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Last Updated: October 27, 2020

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Details for Patent: 8,598,233

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Which drugs does patent 8,598,233 protect, and when does it expire?

Patent 8,598,233 protects NAMENDA XR and NAMZARIC and is included in two NDAs.

Protection for NAMENDA XR has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has fifty-nine patent family members in nineteen countries.

Summary for Patent: 8,598,233
Title:Method for administering an NMDA receptor antagonist to a subject
Abstract: Compositions and methods for administering memantine to a subject are provided. In particular, a solid pharmaceutical composition in a unit dosage form for once daily oral administration is provided. The compositions comprises an extended release formulation of 22.5 mg to 33.75 mg memantine, or a pharmaceutically acceptable salt thereof, wherein administration of a dose of the composition to a human subject provides a mean plasma memantine concentration profile characterized by a change in memantine concentration as a function of time (dC/dT) that is less than 50% of the dC/dT provided by the same quantity of an immediate release form of memantine, determined in a time period between 0 hours to 6 hours after administration of memantine, and wherein dC/dT is measured in a single-dose human PK study. Methods of treating dementia, in particular Alzheimer's diseases, using the compositions are provided.
Inventor(s): Went; Gregory T. (Mill Valley, CA), Fultz; Timothy J. (Pleasant Hill, CA), Meyerson; Laurence R. (Las Vegas, NV)
Assignee: Adamas Pharmacueticals, Inc. (Emeryville, CA)
Application Number:13/751,876
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,598,233
Patent Claim Types:
see list of patent claims
Composition; Formulation; Dosage form;

Drugs Protected by US Patent 8,598,233

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Forest Labs Llc NAMENDA XR memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022525-004 Jun 21, 2010 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Allergan NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-003 Jul 18, 2016 RX Yes No   Start Trial   Start Trial Y   Start Trial
Allergan NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-001 Dec 23, 2014 RX Yes No   Start Trial   Start Trial Y   Start Trial
Allergan NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-004 Jul 18, 2016 RX Yes No   Start Trial   Start Trial Y   Start Trial
Allergan NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-002 Dec 23, 2014 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. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 8,598,233

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria 481096   Start Trial
Australia 2005209310   Start Trial
Australia 2005215767   Start Trial
Australia 2005215775   Start Trial
Australia 2005309601   Start Trial
Australia 2006244297   Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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Serving leading biopharmaceutical companies globally:

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AstraZeneca
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Medtronic
Baxter

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