METHYLPHENIDATE - Generic Drug Details

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What are the generic drug sources for methylphenidate and what is the scope of patent protection?

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, 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-nine NDAs. There are fifty-two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Methylphenidate has nine 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.

Summary for METHYLPHENIDATE

International Patents:	9
US Patents:	52
Tradenames:	18
Applicants:	53
NDAs:	89
Drug Master File Entries:	32
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	25
Clinical Trials:	418
Patent Applications:	6,694
Drug Prices:	Drug price trends for METHYLPHENIDATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for METHYLPHENIDATE
What excipients (inactive ingredients) are in METHYLPHENIDATE?	METHYLPHENIDATE excipients list
DailyMed Link:	METHYLPHENIDATE at DailyMed

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

Sponsor	Phase
University of Florida	Early Phase 1
Medical University of Lodz	Phase 2
Medical University of Gdansk	Phase 2

See all METHYLPHENIDATE clinical trials

Generic filers with tentative approvals for METHYLPHENIDATE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	40MG	TABLET, EXTENDED RELEASE, CHEWABLE;ORAL
⤷ Sign Up	⤷ Sign Up	30MG	TABLET, EXTENDED RELEASE, CHEWABLE;ORAL
⤷ Sign Up	⤷ Sign Up	20MG	TABLET, 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

Drug Class	Central Nervous System Stimulant
Physiological Effect	Central Nervous System Stimulation

Medical Subject Heading (MeSH) Categories for METHYLPHENIDATE

Central Nervous System Stimulants
Dopamine Uptake Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for METHYLPHENIDATE

N06BA	Centrally acting sympathomimetics
N06B	PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS
N06	PSYCHOANALEPTICS
N	Nervous system

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Nextwave Pharms	QUILLICHEW ER	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE, CHEWABLE;ORAL	207960-001	Dec 4, 2015		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-004	Feb 27, 2019		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Nextwave Pharms	QUILLICHEW ER	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE, CHEWABLE;ORAL	207960-002	Dec 4, 2015		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Teva Pharms	METHYLPHENIDATE HYDROCHLORIDE	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	077707-003	Jul 19, 2012	AB2	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Specgx Llc	METHYLIN	methylphenidate hydrochloride	SOLUTION;ORAL	021419-002	Dec 19, 2002	AA	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ 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

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

International Patents for METHYLPHENIDATE

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2013003622		⤷ Sign Up
European Patent Office	2726066	FORMES POSOLOGIQUES POUR ADMINISTRATION ORALE ET MÉTHODES DE TRAITEMENT LES UTILISANT (DOSAGE FORMS FOR ORAL ADMINISTRATION AND METHODS OF TREATMENT USING THE SAME)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2006041911		⤷ Sign Up
South Korea	20190107655	ADHD의 치료를 위한 메틸페니데이트의 효과적인 아동 투여	⤷ Sign Up
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)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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