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Generic Gralise Availability

Last updated on July 7, 2021.

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

GRALISE (gabapentin - tablet;oral)

  • Manufacturer: ALMATICA
    Approval date: January 28, 2011
    Strength(s): 300MG [RLD] [BX], 600MG [RLD] [BX]

Has a generic version of Gralise been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Gralise. 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 FAQ.

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.

  • Optimal polymer mixtures for gastric retentive tablets
    Patent 6,723,340
    Issued: April 20, 2004
    Inventor(s): Gloria; Gusler & Bret; Berner & Mei; Chau & Aimee; Padua
    Assignee(s): DepoMed, Inc.

    Unit dosage form tablets for the delivery of pharmaceuticals are formed of the pharmaceutical dispersed in a solid unitary matrix that is formed of a combination of poly(ethylene oxide) and hydroxypropyl methylcellulose. The combination offers unique benefits in terms of release rate control and reproducibility while allowing both swelling of the tablet to effect gastric retention and gradual disintegration of the tablet to clear the tablet from the gastrointestinal tract after release of the drug has occurred.

    Patent expiration dates:

    • October 25, 2021
      ✓ 
      Drug product
  • Methods of treatment using a gastric retained gabapentin dosage
    Patent 7,438,927
    Issued: October 21, 2008
    Inventor(s): Berner; Bret & Hou; Sui Yuen Eddie & Gusler; Gloria M.
    Assignee(s): Depomed, Inc.

    A method of treatment for epilepsy and other disease states is described, which comprises the delivery of gabapentin in a gastric retained dosage form.

    Patent expiration dates:

    • February 26, 2024
      ✓ 
      Patent use: TREATMENT WITH GABAPENTIN, INCLUDING TREATMENT OF NEUROPATHIC PAIN, INCLUDING NEUROPATHIC PAIN ASSOCIATED WITH POSTHERPETIC NEURALGIA
  • Gastric retained gabapentin dosage form
    Patent 7,731,989
    Issued: June 8, 2010
    Inventor(s): Berner; Bret & Hou; Sui Yuen Eddie & Gusler; Gloria M.
    Assignee(s): Depomed, Inc.

    A method of treatment for epilepsy and other disease states is described, which comprises the delivery of gabapentin in a gastric retained dosage form.

    Patent expiration dates:

    • October 25, 2022
      ✓ 
      Drug product
  • Gastric retained gabapentin dosage form
    Patent 8,192,756
    Issued: June 5, 2012
    Inventor(s): Berner; Bret & Hou; Sui Yuen Eddie & Gusler; Gloria M
    Assignee(s): Depomed, Inc.

    A method of treatment for epilepsy and other disease states is described, which comprises the delivery of gabapentin in a gastric retained dosage form.

    Patent expiration dates:

    • October 25, 2022
      ✓ 
      Patent use: TREATMENT WITH GABAPENTIN, INCLUDING TREATMENT OF NEUROPATHIC PAIN, INCLUDING NEUROPATHIC PAIN ASSOCIATED WITH POSTHERPETIC NEURALGIA
      ✓ 
      Drug product
  • Gastric retained gabapentin dosage form
    Patent 8,252,332
    Issued: August 28, 2012
    Inventor(s): Berner; Bret & Hou; Sui Yuen Eddie & Gusler; Gloria M.

    A method of treatment for epilepsy and other disease states is described, which comprises the delivery of gabapentin in a gastric retained dosage form.

    Patent expiration dates:

    • October 25, 2022
      ✓ 
      Patent use: TREATMENT WITH GABAPENTIN, INCLUDING TREATMENT OF NEUROPATHIC PAIN, INCLUDING NEUROPATHIC PAIN ASSOCIATED WITH POSTHERPETIC NEURALGIA
      ✓ 
      Drug product
  • Gastric retained gabapentin dosage form
    Patent 8,333,992
    Issued: December 18, 2012
    Inventor(s): Berner; Bret & Hou; Sui Yuen Eddie & Gusler; Gloria M.
    Assignee(s): Depomed, Inc.

    A method of treatment for epilepsy and other disease states is described, which comprises the delivery of gabapentin in a gastric retained dosage form.

    Patent expiration dates:

    • October 25, 2022
      ✓ 
      Patent use: TREATMENT WITH GABAPENTIN, INCLUDING TREATMENT OF NEUROPATHIC PAIN, INCLUDING NEUROPATHIC PAIN ASSOCIATED WITH POSTHERPETIC NEURALGIA
      ✓ 
      Drug product

Glossary

Term Definition
Drug Patent A 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 Exclusivity Exclusivity 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.
RLD A 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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.