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Last Updated: March 28, 2024

Methylphenidate - Generic Drug Details


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

Methylphenidate is the generic ingredient in eighteen branded drugs marketed by Noven Pharms Inc, Mylan Tech Viatris, Neos Theraps Inc, Actavis Elizabeth, Purdue Pharma Lp, Rhodes Pharms, Ironshore Pharms, Aytu Biopharma, 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-nine NDAs. There are fifty-one patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Methylphenidate has eight patent family members in five countries.

There are thirty-two drug master file entries for methylphenidate. Four suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for methylphenidate

See drug prices for methylphenidate

Drug Sales Revenue Trends for methylphenidate

See drug sales revenues for methylphenidate

Recent Clinical Trials for methylphenidate

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

SponsorPhase
Ralph H. Johnson VA Medical CenterPhase 2
University Hospital, Strasbourg, FrancePhase 3
School of Health Sciences FribourgPhase 3

See all methylphenidate clinical trials

Generic filers with tentative approvals for METHYLPHENIDATE
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
Medical Subject Heading (MeSH) Categories for methylphenidate
Paragraph IV (Patent) Challenges for METHYLPHENIDATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
COTEMPLA XR-ODT Extended-release Orally Disintegrating Tablets methylphenidate 8.6 mg, 17.3 mg and 25.9 mg 205489 1 2017-09-01
DAYTRANA Transdermal System methylphenidate 10 mg/9 hrs 15 mg/9 hrs 20 mg/9 hrs 30 mg/9 hrs 021514 1 2011-04-13

US Patents and Regulatory Information for methylphenidate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ascent Pharms Inc METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 211009-004 Sep 3, 2019 AB 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
Specgx Llc METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 203583-002 Sep 29, 2015 AB2 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Osmotica Pharm Us RELEXXII methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 216117-001 Jun 23, 2022 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Actavis Elizabeth METHYLPHENIDATE methylphenidate TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL 210924-002 Jun 19, 2020 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Actavis Elizabeth METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 208861-003 Dec 13, 2018 AB3 RX 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Noven Pharms Inc DAYTRANA methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514-002 Apr 6, 2006 ⤷  Try a Trial ⤷  Try a Trial
Noven Pharms Inc DAYTRANA methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514-001 Apr 6, 2006 ⤷  Try a Trial ⤷  Try a Trial
Noven Pharms Inc DAYTRANA methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514-002 Apr 6, 2006 ⤷  Try a Trial ⤷  Try a Trial
Noven Pharms Inc DAYTRANA methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514-004 Apr 6, 2006 ⤷  Try a Trial ⤷  Try a Trial
Noven Pharms Inc DAYTRANA methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514-003 Apr 6, 2006 ⤷  Try a Trial ⤷  Try a Trial
Noven Pharms Inc DAYTRANA methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514-004 Apr 6, 2006 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for methylphenidate

Country Patent Number Title Estimated Expiration
South Korea 20190107655 ADHD의 치료를 위한 메틸페니데이트의 효과적인 아동 투여 ⤷  Try a Trial
European Patent Office 3585439 DOSAGE EFFICACE D'UN ENFANT POUR LE TRAITEMENT DU TDAH AVEC DU MÉTHYLPHÉNIDATE (EFFECTIVE DOSING OF A CHILD FOR THE TREATMENT OF ADHD WITH METHYLPHENIDATE) ⤷  Try a Trial
Japan 2020504763 メチルフェニデートを用いてADHDを処置するための小児の有効な投薬 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2006041911 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2018085256 ⤷  Try a Trial
Australia 2017353921 Effective dosing of a child for the treatment of ADHD with methylphenidate ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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