Details for New Drug Application (NDA): 209410

NDA 209410 describes OSMOLEX ER, which is a drug marketed by Supernus Pharms and is included in one NDA. There are nine patents protecting this drug. Additional details are available on the OSMOLEX ER profile page.

The generic ingredient in OSMOLEX ER is amantadine hydrochloride. There are seven drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the amantadine hydrochloride profile page.

Summary for 209410

Tradename:	OSMOLEX ER
Applicant:	Supernus Pharms
Ingredient:	amantadine hydrochloride
Patents:	9

Medical Subject Heading (MeSH) Categories for 209410

Analgesics, Non-Narcotic

Antiparkinson Agents

Antiviral Agents

Dopamine Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 129MG BASE
Approval Date:	Feb 16, 2018	TE:		RLD:	Yes
Patent:		Patent Expiration:	Feb 15, 2038	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSON'S SYNDROME AND IN NEED OF TREATMENT
Patent:		Patent Expiration:	Feb 15, 2038	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS
Patent:		Patent Expiration:	Feb 15, 2038	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSON'S SYNDROME AND IN NEED OF TREATMENT

Expired US Patents for NDA 209410

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-001	Feb 16, 2018
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-002	Feb 16, 2018
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-003	Feb 16, 2018
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-002	Feb 16, 2018
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-002	Feb 16, 2018
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-004	Apr 22, 2020

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