREATMENT OF ATTENTION DEFICIT DISORDER) ⤷  Try a Trial
Mexico PA06003725 SOLUCION DE FENIDATO DE METILO Y METODOS ASOCIADOS DE ADMINISTRACION Y PRODUCCION. (METHYLPHENIDATE SOLUTION AND ASSOCIATED METHODS OF ADMINISTRATION AND PRODUCTION.) ⤷  Try a Trial
South Africa 201307649 METHODS AND COMPOSITIONS FOR TREATMENT OF ATTENTION DEFICIT DISORDER ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Medtronic
Johnson and Johnson
Colorcon
Dow
Boehringer Ingelheim
Merck

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.