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, Breckenridge, Novel Labs Inc, Novelgenix Theraps, Patrin Pharma Inc, Tris Pharma Inc, Ascent Pharms Inc, Rising, Nextwave Pharms, Janssen Pharms, Able, Actavis Labs Fl, Alvogen Pine Brook, Amneal Pharms, Andor Pharms, Ani Pharms Inc, Cnty Line Pharms, Heritage Pharma, Mylan, Osmotica, Par Pharm, Watson Labs, Abhai Inc, Aurolife Pharma Llc, Bionpharma Inc, Cediprof Inc, Mountain, Oxford Pharms, and Sun Pharm Inds Inc, and is included in seventy-three 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 fifty-three patent family members in twenty-nine countries.

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

Summary for methylphenidate hydrochloride

International Patents:	153
US Patents:	43
Tradenames:	14
Applicants:	44
NDAs:	73
Drug Master File Entries:	32
Suppliers / Packagers:	43
Bulk Api Vendors:	47
Clinical Trials:	381
Patent Applications:	4,227
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
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
Portland VA Medical Center	Phase 4
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

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

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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	212038-003	Feb 27, 2019		RX	Yes	No	Start Trial	Start Trial				Start Trial
Rhodes Pharms	APTENSIO XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	205831-007	Apr 17, 2015	AB3	RX	Yes	Yes	Start Trial	Start Trial				Start Trial
Novartis	RITALIN LA	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021284-005	Oct 27, 2014		DISCN	Yes	No	Start Trial	Start Trial				Start Trial
Ironshore Pharms	JORNAY PM	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	209311-002	Aug 8, 2018		RX	Yes	No	Start Trial	Start Trial				Start 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 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	021121-002	Aug 1, 2000	Start Trial	Start Trial
Janssen Pharms	CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121-001	Aug 1, 2000	Start Trial	Start Trial
Janssen Pharms	CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121-004	Apr 1, 2002	Start Trial	Start Trial
Novartis	RITALIN LA	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021284-002	Jun 5, 2002	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for methylphenidate hydrochloride

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Country	Patent Number	Estimated Expiration
Australia	2122700	Start Trial
Portugal	2688557	Start Trial
Japan	2002532410	Start Trial
Singapore	10201912626W	Start Trial
>Country	>Patent Number	>Estimated Expiration

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