Question 1

Is there a generic for Florbetaben f-18?

Accepted Answer

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

Question 2

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

Accepted Answer

NEURACEQ (NDA 204677, LANTHEUS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Florbetaben f-18?

Accepted Answer

The Orange Book lists 2 patents against Florbetaben f-18 products, with the earliest listed expiry in 2029. 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

What dosage forms of Florbetaben f-18 are approved?

Accepted Answer

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

Patent	Expires	In	Type
7807135	Mar 18, 2029	in 2 yr 9 mo	SubstanceProductU-1497
9308284	Jul 14, 2032	in 6 yr 2 mo	Product

Florbetaben f-18

Brand (NDA) products · solution

Listed patents (2)

Florbetaben f-18 — frequently asked questions

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