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Generic Nityr Availability

Last updated on Jun 8, 2022.

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

NITYR (nitisinone - tablet;oral)

  • Manufacturer: CYCLE PHARMS LTD
    Approval date: July 26, 2017
    Strength(s): 2MG [RLD], 5MG [RLD], 10MG [RLD]

Has a generic version of Nityr been approved?

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

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

  • Pharmaceutical composition
    Patent 10,328,029
    Issued: June 25, 2019

    The present invention relates to oral pharmaceutical compositions comprising nitisinone, or a pharmaceutically acceptable salt thereof, their use in the treatment of tyrosinemia, such as Hereditary Tyrosinemia type-1 (HT-1), or alkaptonuria. The compositions have improved stability characteristics. The invention also relates to processes for producing nitisinone.

    Patent expiration dates:

    • January 5, 2035
      Drug product


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.