Generic Axumin Availability
Last updated on Aug 7, 2024.
Axumin is a brand name of fluciclovine F 18, approved by the FDA in the following formulation(s):
AXUMIN (fluciclovine f-18 - solution;intravenous)
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Manufacturer: BLUE EARTH
Approval date: May 27, 2016
Strength(s): 9-221mCi/ML [RLD]
Has a generic version of Axumin been approved?
No. There is currently no therapeutically equivalent version of Axumin available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Axumin. 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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Precursor compound of radioactive halogen-labeled organic compound
Patent 10,010,632
Issued: July 3, 2018
Inventor(s): Ito Osamu & Hayashi Akio & Kurosaki Fumie & Toyama Masahito & Shinmura Toshiyuki & Harano Arinori
Assignee(s): NIHON MEDI-PHYSICS CO., LTD.It is intended to provide a novel amino acid organic compound which can be used as a labeling precursor compound for radioactive halogen-labeled amino acid compounds including [F]FACBC, and which prevents methanol from remaining in the radioactive halogen-labeled amino acid compounds produced therefrom. The novel amino acid organic compound is a compound represented by the following formula:
Patent expiration dates:
- November 28, 2026✓
- November 28, 2026
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Imaging of metastatic or recurrent cancer
Patent 10,124,079
Issued: November 13, 2018
Inventor(s): Miller Matthew & Gauden David & Schuster David & Fanti Stefano & Nanni Cristina & Zanoni Lucia & Willoch Frode & Bogsrud Trond Velde & Bach-Gansmo Tore & Musto Alessandra
Assignee(s): Blue Earth Diagnostics LimitedThe present disclosure relates to methods of administering [F]-FACBC. The present disclosure also relates to use of [F]-FACBC in methods for imaging, diagnosing and monitoring metastasis or recurrence of cancer.
Patent expiration dates:
- December 30, 2035✓
- December 30, 2035
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Imaging of metastatic or recurrent cancer
Patent 10,716,868
Issued: July 21, 2020
Inventor(s): Miller Matthew & Gauden David & Schuster David & Fanti Stefano & Nanni Cristina & Zanoni Lucia & Willoch Frode & Bogsrud Trond Velde & Bach-Gansmo Tore & Musto Alessandra
Assignee(s): Blue Earth Diagnostics LimitedThe present disclosure relates to methods of administering [F]-FACBC. The present disclosure also relates to use of [F]-FACBC in methods for imaging, diagnosing and monitoring metastasis or recurrence of cancer.
Patent expiration dates:
- December 30, 2035✓
- December 30, 2035
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Imaging of metastatic or recurrent cancer
Patent 10,933,147
Issued: March 2, 2021
Inventor(s): Miller Matthew & Gauden David & Schuster David & Fanti Stefano & Nanni Cristina & Zanoni Lucia & Willoch Frode & Bogsrud Trond & Bach-Gansmo Tore & Musto Alessandra
Assignee(s): Blue Earth Diagnostics LimitedThe present disclosure relates to methods of administering [F]-FACBC. The present disclosure also relates to use of [F]-FACBC in methods for imaging, diagnosing and monitoring metastasis or recurrence of cancer.
Patent expiration dates:
- December 30, 2035✓
- December 30, 2035
-
Precursor compound of radioactive halogen-labeled organic compound
Patent 10,953,112
Issued: March 23, 2021
Inventor(s): Ito Osamu & Hayashi Akio & Kurosaki Fumie & Toyama Masahito & Shinmura Toshiyuki & Harano Arinori
Assignee(s): NIHON MEDI-PHYSICS CO., LTD.It is intended to provide a novel amino acid organic compound which can be used as a labeling precursor compound for radioactive halogen-labeled amino acid compounds including [F]FACBC, and which prevents methanol from remaining in the radioactive halogen-labeled amino acid compounds produced therefrom. The novel amino acid organic compound is a compound represented by the following formula:
Patent expiration dates:
- November 28, 2026✓
- November 28, 2026
-
Imaging of metastatic or recurrent cancer
Patent 10,967,077
Issued: April 6, 2021
Inventor(s): Miller Matthew & Gauden David & Schuster David & Fanti Stefano & Nanni Cristina & Zanoni Lucia & Willoch Frode & Bogsrud Trond Velde & Bach-Gansmo Tore & Musto Alessandra
Assignee(s): Blue Earth Diagnostics LimitedThe present disclosure relates to methods of administering [F]-FACBC. The present disclosure also relates to use of [F]-FACBC in methods for imaging, diagnosing and monitoring metastasis or recurrence of cancer.
Patent expiration dates:
- December 30, 2035✓
- December 30, 2035
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Patent 11,980,674
Patent expiration dates:
- April 23, 2042✓
- April 23, 2042
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Precursor compound of radioactive halogen-labeled organic compound
Patent 9,387,266
Issued: July 12, 2016
Inventor(s): Ito Osamu & Hayashi Akio & Kurosaki Fumie & Toyama Masahito & Shinmura Toshiyuki & Harano Arinori
Assignee(s): NIHON MEDI-PHYSICS CO., LTD.It is intended to provide a novel amino acid organic compound which can be used as a labeling precursor compound for radioactive halogen-labeled amino acid compounds including [F]FACBC, and which prevents methanol from remaining in the radioactive halogen-labeled amino acid compounds produced therefrom. The novel amino acid organic compound is a compound represented by the following formula:
Patent expiration dates:
- November 28, 2026✓
- November 28, 2026
More about Axumin (fluciclovine F 18)
- Compare alternatives
- Side effects
- Dosage information
- During pregnancy
- FDA approval history
- Drug class: diagnostic radiopharmaceuticals
Patient resources
Professional resources
Related treatment guides
Glossary
Term | Definition |
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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.