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Generic Oxbryta Availability

Last updated on Jan 11, 2023.

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

OXBRYTA (voxelotor - tablet, for suspension;oral)

  • Manufacturer: GLOBAL BLOOD THERAPS
    Approval date: December 17, 2021
    Strength(s): 300MG [RLD]

OXBRYTA (voxelotor - tablet;oral)

  • Manufacturer: GLOBAL BLOOD THERAPS
    Approval date: November 25, 2019
    Strength(s): 500MG [RLD]
  • Manufacturer: GLOBAL BLOOD THERAPS
    Approval date: October 14, 2022
    Strength(s): 300MG [RLD]

Has a generic version of Oxbryta been approved?

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

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

  • Compounds and uses thereof for the modulation of hemoglobin
    Patent 10,017,491
    Issued: July 10, 2018
    Assignee(s): Global Blood Therapeutics, Inc.

    Provide herein are compounds and pharmaceutical compositions suitable as modulators of hemoglobin, methods and intermediates for their preparation, and methods for their use in treating disorders mediated by hemoglobin and disorders that would benefit from tissue and/or cellular oxygenation.

    Patent expiration dates:

    • December 28, 2032
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      Drug product
  • Substituted benzaldehyde compounds and methods for their use in increasing tissue oxygenation
    Patent 10,034,879
    Issued: July 31, 2018
    Assignee(s): Global Blood Therapeutics, Inc.

    Provided are substituted benzaldehydes and derivatives thereof that act as allosteric modulators of hemoglobin, methods and intermediates for their preparation, pharmaceutical compositions comprising the modulators, and methods for their use in treating disorders mediate by hemoglobin and disorders that would benefit from increased tissue oxygenation.

    Patent expiration dates:

    • December 28, 2032
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  • Patent 10,493,035

    Patent expiration dates:

    • October 12, 2037
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      Drug product
  • Patent 10,722,502

    Patent expiration dates:

    • February 6, 2035
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      Drug product
  • Patent 10,806,733

    Patent expiration dates:

    • December 28, 2032
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      Drug substance
  • Patent 11,020,382

    Patent expiration dates:

    • December 2, 2036
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      Patent use: TREATING SICKLE CELL DISEASE BY ADMINISTERING 1500 MG OF VOXELOTOR ORALLY ONCE DAILY
    • December 2, 2036
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      Patent use: INCREASING HEMOGLOBIN TO TREAT SICKLE CELL DISEASE BY ADMINISTERING 1500 MG OF VOXELOTOR ORALLY ONCE DAILY
  • Patent 11,452,720

    Patent expiration dates:

    • February 6, 2035
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      Patent use: TREATING SICKLE CELL DISEASE BY ADMINISTERING VOXELOTOR AND ANOTHER ACTIVE AGENT
  • Substituted benzaldehyde compounds and methods for their use in increasing tissue oxygenation
    Patent 9,018,210
    Issued: April 28, 2015
    Assignee(s): Global Blood Therapeutics, Inc. Cytokinetics, Inc. The Regents of the University of California

    Provided are substituted benzaldehydes and derivatives thereof that act as allosteric modulators of hemoglobin, methods and intermediates for their preparation, pharmaceutical compositions comprising the modulators, and methods for their use in treating disorders mediate by hemoglobin and disorders that would benefit from increased tissue oxygenation.

    Patent expiration dates:

    • November 25, 2033
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  • 1:1 adducts of sickle hemoglobin
    Patent 9,248,199
    Issued: February 2, 2016
    Assignee(s): GLOBAL BLOOD THERAPEUTICS, INC.

    Provide herein are 1:1 adducts of sickle hemoglobin (HbS) and a compound of formula (I), as defined herein, suitable as modulators of HbS, and methods for their use in treating disorders mediated by hemoglobin and disorders that would benefit from tissue and/or cellular oxygenation.

    Patent expiration dates:

    • January 29, 2034
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      Patent use: TREATMENT OF SICKLE CELL DISEASE BY ADMINISTERING VOXELOTOR, AS RECITED IN CLAIM 1
    • January 29, 2034
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      Patent use: TREATMENT OF SICKLE CELL DISEASE BY ADMINISTERING VOXELOTOR, AS RECITED IN CLAIM 2
  • Crystalline polymorphs of the free base of 2-hydroxy-6-((2-(1-isopropyl-1H-pyrazol-5-yl)pyridin-3-yl)methoxy)benzaldehyde
    Patent 9,447,071
    Issued: September 20, 2016
    Assignee(s): Global Blood Therapeutics, Inc.

    Disclosed are crystalline free base ansolvate forms of 2-hydroxy-6-((2-(1-isopropyl-1H-pyrazol-5-yl)pyridin-3-yl)methoxy)benzaldehyde (or Compound 1), such as the free base Form I, Form II and Material N. Also disclosed are crystalline free base solvates of 2-hydroxy-6-((2-(1-isopropyl-1H-pyrazol-5-yl)pyridin-3-yl)methoxy)benzaldehyde (or Compound 1).

    Patent expiration dates:

    • February 6, 2035
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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 25, 2024 - NEW CHEMICAL ENTITY
    • November 25, 2026 - INDICATED FOR THE TREATMENT OF SICKLE CELL DISEASE (SCD) IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER

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.

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