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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 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 Pharms, Impax Labs Inc, Mayne Pharma, Specgx Llc, Teva Pharms, Novartis, Actavis Labs Fl Inc, Nextwave, Abhai Llc, Alkem Labs Ltd, Anda Repository, Breckenridge, Eywa, Novel Labs Inc, Quagen, Tris Pharma Inc, Ascent Pharms Inc, Nostrum Labs Inc, Rising, Nextwave Pharms, Janssen Pharms, Able, Actavis Labs Fl, Alvogen Pine Brook, Amneal Pharms, Andor Pharms, Ani Pharms Inc, Cnty Line 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 NDAs. There are forty-six 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 fifty-six patent family members in twenty-nine countries.

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

Summary for methylphenidate hydrochloride

International Patents:	156
US Patents:	46
Tradenames:	14
Applicants:	49
NDAs:	80
Drug Master File Entries:	32
Suppliers / Packagers:	45
Bulk Api Vendors:	48
Clinical Trials:	386
Patent Applications:	4,353
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
Miami VA Healthcare System	Phase 4
VA New York Harbor Healthcare System	Phase 4
Purdue	Phase 4

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
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-002	Feb 27, 2019		RX	Yes	No
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-001	Feb 27, 2019		RX	Yes	No
Ironshore Pharms	JORNAY PM	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	209311-001	Aug 8, 2018		RX	Yes	No			Y
Ascent Pharms Inc	METHYLPHENIDATE HYDROCHLORIDE	methylphenidate hydrochloride	TABLET;ORAL	207416-002	Sep 22, 2015	AB	RX	No	No
Specgx Llc	METHYLPHENIDATE HYDROCHLORIDE	methylphenidate hydrochloride	TABLET;ORAL	040300-002	Nov 27, 1998	AB	RX	No	No
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-003	Feb 27, 2019		RX	Yes	No			Y
Ironshore Pharms	JORNAY PM	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	209311-002	Aug 8, 2018		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	021121-002	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	021121-003	Dec 8, 2000
Novartis	RITALIN LA	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021284-002	Jun 5, 2002
Novartis	RITALIN LA	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021284-004	Apr 10, 2004
Lannett Co Inc	METADATE CD	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021259-004	Feb 19, 2006

International Patents for methylphenidate hydrochloride

Country	Patent Number	Estimated Expiration
Australia	2020227022
Portugal	1143937
World Intellectual Property Organization (WIPO)	2016065481
World Intellectual Property Organization (WIPO)	0035426
Slovenia	1140088
Japan	4959335
Singapore	11201703535W