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Generic Spritam Availability

Last updated on Sep 8, 2022.

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

SPRITAM (levetiracetam - tablet, for suspension;oral)

  • Manufacturer: APRECIA PHARMS
    Approval date: July 31, 2015
    Strength(s): 1GM [RLD], 250MG [RLD], 500MG [RLD], 750MG [RLD]

Has a generic version of Spritam been approved?

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

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

  • Patent 11,160,786

    Patent expiration dates:

    • March 14, 2034
      ✓ 
      Drug product
  • Rapid disperse dosage form containing levetiracetam
    Patent 9,339,489
    Issued: May 17, 2016
    Assignee(s): Aprecia Pharmaceuticals Company

    A high dose rapidly dispersing three-dimensionally printed dosage form comprising a high dose of levetiracetam in a porous matrix that disperses in water within a period of less than about 10 seconds is disclosed. Also disclosed are methods of preparing the dosage form and of treating a condition, disease or disorder that is therapeutically responsive to levetiracetam.

    Patent expiration dates:

    • March 14, 2034
      ✓ 
      Patent use: METHOD OF ADMINISTERING LEVETIRACETAM
      ✓ 
      Drug product
  • Rapid disperse dosage form containing levetiracetam
    Patent 9,669,009
    Issued: June 6, 2017
    Assignee(s): Aprecia Pharmaceuticals Company

    A high dose rapidly dispersing three-dimensionally printed dosage form comprising a high dose of levetiracetam in a porous matrix that disperses in water within a period of less than about 15 seconds is disclosed. Also disclosed are methods of preparing the dosage form and of treating a condition, disease or disorder that is therapeutically responsive to levetiracetam.

    Patent expiration dates:

    • March 14, 2034
      ✓ 
      Patent use: METHOD OF ADMINISTERING LEVETIRACETAM
    • March 14, 2034
      ✓ 
      Patent use: METHOD OF ADMINISTERING LEVETIRACETAM UNDER FASTED CONDITIONS
    • March 14, 2034
      ✓ 
      Patent use: METHOD OF ADMINISTERING LEVETIRACETAM UNDER FED CONDITIONS

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.

Medical Disclaimer