Vericiguat - Generic Drug Details

What are the generic drug sources for vericiguat and what is the scope of patent protection?

Vericiguat is the generic ingredient in one branded drug marketed by MSD and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Vericiguat has two hundred and fourteen patent family members in fifty countries.

One supplier is listed for this compound. There are two tentative approvals for this compound.

Summary for vericiguat

International Patents:	214
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	52
Clinical Trials:	29
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for vericiguat
What excipients (inactive ingredients) are in vericiguat?	vericiguat excipients list
DailyMed Link:	vericiguat at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for vericiguat

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for vericiguat

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Alabama at Birmingham	PHASE2
University of Alberta	PHASE2
Ottawa Heart Institute Research Corporation	PHASE2

See all vericiguat clinical trials

Generic filers with tentative approvals for VERICIGUAT

Applicant	Application No.	Strength	Dosage Form
		10MG	TABLET
		2.5MG	TABLET
		10MG	TABLET

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for vericiguat

Drug Class	Soluble Guanylate Cyclase Stimulator
Mechanism of Action	Guanylate Cyclase Stimulators

Anatomical Therapeutic Chemical (ATC) Classes for vericiguat

C01DX	Other vasodilators used in cardiac diseases
C01D	VASODILATORS USED IN CARDIAC DISEASES
C01	CARDIAC THERAPY
C	Cardiovascular system

Paragraph IV (Patent) Challenges for VERICIGUAT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VERQUVO	Tablets	vericiguat	5 mg and 10 mg	214377	4	2025-01-21

US Patents and Regulatory Information for vericiguat

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Msd	VERQUVO	vericiguat	TABLET;ORAL	214377-002	Jan 19, 2021		RX	Yes	No
Msd	VERQUVO	vericiguat	TABLET;ORAL	214377-003	Jan 19, 2021		RX	Yes	Yes			Y	Y
Msd	VERQUVO	vericiguat	TABLET;ORAL	214377-003	Jan 19, 2021		RX	Yes	Yes
Msd	VERQUVO	vericiguat	TABLET;ORAL	214377-003	Jan 19, 2021		RX	Yes	Yes
Msd	VERQUVO	vericiguat	TABLET;ORAL	214377-003	Jan 19, 2021		RX	Yes	Yes

EU/EMA Drug Approvals for vericiguat

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Bayer AG	Verquvo	vericiguat	EMEA/H/C/005319Treatment of symptomatic chronic heart failure	Authorised	no	no	no	2021-07-16

International Patents for vericiguat

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	201892050	СПОСОБ ПОЛУЧЕНИЯ ЗАМЕЩЕННЫХ 5-ФТОР-1H-ПИРАЗОЛОПИРИДИНОВ
Ukraine	119269	СПОСІБ ОДЕРЖАННЯ ПРОМІЖНИХ СПОЛУК В СПОСОБІ ОДЕРЖАННЯ ЗАМІЩЕНИХ 5-ФТОР-1Н-ПІРАЗОЛОПІРИДИНІВ
Spain	2549979
Japan	2018058860	置換された５−フルオロ−１Ｈ−ピラゾロピリジン類を製造するための方法 (PROCESS FOR PREPARING SUBSTITUTED 5-FLUORO-1H-PYRAZOLOPYRIDINES)
Hong Kong	1203951	用於製備取代的 -氟- -吡唑並吡啶類化合物的方法 (METHOD FOR PRODUCING SUBSTITUTED 5-FLUORO-1H-PYRAZOLOPYRIDINES 5--1H-)

Supplementary Protection Certificates for vericiguat

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2576547	21C1038	France		PRODUCT NAME: VERICIGUAT ET SES SELS, SOLVATES ET SOLVATES DES SELS; REGISTRATION NO/DATE: EU/1/21/1561 20210720
2576547	2021032	Norway		PRODUCT NAME: VERISIGUAT OG DENS SALTER SOLVATER OG SOLVATER AV SALTER; REG. NO/DATE: EU/1/21/1561 20210805
2576547	202140022	Slovenia		PRODUCT NAME: VERICIGUAT AND ITS SALTS, SOLVATES AND SOLVATES OF THE SALTS; NATIONAL AUTHORISATION NUMBER: EU/1/21/1561; DATE OF NATIONAL AUTHORISATION: 20210716; AUTHORITY FOR NATIONAL AUTHORISATION: EU
2576547	SPC/GB21/058	United Kingdom		PRODUCT NAME: VERICIGUAT AND ITS SALTS, SOLVATES AND SOLVATES OF THE SALTS; REGISTERED: UK PLGB 00010/0748 20210719; UK PLGB 00010/0749 20210719; UK PLGB 00010/0750 20210719; UK FURTHER MA ON IPSUM 20210719
2576547	301146	Netherlands		PRODUCT NAME: VERICIGUAT; REGISTRATION NO/DATE: EU/1/21/1561 20210720

Market Dynamics and Financial Trajectory for Vericiguat

Last updated: April 17, 2026

What is Vericiguat’s Market Position?

Vericiguat, developed by Bayer and marketed as Verquvo, is a soluble guanylate cyclase (sGC) stimulator approved for treating chronic heart failure with reduced ejection fraction (HFrEF) in adults. The drug addresses a substantial unmet need in heart failure management, competing primarily against other medications such as sacubitril/valsartan and SGLT2 inhibitors.

Regulatory and Launch Timeline

• Approval Date: February 2021 by the U.S. Food and Drug Administration (FDA).
• Initial Launch: Began in the U.S. post-approval in 2021.
• Key Markets: Inclusion in the European Union and Japan followed in 2022, with subsequent launches in other territories.

Market Size and Forecast

Current Market Valuation

• The global heart failure drugs market was valued at approximately $7.7 billion in 2022.
• Vericiguat's segment accounts for an estimated 2-3% of the total, reflecting around $180-$230 million in revenue globally for 2022.

Projected Growth

• Compound annual growth rate (CAGR) of the heart failure segment estimated at 7% from 2023 to 2030.
• Vericiguat’s market share projected to increase due to expansion into new territories and evolving treatment guidelines.

Revenue Trends

Year	Estimated Revenue (USD millions)	Assumptions
2022	200	Initial launch; modest penetration
2023	250	Expanding prescriber base; increased awareness
2025	350	Broad adoption in Europe; new indications
2030	500+	Potential expansion into chronic heart failure with preserved ejection fraction (HFpEF) and combination therapies

Competitive Landscape

Vericiguat competes with established heart failure medications:

• ARNI (Angiotensin Receptor-Neprilysin Inhibitors), e.g., sacubitril/valsartan.
• SGLT2 inhibitors, e.g., dapagliflozin and empagliflozin.
• Other sGC stimulators (early-stage or under development).

Market acceptance depends on its demonstrated efficacy in reducing cardiovascular mortality and hospitalization, as well as its tolerability.

Key Drivers and Barriers

Drivers

• Unmet clinical need: Patients with worsening heart failure who are not well-managed by existing therapies.
• Guideline inclusion: Updates by American Heart Association (AHA) and European Society of Cardiology (ESC) recommend once-daily treatments that improve quality of life.
• Expanding indications: Potential for use in HFpEF, which accounts for approximately 50% of heart failure cases; clinical trials underway.

Barriers

• Pricing and reimbursement hurdles: As a recently launched innovative drug, reimbursement negotiations could impact uptake.
• Competitive pressure: Existing high-prescription rates for established drugs.
• Clinical data: Long-term efficacy and safety profiles need further confirmation for broader use.

Research and Development Outlook

• Ongoing Trials: The VICTOR trial aims to evaluate long-term effects and expand indications.
• Pipeline: Bayer exploring combinations with other novel agents and potential indications like pulmonary hypertension.

Financial Strategy

Bayer’s forecast for Vericiguat emphasizes a phased ramp-up in revenues aligned with expanding indication approvals and increased prescriber familiarity. The company allocates significant investment toward clinical trials to substantiate broad-spectrum heart failure benefits and position Vericiguat for potential inclusion in treatment guidelines in additional geographies.

Summary

Vericiguat’s market trajectory depends on regulatory approvals, clinical trial outcomes, and competition dynamics. It benefits from an unmet need within specified subpopulations of heart failure patients. Rapid adoption hinges on demonstration of superior outcomes, price competitiveness, and integration into treatment algorithms.

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Key Takeaways

• Launched in 2021, Vericiguat's global revenue in 2022 is estimated at approximately $200 million.
• Market growth is forecasted at 7% CAGR through 2030, with revenues possibly exceeding $500 million.
• Competition from established therapies and positioning in guidelines will influence adoption.
• Clinical trials are pivotal for broader indications, especially HFpEF.
• Reimbursement and pricing negotiations remain critical barriers.

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FAQs

1. What is Vericiguat’s primary clinical benefit?
   It reduces cardiovascular death and heart failure hospitalization in adults with HFrEF post-worsening event.

2. How does Vericiguat compare to existing heart failure therapies?
   It offers a novel mechanism but is positioned to complement rather than replace current standard-of-care medications.

3. What are the main challenges facing Vericiguat’s market expansion?
   Reimbursement barriers, competition, and limited long-term data could slow growth.

4. Are there upcoming expansion opportunities for Vericiguat?
   Yes, clinical trials for HFpEF and combination therapies could broaden its use.

5. What is Bayer’s strategic outlook for Vericiguat?
   Focus on clinical validation, expanding indications, and gaining guideline endorsement to accelerate adoption.

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References

[1] Bayer. (2023). Vericiguat (Verquvo) product information.
[2] MarketWatch. (2023). Heart failure drugs market forecast.
[3] European Society of Cardiology. (2022). Heart failure treatment guidelines update.
[4] Global Data. (2022). Heart failure therapeutics market analysis.
[5] ClinicalTrials.gov. (2023). VICTOR trial information.