Viewing data from:

QUVIVIQ

NDA

DARIDOREXANT HYDROCHLORIDE | N214985 | IDORSIA PHARMACEUTICALS LTD

2 strengths3 unique patents3 unique exclusivities

Patent Timeline

3 unique patents, 3 exclusivities by expiration date

Active (3)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

2034

2035

Today

9732075

Jun. 12, 2033

9790208

Dec. 2, 2034

10023560

Dec. 2, 2034

NCE

Apr. 7, 2027

M-200

Sep. 30, 2027

M-310

Sep. 30, 2027

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

1 trial from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study to Assess the Effect of Single Doses of Daridorexant on Electrocardiogram Parameters in Healthy Subjects NCT04250506	Phase 1	Completed	Idorsia Pharmaceuticals Ltd.	36	2020-02-28 → 2020-07-22

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

$16.72

per ea

Lowest NADAC/Unit

$16.71

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
80491782503QUVIVIQ 25 MG TABLET	$16.72	EA	Brand	—	2026-06-17
80491785003QUVIVIQ 50 MG TABLET	$16.71	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 | 6 NDCs (2 FSS, 2 Big4, 2 NC)

Lowest Price

$115.50

Highest Price

$492.54

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
80491-7850-03QUVIVIQ 50MG TAB	$492.54	FSS	Idorsia Pharmaceuticals US, Inc.	09/30/2027
80491-7850-03QUVIVIQ 50MG TAB	$385.88	Big4	Idorsia Pharmaceuticals US, Inc.	09/30/2027
80491-7850-03QUVIVIQ 50MG TAB,ORAL	$115.50	NC	Idorsia Pharmaceuticals US, Inc.	05/27/2026
80491-7825-03QUVIVIQ 25MG TAB	$492.54	FSS	Idorsia Pharmaceuticals US, Inc.	09/30/2027
80491-7825-03QUVIVIQ 25MG TAB	$386.08	Big4	Idorsia Pharmaceuticals US, Inc.	09/30/2027
80491-7825-03QUVIVIQ 25MG TAB,ORAL	$115.50	NC	Idorsia Pharmaceuticals US, Inc.	05/27/2026

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

Medicare Part D Spending

CMS annual spending data for Quviviq (2024)

Total Spending

$24.4M

Total Claims

46,269

Beneficiaries

12,891

Avg Cost/Unit

$16.30

Spending Trend

$2.4M(2022)→$16.3M(2023)→$24.4M(2024)

YoY Change:-3.5%

5yr CAGR:+1.0%

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

API Supply Chain4 active DMFs

4 active API suppliers hold Drug Master Files for this ingredient.

MOEHS IBERICA SLDARIDOREXANT

DMF 412272025

MAITHRI DRUGS PRIVATE LTDDARIDOREXANT HYDROCHLORIDE

DMF 423552025

ALP PHARM BEIJING CO LTDDARIDOREXANT HYDROCHLORIDE , NON STERILE

DMF 428912025

MAITHRI LABORATORIES PRIVATE LTDDARIDOREXANT HYDROCHLORIDE

DMF 438212026

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Oct 1, 2024	SUPPL -10	View Letter (PDF)
Oct 1, 2024	SUPPL -11	View Letter (PDF)
Oct 1, 2024	SUPPL -12	View Letter (PDF)
Oct 31, 2023	SUPPL -8	View Letter (PDF)
Oct 31, 2023	SUPPL -7	View Letter (PDF)
Nov 9, 2022	SUPPL -2	View Letter (PDF)
Jan 11, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 25MG BASE

RLD

3 patents3 exclusivities▴

TABLET;ORAL | Approved: Apr 7, 2022

Patents (3) · 2 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9732075	Jun 12, 2033	—	Yes	Yes		—
9790208	Dec 2, 2034	—	Yes	Yes	—	—
10023560	Dec 2, 2034	—	—	—		—

Exclusivities (3)

Code	Date	Status
M-200	Sep 30, 2027	Active
M-310	Sep 30, 2027	Active
NCE	Apr 7, 2027	< 1 year

#002 — EQ 50MG BASE

RLD

3 patents3 exclusivities▾

TABLET;ORAL | Approved: Apr 7, 2022