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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

4 trials from ClinicalTrials.gov — 4 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Efficacy of Verciguat in TR and RV Failure NCT07668739	Phase 4	Not Yet Recruiting	Daejeon St. Mary's hospital	100	2026-07-01 → 2028-05-31
Micro-axial Flow Pump-Supported PCI in Complex Coronary Artery Disease With Ischemic LV Dysfunction NCT07678021	N/A	Not Yet Recruiting	China National Center for Cardiovascular Diseases	452	2026-08-01 → 2029-12-31
Vericiguat in Patients With Coronary Microvascular Dysfunction Causing Stable Chest Pain (V-COM)NCT06239974	N/A	Recruiting	The University of Hong Kong	94	2024-09-01 → 2027-08-31
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)NCT05714085	Phase 2/3	Recruiting	Merck Sharp & Dohme LLC	342	2023-05-31 → 2032-04-15

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

Medicare Part D Spending

CMS annual spending data for Verquvo (2023)

Total Spending

$34.4M

Total Claims

34,487

Beneficiaries

8,218

Avg Cost/Unit

$22.41

Spending Trend

$3.0M(2021)→$15.7M(2022)→$34.4M(2023)

YoY Change:+6.0%

5yr CAGR:+6.3%

Source: CMS Medicare Part D Spending by Drug (2023). 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)

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