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Generic Gocovri Availability

Gocovri is a brand name of amantadine, approved by the FDA in the following formulation(s):

GOCOVRI (amantadine hydrochloride - capsule, extended release;oral)

  • Manufacturer: ADAMAS PHARMA
    Approval date: August 24, 2017
    Strength(s): EQ 68.5MG BASE [RLD], EQ 137MG BASE [RLD]

Has a generic version of Gocovri been approved?

No. There is currently no therapeutically equivalent version of Gocovri available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Gocovri. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: Generic Drug FAQs.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

  • Composition and method for treating neurological disease
    Patent 8,389,578
    Issued: March 5, 2013
    Assignee(s): Adamas Pharmaceuticals, Inc
    The invention provides methods and compositions for treating or preventing neurological disorders.
    Patent expiration dates:
    • January 22, 2028
      ✓ 
      Patent 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 8,741,343
    Issued: June 3, 2014
    Assignee(s): Adamas Pharmaceuticals, Inc.
    Methods of nighttime administration of amantadine to reduce sleep disturbances in patient undergoing treatment with amantadine are described, as well as compositions of extended release amantadine that are suitable for nighttime administration.
    Patent expiration dates:
    • December 2, 2030
      ✓ 
      Patent 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 8,796,337
    Issued: August 5, 2014
    Assignee(s): Adamas Pharmaceutical, Inc.
    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.
    Patent expiration dates:
    • November 23, 2025
      ✓ 
      Patent 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 8,889,740
    Issued: November 18, 2014
    Assignee(s): Adamas Pharmaceuticals, Inc.
    Disclosed are compositions comprising amantadine, or a pharmaceutically acceptable salt thereof, and one or more excipients, wherein at least one of the excipients modifies release of amantadine. Methods of administering the same are also provided.
    Patent expiration dates:
    • November 23, 2025
      ✓ 
      Drug product
  • Composition and method for treating neurological disease
    Patent 8,895,614
    Issued: November 25, 2014
    Assignee(s): Adamas Pharmaceuticals, Inc.
    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.
    Patent expiration dates:
    • November 23, 2025
      ✓ 
      Drug product
  • Composition and method for treating neurological disease
    Patent 8,895,615
    Issued: November 25, 2014
    Assignee(s): Adamas Pharmaceuticals, Inc.
    Disclosed are compositions comprising amantadine, or a pharmaceutically acceptable salt thereof, and one or more excipients, wherein at least one of the excipients modifies release of amantadine. Methods of administering the same are also provided.
    Patent expiration dates:
    • November 23, 2025
      ✓ 
      Patent 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 8,895,616
    Issued: November 25, 2014
    Assignee(s): Adamas Pharmaceuticals, Inc.
    Disclosed are compositions comprising amantadine, or a pharmaceutically acceptable salt thereof, and one or more excipients, wherein at least one of the excipients modifies release of amantadine. Methods of administering the same are also provided.
    Patent expiration dates:
    • November 23, 2025
      ✓ 
      Patent 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 8,895,617
    Issued: November 25, 2014
    Assignee(s): Adamas Pharmaceuticals, Inc.
    Disclosed are compositions comprising amantadine, or a pharmaceutically acceptable salt thereof, and one or more excipients, wherein at least one of the excipients modifies release of amantadine. Methods of administering the same are also provided.
    Patent expiration dates:
    • November 23, 2025
      ✓ 
      Patent 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 8,895,618
    Issued: November 25, 2014
    Assignee(s): Adamas Pharmaceuticals, Inc.
    Disclosed are compositions comprising amantadine, or a pharmaceutically acceptable salt thereof, and one or more excipients, wherein at least one of the excipients modifies release of amantadine. Methods of administering the same are also provided.
    Patent expiration dates:
    • November 23, 2025
      ✓ 
      Drug product
  • Method of administering amantadine prior to a sleep period
    Patent 9,867,791
    Issued: January 16, 2018
    Assignee(s): Adamas Pharma, LLC
    Methods of nighttime administration of amantadine to reduce sleep disturbances in patient undergoing treatment with amantadine are described, as well as compositions of extended release amantadine that are suitable for nighttime administration.
    Patent expiration dates:
    • December 2, 2030
      ✓ 
      Patent 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 9,867,792
    Issued: January 16, 2018
    Assignee(s): Adamas Pharma, LLC
    Methods of nighttime administration of amantadine to reduce sleep disturbances in patient undergoing treatment with amantadine are described, as well as compositions of extended release amantadine that are suitable for nighttime administration.
    Patent expiration dates:
    • December 2, 2030
      ✓ 
      Patent 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 9,867,793
    Issued: January 16, 2018
    Assignee(s): Adamas Pharma, LLC
    Methods of nighttime administration of amantadine to reduce sleep disturbances in patient undergoing treatment with amantadine are described, as well as compositions of extended release amantadine that are suitable for nighttime administration.
    Patent expiration dates:
    • December 2, 2030
      ✓ 
      Patent 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 9,877,933
    Issued: January 30, 2018
    Assignee(s): Adamas Pharma, LLC
    Methods of nighttime administration of amantadine to reduce sleep disturbances in patient undergoing treatment with amantadine are described, as well as compositions of extended release amantadine that are suitable for nighttime administration.
    Patent expiration dates:
    • December 2, 2030
      ✓ 
      Patent 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

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:
    • August 24, 2020 - TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSON'S DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
    • August 24, 2024 -
Glossary
TermDefinition
Drug PatentA drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug ExclusivityExclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLDA Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
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