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OSMOLEX ER Drug 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 Pharma 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.
Summary for OSMOLEX ER
| International Patents: | 15 |
| US Patents: | 18 |
| 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 |
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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adamas Pharma | OSMOLEX ER | amantadine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209410-002 | Feb 16, 2018 | RX | Yes | No | Get Started for $10 | Get Started for $10 | Y | Get Started for $10 | |||
| Adamas Pharma | OSMOLEX ER | amantadine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209410-004 | Apr 22, 2020 | DISCN | Yes | No | Get Started for $10 | Get Started for $10 | Get Started for $10 | ||||
| Adamas Pharma | OSMOLEX ER | amantadine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209410-004 | Apr 22, 2020 | DISCN | Yes | No | Get Started for $10 | Get Started for $10 | Y | Get Started for $10 | |||
| >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 Pharma | OSMOLEX ER | amantadine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209410-001 | Feb 16, 2018 | Get Started for $10 | Get Started for $10 |
| Adamas Pharma | OSMOLEX ER | amantadine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209410-002 | Feb 16, 2018 | Get Started for $10 | Get Started for $10 |
| Adamas Pharma | OSMOLEX ER | amantadine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209410-003 | Feb 16, 2018 | Get Started for $10 | Get Started for $10 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for OSMOLEX ER
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Brazil | PI0515761 | Get Started for $10 |
| European Patent Office | 2623099 | Get Started for $10 |
| China | 1158071 | Get Started for $10 |
| >Country | >Patent Number | >Estimated Expiration |
