Details for New Drug Application (NDA): 220089
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The generic ingredient in PYLARIFY TRUVU is piflufolastat f-18. One supplier is listed for this compound. Additional details are available on the piflufolastat f-18 profile page.
Summary for 220089
| Tradename: | PYLARIFY TRUVU |
| Applicant: | Aphelion |
| Ingredient: | piflufolastat f-18 |
| Patents: | 6 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 220089
Generic Entry Date for 220089*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;INTRAVENOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 1mCi/mL-120mCi/mL | ||||
| Approval Date: | Mar 6, 2026 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jun 9, 2037 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | POSITRON EMISSION TOMOGRAPHY (PET) OF PROSTATE-SPECIFIC MEMBRANE ANTIGEN (PSMA) POSITIVE LESIONS IN MEN WITH PROSTATE CANCER | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jun 9, 2037 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | POSITRON EMISSION TOMOGRAPHY (PET) OF PROSTATE-SPECIFIC MEMBRANE ANTIGEN (PSMA) POSITIVE LESIONS IN MEN WITH PROSTATE CANCER | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jul 31, 2029 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | POSITRON EMISSION TOMOGRAPHY (PET) OF PROSTATE-SPECIFIC MEMBRANE ANTIGEN (PSMA) POSITIVE LESIONS IN MEN WITH PROSTATE CANCER | ||||||||
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