Generic Pylarify Availability
Last updated on Apr 10, 2025.
Pylarify is a brand name of piflufolastat F 18, approved by the FDA in the following formulation(s):
PYLARIFY (piflufolastat f-18 - solution;intravenous)
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Manufacturer: PROGENICS PHARMS INC
Approval date: May 26, 2021
Strength(s): 50ML (1-80mCi/ML) [RLD]
Is there a generic version of Pylarify available?
No. There is currently no therapeutically equivalent version of Pylarify available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Pylarify. 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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Synthesis of the radiolabeled prostate-specific membrane antigen (PSMA) inhibitor [F]DCFPyL
Patent 10,947,197
Issued: March 16, 2021
Inventor(s): Ravert Hayden T. & Holt Daniel P. & Chen Ying & Mease Ronnie C. & Fan Hong & Pomper Martin G. & Dannals Robert F.
Assignee(s): The Johns Hopkins UniversityMethods, and related compositions, for the improved synthesis of [F]DCFPyL are disclosed. Also provided are methods, and related compositions, for the use of [F]DCFPyL so produced.
Patent expiration dates:
- June 9, 2037✓✓✓
- June 9, 2037
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Synthesis of the radiolabeled prostate-specific membrane antigen (PSMA) inhibitor [.SUP.18.F]DCFPYL
Patent 11,851,407
Issued: December 26, 2023
Inventor(s): Ravert; Hayden T. et al.
Assignee(s): THE JOHNS HOPKINS UNIVERSTY (Baltimore, MD)Methods, and related compositions, for the improved synthesis of [.sup.18F]DCFPyL are disclosed. Also provided are methods, and related compositions, for the use of [.sup.18F]DCFPyL so produced.
Patent expiration dates:
- June 9, 2037✓✓✓
- June 9, 2037
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PSMA-binding agents and uses thereof
Patent 12,070,513
Issued: August 27, 2024
Inventor(s): Pomper; Martin G. et al.
Assignee(s): THE JOHNS HOPKINS UNIVERSTY (Baltimore, MD)Prostate-specific membrane antigen (PSMA) binding compounds having radioisotope substituents are described, as well as chemical precursors thereof. Compounds include pyridine containing compounds, compounds having phenylhydrazine structures, and acylated lysine compounds. The compounds allow ready incorporation of radionuclides for single photon emission computed tomography (SPECT) and positron emission tomography (PET) for imaging, for example, prostate cancer cells and angiogenesis.
Patent expiration dates:
- July 31, 2029✓✓✓
- July 31, 2029
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Heterodimers of glutamic acid
Patent 8,487,129
Issued: July 16, 2013
Inventor(s): Babich John W. & Zimmerman Craig N. & Maresca Kevin P.
Assignee(s): Molecular Insight Pharmaceuticals, Inc.Compounds of Formula (Ia)
Patent expiration dates:
- November 7, 2027✓✓
- November 7, 2027
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PSMA-binding agents and uses thereof
Patent 8,778,305
Issued: July 15, 2014
Inventor(s): Pomper Martin & Mease Ronnie Charles & Chen Ying
Assignee(s): The Johns Hopkins UniversityProstate-specific membrane antigen (PSMA) binding compounds having radioisotope substituents are described, as well as chemical precursors thereof. Compounds include pyridine containing compounds, compounds having phenylhydrazine structures, and acylated lysine compounds. The compounds allow ready incorporation of radionuclides for single photon emission computed tomography (SPECT) and positron emission tomography (PET) for imaging, for example, prostate cancer cells and angiogenesis.
Patent expiration dates:
- September 21, 2030✓✓✓
- September 21, 2030
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PSMA-binding agents and uses thereof
Patent 9,861,713
Issued: January 9, 2018
Inventor(s): Pomper Martin G. & Mease Ronnie Charles & Chen Ying
Assignee(s): THE JOHNS HOPKINS UNIVERSITYProstate-specific membrane antigen (PSMA) binding compounds having radioisotope substituents are described, as well as chemical precursors thereof. Compounds include pyridine containing compounds, compounds having phenylhydrazine structures, and acylated lysine compounds. The compounds allow ready incorporation of radionuclides for single photon emission computed tomography (SPECT) and positron emission tomography (PET) for imaging, for example, prostate cancer cells and angiogenesis.
Patent expiration dates:
- July 31, 2029✓✓✓
- July 31, 2029
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 26, 2026 - NEW CHEMICAL ENTITY
More about Pylarify (piflufolastat F 18)
- Check interactions
- 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 |
|---|---|
| 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.