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Generic Inqovi Availability

Medically reviewed by Drugs.com. Last updated on May 11, 2021.

Inqovi is a brand name of cedazuridine/decitabine, approved by the FDA in the following formulation(s):

INQOVI (cedazuridine; decitabine - tablet;oral)

  • Manufacturer: OTSUKA
    Approval date: July 7, 2020
    Strength(s): 100MG;35MG [RLD]

Has a generic version of Inqovi been approved?

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

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

  • Certain compounds, compositions and methods
    Patent 8,268,800
    Issued: September 18, 2012
    Inventor(s): Hamilton; Gregory S. & Tsukamoto; Takashi & Ferraris; Dana V. & Duvall; Bridget & Lapidus; Rena
    Assignee(s): Eisai Inc.

    The present invention provides certain tetrahydrouridine derivative compounds, pharmaceutical compositions and kits comprising such compounds, and methods of making and using such compounds.

    Patent expiration dates:

    • August 22, 2030
      ✓ 
      Patent use: TREATMENT OF CHRONIC MYELOMONOCYTIC LEUKEMIA
      ✓ 
      Drug substance
    • August 22, 2030
      ✓ 
      Patent use: TREATMENT OF MYELODYSPLASTIC SYNDROME
      ✓ 
      Drug substance
    • August 22, 2030
      ✓ 
      Patent use: METHOD FOR INHIBITING CYTIDINE DEAMINASE BY ADMINISTERING CEDAZURIDINE
      ✓ 
      Drug substance
    • August 22, 2030
      ✓ 
      Patent use: METHOD FOR INHIBITING DEGRADATION OF A CDA SUBSTRATE BY ADMINISTERING CEDAZURIDINE
      ✓ 
      Drug substance
  • Certain compounds, compositions and methods
    Patent 8,618,075
    Issued: December 31, 2013
    Assignee(s): Eisai Inc.

    The present invention provides certain tetrahydrouridine derivative compounds, pharmaceutical compositions and kits comprising such compounds, and methods of making and using such compounds.

    Patent expiration dates:

    • October 16, 2028
      ✓ 
      Patent use: METHOD FOR INHIBITING CYTIDINE DEAMINASE BY ADMINISTERING CEDAZURIDINE
    • October 16, 2028
      ✓ 
      Patent use: METHOD FOR INHIBITING DEGRADATION OF A CDA SUBSTRATE BY ADMINISTERING CEDAZURIDINE
  • Certain compounds, compositions and methods
    Patent 9,567,363
    Issued: February 14, 2017
    Assignee(s): OTSUKA PHARMACEUTICAL CO., LTD.

    The present invention provides certain tetrahydrouridine derivative compounds, pharmaceutical compositions and kits comprising such compounds, and methods of making and using such compounds.

    Patent expiration dates:

    • October 16, 2028
      ✓ 
      Drug substance

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:

    • July 7, 2025 - NEW CHEMICAL ENTITY
    • July 7, 2027 -

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.