Is there a generic for Lemborexant?

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

What is the reference-listed drug for Lemborexant?

DAYVIGO (NDA 212028, EISAI INC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Lemborexant?

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.

Does Lemborexant have FDA marketing exclusivity?

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.

What dosage forms of Lemborexant are approved?

Lemborexant is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Lemborexant

Lemborexant: 1 brand, 0 generics; first approved Apr 07, 2020; on patent until Sep 20, 2031.

On patent2 exclusivity periods

Generic status & protection

Protected until Sep 20, 2031 (earliest listed patent expiry).

Earliest patent expiry Sep 20, 2031Latest exclusivity ends Apr 20, 2026

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Sep 20, 2031

in 5 yr 3 mo

Originator applications

Brand (NDA) products

DAYVIGORLD

EISAI INCNDA 21202820202 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	—
10MG	TABLET	ORAL	Rx	—

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Hatch-Waxman

Marketing exclusivity

Marketing exclusivity (2)

M-293New use / labeling-change exclusivity (3 years)
Apr 20, 2026
3 mo ago
M-293New use / labeling-change exclusivity (3 years)
Apr 20, 2026
3 mo ago

Orange Book patent file

Listed patents

Listed patents (4)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8268848	Sep 20, 2031	in 5 yr 3 mo	SubstanceProductU-2791
10188652	Oct 21, 2035	in 9 yr 5 mo	ProductU-2791
11026944	Oct 21, 2035	in 9 yr 5 mo	Product
10702529	Oct 21, 2035	in 9 yr 5 mo	Product

FDA approval span

Approval history

First approval

Apr 07, 2020

6 yr 4 mo ago

Most recent approval

Apr 07, 2020

6 yr 4 mo ago

All 1 application were approved in 2020.

Brand (NDA) 1100%

Generic (ANDA) 00%

Lemborexant — 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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