OSMOLEX ER Drug Patent Profile

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When do Osmolex Er patents expire, and when can generic versions of Osmolex Er launch?

Osmolex Er is a drug marketed by Adamas Operations 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-two 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
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

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

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-six US patents.

Patents protecting OSMOLEX ER

Composition and method for treating neurological disease
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS

Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS

Osmotic device containing amantadine and an osmotic salt
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

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

Osmotic device containing amantadine and an osmotic salt
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PARKINSON'S DISEASE

Composition and method for treating neurological disease
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

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

Composition and method for treating neurological disease
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Composition and method for treating neurological disease
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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
Adamas Operations	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-003	Feb 16, 2018		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Adamas Operations	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-004	Apr 22, 2020		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Adamas Operations	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-004	Apr 22, 2020		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Adamas Operations	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-004	Apr 22, 2020		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
>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
Adamas Operations	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-003	Feb 16, 2018	⤷ Try a Trial	⤷ Try a Trial
Adamas Operations	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-001	Feb 16, 2018	⤷ Try a Trial	⤷ Try a Trial
Adamas Operations	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-002	Feb 16, 2018	⤷ Try a Trial	⤷ Try a Trial
>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
Spain	2549581		⤷ Try a Trial
World Intellectual Property Organization (WIPO)	9853802		⤷ Try a Trial
China	1158071		⤷ Try a Trial
Spain	2203963		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Summary for OSMOLEX ER

Pharmacology for OSMOLEX ER

Anatomical Therapeutic Chemical (ATC) Classes for OSMOLEX ER

Patents protecting OSMOLEX ER

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