Question 1

Is there a generic for Flotufolastat f-18 gallium?

Accepted Answer

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

Question 2

What is the reference-listed drug for Flotufolastat f-18 gallium?

Accepted Answer

POSLUMA (NDA 216023, BLUE EARTH) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Flotufolastat f-18 gallium?

Accepted Answer

The Orange Book lists 6 patents against Flotufolastat f-18 gallium products, with the earliest listed expiry in 2038. 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 Flotufolastat f-18 gallium have FDA marketing exclusivity?

Accepted Answer

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

Accepted Answer

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

Patent	Expires	In	Type
12390540	Aug 23, 2038	in 12 yr 4 mo	Substance
11413360	Nov 22, 2038	in 12 yr 7 mo	SubstanceU-3614
12357711	Nov 22, 2038	in 12 yr 7 mo	Substance
12377176	Nov 22, 2038	in 12 yr 7 mo	Substance
12036290	Nov 27, 2041	in 15 yr 8 mo	ProductU-3614
12427207	Nov 27, 2041	in 15 yr 8 mo	Product

Flotufolastat f-18 gallium

Brand (NDA) products · solution

Marketing exclusivity (1)

Listed patents (6)

Flotufolastat f-18 gallium — frequently asked questions

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.