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 eighty-one patent family members in twenty-nine countries.

One supplier is listed for this compound.

Summary for dexmethylphenidate hydrochloride; serdexmethylphenidate chloride

International Patents:	81
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	Y
Commave Therap	AZSTARYS	dexmethylphenidate hydrochloride; serdexmethylphenidate chloride	CAPSULE;ORAL	212994-002	May 7, 2021		RX	Yes	No
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
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

International Patents for dexmethylphenidate hydrochloride; serdexmethylphenidate chloride

Country	Patent Number	Title	Estimated Expiration
Israel	269322	מתילפנידאט-מטרימי תרופות תהליכים להכנתם ולשימוש בהם (Methylphenidate-prodrugs, processes of making and using the same)
South Korea	101869885
Denmark	3551619
Slovenia	2736510
Colombia	6900135	Profármacos de metilfenidato, procesos de elaboración y utilización de los mismos
Russian Federation	2573835	ПРОЛЕКАРСТВА МЕТИЛФЕНИДАТА, СПОСОБЫ ИХ ПОЛУЧЕНИЯ И ПРИМЕНЕНИЯ (METHYLPHENIDATE PRODRUGS, METHODS OF THEIR OBTAINING AND APPLICATION)