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Dexmethylphenidate hydrochloride - Generic Drug Details

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What are the generic drug sources for dexmethylphenidate hydrochloride and what is the scope of freedom to operate?

Dexmethylphenidate hydrochloride is the generic ingredient in three branded drugs marketed by Adare Pharms Inc, Impax Labs Inc, Intellipharmaceutics, Mylan, Par Pharm Inc, Teva Pharms Usa, Novartis, Abhai Inc, Alkem Labs Ltd, Bionpharma Inc, Cediprof Inc, Lannett Co Inc, Novel Labs Inc, Rhodes Pharms, Sun Pharm Industries, Teva Pharms, and Tris Pharma Inc, and is included in twenty-one NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for dexmethylphenidate hydrochloride. Fourteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for dexmethylphenidate hydrochloride

US Patents:	0
Tradenames:	3
Applicants:	17
NDAs:	21
Drug Master File Entries:	6
Suppliers / Packagers:	14
Bulk Api Vendors:	12
Clinical Trials:	13
Patent Applications:	6
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for dexmethylphenidate hydrochloride
DailyMed Link:	dexmethylphenidate hydrochloride at DailyMed

Recent Clinical Trials for dexmethylphenidate hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Cingulate Therapeutics	Phase 1
Cingulate Therapeutics	Phase 1/Phase 2
Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)	N/A

See all dexmethylphenidate hydrochloride clinical trials

Generic filers with tentative approvals for DEXMETHYLPHENIDATE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		5MG	CAPSULE, EXTENDED RELEASE;ORAL
		40MG	CAPSULE, EXTENDED RELEASE;ORAL
		35MG	CAPSULE, EXTENDED RELEASE;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 dexmethylphenidate hydrochloride

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

Medical Subject Heading (MeSH) Categories for dexmethylphenidate hydrochloride

Central Nervous System Stimulants

Dopamine Uptake Inhibitors

Paragraph IV (Patent) Challenges for DEXMETHYLPHENIDATE HYDROCHLORIDE

Tradename	Dosage	Ingredient	NDA	Submissiondate
FOCALIN XR	CAPSULE, EXTENDED RELEASE;ORAL	dexmethylphenidate hydrochloride	021802	2011-09-30
FOCALIN XR	CAPSULE, EXTENDED RELEASE;ORAL	dexmethylphenidate hydrochloride	021802	2011-09-29
FOCALIN XR	CAPSULE, EXTENDED RELEASE;ORAL	dexmethylphenidate hydrochloride	021802	2010-12-20
FOCALIN XR	CAPSULE, EXTENDED RELEASE;ORAL	dexmethylphenidate hydrochloride	021802	2010-12-15
FOCALIN XR	CAPSULE, EXTENDED RELEASE;ORAL	dexmethylphenidate hydrochloride	021802	2007-05-14
FOCALIN XR	CAPSULE, EXTENDED RELEASE;ORAL	dexmethylphenidate hydrochloride	021802	2007-03-30
FOCALIN	TABLET;ORAL	dexmethylphenidate hydrochloride	021278	2004-07-27
FOCALIN	TABLET;ORAL	dexmethylphenidate hydrochloride	021278	2004-05-27

US Patents and Regulatory Information for dexmethylphenidate hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Impax Labs Inc	DEXMETHYLPHENIDATE HYDROCHLORIDE	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	079108-005	Nov 21, 2013	AB	RX	No	No
Novel Labs Inc	DEXMETHYLPHENIDATE HYDROCHLORIDE	dexmethylphenidate hydrochloride	TABLET;ORAL	204534-002	Dec 4, 2015	AB	RX	No	No
Teva Pharms Usa	DEXMETHYLPHENIDATE HYDROCHLORIDE	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	202731-003	May 19, 2014	AB	RX	No	No
Par Pharm Inc	DEXMETHYLPHENIDATE HYDROCHLORIDE	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	202842-001	Nov 30, 2016	AB	RX	No	No
Lannett Co Inc	DEXMETHYLPHENIDATE HYDROCHLORIDE	dexmethylphenidate hydrochloride	TABLET;ORAL	209468-003	Sep 25, 2017		DISCN	No	No
Mylan	DEXMETHYLPHENIDATE HYDROCHLORIDE	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	202580-001	Aug 28, 2013	AB	RX	No	No
Par Pharm Inc	DEXMETHYLPHENIDATE HYDROCHLORIDE	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	202842-007	Nov 30, 2016	AB	RX	No	No

Expired US Patents for dexmethylphenidate hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	FOCALIN XR	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021802-005	Oct 23, 2009
Novartis	FOCALIN XR	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021802-003	May 26, 2005
Novartis	FOCALIN XR	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021802-003	May 26, 2005
Novartis	FOCALIN	dexmethylphenidate hydrochloride	TABLET;ORAL	021278-003	Nov 13, 2001
Novartis	FOCALIN	dexmethylphenidate hydrochloride	TABLET;ORAL	021278-001	Nov 13, 2001
Novartis	FOCALIN XR	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021802-006	Aug 11, 2010
Novartis	FOCALIN XR	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021802-002	May 26, 2005