Generic Horizant Availability

Horizant is a brand name of gabapentin enacarbil, approved by the FDA in the following formulation(s):

HORIZANT (gabapentin enacarbil - tablet, extended release;oral)

  • Manufacturer: XENOPORT INC
    Approval date: April 6, 2011
    Strength(s): 600MG [RLD]
  • Manufacturer: XENOPORT INC
    Approval date: December 13, 2011
    Strength(s): 300MG

Has a generic version of Horizant been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Horizant. 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: About generic drugs.

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.

  • Prodrugs of GABA analogs, compositions and uses thereof
    Patent 6,818,787
    Issued: November 16, 2004
    Inventor(s): Mark A.; Gallop & Kenneth C.; Cundy & Cindy X.; Zhou & Fenmei; Yao & Jia-Ning; Xiang
    Assignee(s): Xenoport, Inc.
    The present invention provides prodrugs of GABA analogs, pharmaceutical compositions of prodrugs of GABA analogs and methods for making prodrugs of GABA analogs. The present invention also provides methods for using prodrugs of GABA analogs and methods for using pharmaceutical compositions of prodrugs of GABA analogs for treating or preventing common diseases and/or disorders.
    Patent expiration dates:
    • November 6, 2022
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  • Crystalline form of γ-aminobutyric acid analog
    Patent 8,026,279
    Issued: September 27, 2011
    Inventor(s): Estrada; Tono & Raillard; Stephen P.
    Assignee(s): XenoPort, Inc.
    A crystalline form of a γ-aminobutyric acid analog, and methods of preparing same, are provided.
    Patent expiration dates:
    • November 10, 2026
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  • Prodrugs of GABA analogs, compositions and uses thereof
    Patent 8,048,917
    Issued: November 1, 2011
    Inventor(s): Gallop; Mark A. & Cundy; Kenneth C. & Zhou; Cindy X. & Yao; Fenmei & Xiang; Jia-Ning
    Assignee(s): XenoPort, Inc.
    The present invention provides prodrugs of GABA analogs, pharmaceutical compositions of prodrugs of GABA analogs and methods for making prodrugs of GABA analogs. The present invention also provides methods for using prodrugs of GABA analogs and methods for using pharmaceutical compositions of prodrugs of GABA analogs for treating or preventing common diseases and/or disorders.
    Patent expiration dates:
    • November 6, 2022
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      Patent use: MANAGEMENT OF POSTHERPETIC NEURALGIA (PHN) IN ADULTS
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  • Treating or preventing restless legs syndrome using prodrugs of GABA analogs
    Patent 8,114,909
    Issued: February 14, 2012
    Inventor(s): Barrett; Ronald W. & Canafax; Daniel M.
    Assignee(s): XenoPort, Inc.
    Disclosed herein are methods of using prodrugs of gamma aminobutyric acid (GABA) analogs and pharmaceutical compositions thereof to treat or prevent restless legs syndrome in humans, and pharmaceutical compositions of prodrugs of GABA analogs useful in treating or preventing restless legs syndrome.
    Patent expiration dates:
    • April 11, 2026
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      Patent use: TREATMENT OF MODERATE-TO-SEVERE PRIMARY RESTLESS LEG SYNDROME IN ADULTS
  • Crystalline form of γ-aminobutyric acid analog
    Patent 8,686,034
    Issued: April 1, 2014
    Assignee(s): XenoPort, Inc.
    A crystalline form of a γ-aminobutyric acid analog, and methods of preparing same, are provided.
    Patent expiration dates:
    • January 24, 2025
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      Patent use: TREATMENT OF MODERATE-TO-SEVERE PRIMARY RESTLESS LEG SYNDROME IN ADULTS
    • January 24, 2025
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      Patent use: MANAGEMENT OF POSTHERPETIC NEURALGIA (PHN) IN ADULTS
  • GABA analog prodrug sustained release oral dosage forms
    Patent 8,795,725
    Issued: August 5, 2014
    Assignee(s): XenoPort, Inc.
    Sustained release oral dosage forms of a gabapentin prodrug, 1-{[(α-isobutanoyloxyethoxy)carbonyl]aminomethyl}-1-cyclohexane acetic acid, are disclosed. The dosage forms are useful for treating or preventing diseases and disorders for which gabapentin is therapeutically effective.
    Patent expiration dates:
    • June 10, 2029
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      Patent use: MANAGEMENT OF POSTHERPETIC NEURALGIA (PHN) IN ADULTS
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    • June 10, 2029
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      Patent use: TREATMENT OF MODERATE-TO-SEVERE PRIMARY RESTLESS LEG SYNDROME IN ADULTS
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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:
    • June 6, 2015 - MANAGEMENT OF POSTHERPETIC NEURALGIA
    • April 6, 2016 -
    • June 6, 2019 -

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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