OSMOLEX ER Drug Patent Profile

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

Osmolex Er is a drug marketed by Supernus Pharms and is included in one NDA. There are nineteen 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. Thirty-three 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.

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Summary for OSMOLEX ER

International Patents:	15
US Patents:	19
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
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

Drug patent expirations by year for OSMOLEX ER

Pharmacology for OSMOLEX ER

Drug Class	Influenza A M2 Protein Inhibitor
Mechanism of Action	M2 Protein Inhibitors

US Patents and Regulatory Information for OSMOLEX ER

OSMOLEX ER is protected by twenty-six US patents.

Patents protecting OSMOLEX ER

Composition and method for treating neurological disease
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Patent Expiration: ⤷ Sign Up
Patented Use: A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSON'S SYNDROME AND IN NEED OF TREATMENT

Composition and method for treating neurological disease
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Patented Use: TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS

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Patented Use: TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS

Osmotic device containing amantadine and an osmotic salt
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Patent Expiration: ⤷ Sign Up

Composition and method for treating neurological disease
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Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PARKINSON'S DISEASE

Osmotic device containing amantadine and an osmotic salt
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Patent Expiration: ⤷ Sign Up
Patented Use: A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSON'S SYNDROME AND IN NEED OF TREATMENT

Composition and method for treating neurological disease
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PARKINSON'S DISEASE

Composition and method for treating neurological disease
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Composition and method for treating neurological disease
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PARKINSON'S DISEASE

Composition and method for treating neurological disease
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Composition and method for treating neurological disease
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Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PARKINSON'S DISEASE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-003	Feb 16, 2018		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-004	Apr 22, 2020		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-004	Apr 22, 2020		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-004	Apr 22, 2020		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-002	Feb 16, 2018		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-004	Apr 22, 2020		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for OSMOLEX ER

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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

International Patents for OSMOLEX ER

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

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	2965753	DISPOSITIF OSMOTIQUE CONTENANT DE L'AMANTADINE ET UN SEL OSMOTIQUE (OSMOTIC DEVICE CONTAINING AMANTADINE AND AN OSMOTIC SALT)	⤷ Sign Up
China	1158071		⤷ Sign Up
Israel	128043	MULTI-LAYERED OSMOTIC DEVICE FOR CONTROLLED DELIVERY OF ACTIVE AGENTS	⤷ Sign Up
Canada	2589479	DISPOSITIF OSMOTIQUE CONTENANT DE L'AMANTADINE ET UN SEL OSMOTIQUE (OSMOTIC DEVICE CONTAINING AMANTADINE AND AN OSMOTIC SALT)	⤷ Sign Up
European Patent Office	1834638	DISPOSITIF OSMOTIQUE CONTENANT DE L'AMANTADINE ET UN SEL OSMOTIQUE (OSMOTIC DEVICE CONTAINING AMANTADINE AND AN OSMOTIC SALT)	⤷ Sign Up
Australia	2005328058	Osmotic device containing amantadine and an osmotic salt	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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Summary for OSMOLEX ER

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Patents protecting OSMOLEX ER

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