Generic Oxbryta Availability
Last updated on Aug 7, 2024.
Oxbryta is a brand name of voxelotor, approved by the FDA in the following formulation(s):
OXBRYTA (voxelotor - tablet, for suspension;oral)
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Manufacturer: GLOBAL BLOOD THERAPS
Approval date: December 17, 2021
Strength(s): 300MG [RLD]
OXBRYTA (voxelotor - tablet;oral)
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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.
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Compounds and uses thereof for the modulation of hemoglobin
Patent 10,017,491
Issued: July 10, 2018
Inventor(s): Metcalf Brian W. & Chuang Chihyuan
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✓
- December 28, 2032
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Substituted benzaldehyde compounds and methods for their use in increasing tissue oxygenation
Patent 10,034,879
Issued: July 31, 2018
Inventor(s): Metcalf Brian & Chuang Chihyuan
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✓✓
- December 28, 2032
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Tablets comprising 2-hydroxy-6-((2-(1-isopropyl-1H-pyrazol-5-yl)pyridin-3-yl)methoxy)benzaldehyde
Patent 10,493,035
Issued: December 3, 2019
Inventor(s): Dalziel Sean Mark & Bejugam Naveen & Habibizad Nazila & Komeyli Ali & Leung DeMei
Assignee(s): Global Blood Therapeutics, Inc.Provided herein are high strength/high drug load tablets comprising 2-hydroxy-6-((2-(1-isopropyl-1H-pyrazol-5-yl)pyridin-3-yl)methoxy)benzaldehyde (“Compound 1”), dispersible tablets comprising Compound 1, processes of manufacturing such tablets, and methods for treating patients with the tablets. Compound 1 is useful for treating hematological disorders such as sickle cell disease, pulmonary disease such as idiopathic pulmonary fibrosis, and hypoxia and hypoxemia conditions.
Patent expiration dates:
- October 12, 2037✓
- October 12, 2037
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Crystalline polymorphs of the free base of 2-hydroxy-6-((2-(1-isopropyl-1H-pyrazol-5-yl)pyridin-3-yl)methoxy)benzaldehyde
Patent 10,722,502
Issued: July 28, 2020
Inventor(s): Li Zhe & Parent Stephan D. & Houston Travis
Assignee(s): Global Blood Therapeutics, Inc.Disclosed are crystalline free base an solvate 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✓
- February 6, 2035
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Substituted benzaldehyde compounds and methods for their use in increasing tissue oxygenation
Patent 10,806,733
Issued: October 20, 2020
Inventor(s): Metcalf Brian & Chuang Chihyuan
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✓
- December 28, 2032
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Dosing regimens for 2-hydroxy-6-((2-(1-isopropyl-1h-pyrazol-5-yl)pyridin-3-yl)methoxy)benzaldehyde
Patent 11,020,382
Issued: June 1, 2021
Inventor(s): Ramos Eleanor L. & Lehrer-Graiwer Joshua Eli & Hutchaleelaha Athiwat
Assignee(s): Global Blood Therapeutics, Inc.Provided herein are methods for treating sickle cell disease, comprising administering to a subject 2-hydroxy-6-((2-(1-isopropyl-1H-pyrazol-5-yl)pyridin-3-yl)-methoxy)benzaldehyde (Compound 1), or a polymorph thereof, in certain dosing regimens.
Patent expiration dates:
- December 2, 2036✓
- December 2, 2036✓
- December 2, 2036
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Patent 11,452,720
Patent expiration dates:
- February 6, 2035✓
- February 6, 2035
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Patent 11,944,612
Patent expiration dates:
- December 2, 2036✓
- December 2, 2036
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Substituted benzaldehyde compounds and methods for their use in increasing tissue oxygenation
Patent 9,018,210
Issued: April 28, 2015
Inventor(s): Metcalf Brian & Chuang ChihyuanProvided 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✓✓
- November 25, 2033
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1:1 adducts of sickle hemoglobin
Patent 9,248,199
Issued: February 2, 2016
Inventor(s): Metcalf Brian W.
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✓
- January 29, 2034✓
- January 29, 2034
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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
Inventor(s): Li Zhe & Parent Stephan D. & Houston Travis
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✓✓
- February 6, 2035
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
- December 17, 2028 - FOR TREATMENT OF SICKLE CELL DISEASE (SCD) IN PEDIATRIC PATIENTS 4 YEARS OF AGE TO LESS THAN 12 YEARS OF AGE
More about Oxbryta (voxelotor)
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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
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