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Generic Mydayis Availability

Last updated on Sep 8, 2021.

Mydayis is a brand name of amphetamine/dextroamphetamine, approved by the FDA in the following formulation(s):

MYDAYIS (amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate - capsule, extended release;oral)

  • Manufacturer: TAKEDA PHARMS USA
    Approval date: June 20, 2017
    Strength(s): 3.125MG;3.125MG;3.125MG;3.125MG [RLD], 6.25MG;6.25MG;6.25MG;6.25MG [RLD], 9.375MG;9.375MG;9.375MG;9.375MG [RLD], 12.5MG;12.5MG;12.5MG;12.5MG [RLD]

Has a generic version of Mydayis been approved?

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

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

  • Sustained release delivery of amphetamine salts
    Patent 6,913,768
    Issued: July 5, 2005
    Inventor(s): Couch; Richard A. & Burnside; Beth A. & Chang; Rong-Kun
    Assignee(s): Shire Laboratories, Inc.

    A pharmaceutical composition comprises a once-a-day sustained release formulation of at least one amphetamine salt which provides mean plasma concentration profile aspects in human ADHD patients which are substantially the same as that provided by ADDERALL XR® type pulsatile formulations.

    Patent expiration dates:

    • May 24, 2023
      ✓ 
      Patent use: TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER
      ✓ 
      Drug product
  • Controlled dose drug delivery system
    Patent 8,846,100
    Issued: September 30, 2014
    Assignee(s): Shire LLC

    A multiple pulsed dose drug delivery system for pharmaceutically active amphetamine salts, comprising a pharmaceutically active amphetamine salt covered with an immediate-release coating and a pharmaceutically active amphetamine salt covered with an enteric coating wherein the immediate release coating and the enteric coating provide for multiple pulsed dose delivery of the pharmaceutically active amphetamine salt. The product can be composed of either one or a number of beads in a dosage form, including either capsule, tablet, or sachet method for administering the beads.

    Patent expiration dates:

    • August 24, 2029
      ✓ 
      Drug product
  • Controlled dose drug delivery system
    Patent 9,173,857
    Issued: November 3, 2015
    Assignee(s): Shire LLC

    A multiple pulsed dose drug delivery system for pharmaceutically active amphetamine salts, comprising a pharmaceutically active amphetamine salt covered with an immediate-release coating and a pharmaceutically active amphetamine salt covered with an enteric coating wherein the immediate release coating and the enteric coating provide for multiple pulsed dose delivery of the pharmaceutically active amphetamine salt. The product can be composed of either one or a number of beads in a dosage form, including either capsule, tablet, or sachet method for administering the beads.

    Patent expiration dates:

    • May 12, 2026
      ✓ 
      Patent use: TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER

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:

    • September 13, 2022 - INFORMATION ADDED TO THE LABELING TO DESCRIBE A TRIAL EVALUATING A LOWER DOSE THAN THOSE APPROVED FOR PEDIATRIC PATIENTS 13 TO 17 YEARS OF AGE
    • March 13, 2023 - PEDIATRIC EXCLUSIVITY

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.