Prescription medicine
Piflufolastat f 18 Brand names: Pylarify
Piflufolastat f 18 (Pylarify) is a prescription medicine with an FDA approval on record since 2021. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the piflufolastat f 18 FDA label on DailyMed (effective July 1, 2026, Aphelion LLC); the NDA 214793 record on Drugs@FDA; every piflufolastat f 18 label on DailyMed.
Highlights of the record
FDA label of July 1, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usagePYLARIFY TRUVU is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level PYLARIFY TRUVU is a radioactive diagnostic drug indicated for positron emission tomography (PET) o
Forms and strengths
Injection.
On the market
- Earliest approval on file
- May 26, 2021 Pylarify, Progenics Pharms Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- June 9, 2037 Pylarify injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 197 through July 30, 2026
What is piflufolastat f 18 used for?
From the label: indications and usagePYLARIFY TRUVU is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level PYLARIFY TRUVU is a radioactive diagnostic drug indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level
FDA pharmacologic class: Radioactive Diagnostic Agent.
Source: FDA drug label (PYLARIFY TRUVU), Aphelion LLC, effective July 1, 2026 (SPL set 121c1cb8-6f60-4644-a775-b81c6f21d812), via openFDA; the full label on DailyMed
Is there a generic for piflufolastat f 18 (Pylarify)?
No generic piflufolastat f 18 is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 6 patents for Pylarify injection: the compound patent runs to June 9, 2037. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2021 earliest approval on file
- 2037 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for piflufolastat f 18?
The FDA Adverse Event Reporting System holds 197 reports that list piflufolastat f 18 among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 4 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other radioactive diagnostic agents
- the pharmacologic class, with prices and generics
- Piflufolastat f 18 side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other