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Last Updated: March 29, 2024

Methylphenidate hydrochloride - Generic Drug Details


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What are the generic 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, Ascent Pharms Inc, Breckenridge, Chartwell Molecular, Novel Labs Inc, Patrin, 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-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 eighteen 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
Ralph H. Johnson VA Medical CenterPhase 2
University Hospital, Strasbourg, FrancePhase 3
Stéphanie BaggioPhase 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 Trial40MGTABLET, EXTENDED RELEASE, CHEWABLE;ORAL
⤷  Try a Trial⤷  Try a Trial30MGTABLET, EXTENDED RELEASE, CHEWABLE;ORAL
⤷  Try a Trial⤷  Try a Trial20MGTABLET, 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
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
Aurolife Pharma Llc METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 206726-004 Oct 21, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Nextwave Pharms QUILLICHEW ER methylphenidate hydrochloride TABLET, EXTENDED RELEASE, CHEWABLE;ORAL 207960-002 Dec 4, 2015 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Purdue Pharma Lp ADHANSIA XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 212038-002 Feb 27, 2019 DISCN Yes 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
Sandoz RITALIN LA methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021284-001 Jun 5, 2002 ⤷  Try a Trial ⤷  Try a Trial
Sandoz RITALIN LA methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021284-002 Jun 5, 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 2936746 METHODES ET COMPOSITIONS DESTINEES AU TRAITEMENT DU TROUBLE DE DEFICIT D'ATTENTION (METHODS AND COMPOSITIONS PARTICULARLY FOR TREATMENT OF ATTENTION DEFICIT DISORDER) ⤷  Try a Trial
South Korea 20170115036 특히 주의력 결핍 장애의 치료를 위한 방법 및 조성물 (METHODS AND COMPOSITIONS PARTICULARLY FOR TREATMENT OF ATTENTION DEFICIT DISORDER) ⤷  Try a Trial
Chile 2017001026 Métodos y composiciones particularmente para el tratamiento del trastorno por déficit de atención. ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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