Viewing data from:

VERQUVO

NDA

VERICIGUAT | N214377 | MERCK SHARP AND DOHME LLC

3 strengths6 unique patents2 unique exclusivities

Patent Timeline

6 unique patents, 2 exclusivities by expiration date

Active (6)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

Today

May. 19, 2031

May. 19, 2031

Nov. 26, 2032

May. 19, 2031

May. 19, 2031

May. 19, 2031

NCE

Jan. 19, 2026

D-198

Jan. 21, 2029

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

1 case on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
Adverio Pharma GmbH et al v. Changzhou Pharmaceutical Factory et al 1:2025cv00479 6 patentsANDA 220264, 220286, 220221, 220354, 220244vericiguat	D. Del.	2025-04-18	Active	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

8 trials from ClinicalTrials.gov, 8 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Relative Bioavailability and Food Effect Study With Vericiguat to Characterize the Pediatric Formulation in Adult Healthy Subjects NCT03145038	Phase 1	Completed	Bayer	30	2017-05-16 → 2017-10-09
A Study of Vericiguat in Participants With Heart Failure With Reduced Ejection Fraction (HFrEF) (MK-1242-001)NCT02861534	Phase 3	Completed	Merck Sharp & Dohme LLC	5,050	2016-09-20 → 2019-09-02
Study to Evaluate the QT / QTc Interval Prolongation Potential of Vericiguat NCT03504982	Phase 1	Completed	Bayer	74	2018-05-17 → 2019-02-26
Vericiguat Drug-drug Interaction Study With Isosorbite Mononitrate in Stable Coronary Artery Disease Patients NCT03255512	Phase 1	Completed	Bayer	41	2017-08-17 → 2018-03-23
Vericiguat Drug-drug Interaction With Nitroglycerin in Stable Coronary Artery Disease Patients NCT02617550	Phase 1	Completed	Bayer	36	2015-11-18 → 2016-08-11
Phase IIb Safety and Efficacy Study of Four Dose Regimens of BAY1021189 in Patients With Heart Failure With Reduced Ejection Fraction Suffering From Worsening Chronic Heart Failure (SOCRATES-REDUCED)NCT01951625	Phase 2	Completed	Bayer	456	2013-11-29 → 2015-06-09
Phase IIb Safety and Efficacy Study of Four Dose Regimens of BAY1021189 in Patients With Heart Failure and Preserved Ejection Fraction Suffering From Worsening Chronic Heart Failure (SOCRATES-PRESERVED)NCT01951638	Phase 2	Completed	Bayer	477	2013-11-06 → 2015-09-16
Patient-reported Outcomes in Vericiguat-treated Patients With HFpEF NCT03547583	Phase 2	Completed	Bayer	789	2018-06-15 → 2019-11-04

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 9 NDCs

Highest NADAC/Unit

$22.75

per ea

Lowest NADAC/Unit

$22.71

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00006502902VERQUVO 5 MG TABLET	$22.75	EA	Brand	—	2026-06-17
00006502904VERQUVO 5 MG TABLET	$22.75	EA	Brand	—	2026-06-17
00006502901VERQUVO 5 MG TABLET	$22.75	EA	Brand	—	2026-06-17
00006502802VERQUVO 2.5 MG TABLET	$22.74	EA	Brand	—	2026-06-17
00006502801VERQUVO 2.5 MG TABLET	$22.74	EA	Brand	—	2026-06-17
00006502804VERQUVO 2.5 MG TABLET	$22.74	EA	Brand	—	2026-06-17

Showing 6 of 9 NDCs.

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

VA Federal Supply Schedule

Government-negotiated contract prices | 18 NDCs (9 FSS, 9 Big4)

Lowest Price

$236.50

Highest Price

$2276.11

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00006-5030-01VERQUVO 10MG TAB	$682.80	FSS	Merck Sharp & Dohme LLC	05/31/2030
00006-5030-01VERQUVO 10MG TAB	$506.49	Big4	Merck Sharp & Dohme LLC	05/31/2030
00006-5030-02VERQUVO 10MG TAB	$2048.49	FSS	Merck Sharp & Dohme LLC	05/31/2030
00006-5030-02VERQUVO 10MG TAB	$1522.06	Big4	Merck Sharp & Dohme LLC	05/31/2030
00006-5030-04VERQUVO 10MG TAB	$2276.11	FSS	Merck Sharp & Dohme LLC	05/31/2030
00006-5030-04VERQUVO 10MG TAB	$1645.25	Big4	Merck Sharp & Dohme LLC	05/31/2030

Showing 6 of 18 NDCs.

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

Medicare Part D Spending

CMS annual spending data for Verquvo (2024)

Total Spending

$49.7M

Total Claims

49,590

Beneficiaries

11,127

Avg Cost/Unit

$21.88

Spending Trend

$3.0M(2021)→$15.7M(2022)→$34.4M(2023)→$49.7M(2024)

YoY Change:-2.4%

5yr CAGR:+3.3%

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

API Supply Chain7 active DMFs

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

MOEHS IBERICA SLVERICIGUAT

DMF 377962022

CHANGZHOU PHARMACEUTICAL FACTORYVERICIGUAT

DMF 379842023

HETERO LABS LTDVERICIGUAT (FORM-I)

DMF 402672024

MSN LIFE SCIENCES PRIVATE LTDVERICIGUAT

DMF 404592024

TORRENT PHARMACEUTICALS LTDVERICIGUAT

DMF 406652024

MAITHRI DRUGS PRIVATE LTDVERICIGUAT

DMF 407762024

LEE PHARMA LTDVERICIGUAT

DMF 424692025

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Jan 22, 2026	SUPPL -5	View Letter (PDF)
May 11, 2023	SUPPL -2	View Letter (PDF)
Nov 25, 2022	SUPPL -1	View Letter (PDF)
Jan 21, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 2.5MG

RLD

6 patents2 exclusivities▴

TABLET;ORAL | Approved: Jan 19, 2021

Patents (6) · 4 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8420656	May 19, 2031	—	Yes	Yes	—	—
8921377	May 19, 2031	—	—	—		—
9604948	Nov 26, 2032	—	Yes	Yes		—
9993476	May 19, 2031	—	—	—		—
10736896	May 19, 2031	—	Yes	Yes	—	—
11439642	May 19, 2031	—	—	—		—

Exclusivities (2)

Code	Date	Status
D-198	Jan 21, 2029	Active
NCE	Jan 19, 2026	Expired

#002 — 5MG

RLD

6 patents2 exclusivities▾

TABLET;ORAL | Approved: Jan 19, 2021

#003 — 10MG

RLD

6 patents2 exclusivities▾

TABLET;ORAL | Approved: Jan 19, 2021