Question 1

Is there a generic for Flurpiridaz f-18?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Flurpiridaz f-18. It is available as 1 brand (NDA) application.

Question 2

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

Accepted Answer

FLYRCADO (NDA 215168, GE HLTHCARE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Flurpiridaz f-18?

Accepted Answer

The Orange Book lists 7 patents against Flurpiridaz f-18 products, with the earliest listed expiry in 2026. 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 Flurpiridaz f-18 have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Flurpiridaz 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 Flurpiridaz f-18 are approved?

Accepted Answer

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

Patent	Expires	In	Type
9161997	Feb 04, 2026	5 mo ago	SubstanceProductU-4011
7344702	May 26, 2026	24 d ago	Substance
8226929	Jun 21, 2028	in 2 yr	U-4011
9603951	May 02, 2031	in 4 yr 11 mo	U-4011
8936777	Jun 30, 2031	in 5 yr 1 mo	U-4011
9687571	Nov 01, 2032	in 6 yr 6 mo	ProductU-4011
12527884	May 13, 2042	in 16 yr 2 mo	ProductU-4406

Flurpiridaz f-18

Brand (NDA) products · solution

Marketing exclusivity (1)

Listed patents (7)

Flurpiridaz f-18 — frequently asked questions

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