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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Quviviq (2023)

Total Spending

$16.3M

Total Claims

30,811

Beneficiaries

10,838

Avg Cost/Unit

$16.88

Spending Trend

$2.4M(2022)→$16.3M(2023)

YoY Change:+5.7%

5yr CAGR:+5.7%

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

API Supply Chain3 active DMFs

3 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

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)

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