OSMOLEX Drug Patent Profile
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When do Osmolex patents expire, and what generic alternatives are available?
Osmolex is a drug marketed by Supernus Pharms and is included in one NDA. There are nine patents protecting this drug.
The generic ingredient in OSMOLEX is amantadine hydrochloride. There are seven drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the amantadine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Osmolex
A generic version of OSMOLEX was approved as amantadine hydrochloride by UPSHER SMITH LABS on August 5th, 1986.
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Questions you can ask:
- What is the 5 year forecast for OSMOLEX?
- What are the global sales for OSMOLEX?
- What is Average Wholesale Price for OSMOLEX?
Summary for OSMOLEX
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Prices: | Drug price information for OSMOLEX |
| DailyMed Link: | OSMOLEX at DailyMed |
US Patents and Regulatory Information for OSMOLEX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Supernus Pharms | OSMOLEX ER | amantadine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209410-003 | Feb 16, 2018 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Supernus Pharms | OSMOLEX ER | amantadine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209410-003 | Feb 16, 2018 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Supernus Pharms | OSMOLEX ER | amantadine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209410-002 | Feb 16, 2018 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Supernus Pharms | OSMOLEX ER | amantadine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209410-001 | Feb 16, 2018 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Supernus Pharms | OSMOLEX ER | amantadine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209410-002 | Feb 16, 2018 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Supernus Pharms | OSMOLEX ER | amantadine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209410-001 | Feb 16, 2018 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
