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Generic Evekeo ODT Availability

Last updated on Aug 11, 2021.

Evekeo ODT is a brand name of amphetamine, approved by the FDA in the following formulation(s):

EVEKEO ODT (amphetamine sulfate - tablet, orally disintegrating;oral)

  • Manufacturer: ARBOR PHARMS LLC
    Approval date: January 30, 2019
    Strength(s): 15MG [RLD], 20MG [RLD], 5MG [RLD], 10MG [RLD]
  • Manufacturer: ARBOR PHARMS LLC
    Approval date: April 16, 2021
    Strength(s): 2.5MG (discontinued) [RLD]

Has a generic version of Evekeo ODT been approved?

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

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

  • Taste-masked pharmaceutical compositions
    Patent 10,130,580
    Issued: November 20, 2018
    Assignee(s): ADARE PHARMACEUTICALS, INC.

    There is provided a method for preparing an orally disintegrating tablet (ODT) composition comprising microparticles of one or more taste-masked active pharmaceutical ingredient(s), rapidly-dispersing microgranules, and other optional, pharmaceutically acceptable excipients wherein the ODT disintegrates on contact with saliva in the buccal cavity in about 60 seconds forming a smooth, easy-to-swallow suspension. Furthermore, the microparticles (crystals, granules, beads or pellets containing the active) applied with a taste-masking membrane comprising a combination of water-insoluble and gastrosoluble polymers release not less than about 60% of the dose is in the stomach in about 30 minutes, thus maximizing the probability of achieving bioequivalence to the reference IR product having rapid onset of action (short Tmax). A process for preparing such compositions for oral administration using conventional fluid-bed equipment and rotary tablet press is also disclosed.

    Patent expiration dates:

    • April 19, 2024
      ✓ 
      Drug product
  • Patent 10,441,554

    Patent expiration dates:

    • March 10, 2037
      ✓ 
      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.