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Last Updated: May 28, 2024

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 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 5th, 1986.

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Drug patent expirations by year for OSMOLEX ER
Drug Prices for OSMOLEX ER

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Pharmacology for OSMOLEX ER
Anatomical Therapeutic Chemical (ATC) Classes for OSMOLEX ER

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
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS

Composition and method for treating neurological disease
Patent Number: ⤷  Sign Up
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 DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS

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

Composition and method for treating neurological disease
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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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Composition and method for treating neurological disease
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Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSON'S DISEASE

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
Patent Number: ⤷  Sign Up
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
Patented Use: TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSON'S DISEASE

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

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

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
Patented Use: TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSON'S DISEASE

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
Patented Use: TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSON'S DISEASE

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

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
Patented Use: TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSON'S DISEASE

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 ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Adamas Operations OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-004 Apr 22, 2020 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Adamas Operations OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-004 Apr 22, 2020 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Adamas Operations OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-004 Apr 22, 2020 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Adamas Operations OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-002 Feb 16, 2018 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Adamas Operations OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-004 Apr 22, 2020 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Adamas Operations OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-003 Feb 16, 2018 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  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

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

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
Japan 2007126478 MULTI-LAYERED PERMEATION DEVICE ⤷  Sign Up
Brazil 9802144 ⤷  Sign Up
Argentina 053986 DISPOSITIVO OSMOTICO QUE CONTIENE AMANTADINA Y UNA SAL OSMOTICA ⤷  Sign Up
World Intellectual Property Organization (WIPO) 9853802 ⤷  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
Brazil PI0515761 dispositivo osmótico contendo amantadina e um sal osmótico ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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