Generic Vanflyta Availability
Last updated on Dec 12, 2024.
Vanflyta is a brand name of quizartinib, approved by the FDA in the following formulation(s):
VANFLYTA (quizartinib dihydrochloride - tablet;oral)
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Manufacturer: DAIICHI SANKYO INC
Approval date: July 20, 2023
Strength(s): EQ 17.7MG BASE [RLD], EQ 26.5MG BASE [RLD]
Has a generic version of Vanflyta been approved?
No. There is currently no therapeutically equivalent version of Vanflyta available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Vanflyta. 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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Patent 7,820,657
Patent expiration dates:
- September 26, 2028✓
- September 26, 2028
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Patent 7,968,543
Patent expiration dates:
- August 15, 2029✓✓
- August 15, 2029
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Method of using imidazolothiazole compounds for the treatment of disease
Patent 8,129,374
Issued: March 6, 2012
Inventor(s): Bhagwat Shripad & Chao Qi & Grotzfeld Robert M. & Patel Hitesh K. & Sprankle Kelly G.
Assignee(s): Ambit Bioscience CorporationCompounds, compositions and methods are provided for modulating the activity of receptor kinases and for the treatment, prevention, or amelioration of one or more symptoms of disease or disorder mediated by receptor kinases.
Patent expiration dates:
- March 16, 2027✓
- March 16, 2027
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Methods of treatment using combination therapy
Patent 8,357,690
Issued: January 22, 2013
Inventor(s): Armstrong Robert C. & Belli Barbara A.
Assignee(s): Ambit Biosciences CorporationProvided herein are methods of treating a proliferative disease in a subject, comprising administering to the subject a therapeutically effective amount of AC220 and a nucleoside analog, a topoisomerase inhibitor or an anthracycline, or a combination thereof.
Patent expiration dates:
- February 26, 2031✓
- February 26, 2031
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Imidazolothiazole compounds for the treatment of disease
Patent 8,557,810
Issued: October 15, 2013
Inventor(s): Bhagwat Shripad & Chao Qi & Grotzfeld Robert M. & Patel Hitesh K. & Sprankle Kelly G.
Assignee(s): Ambit Biosciences CorporationCompounds, compositions and methods are provided for modulating the activity of receptor kinases and for the treatment, prevention, or amelioration of one or more symptoms of disease or disorder mediated by receptor kinases.
Patent expiration dates:
- March 16, 2027✓
- March 16, 2027
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Methods of treatment using combination therapy
Patent 8,836,218
Issued: September 16, 2014
Inventor(s): Armstrong Robert C. & Belli Barbara A.
Assignee(s): Ambit Biosciences CorporationProvided herein are methods of treating a proliferative disease in a subject, comprising administering to the subject a therapeutically effective amount of AC220 and a nucleoside analog, a topoisomerase inhibitor or an anthracycline, or a combination thereof.
Patent expiration dates:
- March 23, 2030✓
- March 23, 2030
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Methods of treating proliferative diseases
Patent 8,865,710
Issued: October 21, 2014
Inventor(s): Corringham Robert E. & "ODonnell Patrick B." & James Joyce K.
Assignee(s): Ambit Biosciences CorporationProvided herein are methods of administering N-(5-tert-butyl-isoxazol-3-yl)-N′-{4-[7-(2-morpholin-4-yl-ethoxy)imidazo[2,1-b][1,3]benzothiazol-2-yl]phenyl}urea, or a pharmaceutically acceptable salt or solvate thereof, to human patients, including a specific patient population. Specifically, dosing, dosing schedules or dosing regimens are provided herein. Methods of treating proliferative diseases or FLT-3 mediated diseases in humans are also provided.
Patent expiration dates:
- August 15, 2029✓
- August 15, 2029
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Solid forms comprising N-(5-tert-butyl-isoxazol-3-yl)-N′-{4-[7-(2-morpholin-4-yl-ethoxy)imidazo[2,1-b][1,3]benzothiazol-2-yl]phenyl}urea, compositions thereof, and uses therewith
Patent 8,883,783
Issued: November 11, 2014
Inventor(s): Bhagwat Shripad S. & Lai Wei & Parent Stephan D. & Roe Melanie J. & Schwartz Alan & Smolenskaya Valeriya N.
Assignee(s): Ambit Biosciences CorporationSolid forms comprising N-(5-tert-butyl-isoxazol-3-yl)-N′-{4-[7-(2-morpholin-4-yl-ethoxy)imidazo[2,1-b][1,3]benzothiazol-2-yl]phenyl}urea, compositions comprising the solid forms, methods of making the solid forms and methods of their use for the treatment of various diseases and/or disorders are disclosed.
Patent expiration dates:
- March 16, 2027✓
- March 16, 2027
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Methods of treating proliferative diseases
Patent 9,555,040
Issued: January 31, 2017
Inventor(s): Corringham Robert E. & James Joyce K. & "ODonnell Patrick B."
Assignee(s): Ambit Biosciences CorporationProvided herein are methods of administering N-(5-tert-butyl-isoxazol-3-yl)-N′-{4-[7-(2-morpholin-4-yl-ethoxy)imidazo[2,1-b][1,3]benzothiazol-2-yl]phenyl}urea, or a pharmaceutically acceptable salt or solvate thereof, to human patients, including a specific patient population. Specifically, dosing, dosing schedules or dosing regimens are provided herein. Methods of treating proliferative diseases or FLT-3 mediated diseases in humans are also provided.
Patent expiration dates:
- May 14, 2030✓
- May 14, 2030
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Solid forms comprising N-(5-tert-butyl-isoxazol-3-yl)-N′-{4-[7-(2-morpholin-4-yl-ethoxy)imidazo[2,1-b][1,3]benzothiazol-2-yl]phenyl}urea, compositions thereof, and uses therewith
Patent 9,585,892
Issued: March 7, 2017
Inventor(s): Bhagwat Shripad S. & Lai Wei & Parent Stephan D. & Bevill Melanie J. & Schwartz Alan & Smolenskaya Valeriya N.
Assignee(s): Ambit BiosciencesSolid forms comprising N-(5-tert-butyl-isoxazol-3-yl)-N′-{4-[7-(2-morpholin-4-yl-ethoxy)imidazo[2,1-b][1,3]benzothiazol-2-yl]phenyl}urea, compositions comprising the solid forms, methods of making the solid forms and methods of their use for the treatment of various diseases and/or disorders are disclosed.
Patent expiration dates:
- March 16, 2027✓
- March 16, 2027
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Tablet containing composite with cyclodextrin
Patent 9,675,549
Issued: June 13, 2017
Inventor(s): Oba Shinsuke & Toyota Hiroyasu & Ikeuchi Satomi & Hara Takumi & Murayama Emiko & Motonaga Kei
Assignee(s): Ambit Biosciences CorporationProvided herein is a tablet comprising, as a drug, N-(5-tert-butyl-isoxazol-3-yl)-N′-{4-[7-(2-morpholin-4-yl-ethoxy)imidazo[2,1-b][1,3]benzothiazol-2-yl]phenyl}urea or a pharmaceutically acceptable salt thereof, which is a medicament for treating acute myeloid leukemia (AML), the tablet characterized by comprising a composite of N-(5-tert-butyl-isoxazol-3-yl)-N′-{4-[7-(2-morpholin-4-yl-ethoxy)imidazo[2,1-b][1,3]benzothiazol-2-yl]phenyl}urea or a pharmaceutically acceptable salt thereof and hydroxypropyl-β-cyclodextrin in a ratio ranging from 1:8 to 1:20.
Patent expiration dates:
- September 30, 2033✓
- September 30, 2033
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 20, 2028 - NEW CHEMICAL ENTITY
- July 20, 2030 - FOR USE IN COMBINATION WITH STANDARD INDUCTION AND CONSOLIDATION, AND AS MAINTENANCE THERAPY FOLLOWING CONSOLIDATION CHEMOTHERAPY, FOR THE TREATMENT OF ADULT PATIENTS WITH NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) THAT IS FLT3 INTERNAL TANDEM DUPLICATI
More about Vanflyta (quizartinib)
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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
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
