Is there a generic for Flortaucipir f-18?

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

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

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.

What patents protect Flortaucipir f-18?

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.

What dosage forms of Flortaucipir f-18 are approved?

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

FDA Orange Book · active-ingredient family

Flortaucipir f-18

Flortaucipir f-18: 1 brand, 0 generics; first approved May 28, 2020; on patent until May 26, 2032.

On patentHas discontinued products

Generic status & protection

Protected until May 26, 2032 (earliest listed patent expiry).

Earliest patent expiry May 26, 2032

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

May 26, 2032

in 5 yr 11 mo

Originator applications

Brand (NDA) products

TAUVIDRLD

AVID RADIOPHARMS INCNDA 21212320204 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
30ML (8.1-51mCi/ML)	SOLUTION	INTRAVENOUS	Discontinued	—
50ML (8.1-51mCi/ML)	SOLUTION	INTRAVENOUS	Discontinued	—
50ML (8.1-100mCi/ML)	SOLUTION	INTRAVENOUS	Rx	—
100ML (8.1-100mCi/ML)	SOLUTION	INTRAVENOUS	Rx	—

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Orange Book patent file

Listed patents

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8932557	May 26, 2032	in 5 yr 11 mo	Substance

FDA approval span

Approval history

First approval

May 28, 2020

6 yr 3 mo ago

Most recent approval

Jul 01, 2022

4 yr 1 mo ago

Approvals span 2020–2022 across 1 FDA application.

Brand (NDA) 1100%

Generic (ANDA) 00%

Flortaucipir f-18 — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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