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.
Summary for GOCOVRI
| International Patents: | 31 |
| US Patents: | 18 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 151 |
| Clinical Trials: | 2 |
| Patent Applications: | 7,258 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for GOCOVRI |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for GOCOVRI |
| What excipients (inactive ingredients) are in GOCOVRI? | GOCOVRI excipients list |
| DailyMed Link: | GOCOVRI at DailyMed |
Recent Clinical Trials for GOCOVRI
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Oregon Health and Science University | Phase 4 |
| Adamas Pharmaceuticals, Inc. | Phase 4 |
| Columbia University | Phase 4 |
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
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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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