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Last Updated: March 29, 2024

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 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. Thirty-one 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-five 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

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

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

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

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 DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSON'S DISEASE

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

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

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

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

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

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

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
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 209410-002 Feb 16, 2018 RX 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 Y ⤷  Try a Trial
Adamas Operations OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-002 Feb 16, 2018 RX 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
Adamas Operations OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-002 Feb 16, 2018 RX 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
>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 ⤷  Try a Trial ⤷  Try a Trial
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 209410-002 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.

Country Patent Number Title Estimated Expiration
Mexico 2007006472 DISPOSITIVO OSMOTICO QUE CONTIENE AMANTADINA Y UNA SAL OSMOTICA. (OSMOTIC DEVICE CONTAINING AMANTADINE AND AN OSMOTIC SALT.) ⤷  Try a Trial
European Patent Office 2623099 Composition et procédé de traitement d'une maladie neurologique (Composition and method for treating neurological disease) ⤷  Try a Trial
Brazil 9802144 ⤷  Try a Trial
Japan 2007126478 MULTI-LAYERED PERMEATION DEVICE ⤷  Try a Trial
Spain 2549581 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 9853802 ⤷  Try a Trial
Japan 5059421 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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