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Last Updated: May 25, 2022

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 Pharma and is included in one NDA. There are eighteen patents protecting this drug and two Paragraph IV challenges.

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

The generic ingredient in GOCOVRI is amantadine hydrochloride. There are seven drug master file entries for this compound. Twenty-nine 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

See drug prices for GOCOVRI

Recent Clinical Trials for GOCOVRI

Identify potential brand extensions & 505(b)(2) entrants

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

See all GOCOVRI clinical trials

Anatomical Therapeutic Chemical (ATC) Classes 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 US patents and one FDA Regulatory Exclusivity.

Patents protecting GOCOVRI

Methods of administering amantadine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods of using amantadine compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Composition and method for treating neurological disease
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Composition and method for treating neurological disease
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Method of administering amantadine prior to a sleep period
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Adamas Pharma GOCOVRI amantadine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 208944-002 Aug 24, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Adamas Pharma GOCOVRI amantadine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 208944-002 Aug 24, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Adamas Pharma GOCOVRI amantadine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 208944-002 Aug 24, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Adamas Pharma GOCOVRI amantadine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 208944-002 Aug 24, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Adamas Pharma GOCOVRI amantadine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 208944-002 Aug 24, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Adamas Pharma GOCOVRI amantadine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 208944-001 Aug 24, 2017 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Canada 3072764 COMPOSITIONS D'AMANTADINE, LEURS PREPARATION, ET PROCEDES D'UTILISATION (AMANTADINE COMPOSITIONS, PREPARATIONS THEREOF, AND METHODS OF USE) See Plans and Pricing
China 102883601 Amantadine compositions and methods of use See Plans and Pricing
Japan 2017019874 アマンタジン組成物および使用方法 (AMANTADINE COMPOSITIONS AND METHODS OF USE) See Plans and Pricing
Mexico 365650 COMPOSICIONES DE AMANTADINA Y METODOS PARA SU USO. (AMANTADINE COMPOSITIONS AND METHODS OF USE.) See Plans and Pricing
Canada 2994873 COMPOSITIONS D'AMANTADINE ET PROCEDES D'UTILISATION ASSOCIES (AMANTADINE COMPOSITIONS AND METHODS OF USE) See Plans and Pricing
Australia 2018320946 Amantadine compositions, preparations thereof, and methods of use See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

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Johnson and Johnson
Mallinckrodt
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Harvard Business School
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