Question 1

Is there a generic for Elinzanetant?

Accepted Answer

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

Question 2

What is the reference-listed drug for Elinzanetant?

Accepted Answer

LYNKUET (NDA 219469, BAYER HLTHCARE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Elinzanetant?

Accepted Answer

The Orange Book lists 6 patents against Elinzanetant products, with the earliest listed expiry in 2027. 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 Elinzanetant have FDA marketing exclusivity?

Accepted Answer

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

Accepted Answer

Elinzanetant is approved in the following dosage form: capsule.

Patent	Expires	In	Type
7683056	Sep 15, 2027	in 1 yr 3 mo	SubstanceProduct
10195205	May 18, 2036	in 10 yr 1 mo	U-3622
12264164	Mar 13, 2039	in 12 yr 11 mo	U-3622
11787820	Mar 13, 2039	in 12 yr 11 mo	U-3622
10774091	Mar 13, 2039	in 12 yr 11 mo	Product
12533358	May 14, 2045	in 19 yr 2 mo	U-4402

Elinzanetant

Brand (NDA) products · capsule

Marketing exclusivity (1)

Listed patents (6)

Elinzanetant — frequently asked questions

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