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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 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, Dr Reddys, Heritage Pharma, Mylan, Osmotica, Par Pharm, Sun Pharm Inds Inc, Watson Labs, Abhai Inc, Accord Hlthcare, Aurolife Pharma Llc, Cediprof Inc, Mountain, Oxford Pharms, Prinston Inc, and Uspharma, and is included in eighty-one NDAs. There are forty-one 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 seven patent family members in twenty-two countries.

There are thirty-two drug master file entries for methylphenidate hydrochloride. Forty-six suppliers are listed for this compound.

Summary for methylphenidate hydrochloride

International Patents:	107
US Patents:	41
Tradenames:	14
Applicants:	48
NDAs:	81
Drug Master File Entries:	32
Finished Product Suppliers / Packagers:	46
Raw Ingredient (Bulk) Api Vendors:	50
Clinical Trials:	390
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
VA New York Harbor Healthcare System	Phase 4
Miami VA Healthcare System	Phase 4
VA Office of Research and Development	Phase 2

See all methylphenidate hydrochloride clinical trials

Pharmacology for methylphenidate hydrochloride

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

Paragraph IV (Patent) Challenges for METHYLPHENIDATE HYDROCHLORIDE

Tradename	Dosage	Ingredient	NDA	Submissiondate
QUILLICHEW ER	TABLET, EXTENDED RELEASE, CHEWABLE;ORAL	methylphenidate hydrochloride	207960	2016-04-25
APTENSIO XR	CAPSULE, EXTENDED RELEASE;ORAL	methylphenidate hydrochloride	205831	2016-03-28
APTENSIO XR	CAPSULE, EXTENDED RELEASE;ORAL	methylphenidate hydrochloride	205831	2015-12-24
APTENSIO XR	CAPSULE, EXTENDED RELEASE;ORAL	methylphenidate hydrochloride	205831	2015-12-23
QUILLIVANT XR	FOR SUSPENSION, EXTENDED RELEASE;ORAL	methylphenidate hydrochloride	202100	2013-08-02
METHYLIN	SOLUTION;ORAL	methylphenidate hydrochloride	021419	2010-04-13
RITALIN LA	CAPSULE, EXTENDED RELEASE;ORAL	methylphenidate hydrochloride	021284	2007-05-21
METADATE CD	CAPSULE, EXTENDED RELEASE;ORAL	methylphenidate hydrochloride	021259	2007-03-15
RITALIN LA	CAPSULE, EXTENDED RELEASE;ORAL	methylphenidate hydrochloride	021284	2006-08-21
CONCERTA	TABLET, EXTENDED RELEASE;ORAL	methylphenidate hydrochloride	021121	2005-07-19
METADATE CD	CAPSULE, EXTENDED RELEASE;ORAL	methylphenidate hydrochloride	021259	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
Nextwave Pharms	QUILLICHEW ER	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE, CHEWABLE;ORAL	207960-002	Dec 4, 2015		RX	Yes	No			Y
Ani Pharms	METHYLPHENIDATE HYDROCHLORIDE	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208607-001	Jul 14, 2017		DISCN	No	No
Lannett Co Inc	METADATE CD	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021259-002	Jun 19, 2003	AB2	RX	Yes	No
Nextwave	QUILLIVANT XR	methylphenidate hydrochloride	FOR SUSPENSION, EXTENDED RELEASE;ORAL	202100-001	Sep 27, 2012	AB	RX	Yes	Yes			Y
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-003	Feb 27, 2019		RX	Yes	No

Expired US Patents for methylphenidate hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	RITALIN LA	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021284-002	Jun 5, 2002
Janssen Pharms	CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121-001	Aug 1, 2000
Janssen Pharms	CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121-003	Dec 8, 2000
Janssen Pharms	CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121-001	Aug 1, 2000
Janssen Pharms	CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121-004	Apr 1, 2002

International Patents for methylphenidate hydrochloride

Country	Patent Number	Estimated Expiration
Japan	2009530298
World Intellectual Property Organization (WIPO)	2005035000
European Patent Office	2884961
World Intellectual Property Organization (WIPO)	2012112140
Mexico	2017005425