Skip to main content

Generic Azstarys Availability

Last updated on Aug 10, 2022.

Azstarys is a brand name of dexmethylphenidate/serdexmethylphenidate, approved by the FDA in the following formulation(s):

AZSTARYS (dexmethylphenidate hydrochloride; serdexmethylphenidate chloride - capsule;oral)

  • Manufacturer: COMMAVE THERAP
    Approval date: May 7, 2021
    Strength(s): EQ 5.2MG BASE;EQ 26.1MG BASE [RLD], EQ 7.8MG BASE;EQ 39.2MG BASE [RLD], EQ 10.4MG BASE;EQ 52.3MG BASE [RLD]

Has a generic version of Azstarys been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Azstarys. 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 10,584,112

    Patent expiration dates:

    • December 9, 2037
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Patent 10,584,113

    Patent expiration dates:

    • December 9, 2037
      ✓ 
      Drug product
  • Patent 10,759,778

    Patent expiration dates:

    • December 9, 2037
      ✓ 
      Drug product
  • Patent 10,858,341

    Patent expiration dates:

    • December 9, 2037
      ✓ 
      Patent use: TREATMENT OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER (ADHD) WITH SERDEXMETHYLPHENIDATE AND DEXMETHYLPHENIDATE
  • Patent 10,954,213

    Patent expiration dates:

    • December 9, 2037
      ✓ 
      Patent use: TREATMENT OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER (ADHD) WITH SERDEXMETHYLPHENIDATE AND DEXMETHYLPHENIDATE
  • Methylphenidate-oxoacid conjugates, processes of making and using the same
    Patent 9,079,928
    Issued: July 14, 2015
    Assignee(s): KemPharm, Inc.

    The present technology is directed to prodrugs and compositions for the treatment of various diseases and/or disorders comprising methylphenidate, or methylphenidate derivatives, conjugated to at least one alcohol, amine, oxoacid, thiol, or derivatives thereof. In some embodiments, the conjugates further include at least one linker. The present technology also relates to the synthesis of methylphenidate, or methylphenidate derivatives, conjugated to at least one alcohol, amine, oxoacid, thiol, or derivatives thereof or combinations thereof.

    Patent expiration dates:

    • July 27, 2032
      ✓ 
      Drug product

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:

    • May 7, 2026 - NEW CHEMICAL ENTITY

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.