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Last Updated: May 27, 2022

Methylphenidate hydrochloride - Generic Drug Details


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

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, Aurolife Pharma Llc, Dr Reddys, Heritage Pharma, Osmotica, Strides Pharma, Sun Pharm Inds Inc, Watson Labs, Abhai Inc, Accord Hlthcare, Bionpharma Inc, Cediprof Inc, Mountain, Oxford Pharms, and Prinston Inc, and is included in eighty-one 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 nine patent family members in twenty-two countries.

There are twenty-three drug master file entries for methylphenidate hydrochloride. Forty-four suppliers are listed 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
University of California, DavisPhase 1
VA New York Harbor Healthcare SystemPhase 4
Miami VA Healthcare SystemPhase 4

See all methylphenidate hydrochloride clinical trials

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
Purdue Pharma Lp ADHANSIA XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 212038-002 Feb 27, 2019 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Amneal Pharms METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 207515-004 Feb 1, 2018 BX RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Osmotica METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 205327-001 Jul 28, 2017 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Prinston Inc METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET;ORAL 212697-001 Jul 23, 2020 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ironshore Pharms JORNAY PM methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 209311-005 Aug 8, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amneal Pharms METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 207515-001 Feb 1, 2018 BX RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Purdue Pharma Lp ADHANSIA XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 212038-005 Feb 27, 2019 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-001 Aug 1, 2000 See Plans and Pricing See Plans and Pricing
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-002 Aug 1, 2000 See Plans and Pricing See Plans and Pricing
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-002 Aug 1, 2000 See Plans and Pricing See Plans and Pricing
Novartis RITALIN LA methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021284-002 Jun 5, 2002 See Plans and Pricing See Plans and Pricing
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-002 Aug 1, 2000 See Plans and Pricing See Plans and Pricing
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-004 Apr 1, 2002 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for methylphenidate hydrochloride

Country Patent Number Title Estimated Expiration
European Patent Office 3212172 MÉTHODES ET COMPOSITIONS DESTINÉES EN PARTICULIER AU TRAITEMENT DU TROUBLE DÉFICITAIRE DE L'ATTENTION (METHODS AND COMPOSITIONS PARTICULARLY FOR TREATMENT OF ATTENTION DEFICIT DISORDER) See Plans and Pricing
European Patent Office 1680144 SOLUTION DE METHYLPHENIDATE ET PROCEDES ASSOCIES D'ADMINISTRATION ET DE PRODUCTION (METHYLPHENIDATE SOLUTION AND ASSOCIATED METHODS OF ADMINISTRATION AND PRODUCTION) See Plans and Pricing
Mexico PA06003725 SOLUCION DE FENIDATO DE METILO Y METODOS ASOCIADOS DE ADMINISTRACION Y PRODUCCION. (METHYLPHENIDATE SOLUTION AND ASSOCIATED METHODS OF ADMINISTRATION AND PRODUCTION.) See Plans and Pricing
Japan 5479086 See Plans and Pricing
Portugal 2688557 See Plans and Pricing
Singapore 11201703535W METHODS AND COMPOSITIONS PARTICULARLY FOR TREATMENT OF ATTENTION DEFICIT DISORDER See Plans and Pricing
World Intellectual Property Organization (WIPO) 2012112140 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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