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Last Updated: July 23, 2024

GOCOVRI Drug Patent Profile


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When do Gocovri patents expire, and what generic alternatives are available?

Gocovri is a drug marketed by Adamas Operations and is included in one NDA. There are nineteen patents protecting this drug and two Paragraph IV challenges.

This drug has thirty-five patent family members in nine countries.

The generic ingredient in GOCOVRI is amantadine hydrochloride. There are seven drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the amantadine hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Gocovri

A generic version of GOCOVRI was approved as amantadine hydrochloride by UPSHER SMITH LABS on August 5th, 1986.

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Drug patent expirations by year for GOCOVRI
Drug Prices for GOCOVRI

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Recent Clinical Trials for GOCOVRI

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SponsorPhase
Oregon Health and Science UniversityPhase 4
Adamas Pharmaceuticals, Inc.Phase 4
Columbia UniversityPhase 4

See all GOCOVRI clinical trials

Pharmacology for GOCOVRI
Paragraph IV (Patent) Challenges for GOCOVRI
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
GOCOVRI Extended-release Capsules amantadine hydrochloride 68.5 mg 208944 1 2020-04-30
GOCOVRI Extended-release Capsules amantadine hydrochloride 137 mg 208944 1 2018-01-16

US Patents and Regulatory Information for GOCOVRI

GOCOVRI is protected by twenty-one US patents and one FDA Regulatory Exclusivity.

Patents protecting GOCOVRI

Methods of administering amantadine
Patent Number: ⤷  Sign Up
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Patented Use: TREATMENT OF DYSKINESIA AND DECREASING OFF TIME IN PATIENTS WITH PARKINSON'S DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS

Methods of administering amantadine
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Patented Use: TREATMENT OF DYSKINESIA, DECREASING OFF TIME, AND INCREASING ON TIME WITHOUT TROUBLESOME DYSKINESIA IN PATIENTS WITH PARKINSON'S DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS

Amantadine compositions and preparations thereof
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Methods of using amantadine compositions
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Patented Use: TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSON'S DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS

Methods of using amantadine compositions
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Patented Use: TREATMENT OF DYSKINESIA AND INCREASING ON TIME WITHOUT TROUBLESOME DYSKINESIA IN PATIENTS WITH PARKINSON'S DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS

Methods of using amantadine compositions
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Patented Use: DECREASING OFF TIME IN PATIENTS WITH PARKINSON'S DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS

Method of administering amantadine prior to a sleep period
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Patented Use: TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSON'S DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS


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Patented Use: AS ADJUNCTIVE TREATMENT TO LEVODOPA/CARBIDOPA IN PATIENTS WITH PARKINSON'S DISEASE EXPERIENCING 'OFF' EPISODES

Composition and method for treating neurological disease
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Patented Use: TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSON'S DISEASE RECEIVING IMMEDIATE RELEASE LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS

Method of administering amantadine prior to a sleep period
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSON'S DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS

Composition and method for treating neurological disease
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSON'S DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS

Composition and method for treating neurological disease
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Composition and method for treating neurological disease
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Patent Expiration: ⤷  Sign Up

Composition and method for treating neurological disease
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSON'S DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS

Composition and method for treating neurological disease
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSON'S DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS

Composition and method for treating neurological disease
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSON'S DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS

Composition and method for treating neurological disease
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Patent Expiration: ⤷  Sign Up

Method of administering amantadine prior to a sleep period
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSON'S DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS

Method of administering amantadine prior to a sleep period
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSON'S DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS

Method of administering amantadine prior to a sleep period
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSON'S DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS

Method of administering amantadine prior to a sleep period
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF DYSKINESIA AND INCREASING ON TIME WITHOUT TROUBLESOME DYSKINESIA IN PATIENTS WITH PARKINSON'S DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS

FDA Regulatory Exclusivity protecting GOCOVRI

TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSON'S DISEASE RECEIVING LEVODOPA-BASED THERAPY WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
Exclusivity Expiration: ⤷  Sign Up

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Adamas Operations GOCOVRI amantadine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 208944-002 Aug 24, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Adamas Operations GOCOVRI amantadine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 208944-002 Aug 24, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Adamas Operations GOCOVRI amantadine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 208944-002 Aug 24, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for GOCOVRI

See the table below for patents covering GOCOVRI around the world.

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2006058236 ⤷  Sign Up
Canada 2588296 COMPOSITION ET METHODE POUR TRAITER DES AFFECTIONS NEUROLOGIQUES (COMPOSITION COMPRISING AN NMDA RECEPTOR ANTAGONIST AND LEVODOPA AND USE THEREOF FOR TREATING NEUROLOGICAL DISEASE) ⤷  Sign Up
China 106389381 金刚烷胺组合物及其使用方法 (Amantadine compositions and methods of use) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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