Question 1

Is there a generic for Flortaucipir f-18?

Accepted Answer

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

Question 2

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

Accepted Answer

TAUVID (NDA 212123, AVID RADIOPHARMS INC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Flortaucipir f-18?

Accepted Answer

The Orange Book lists 1 patent against Flortaucipir f-18 products, with the earliest listed expiry in 2032. 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 Flortaucipir f-18 are approved?

Accepted Answer

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

Flortaucipir f-18

Brand (NDA) products · solution

Listed patents (1)

Flortaucipir f-18 — frequently asked questions

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