Details for New Drug Application (NDA): 209410

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NDA 209410 describes OSMOLEX ER, which is a drug marketed by Supernus Pharms and is included in one NDA. It is available from one supplier. There are nineteen 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-three 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:	19

Pharmacology for NDA: 209410

Mechanism of Action	M2 Protein Inhibitors

Medical Subject Heading (MeSH) Categories for 209410

Analgesics, Non-Narcotic
Antiparkinson Agents
Antiviral Agents
Dopamine Agents

Suppliers and Packaging for NDA: 209410

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410	NDA	Adamas Pharma, LLC	70482-075	70482-075-07	2 BLISTER PACK in 1 CARTON (70482-075-07) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410	NDA	Adamas Pharma, LLC	70482-075	70482-075-14	14 TABLET, EXTENDED RELEASE in 1 BOTTLE (70482-075-14)

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:	⤷ Sign Up	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:	⤷ Sign Up	Patent Expiration:	Feb 15, 2038	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS
Patent:	⤷ Sign Up	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

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

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