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OSMOLEX ER Drug Profile

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Which patents cover Osmolex Er, and when can generic versions of Osmolex Er launch?

Osmolex Er is a drug marketed by Osmotica Pharm and is included in one NDA. There are three patents protecting this drug.

This drug has twenty-nine patent family members in fourteen countries.

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

Summary for OSMOLEX ER

International Patents:	29
US Patents:	3
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OSMOLEX ER
DailyMed Link:	OSMOLEX ER at DailyMed

Medical Subject Heading (MeSH) Categories for OSMOLEX ER

Analgesics, Non-Narcotic

Antiparkinson Agents

Antiviral Agents

Dopamine Agents

US Patents and Regulatory Information for OSMOLEX ER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Osmotica Pharm	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-001	Feb 16, 2018		RX	Yes	No			Y
Osmotica Pharm	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-003	Feb 16, 2018		RX	Yes	Yes			Y
Osmotica Pharm	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-002	Feb 16, 2018		RX	Yes	No			Y
Osmotica Pharm	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-003	Feb 16, 2018		RX	Yes	Yes			Y
Osmotica Pharm	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-001	Feb 16, 2018		RX	Yes	No			Y
Osmotica Pharm	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-001	Feb 16, 2018		RX	Yes	No			Y

Expired US Patents for OSMOLEX ER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Osmotica Pharm	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-002	Feb 16, 2018
Osmotica Pharm	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-001	Feb 16, 2018
Osmotica Pharm	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-003	Feb 16, 2018

International Patents for OSMOLEX ER

Country	Document Number	Estimated Expiration
Israel	128043
Australia	2005328058
Japan	2009517332
World Intellectual Property Organization (WIPO)	2006089494
Mexico	2007006472
Japan	3950175