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Last Updated: October 16, 2019

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Details for Patent: 8,796,337

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Which drugs does patent 8,796,337 protect, and when does it expire?

Patent 8,796,337 protects GOCOVRI and is included in one NDA.

This patent has four patent family members in three countries.

Summary for Patent: 8,796,337
Title:Composition and method for treating neurological disease
Abstract: A method of administering amantadine is provided. The method comprises orally administering to a subject a pharmaceutical composition comprising amantadine, or a pharmaceutically acceptable salt thereof, and one or more excipients, wherein at least one of the excipients modifies release of the amantadine. A dose of the composition provides a mean change in amantadine plasma concentration as a function of time (dC/dT) that is less than 40% of the change in amantadine plasma concentration provided by a dose of the same quantity of an immediate release form of amantadine. The change in plasma concentration over time (dC/dT) is measured in a single dose human pharmacokinetic study in a defined time period of 0 to 4 hours after administration. The amantadine, or pharmaceutically acceptable salt thereof, is administered once daily at a dose of 300 to 500 mg per day.
Inventor(s): Went; Gregory T. (Mill Valley, CA), Fultz; Timothy J. (Pleasant Hill, CA), Porter; Seth (San Carlos, CA), Meyerson; Laurence R. (Las Vegas, NV), Burkoth; Timothy S. (Lake Bluff, IL)
Assignee: Adamas Pharmaceutical, Inc. (Emeryville, CA)
Application Number:13/958,153
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,796,337
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation;

Drugs Protected by US Patent 8,796,337

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Adamas Pharma GOCOVRI amantadine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 208944-001 Aug 24, 2017 RX Yes No   See Pricing   See Pricing TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSON'S DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS   See Pricing
Adamas Pharma GOCOVRI amantadine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 208944-002 Aug 24, 2017 RX Yes Yes   See Pricing   See Pricing TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSON'S DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS   See Pricing
>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 8,796,337

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Canada 2588296   See Pricing
European Patent Office 1845968   See Pricing
European Patent Office 2623099   See Pricing
World Intellectual Property Organization (WIPO) 2006058236   See Pricing
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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