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Generic Spritam Availability

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 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.

  • Dosage form exhibiting rapid disperse properties, methods of use and process for the manufacture of same
    Patent 6,471,992
    Issued: October 29, 2002
    Inventor(s): Jaedeok; Yoo & Sandeep; Kumar & Donald C.; Monkhouse
    Assignee(s): Therics, Inc.

    A rapidly dispersing dosage form is described, which releases its active ingredients within a period of less than about ninety seconds. These dosage forms exhibit a three-dimensional shape that is retained for adequate storage but is readily dispersed in the presence of excess moisture. Also disclosed are methods of administration of a medicament and a process for the preparation of rapidly dispersing dosage forms.

    Patent expiration dates:

    • February 20, 2018
      ✓ 
      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
  • Dosage form exhibiting rapid disperse properties, methods of use and process for the manufacture of same
    Patent 9,463,160
    Issued: October 11, 2016
    Assignee(s): Massachusetts Institute of Technology

    A rapidly dispersing dosage form is described. The dosage form releases its active ingredients within a period of less than about ninety seconds. These dosage forms exhibit a three-dimensional shape that is retained for adequate storage but is readily dispersed in the presence of excess moisture. Also disclosed are methods of administration of a medicament and a process for the preparation of rapidly dispersing dosage forms.

    Patent expiration dates:

    • February 20, 2018
      ✓ 
      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 FED CONDITIONS
    • March 14, 2034
      ✓ 
      Patent use: METHOD OF ADMINISTERING LEVETIRACETAM UNDER FASTED CONDITIONS

Further information

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

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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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