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Generic Xofluza Availability

Last updated on May 11, 2021.

Xofluza is a brand name of baloxavir marboxil, approved by the FDA in the following formulation(s):

XOFLUZA (baloxavir marboxil - for suspension;oral)

  • Manufacturer: GENENTECH INC
    Approval date: November 23, 2020
    Strength(s): 2MG/ML [RLD]

XOFLUZA (baloxavir marboxil - tablet;oral)

  • Manufacturer: GENENTECH INC
    Approval date: October 24, 2018
    Strength(s): 20MG [RLD], 40MG [RLD]
  • Manufacturer: GENENTECH INC
    Approval date: March 18, 2021
    Strength(s): 80MG [RLD]

Has a generic version of Xofluza been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Xofluza. 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 10,392,406

    Patent expiration dates:

    • April 27, 2036
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      Drug substance
  • Patent 10,633,397

    Patent expiration dates:

    • April 27, 2036
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      Patent use: METHOD FOR TREATING INFLUENZA
    • April 27, 2036
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      Patent use: METHOD FOR POST-EXPOSURE PROPHYLAXIS OF INFLUENZA
  • Patent 10,759,814

    Patent expiration dates:

    • August 9, 2037
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      Drug substance
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      Drug product
  • Substituted polycyclic carbamoylpyridone derivative
    Patent 8,927,710
    Issued: January 6, 2015
    Assignee(s): Shionogi & Co., Ltd.

    This invention provides compounds having antiviral activities especially inhibiting activity for influenza virus, more preferably provides substituted 3-hydroxy-4-pyridone derivatives having cap-dependent endonuclease inhibitory activity.

    Patent expiration dates:

    • May 5, 2031
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      Drug product
  • Substituted polycyclic carbamoyl pyridone derivative prodrug
    Patent 8,987,441
    Issued: March 24, 2015
    Assignee(s): Shionogi & Co., Ltd.

    The present invention provides a compound having antiviral effects, particularly having growth inhibitory activity on influenza viruses, a preferred example of the compound being a substituted 3-hydroxy-4-pyridone derivative prodrug having cap-dependent endonuclease inhibitory activity.

    Patent expiration dates:

    • September 21, 2031
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      Drug substance
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      Drug product
  • Patent 9,815,835

    Patent expiration dates:

    • June 14, 2030
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      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:

    • October 16, 2022 - TREATMENT OF ACUTE UNCOMPLICATED INFLUENZA IN PATIENTS 12 YEARS OF AGE OR OLDER, WHO HAVE BEEN SYMPTOMATIC FOR NO MORE THAN 48 HOURS AND ARE AT HIGH RISK OF DEVELOPING INFLUENZA-RELATED COMPLICATIONS
    • October 24, 2023 - 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.