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Generated: May 22, 2019

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OSMOLEX ER Drug Profile

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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.

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

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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

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