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Last Updated: March 29, 2024

Methylphenidate - Generic Drug Details


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What are the generic 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

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Drug Sales Revenue Trends for methylphenidate

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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
University of Geneva, SwitzerlandPhase 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
Actavis Labs Fl METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 076655-002 Feb 28, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Tris Pharma Inc METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride SOLUTION;ORAL 091601-001 Jul 23, 2010 AA RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan Tech Viatris METHYLPHENIDATE methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 206497-002 Mar 14, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Purdue Pharma Lp ADHANSIA XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 212038-001 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

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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for methylphenidate

Country Patent Number Title Estimated Expiration
Australia 2017353921 Effective dosing of a child for the treatment of ADHD with methylphenidate ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2013003622 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2006041911 ⤷  Try a Trial
South Korea 20190107655 ADHD의 치료를 위한 메틸페니데이트의 효과적인 아동 투여 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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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.