Question 1

Is there a generic for Fezolinetant?

Accepted Answer

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

Question 2

What is the reference-listed drug for Fezolinetant?

Accepted Answer

VEOZAH (NDA 216578, ASTELLAS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Fezolinetant?

Accepted Answer

The Orange Book lists 4 patents against Fezolinetant products, with the earliest listed expiry in 2031. 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 Fezolinetant have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Fezolinetant. 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 Fezolinetant are approved?

Accepted Answer

Fezolinetant is approved in the following dosage form: tablet.

Patent	Expires	In	Type
8871761	Apr 04, 2031	in 4 yr 10 mo	Substance
10836768	Mar 28, 2034	in 7 yr 11 mo	U-3622
9987274	Mar 28, 2034	in 7 yr 11 mo	U-3622
9422299	Mar 28, 2034	in 7 yr 11 mo	SubstanceProductU-3622

Fezolinetant

Brand (NDA) products · tablet

Marketing exclusivity (1)

Listed patents (4)

Fezolinetant — frequently asked questions

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