Methylphenidate hydrochloride - Generic Drug Details

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

Methylphenidate hydrochloride is the generic ingredient in fourteen branded drugs marketed by Purdue Pharma Lp, Rhodes Pharms, Ironshore Pharms, Lannett Co Inc, Actavis Elizabeth, Barr Labs Inc, Granules, Impax Labs Inc, Mayne Pharma, Specgx Llc, Teva Pharms, Novartis, Actavis Labs Fl Inc, Nextwave, Abhai Llc, Alkem Labs Ltd, Anda Repository, Ascent Pharms Inc, Breckenridge, Eywa, Novel Labs Inc, Quagen, Tris Pharma Inc, Nostrum Labs Inc, Rising, Nextwave Pharms, Janssen Pharms, Able, Actavis Labs Fl, Alvogen, Amneal Pharms, Andor Pharms, Ani Pharms, Aurolife Pharma Llc, Dr Reddys, Heritage Pharma, Osmotica, Strides Pharma, Sun Pharm Inds Inc, Watson Labs, Abhai Inc, Accord Hlthcare, Bionpharma Inc, Cediprof Inc, Mountain, Oxford Pharms, and Prinston Inc, and is included in eighty-one NDAs. There are forty-three 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 nine patent family members in twenty-two countries.

There are twenty-three drug master file entries for methylphenidate hydrochloride. Forty-four suppliers are listed for this compound.

Summary for methylphenidate hydrochloride

International Patents:	109
US Patents:	43
Tradenames:	14
Applicants:	47
NDAs:	81
Drug Master File Entries:	23
Finished Product Suppliers / Packagers:	44
Raw Ingredient (Bulk) Api Vendors:	54
Clinical Trials:	400
Patent Applications:	4,701
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for methylphenidate hydrochloride
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for methylphenidate hydrochloride
What excipients (inactive ingredients) are in methylphenidate hydrochloride?	methylphenidate hydrochloride excipients list
DailyMed Link:	methylphenidate hydrochloride at DailyMed

See drug prices for methylphenidate hydrochloride

Recent Clinical Trials for methylphenidate hydrochloride

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

Sponsor	Phase
University of California, Davis	Phase 1
VA New York Harbor Healthcare System	Phase 4
Miami VA Healthcare System	Phase 4

See all methylphenidate hydrochloride clinical trials

Pharmacology for methylphenidate hydrochloride

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

Anatomical Therapeutic Chemical (ATC) Classes for methylphenidate hydrochloride

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

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

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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
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-002	Feb 27, 2019		RX	Yes	No	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Amneal Pharms	METHYLPHENIDATE HYDROCHLORIDE	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	207515-004	Feb 1, 2018	BX	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Osmotica	METHYLPHENIDATE HYDROCHLORIDE	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205327-001	Jul 28, 2017	AB	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Prinston Inc	METHYLPHENIDATE HYDROCHLORIDE	methylphenidate hydrochloride	TABLET;ORAL	212697-001	Jul 23, 2020	AB	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Ironshore Pharms	JORNAY PM	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	209311-005	Aug 8, 2018		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Amneal Pharms	METHYLPHENIDATE HYDROCHLORIDE	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	207515-001	Feb 1, 2018	BX	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-005	Feb 27, 2019		RX	Yes	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
>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

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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	See Plans and Pricing	See Plans and Pricing
Janssen Pharms	CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121-001	Aug 1, 2000	See Plans and Pricing	See Plans and Pricing
Janssen Pharms	CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121-002	Aug 1, 2000	See Plans and Pricing	See Plans and Pricing
Janssen Pharms	CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121-002	Aug 1, 2000	See Plans and Pricing	See Plans and Pricing
Novartis	RITALIN LA	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021284-002	Jun 5, 2002	See Plans and Pricing	See Plans and Pricing
Janssen Pharms	CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121-002	Aug 1, 2000	See Plans and Pricing	See Plans and Pricing
Janssen Pharms	CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121-004	Apr 1, 2002	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for methylphenidate hydrochloride

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	3212172	MÉTHODES ET COMPOSITIONS DESTINÉES EN PARTICULIER AU TRAITEMENT DU TROUBLE DÉFICITAIRE DE L'ATTENTION (METHODS AND COMPOSITIONS PARTICULARLY FOR TREATMENT OF ATTENTION DEFICIT DISORDER)	See Plans and Pricing
European Patent Office	1680144	SOLUTION DE METHYLPHENIDATE ET PROCEDES ASSOCIES D'ADMINISTRATION ET DE PRODUCTION (METHYLPHENIDATE SOLUTION AND ASSOCIATED METHODS OF ADMINISTRATION AND PRODUCTION)	See Plans and Pricing
Mexico	PA06003725	SOLUCION DE FENIDATO DE METILO Y METODOS ASOCIADOS DE ADMINISTRACION Y PRODUCCION. (METHYLPHENIDATE SOLUTION AND ASSOCIATED METHODS OF ADMINISTRATION AND PRODUCTION.)	See Plans and Pricing
Japan	5479086		See Plans and Pricing
Portugal	2688557		See Plans and Pricing
Singapore	11201703535W	METHODS AND COMPOSITIONS PARTICULARLY FOR TREATMENT OF ATTENTION DEFICIT DISORDER	See Plans and Pricing
World Intellectual Property Organization (WIPO)	2012112140		See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

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