Generic Posluma Availability
Last updated on Apr 10, 2025.
Posluma is a brand name of flotufolastat F 18, approved by the FDA in the following formulation(s):
POSLUMA (flotufolastat f-18 gallium - solution;intravenous)
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Manufacturer: BLUE EARTH
Approval date: May 25, 2023
Strength(s): 25ML (8-158mCi/ML) [RLD]
Is there a generic version of Posluma available?
No. There is currently no therapeutically equivalent version of Posluma available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Posluma. 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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Dual mode radiotracer and—therapeutics
Patent 11,413,360
Issued: August 16, 2022
Inventor(s): Wurzer; Alexander Josef et al.
Assignee(s): Technische Universität München (Munich, DE); Technische Universität München—Klinikum Rechts der Isar (Munich, DE)The present invention relates to a ligand-SIFA-chelator conjugate, comprising, within in a single molecule three separate moieties: (a) one or more ligands which are capable of binding to a disease-relevant target molecule, (b) a silicon-fluoride acceptor (SIFA) moiety which comprises a covalent bond between a silicon atom and a fluorine atom, and (c) one or more chelating groups, optionally containing a chelated nonradioactive or radioactive cation.
Patent expiration dates:
- November 22, 2038✓✓
- November 22, 2038✓✓
- November 22, 2038
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Pharmaceutical formulations
Patent 12,036,290
Issued: July 16, 2024
Inventor(s): Bejot; Romain et al.
Assignee(s): Blue Earth Diagnostics Limited (Oxford, GB); Siemens Medical Solutions USA, Inc. (Malvern, PA)The present invention relates to a pharmaceutical composition comprising a radiohybrid agent containing a silicon-fluoride and a chelating group wherein either the fluorine is .sup.18F or the chelating group contains a chelated radioactive metal, wherein the composition has a pH of 4.0-6.0 and further comprises: 0.1-200 mM citrate buffer; 1-100 mg/mL ethanol; and 5-10 mg/mL sodium chloride.
Patent expiration dates:
- November 27, 2041✓✓
- November 27, 2041✓✓
- November 27, 2041
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:
- May 25, 2028 - NEW CHEMICAL ENTITY
More about Posluma (flotufolastat F 18)
- Check interactions
- Compare alternatives
- Side effects
- Dosage information
- During pregnancy
- FDA approval history
- Drug class: diagnostic radiopharmaceuticals
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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.