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OSMOLEX ER Drug Profile
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See Plans and PricingWhich patents cover Osmolex Er, and when can generic versions of Osmolex Er launch?
Osmolex Er is a drug marketed by Osmotica Pharm and is included in one NDA. There are eight patents protecting this drug.
This drug has eleven 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 suppliers are listed for this compound. Additional details are available on the amantadine hydrochloride profile page.
US ANDA 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: | 11 |
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 1 |
| 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 |
| DailyMed Link: | OSMOLEX ER at DailyMed |
Recent Litigation for OSMOLEX ER
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| ADAMAS PHARMA, LLC v. SANDOZ INC. | 2018-05-10 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Osmotica Pharm | OSMOLEX ER | amantadine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209410-001 | Feb 16, 2018 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Osmotica Pharm | OSMOLEX ER | amantadine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209410-003 | Feb 16, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Osmotica Pharm | OSMOLEX ER | amantadine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209410-003 | Feb 16, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start 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 |
|---|---|---|---|---|---|---|---|
| Osmotica Pharm | OSMOLEX ER | amantadine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209410-001 | Feb 16, 2018 | Start Trial | Start Trial |
| Osmotica Pharm | OSMOLEX ER | amantadine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209410-002 | Feb 16, 2018 | Start Trial | Start Trial |
| Osmotica Pharm | OSMOLEX ER | amantadine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209410-003 | Feb 16, 2018 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for OSMOLEX ER
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Mexico | 2007006472 | Start Trial |
| Japan | 2009517332 | Start Trial |
| European Patent Office | 1834638 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
