Skip to main content
Print Save

Generic Onureg Availability

Last updated on May 11, 2023.

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

ONUREG (azacitidine - tablet;oral)

  • Manufacturer: BRISTOL
    Approval date: September 1, 2020
    Strength(s): 200MG [RLD], 300MG [RLD]

Has a generic version of Onureg been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Onureg. 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 11,571,436

    Patent expiration dates:

    • May 14, 2029
      ✓ 
      Drug product
  • Oral formulations of cytidine analogs and methods of use thereof
    Patent 8,846,628
    Issued: September 30, 2014
    Assignee(s): Celgene Corporation

    The present disclosure provides pharmaceutical compositions comprising cytidine analogs, for example, 5-azacytidine or decitabine, for oral administration, wherein the compositions release the cytidine analog, for example, 5-azacytidine or decitabine, substantially in the stomach. Also provided are methods of treating diseases and disorders using the oral formulations provided herein.

    Patent expiration dates:

    • June 3, 2030
      ✓ 
      Patent use: CONTINUED TREATMENT OF ADULTS WITH ACUTE MYELOID LEUKEMIA WHO ACHIEVED FIRST COMPLETE REMISSION (CR) OR CR WITH INCOMPLETE BLOOD COUNT RECOVERY FOLLOWING INTENSIVE INDUCTION CHEMOTHERAPY AND ARE NOT ABLE TO COMPLETE INTENSIVE CURATIVE THERAPY
      ✓ 
      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:

    • September 1, 2023 - NEW PRODUCT
    • September 1, 2027 - INDICATED FOR CONTINUED TREATMENT OF ADULT PATIENTS WITH ACUTE MYELOID LEUKEMIA WHO ACHIEVED FIRST COMPLETE REMISSION (CR) OR COMPLETE REMISSION WITH INCOMPLETE BLOOD COUNT RECOVERY (CRI) FOLLOWING INTENSIVE INDUCTION CHEMOTHERAPY AND ARE NOT ABLE TO COMP

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.

Medical Disclaimer