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 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-four 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.
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 |


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
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 | |||
>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 | 209410-003 | 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.
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) | ⤷ Try a Trial |
Japan | 2007126478 | MULTI-LAYERED PERMEATION DEVICE | ⤷ Try a Trial |
Brazil | 9802144 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |