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Generic Xospata Availability

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

XOSPATA (gilteritinib fumarate - tablet;oral)

  • Manufacturer: ASTELLAS
    Approval date: November 28, 2018
    Strength(s): EQ 40MG BASE [RLD]

Has a generic version of Xospata been approved?

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

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

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 10,786,500

    Patent expiration dates:

    • July 1, 2036
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      Drug product
  • Diamino heterocyclic carboxamide compound
    Patent 8,969,336
    Issued: March 3, 2015
    Assignee(s): Astellas Pharma Inc. Kotobuki Pharmaceutical Co., Ltd.

    Provided is a compound useful as an inhibitor against the kinase activity of EML4-ALK fusion protein. As a result of intensive and extensive studies on compounds having inhibitory activity against the kinase activity of EML4-ALK fusion protein, the present inventors found that the diamino heterocyclic carboxamide compounds of the present invention had inhibitory activity against the kinase activity of EML4-ALK fusion protein. By this finding, the present invention was completed. The compounds of the present invention can be used as a pharmaceutical composition for preventing and/or treating cancer, such as lung cancer, non-small cell lung cancer, and small cell lung cancer.

    Patent expiration dates:

    • January 27, 2031
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Diamino heterocyclic carboxamide compound
    Patent 9,487,491
    Issued: November 8, 2016
    Assignee(s): ASTELLAS PHARMA INC. KOTOBUKI PHARMACEUTICAL CO., LTD.

    Provided is a compound useful as an inhibitor against the kinase activity of EML4-ALK fusion protein. As a result of intensive and extensive studies on compounds having inhibitory activity against the kinase activity of EML4-ALK fusion protein, the present inventors found that the diamino heterocyclic carboxamide compounds of the present invention had inhibitory activity against the kinase activity of EML4-ALK fusion protein. By this finding, the present invention was completed. The compounds of the present invention can be used as a pharmaceutical composition for preventing and/or treating cancer, such as lung cancer, non-small cell lung cancer, and small cell lung cancer.

    Patent expiration dates:

    • July 28, 2030
      ✓ 
      Patent use: TREATMENT OF ACUTE MYELOID LEUKEMIA (AML)

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:

    • November 28, 2023 - NEW CHEMICAL ENTITY
    • November 28, 2025 -

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.