OSMOLEX ER Drug Patent Profile

When do Osmolex Er patents expire, and what generic alternatives are available?

Osmolex Er is a drug marketed by Adamas Pharma and is included in one NDA. There are eighteen patents protecting this drug.

This drug has fifteen patent family members in nine countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Osmolex Er

A generic version of OSMOLEX ER was approved as amantadine hydrochloride by UPSHER SMITH LABS on August 5^th, 1986.

Summary for OSMOLEX ER

International Patents:	15
US Patents:	18
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for OSMOLEX ER
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OSMOLEX ER
What excipients (inactive ingredients) are in OSMOLEX ER?	OSMOLEX ER excipients list
DailyMed Link:	OSMOLEX ER at DailyMed

See drug prices for OSMOLEX ER

Anatomical Therapeutic Chemical (ATC) Classes for OSMOLEX ER

N04BB	Adamantane derivatives
N04B	DOPAMINERGIC AGENTS
N04	ANTI-PARKINSON DRUGS
N	Nervous system

US Patents and Regulatory Information for OSMOLEX ER

OSMOLEX ER is protected by twenty-five US patents.

Patents protecting OSMOLEX ER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Adamas Pharma	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-002	Feb 16, 2018		RX	Yes	No			Y
Adamas Pharma	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-004	Apr 22, 2020		DISCN	Yes	No
Adamas Pharma	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-004	Apr 22, 2020		DISCN	Yes	No			Y
Adamas Pharma	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-002	Feb 16, 2018		RX	Yes	No
Adamas Pharma	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-004	Apr 22, 2020		DISCN	Yes	No			Y
Adamas Pharma	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-002	Feb 16, 2018		RX	Yes	No

Expired US Patents for OSMOLEX ER

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

International Patents for OSMOLEX ER

See the table below for patents covering OSMOLEX ER around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1845968	COMPOSITION ET METHODE POUR TRAITER DES AFFECTIONS NEUROLOGIQUES (COMPOSITION COMPRISING AN NMDA RECEPTOR ANTAGONIST AND LEVODOPA AND USE THEREOF FOR TREATING NEUROLOGICAL DISEASE)
Brazil	PI0515761	dispositivo osmótico contendo amantadina e um sal osmótico
European Patent Office	0914098	DISPOSITIF A OSMOSE MULTICOUCHES (MULTI-LAYERED OSMOTIC DEVICE)
Japan	5059421
Spain	2203963
Canada	2588296	COMPOSITION ET METHODE POUR TRAITER DES AFFECTIONS NEUROLOGIQUES (COMPOSITION COMPRISING AN NMDA RECEPTOR ANTAGONIST AND LEVODOPA AND USE THEREOF FOR TREATING NEUROLOGICAL DISEASE)