Question 1

Is there a generic for Piflufolastat f-18?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Piflufolastat f-18. It is available as 2 brand (NDA) applications.

Question 2

What is the reference-listed drug for Piflufolastat f-18?

Accepted Answer

PYLARIFY TRUVU (NDA 220089, APHELION) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Piflufolastat f-18?

Accepted Answer

The Orange Book lists 6 patents against Piflufolastat f-18 products, with the earliest listed expiry in 2027. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

Does Piflufolastat f-18 have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 2 marketing-exclusivity periods for Piflufolastat f-18. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 5

What dosage forms of Piflufolastat f-18 are approved?

Accepted Answer

Piflufolastat f-18 is approved in the following dosage form: solution.

Product	Applicant	Application	TE	Approved
PYLARIFY TRUVURLD	APHELION	NDA 220089	—	Mar 06, 2026
PYLARIFYRLD	PROGENICS PHARMS INC	NDA 214793	—	May 26, 2021

Patent	Expires	In	Type
8487129	Nov 07, 2027	in 1 yr 5 mo	SubstanceProduct
9861713	Jul 31, 2029	in 3 yr 2 mo	SubstanceProductU-3130
12070513	Jul 31, 2029	in 3 yr 2 mo	SubstanceProductU-3130
8778305	Sep 21, 2030	in 4 yr 4 mo	SubstanceProductU-3130
10947197	Jun 09, 2037	in 11 yr 2 mo	SubstanceProductU-3130
11851407	Jun 09, 2037	in 11 yr 2 mo	SubstanceProductU-3130

Piflufolastat f-18

Brand (NDA) products · solution

Marketing exclusivity (2)

Listed patents (6)

Piflufolastat f-18 — frequently asked questions

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