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Last Updated: December 9, 2024

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 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, Sandoz, Actavis Labs Fl Inc, Nextwave, Abhai Llc, Alkem Labs Ltd, Anda Repository, Ascent Pharms Inc, Breckenridge, Chartwell Molecular, Novel Labs Inc, Quagen, Tris Pharma Inc, Wes 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 Pharm Us, Strides Pharma, Sun Pharm Inds Inc, Watson Labs, Novartis, Abhai Inc, Accord Hlthcare, Bionpharma, Cediprof Inc, Mountain, Oxford Pharms, and Prinston Inc, and is included in eighty-five NDAs. There are forty-five 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 twenty-one patent family members in twenty-two countries.

There are twenty-three drug master file entries for methylphenidate hydrochloride. Forty-six suppliers are listed for this compound. There is one tentative approval 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 FloridaEarly Phase 1
Pediatric Center of the Central Clinical Hospital of the Medical University of LodzPhase 2
Institute of Medical Sciences of the University of OpolePhase 2

See all METHYLPHENIDATE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for METHYLPHENIDATE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up40MGTABLET, EXTENDED RELEASE, CHEWABLE;ORAL
⤷  Sign Up⤷  Sign Up30MGTABLET, EXTENDED RELEASE, CHEWABLE;ORAL
⤷  Sign Up⤷  Sign Up20MGTABLET, 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
Purdue Pharma Lp ADHANSIA XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 212038-002 Feb 27, 2019 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Barr Labs Inc METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 079031-001 Jul 13, 2012 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Impax Labs Inc METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205105-005 Jul 28, 2016 AB2 RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ironshore Pharms JORNAY PM methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 209311-003 Aug 8, 2018 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Oxford Pharms METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET;ORAL 202892-002 Sep 23, 2014 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Actavis Elizabeth METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 208861-004 Dec 13, 2018 AB3 RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Actavis Labs Fl Inc METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride FOR SUSPENSION, EXTENDED RELEASE;ORAL 206049-001 May 17, 2018 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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
Sandoz RITALIN LA methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021284-001 Jun 5, 2002 ⤷  Sign Up ⤷  Sign Up
Sandoz RITALIN LA methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021284-001 Jun 5, 2002 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-003 Dec 8, 2000 ⤷  Sign Up ⤷  Sign Up
Rhodes Pharms APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831-007 Apr 17, 2015 ⤷  Sign Up ⤷  Sign Up
Sandoz RITALIN LA methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021284-002 Jun 5, 2002 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-004 Apr 1, 2002 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-001 Aug 1, 2000 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for METHYLPHENIDATE HYDROCHLORIDE

Country Patent Number Title Estimated Expiration
South Africa 201702716 METHODS AND COMPOSITIONS PARTICULARLY FOR TREATMENT OF ATTENTION DEFICIT DISORDER ⤷  Sign Up
Singapore 10201912626W METHODS AND COMPOSITIONS PARTICULARLY FOR TREATMENT OF ATTENTION DEFICIT DISORDER ⤷  Sign Up
European Patent Office 2884961 COMPRIMÉ À CROQUER DE MÉTHYLPHÉNIDATE À LIBÉRATION MODIFIÉE (METHYLPHENIDATE EXTENDED RELEASE CHEWABLE TABLET) ⤷  Sign Up
Denmark 2688557 ⤷  Sign Up
China 107205954 ⤷  Sign Up
China 110151731 ⤷  Sign Up
Canada 2902911 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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