Vericiguat - Generic Drug Details

What are the generic drug sources for vericiguat and what is the scope of freedom to operate?

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.

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

Constraining patent/regulatory exclusivity:

9,604,948

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
Ottawa Heart Institute Research Corporation	PHASE2
Heart and Stroke Foundation of Canada	PHASE2

See all vericiguat clinical trials

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
Msd	VERQUVO	vericiguat	TABLET;ORAL	214377-002	Jan 19, 2021		RX	Yes	No	11,439,642

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
Israel	223128	שימוש במגרי sgc, מפעילי sgc לבד וצירופים עם מעכבי 5pde לטיפול בטרשת מערכתית (Use of sgc stimulators, sgc activators. alone and in combinations with pde5 inhibitors for the treatment of systemic sclerosis (ssc))
Hungary	S2100032
Morocco	34249	UTILISATION DE STIMULATEURS DE LA SGC, D'ACTIVATEURS DE LA SGC, SEULS ET EN ASSOCIATION AVEC DES INHIBITEURS DE LA PDE5 EN VUE DU TRAITEMENT DE LA SCLÉRODERMIE SYSTÉMIQUE

Supplementary Protection Certificates for vericiguat

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2576547	C20210029 00408	Estonia		PRODUCT NAME: VERITSIGUAAT;REG NO/DATE: EU/1/21/1561 20.07.2021
2576547	21C1038	France		PRODUCT NAME: VERICIGUAT ET SES SELS, SOLVATES ET SOLVATES DES SELS; REGISTRATION NO/DATE: EU/1/21/1561 20210720
2576547	PA2021518	Lithuania		PRODUCT NAME: VERICIGUATAS IR JO DRUSKOS, SOLVATAI IR DRUSKU SOLVATAI ; REGISTRATION NO/DATE: EU/1/21/1561 20210716

Market Dynamics and Financial Trajectory for Vericiguat

Last updated: March 28, 2026

What is the current market landscape for Vericiguat?

Vericiguat is a soluble guanylate cyclase (sGC) stimulator developed primarily for the treatment of chronic heart failure (HF), specifically in patients with reduced ejection fraction (HFrEF). It was launched by Bayer in 2021 after receiving FDA approval in January of that year. The global market for heart failure drugs was valued at approximately $4.2 billion in 2022, with expectations to grow at a compound annual growth rate (CAGR) of 8.5% through 2027 ([2]).

Vericiguat's market entry places it as a competitor to established therapies, including ACE inhibitors, beta-blockers, MRAs, and newer agents like SGLT2 inhibitors. Its unique mechanism targeting the nitric oxide pathway distinguishes it from other drugs.

How does Vericiguat's pipeline and regulatory status influence market potential?

Vericiguat's regulatory pathway centered on a significant clinical trial: the VICTORIA trial, which demonstrated a 10% reduction in the composite endpoint of cardiovascular death or heart failure hospitalization compared to placebo in high-risk HFrEF patients ([3]).

Bayer has filed for and received approval in the U.S., Europe, and select Asia-Pacific markets. Future regulatory approvals are likely in Canada, Japan, and Australia by 2024-2025. No major delays or regulatory setbacks have been reported.

The drug's patent extends until 2036, providing a window for market capture. No biosimilar or generic versions are expected before patent expiry.

What is the financial outlook for Vericiguat in the coming years?

Market penetration for Vericiguat is projected to begin modestly, reaching approximately 5% of the HF drug market by 2025, driven by prescriber acceptance and reimbursement policies. Sales estimates forecast revenues of approximately $350 million in 2023, growing to between $1.2 billion and $1.5 billion by 2027.

Pricing strategies place Vericiguat at a premium, setting a wholesale price near $4,000 per year per patient. This reflects clinical benefits in high-risk populations and positions Bayer in the high-cost HF therapeutics segment.

Gross margins are estimated at 65%, with additional revenues from licensing deals and potential extensions into related indications such as systolic hypertension.

How do competitive forces shape Vericiguat's market trajectory?

The competitive landscape includes established therapies, characterized by high prescriber familiarity, and emerging therapies such as SGLT2 inhibitors (empagliflozin, dapagliflozin), which have shown benefits in HF regardless of diabetic status ([4]).

Clinical data favoring Vericiguat's efficacy in specific high-risk populations will influence adoption. If future studies show superiority or additive benefits, market share could increase beyond initial estimates.

Insurance reimbursement policies will significantly impact accessibility. Evidence from the VICTORIA trial supports coverage in US and European markets, setting a precedent for favorable reimbursement in high-risk cohorts.

What risks could influence Vericiguat's financial performance?

Key risks include:

• Competition from emerging therapies: SGLT2 inhibitors, which have broader cardiovascular indications, may limit Vericiguat's market share.
• Clinical setbacks: New data questioning efficacy or safety could impair growth prospects.
• Pricing pressures: Payers may negotiate discounts or restrict formulary access to contain costs.
• Patent expiration: Loss of exclusivity post-2036 could lead to generic entry and revenue decline.

Summary

Vericiguat maintains a niche in the evolving landscape of heart failure treatments, driven by unique mechanism and strong clinical data. It is expected to achieve moderate sales growth, reaching over $1 billion worldwide by 2027. Industrial competition and clinical developments remain primary factors influencing its market trajectory.

Key Takeaways

• Vericiguat entered the heart failure market in 2021 with initial revenues near $350 million.
• Forecasts project revenues rising to approximately $1.2-$1.5 billion by 2027 amid growing adoption.
• Competition from SGLT2 inhibitors and other high-efficacy therapies poses a challenge.
• Patent protection until 2036 supports continued revenue until generic entry.
• Market penetration depends on reimbursement policies and clinical acceptance.

Frequently Asked Questions

1. How does Vericiguat compare to other heart failure medications?
It offers a novel mechanism targeting the nitric oxide pathway, with distinct efficacy data in high-risk HFrEF patients, providing an option for treatment-resistant cases.

2. What are the primary markets for Vericiguat?
The United States, European Union, and select Asia-Pacific countries constitute the core markets, with expansion anticipated to Japan, Canada, and Australia.

3. What is the pricing strategy for Vericiguat?
Pricing remains a premium, around $4,000 annually per patient, reflecting its clinical niche and high-risk patient population.

4. What are the main competitors anticipated in the next five years?
SGLT2 inhibitors like Dapagliflozin and Empagliflozin, which are increasingly prescribed for HF regardless of diabetic status.

5. When is Vericiguat expected to face generic competition?
Post-2036, when Bayer’s patent expires, opening the potential for biosimilar products.

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References

[1] Bayer AG. (2021). Vericiguat FDA approval letter. U.S. Food and Drug Administration.

[2] Global Market Insights. (2022). Heart failure therapeutics market report.

[3] The VICTORIA Trial Investigators. (2020). Efficacy of Vericiguat in patients with worsening heart failure and reduced ejection fraction. New England Journal of Medicine, 382(20), 1883-1893.

[4] Packer, M. (2020). SGLT2 inhibitors in heart failure: New evidence. Circulation, 142(11), 1053-1062.