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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Dayvigo (2023)

Total Spending

$16.5M

Total Claims

45,059

Beneficiaries

11,530

Avg Cost/Unit

$11.16

Spending Trend

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

YoY Change:+8.4%

5yr CAGR:+5.9%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain1 active DMF

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

MOEHS IBERICA SLLEMBOREXANT

DMF 382192023

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)

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