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 four branded drugs marketed by Adare Pharms Inc, Ascent Pharms Inc, Aurolife Pharma Llc, Granules, Impax Labs Inc, Intellipharmaceutics, Par Pharm Inc, Sun Pharm Inds 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, Tris Pharma Inc, and Commave Therap, and is included in twenty-five NDAs. There are six patents protecting this compound and eight Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for dexmethylphenidate hydrochloride. Eighteen suppliers are listed for this compound.

Summary for dexmethylphenidate hydrochloride

US Patents:	6
Tradenames:	4
Applicants:	21
NDAs:	25
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	20
Clinical Trials:	14
Patent Applications:	116
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for dexmethylphenidate hydrochloride
What excipients (inactive ingredients) are in dexmethylphenidate hydrochloride?	dexmethylphenidate hydrochloride excipients list
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 3
Premier Research Group plc	Phase 3
Cingulate Therapeutics	Phase 1

See all dexmethylphenidate hydrochloride clinical trials

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

Anatomical Therapeutic Chemical (ATC) Classes for dexmethylphenidate hydrochloride

N06BA	Centrally acting sympathomimetics
N06B	PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS
N06	PSYCHOANALEPTICS
N	Nervous system

N06BA	Centrally acting sympathomimetics
N06B	PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS
N06	PSYCHOANALEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for DEXMETHYLPHENIDATE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FOCALIN XR	Extended-release Capsules	dexmethylphenidate hydrochloride	25 mg	021802	1	2011-09-30
FOCALIN XR	Extended-release Capsules	dexmethylphenidate hydrochloride	35 mg	021802	1	2011-09-29
FOCALIN XR	Extended-release Capsules	dexmethylphenidate hydrochloride	40 mg	021802	1	2010-12-20
FOCALIN XR	Extended-release Capsules	dexmethylphenidate hydrochloride	30 mg	021802	1	2010-12-15
FOCALIN XR	Extended-release Capsules	dexmethylphenidate hydrochloride	15 mg	021802	1	2007-05-14
FOCALIN XR	Extended-release Capsules	dexmethylphenidate hydrochloride	5 mg, 10 mg and 20 mg	021802	1	2007-03-30
FOCALIN	Tablets	dexmethylphenidate hydrochloride	2.5 mg	021278	1	2004-07-27
FOCALIN	Tablets	dexmethylphenidate hydrochloride	5 mg and 10 mg	021278	1	2004-05-27

US Patents and Regulatory Information for dexmethylphenidate 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
Commave Therap	AZSTARYS	dexmethylphenidate hydrochloride; serdexmethylphenidate chloride	CAPSULE;ORAL	212994-003	May 7, 2021		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Commave Therap	AZSTARYS	dexmethylphenidate hydrochloride; serdexmethylphenidate chloride	CAPSULE;ORAL	212994-002	May 7, 2021		RX	Yes	No	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Ascent Pharms Inc	DEXMETHYLPHENIDATE HYDROCHLORIDE	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	215523-007	Dec 8, 2021	AB	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
>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 dexmethylphenidate hydrochloride

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	FOCALIN XR	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021802-002	May 26, 2005	See Plans and Pricing	See Plans and Pricing
Novartis	FOCALIN XR	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021802-006	Aug 11, 2010	See Plans and Pricing	See Plans and Pricing
Novartis	FOCALIN XR	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021802-002	May 26, 2005	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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