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Last Updated: September 27, 2023

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 fifteen branded drugs marketed by Purdue Pharma Lp, Rhodes Pharms, Ironshore Pharms, Aytu Biopharma, Actavis Elizabeth, Barr Labs Inc, Dr Reddys Labs Sa, Granules, Impax Labs Inc, Specgx Llc, Teva Pharms, Novartis, Actavis Labs Fl Inc, Nextwave, Abhai Llc, Alkem Labs Ltd, Anda Repository, Ascent Pharms Inc, Breckenridge, Chartwell Molecular, Eywa, Novel Labs Inc, Quagen, Tris 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, Strides Pharma, Sun Pharm Inds Inc, Watson Labs, Osmotica Pharm Us, Abhai Inc, Accord Hlthcare, Bionpharma, Cediprof Inc, Mountain, Oxford Pharms, and Prinston Inc, and is included in eighty-four NDAs. There are forty-four 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 fifteen patent family members in twenty-two countries.

There are twenty-three drug master file entries for methylphenidate hydrochloride. Forty-seven suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for methylphenidate hydrochloride

International Patents:	115
US Patents:	44
Tradenames:	15
Applicants:	50
NDAs:	84
Drug Master File Entries:	23
Finished Product Suppliers / Packagers:	47
Raw Ingredient (Bulk) Api Vendors:	61
Clinical Trials:	414
Patent Applications:	4,944
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
Ralph H. Johnson VA Medical Center	Phase 2
University Hospital, Strasbourg, France	Phase 3
University of Geneva, Switzerland	Phase 3

See all methylphenidate hydrochloride clinical trials

Generic filers with tentative approvals for METHYLPHENIDATE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	30MG	TABLET, EXTENDED RELEASE, CHEWABLE;ORAL
⤷ Try a Trial	⤷ Try a Trial	20MG	TABLET, EXTENDED RELEASE, CHEWABLE;ORAL
⤷ Try a Trial	⤷ Try a Trial	40MG	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 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
Ironshore Pharms	JORNAY PM	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	209311-005	Aug 8, 2018		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Dr Reddys Labs Sa	METHYLPHENIDATE HYDROCHLORIDE	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	078458-003	Dec 1, 2011	AB1	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-005	Feb 27, 2019		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Alvogen	METHYLPHENIDATE HYDROCHLORIDE	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	204772-002	Feb 29, 2016		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a 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	021121-003	Dec 8, 2000	⤷ Try a Trial	⤷ Try a Trial
Janssen Pharms	CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121-003	Dec 8, 2000	⤷ Try a Trial	⤷ Try a Trial
Janssen Pharms	CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121-004	Apr 1, 2002	⤷ Try a Trial	⤷ Try a Trial
Janssen Pharms	CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121-004	Apr 1, 2002	⤷ Try a Trial	⤷ Try a 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	Title	Estimated Expiration
Canada	2880456	COMPRIME A CROQUER DE METHYLPHENIDATE A LIBERATION MODIFIEE (METHYLPHENIDATE EXTENDED RELEASE CHEWABLE TABLET)	⤷ Try a Trial
Japan	2016117767	注意欠陥障害の処置のための方法および組成物 (METHODS AND COMPOSITIONS FOR TREATMENT OF ATTENTION DEFICIT DISORDER)	⤷ Try a Trial
Mexico	PA06003725	SOLUCION DE FENIDATO DE METILO Y METODOS ASOCIADOS DE ADMINISTRACION Y PRODUCCION. (METHYLPHENIDATE SOLUTION AND ASSOCIATED METHODS OF ADMINISTRATION AND PRODUCTION.)	⤷ Try a Trial
South Africa	201307649	METHODS AND COMPOSITIONS FOR TREATMENT OF ATTENTION DEFICIT DISORDER	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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