Methylphenidate hydrochloride - Generic Drug Details

What are the generic sources for methylphenidate hydrochloride and what is the scope of patent protection?

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, 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, 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 Inc, Cediprof Inc, Mountain, Oxford Pharms, and Prinston Inc, and is included in eighty-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 eleven patent family members in twenty-two countries.

There are twenty-three drug master file entries for methylphenidate hydrochloride. Forty-six suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for methylphenidate hydrochloride

International Patents:	111
US Patents:	43
Tradenames:	15
Applicants:	50
NDAs:	83
Drug Master File Entries:	23
Finished Product Suppliers / Packagers:	46
Raw Ingredient (Bulk) Api Vendors:	56
Clinical Trials:	408
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
Ralph H. Johnson VA Medical Center	Phase 2
Assiut University	N/A
University of California, Davis	Phase 1

See all methylphenidate hydrochloride clinical trials

Generic filers with tentative approvals for METHYLPHENIDATE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		40MG	TABLET, EXTENDED RELEASE, CHEWABLE;ORAL
		30MG	TABLET, EXTENDED RELEASE, CHEWABLE;ORAL
		20MG	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

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

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
Ascent Pharms Inc	METHYLPHENIDATE HYDROCHLORIDE	methylphenidate hydrochloride	TABLET;ORAL	207416-001	Sep 22, 2015	AB	RX	No	No
Osmotica	METHYLPHENIDATE HYDROCHLORIDE	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205327-004	Jul 28, 2017	AB	RX	No	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	021121-003	Dec 8, 2000
Novartis	RITALIN LA	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021284-004	Apr 10, 2004

International Patents for methylphenidate hydrochloride

Country	Patent Number	Title	Estimated Expiration
Canada	3018328	METHODES ET COMPOSITIONS DESTINEES AU TRAITEMENT DU TROUBLE DE DEFICIT D'ATTENTION (METHODS AND COMPOSITIONS PARTICULARLY FOR TREATMENT OF ATTENTION DEFICIT DISORDER)
South Africa	201307649	METHODS AND COMPOSITIONS FOR TREATMENT OF ATTENTION DEFICIT DISORDER
Hong Kong	1244429	特別用於治療注意力缺陷障礙的方法和組合物 (METHODS AND COMPOSITIONS PARTICULARLY FOR TREATMENT OF ATTENTION DEFICIT DISORDER)