Viewing data from:

DAYVIGO

NDA

LEMBOREXANT | N212028 | EISAI INC

2 strengths4 unique patents1 unique exclusivity

Patent Timeline

4 unique patents, 1 exclusivity by expiration date

Active (4)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

Today

Sep. 20, 2031

Oct. 21, 2035

Oct. 21, 2035

Oct. 21, 2035

M-293

Apr. 20, 2026

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

13 trials from ClinicalTrials.gov, 13 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Study to Evaluate the Effect of 2 Dosage Strengths of Lemborexant (E2006) on a Multiple Sleep Latency Test in Participants With Insomnia Disorder NCT02350309	Phase 1	Completed	Eisai Inc.	69	2014-12-13 → 2015-04-21
A Study to Determine the Abuse Potential of Single Oral Doses of Lemborexant Compared to Zolpidem, Suvorexant and Placebo in Healthy, Non-Dependent, Recreational Sedative Users NCT03158025	Phase 1	Completed	Eisai Inc.	39	2017-04-19 → 2018-07-04
Study of Lemborexant for Irregular Sleep-Wake Rhythm Disorder and Mild to Moderate Alzheimer's Disease Dementia NCT03001557	Phase 2	Completed	Eisai Inc.	63	2016-12-20 → 2020-04-17
Study to Evaluate the Respiratory Safety of Lemborexant in Adult and Elderly Healthy Subjects and Adult and Elderly Subjects With Mild Obstructive Sleep Apnea NCT03471871	Phase 1	Completed	Eisai Inc.	146	2018-02-21 → 2018-08-03
A 2-Part Single Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2006 NCT01463098	Phase 1	Completed	Eisai Inc.	122	2011-10-05 → 2012-08-11
Study to Evaluate the Effect of Lemborexant Versus Placebo on Driving Performance in Healthy Adult and Elderly Subjects NCT02583451	Phase 1	Completed	Eisai Inc.	48	2015-11 → 2017-02
Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1)NCT02783729	Phase 3	Completed	Eisai Inc.	1,006	2016-05-31 → 2018-01-30
Study to Evaluate the Pharmacokinetics of Lemborexant (E2006) and Its Metabolites in Subjects With Normal Renal Function or With Severe Renal Impairment NCT03443063	Phase 1	Completed	Eisai Inc.	16	2018-02-07 → 2018-08-24
Study to Assess the Pharmacokinetic Drug-Drug Interactions of Lemborexant When Coadministered With an Oral Contraceptive, Famotidine, or Fluconazole in Healthy Subjects NCT03451110	Phase 1	Completed	Eisai Inc.	50	2018-02-05 → 2018-03-23
Study to Evaluate the Pharmacokinetics of Lemborexant (E2006) and Its Metabolites in Subjects With Mild and Moderate Hepatic Impairment Compared to Healthy Subjects NCT03440424	Phase 1	Completed	Eisai Inc.	24	2018-01-26 → 2018-04-23

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$11.58

per ea

Lowest NADAC/Unit

$11.58

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
62856040530DAYVIGO 5 MG TABLET	$11.58	EA	Brand	—	2026-06-17
62856041030DAYVIGO 10 MG TABLET	$11.58	EA	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$214.22

Highest Price

$214.22

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
62856-0405-30DAYVIGO 5MG TAB	$214.22	FSS	Eisai, Inc.	05/31/2029
62856-0405-30DAYVIGO 5MG TAB	$214.22	Big4	Eisai, Inc.	05/31/2029
62856-0410-30DAYVIGO 10MG TAB	$214.22	FSS	Eisai, Inc.	05/31/2029
62856-0410-30DAYVIGO 10MG TAB	$214.22	Big4	Eisai, Inc.	05/31/2029

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Dayvigo (2024)

Total Spending

$21.0M

Total Claims

57,890

Beneficiaries

14,593

Avg Cost/Unit

$11.03

Spending Trend

$1.2M(2020)→$9.1M(2021)→$13.9M(2022)→$16.5M(2023)→$21.0M(2024)

YoY Change:-1.2%

5yr CAGR:+4.1%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain2 active DMFs

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

MOEHS IBERICA SLLEMBOREXANT

DMF 382192023

SICHUAN QINGMU PHARMACEUTICAL CO LTDLEMBOREXANT

DMF 439622026

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Feb 21, 2025	SUPPL -11	View Letter (PDF)
Apr 21, 2023	SUPPL -8	View Letter (PDF)
Jan 26, 2023	SUPPL -7	View Letter (PDF)
Mar 14, 2022	SUPPL -6	View Letter (PDF)
Aug 25, 2020	SUPPL -2	View Letter (PDF)
Dec 26, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 5MG

RLD

4 patents1 exclusivity▴

TABLET;ORAL | Approved: Apr 7, 2020

Patents (4) · 2 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8268848	Sep 20, 2031	—	Yes	Yes		—
10188652	Oct 21, 2035	—	—	Yes		—
10702529	Oct 21, 2035	—	—	Yes	—	—
11026944	Oct 21, 2035	—	—	Yes	—	—

Exclusivities (1)

Code	Date	Status
M-293	Apr 20, 2026	Expired

#002 — 10MG

RLD

4 patents1 exclusivity▾

TABLET;ORAL | Approved: Apr 7, 2020