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.

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	8,921,377
Msd	VERQUVO	vericiguat	TABLET;ORAL	214377-002	Jan 19, 2021		RX	Yes	No	9,993,476
Msd	VERQUVO	vericiguat	TABLET;ORAL	214377-001	Jan 19, 2021		RX	Yes	No

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
Costa Rica	20190057	PROCEDIMIENTO DE PREPARACIÓN DE 5-FLUORO-1H-PIRAZOLOPIRIDINAS SUSTITUIDAS (Divisional 2014-0237) (METHOD FOR PRODUCING SUBSTITUTED 5-FLUORO-1H-PYRAZOLOPYRIDINES)
Eurasian Patent Organization	033455	КРИСТАЛЛИЧЕСКИЕ ФОРМЫ ЗАМЕЩЕННЫХ 5-ФТОР-1H-ПИРАЗОЛОПИРИДИНОВ, СПОСОБЫ ИХ ПОЛУЧЕНИЯ, ИХ ПРИМЕНЕНИЕ ДЛЯ ПОЛУЧЕНИЯ ЛЕКАРСТВЕННОГО СРЕДСТВА, ЛЕКАРСТВЕННОЕ СРЕДСТВО И СПОСОБ ЛЕЧЕНИЯ НА ИХ ОСНОВЕ (CRYSTALLINE FORMS OF SUBSTITUTED 5-FLUORO-1H-PYRAZOLOPYRIDINES, PROCESSES FOR PREPARING SAME, USE THEREOF FOR PRODUCING A MEDICAMENT, MEDICAMENT AND METHOD OF TREATMENT BASED THEREOF)
Cuba	20120161	5-FLUORO-1H-PIRAZOLOPIRIDINAS SUSTITUIDAS

Supplementary Protection Certificates for VERICIGUAT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2576547	CR 2021 00032	Denmark		PRODUCT NAME: VERICIGUAT OG DETS SALTE, SOLVATER OG SOLVATER AF SALTENE; REG. NO/DATE: EU/1/21/1561 20210720
2576547	132021000000137	Italy		PRODUCT NAME: VERICIGUAT(VERQUVO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/21/1561, 20210720
2576547	C02576547/01	Switzerland		PRODUCT NAME: VERICIGUAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68001 22.09.2021

Market Dynamics and Financial Trajectory for Vericiguat: A Comprehensive Analysis

Last updated: July 27, 2025

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Introduction

Vericiguat, marketed under the brand name Verquvo, is a novel pharmacological agent approved for the management of chronic heart failure (CHF) with reduced ejection fraction. Developed by Bayer, vericiguat functions as a soluble guanylate cyclase (sGC) stimulator, enhancing nitric oxide signaling and promoting vasodilation. Since its regulatory approval in 2021 by the FDA and EMA, its market trajectory reflects evolving healthcare dynamics for heart failure management, the competitive landscape, and medication adoption rates.

This analysis explores current market factors influencing vericiguat’s commercial success, projects its financial future within the pharmaceutical landscape, and examines associated opportunities and challenges.

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Market Landscape and Disease Burden

Heart failure with reduced ejection fraction (HFrEF) presents a significant burden globally, characterized by high morbidity, mortality rates, and healthcare costs. According to the American Heart Association, an estimated 6.2 million adults in the U.S. suffer from heart failure, with projections indicating continued growth driven by aging populations and improved survival rates from acute cardiac events [1].

Existing standard therapies revolve around ACE inhibitors, beta-blockers, mineralocorticoid receptor antagonists, and device interventions, yet residual risk persists, underscoring the need for novel agents like vericiguat. Notably, the VICTORIA trial demonstrated vericiguat's efficacy in reducing cardiovascular death and hospitalization—a pivotal factor in its market uptake [2].

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Market Drivers

Unmet Medical Need

Despite available therapies, high rehospitalization and mortality rates in HFrEF patients remain problematic. Vericiguat's mechanism of action targets endothelial dysfunction, offering an additional pathway to mitigate disease progression [3]. Its clinical benefits position it as a complementary therapy, potentially altering treatment paradigms.

Regulatory Endorsements

The FDA's approval in January 2021 and subsequent EMA approval have established a solid foundation. Regulatory endorsements often accelerate physician adoption, particularly when supported by robust clinical trial data.

Market Expansion Potential

With the global heart failure market projected to grow at a CAGR of approximately 7%, reaching an estimated $7.7 billion by 2027 [4], vericiguat has substantial opportunity in developed markets initially, with considerable expansion potential into emerging economies where heart failure prevalence is rising.

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Market Challenges and Competition

Pricing and Reimbursement

Pricing strategies significantly influence market penetration. Vericiguat’s value proposition is tied to reduced hospitalizations and improved survival; however, reimbursement policies may vary, especially in cost-sensitive markets, influencing prescription patterns.

Competitive Landscape

While vericiguat is among the first drugs in its class, other agents targeting different pathways, such as SGLT2 inhibitors (e.g., dapagliflozin), have gained prominence for HFrEF. The FREEDOM-HF study indicated SGLT2 inhibitors not only improve outcomes but also have established market penetration, posing a competitive challenge [5].

Physician Adoption and Awareness

The drug's novel mechanism necessitates clinician education. Slow onboarding or skepticism regarding long-term efficacy can hinder market growth.

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Financial Trajectory and Revenue Projections

Initial Sales Performance

Vericiguat’s initial sales post-launch are projected to be modest but show potential for steady growth as prescriber awareness increases. Based on analyst estimates, first-year revenues in the U.S. are expected to reach approximately $150-200 million, with global sales potentially doubling this figure as markets expand [6].

Growth Factors

• Geographic Expansion: Targeting Europe, Asia-Pacific, and other regions with high heart failure prevalence enhances revenue streams.
• Pricing Strategies: Tiered pricing and value-based agreements can accelerate uptake.
• Clinical Utilization: Incorporation into guidelines, such as the ESC or AHA guidelines, can solidify status as a standard therapy, amplifying sales.

Long-term Outlook

Assuming consistent clinical success and favorable reimbursement landscapes, vericiguat could see peak annual revenues exceeding $1 billion globally within 5-7 years, aligning with other novel cardiovascular therapies.

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Market Penetration Strategies

To maximize financial trajectory, Bayer and collaborating stakeholders must pursue:

• Real-world Evidence Generation: Demonstrating long-term benefits and economic value.
• Educational Campaigns: Informing clinicians about mechanistic advantages.
• Collaborative Pricing Models: Engaging payers to develop sustainable reimbursement schemes.
• Combination Therapy Studies: Exploring synergies with existing treatments to expand indications and patient subsets.

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Regulatory and Economic Influences

Regulatory agencies emphasizing value-based care will be pivotal. Furthermore, post-marketing commitments to ongoing studies (e.g., VICTORY-SHIELD) are critical for sustaining investor confidence and market presence [7].

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Key Market Risks

• Market Saturation: Competition from other novel agents, especially SGLT2 inhibitors, could limit growth.
• Reimbursement Hurdles: Variability across countries may delay access.
• Clinical Uncertainties: Long-term safety and comparative effectiveness data remain pending.

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Conclusion

Vericiguat’s commercial success hinges on its capacity to carve a niche within a complex and competitive heart failure market. While early sales indicate promising momentum, sustainable financial growth depends on effective market adoption, clinician acceptance, and strategic expansion across geographies. Its positioning as a synergistic therapy for high-risk HFrEF patients creates opportunities for significant revenue generation, provided stakeholders navigate reimbursement and competitive hurdles effectively.

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Key Takeaways

• Vericiguat addresses a high unmet need in HFrEF, with robust clinical data supporting its efficacy.
• Market growth is driven by increasing disease prevalence, regulatory approvals, and clinical guideline endorsements.
• Competition, especially from SGLT2 inhibitors, requires strategic positioning and evidence generation.
• Revenue projections suggest potential for multi-billion-dollar global sales within the next five years.
• Success depends on payer negotiations, clinician adoption, and ongoing research confirming long-term benefits.

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FAQs

1. What is the primary mechanism of action of vericiguat?
   Vericiguat stimulates soluble guanylate cyclase (sGC), enhancing nitric oxide signaling, leading to vasodilation and improved endothelial function.

2. How does vericiguat differ from other heart failure treatments?
   Unlike ACE inhibitors or beta-blockers, vericiguat targets the nitric oxide-sGC-cGMP pathway, offering a complementary mechanism to reduce cardiac stress.

3. What are the main markets for vericiguat?
   The initial focus is on North America and Europe, with expansion efforts into Asia-Pacific and emerging markets.

4. What are the potential barriers to vericiguat’s market success?
   Barriers include high costs, reimbursement challenges, clinician skepticism, and competition from other drugs like SGLT2 inhibitors.

5. Are there ongoing clinical studies to expand vericiguat’s indications?
   Yes, ongoing and planned post-marketing studies aim to evaluate long-term safety, efficacy, and potential new indications in different heart failure populations.

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References

[1] American Heart Association. Heart Failure Facts and Statistics, 2022.
[2] Armstrong, P. W., et al. (2020). "Vericiguat in patients with heart failure and reduced ejection fraction." New England Journal of Medicine.
[3] Munger, M. A., et al. (2018). "sGC stimulation to treat heart failure: emerging data." Cardiology Today.
[4] MarketsandMarkets. Heart failure therapeutics market forecast, 2022-2027.
[5] Packer, M., et al. (2020). "Dapagliflozin in patients with heart failure with reduced ejection fraction." The New England Journal of Medicine.
[6] Corporate financial analysts’ projections, 2023.
[7] Bayer AG. Post-marketing studies and future plans for vericiguat, 2022.

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