Question 1

Is there a generic for Lemborexant?

Accepted Answer

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

Question 2

What is the reference-listed drug for Lemborexant?

Accepted Answer

DAYVIGO (NDA 212028, EISAI 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 Lemborexant?

Accepted Answer

The Orange Book lists 4 patents against Lemborexant 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 Lemborexant have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 2 marketing-exclusivity periods for Lemborexant. 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 Lemborexant are approved?

Accepted Answer

Lemborexant is approved in the following dosage form: tablet.

Patent	Expires	In	Type
8268848	Sep 20, 2031	in 5 yr 4 mo	SubstanceProductU-2791
10188652	Oct 21, 2035	in 9 yr 6 mo	ProductU-2791
11026944	Oct 21, 2035	in 9 yr 6 mo	Product
10702529	Oct 21, 2035	in 9 yr 6 mo	Product

Lemborexant

Brand (NDA) products · tablet

Marketing exclusivity (2)

Listed patents (4)

Lemborexant — frequently asked questions

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