Dexmethylphenidate hydrochloride; serdexmethylphenidate chloride - Generic Drug Details

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

Dexmethylphenidate hydrochloride; serdexmethylphenidate chloride is the generic ingredient in one branded drug marketed by Commave Therap and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Dexmethylphenidate hydrochloride; serdexmethylphenidate chloride has seventy-one patent family members in twenty-eight countries.

One supplier is listed for this compound.

Summary for dexmethylphenidate hydrochloride; serdexmethylphenidate chloride

International Patents:	71
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	dexmethylphenidate hydrochloride; serdexmethylphenidate chloride at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for dexmethylphenidate hydrochloride; serdexmethylphenidate chloride

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for dexmethylphenidate hydrochloride; serdexmethylphenidate chloride

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

Anatomical Therapeutic Chemical (ATC) Classes for dexmethylphenidate hydrochloride; serdexmethylphenidate chloride

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

US Patents and Regulatory Information for dexmethylphenidate hydrochloride; serdexmethylphenidate chloride

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	212994-002	May 7, 2021		RX	Yes	No			Y
Commave Therap	AZSTARYS	dexmethylphenidate hydrochloride; serdexmethylphenidate chloride	CAPSULE;ORAL	212994-001	May 7, 2021		RX	Yes	No			Y
Commave Therap	AZSTARYS	dexmethylphenidate hydrochloride; serdexmethylphenidate chloride	CAPSULE;ORAL	212994-002	May 7, 2021		RX	Yes	No			Y
Commave Therap	AZSTARYS	dexmethylphenidate hydrochloride; serdexmethylphenidate chloride	CAPSULE;ORAL	212994-001	May 7, 2021		RX	Yes	No
Commave Therap	AZSTARYS	dexmethylphenidate hydrochloride; serdexmethylphenidate chloride	CAPSULE;ORAL	212994-003	May 7, 2021		RX	Yes	Yes			Y
Commave Therap	AZSTARYS	dexmethylphenidate hydrochloride; serdexmethylphenidate chloride	CAPSULE;ORAL	212994-001	May 7, 2021		RX	Yes	No			Y	Y

International Patents for dexmethylphenidate hydrochloride; serdexmethylphenidate chloride

Country	Patent Number	Title	Estimated Expiration
Australia	2012286683
Russian Federation	2014107678	ПРОЛЕКАРСТВА МЕТИЛФЕНИДАТА, СПОСОБЫ ИХ ПОЛУЧЕНИЯ И ПРИМЕНЕНИЯ
European Patent Office	2736510	PROMÉDICAMENTS MÉTHYLPHÉNIDATES, PROCÉDÉS DE FABRICATION ET D'UTILISATION DE CEUX-CI (METHYLPHENIDATE-PRODRUGS, PROCESSES OF MAKING AND USING THE SAME)
Spain	2621306
Japan	2018076359	メチルフェニデート−プロドラッグ、その製造法及び使用法 (METHYLPHENIDATE-PRODRUGS, PROCESSES OF MAKING AND USING THE SAME)
Mexico	2013015088	PROFARMACOS DE METILFENIDATO, PROCESOS DE ELABORACION Y USO DE LOS MISMOS. (METHYLPHENIDATE-PRODRUGS, PROCESSES OF MAKING AND USING THE SAME.)