DrugPatentWatch Database Preview
OSMOLEX ER Drug Profile
Which 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 two 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. Forty-five suppliers are listed for this compound. Additional details are available on the amantadine hydrochloride profile page.
Summary for OSMOLEX ER
| International Patents: | 11 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for OSMOLEX ER |
| Prior Art and Litigation Support | Order Prior Art and Litigation support for OSMOLEX ER |
| DailyMed Link: | OSMOLEX ER at DailyMed |
Medical Subject Heading (MeSH) Categories for OSMOLEX ER
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 | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Osmotica Pharm | OSMOLEX ER | amantadine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209410-002 | Feb 16, 2018 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Osmotica Pharm | OSMOLEX ER | amantadine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209410-001 | Feb 16, 2018 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Osmotica Pharm | OSMOLEX ER | amantadine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209410-002 | Feb 16, 2018 | RX | 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 |
|---|---|---|---|---|---|---|---|
| Osmotica Pharm | OSMOLEX ER | amantadine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209410-002 | Feb 16, 2018 | ➤ Sign Up | ➤ Sign Up |
| Osmotica Pharm | OSMOLEX ER | amantadine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209410-001 | Feb 16, 2018 | ➤ Sign Up | ➤ Sign Up |
| Osmotica Pharm | OSMOLEX ER | amantadine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209410-003 | Feb 16, 2018 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
International Patents for OSMOLEX ER
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 5325421 | ➤ Sign Up |
| European Patent Office | 2965753 | ➤ Sign Up |
| Canada | 2589479 | ➤ Sign Up |
| World Intellectual Property Organization (WIPO) | 2006089494 | ➤ Sign Up |
| Country | Patent Number | Estimated Expiration |
