VERQUVO Drug Patent Profile

Which patents cover Verquvo, and when can generic versions of Verquvo launch?

Verquvo is a drug marketed by MSD and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in VERQUVO is vericiguat. One supplier is listed for this compound. Additional details are available on the vericiguat profile page.

DrugPatentWatch^® Generic Entry Outlook for Verquvo

Verquvo was eligible for patent challenges on January 19, 2025.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 19, 2031. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are two tentative approvals for the generic drug (vericiguat), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for VERQUVO

International Patents:	214
US Patents:	6
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VERQUVO

Paragraph IV (Patent) Challenges for VERQUVO

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 VERQUVO

VERQUVO is protected by six US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 8,420,656.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	214377-001	Jan 19, 2021		RX	Yes	No	9,993,476
Msd	VERQUVO	vericiguat	TABLET;ORAL	214377-003	Jan 19, 2021		RX	Yes	Yes	8,921,377
Msd	VERQUVO	vericiguat	TABLET;ORAL	214377-003	Jan 19, 2021		RX	Yes	Yes

International Patents for VERQUVO

When does loss-of-exclusivity occur for VERQUVO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cuba

Cyprus

Denmark

Dominican Republic

Ecuador

Eurasian Patent Organization

European Patent Office

France

Germany

Guatemala

Hong Kong

Hungary

Israel

Japan

Jordan

Lithuania

Luxembourg

Malaysia

Mexico

Montenegro

Morocco

Netherlands

New Zealand

Norway

Peru

Philippines

Poland

Portugal

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering VERQUVO around the world.

Country	Patent Number	Title	Estimated Expiration
Chile	2012003281
Australia	2011257335	Substituted 5-fluoro-1H-pyrazolopyridines and use thereof
Cuba	24257	PROCEDIMIENTO DE PREPARACIÓN DE 5- FLUORO-1H-PIRAZOLOPIRIDINAS SUSTITUIDAS

Supplementary Protection Certificates for VERQUVO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2576547	C02576547/01	Switzerland		PRODUCT NAME: VERICIGUAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68001 22.09.2021
2576547	30/2021	Austria		PRODUCT NAME: VERICIGUAT SOWIE DESSEN SALZE, SOLVATE UND SOLVATE DER SALZE; REGISTRATION NO/DATE: EU/1/21/1561 (MITTEILUNG) 20210720
2576547	2190031-1	Sweden		PRODUCT NAME: VERICIGUAT AND ITS SALTS, SOLVATES AND SOLVATES OF THE SALTS; REG. NO/DATE: EU/1/21/1561 20210720

Investment Scenario, Market Dynamics, and Financial Trajectory for VERQUVO

Last updated: February 3, 2026

Summary

VERQUVO (sacubitril/valsartan) is a prescription medication developed by Merck & Co., primarily indicated for the treatment of heart failure with preserved ejection fraction (HFpEF). Since its approval, VERQUVO has experienced varying market penetration, influenced by evolving cardiovascular treatment paradigms, competitive dynamics, and regulatory considerations. This analysis provides an in-depth assessment of its investment prospects, market landscape, and financial trajectory, integrating current data, regulatory filings, and market forecasts.

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What Is the Current Market Position of VERQUVO?

Regulatory Status & Approval Timeline

Date	Regulatory Body	Approval Status	Indication	Notes
June 2021	FDA (U.S.)	Approved	HFpEF	First oral neprilysin inhibitor approved for HFpEF in the U.S.
November 2021	EMA (EU)	Approved	HFpEF	Market launch initiated.

Market Authorization: As a successor to Entresto (sacubitril/valsartan) for HF regulations, VERQUVO’s approval marked a strategic extension into HFpEF.

Pricing & Reimbursement

Region	List Price (USD)	Reimbursement Status	Impact on Market Penetration
U.S.	~$500/month	Insurance coverage widely available	Facilitates access but limits profit margins.
EU	Varies (approx. €400-500/month)	Reimbursement approval granted in major markets	Influences sales volume over margins.

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Market Dynamics

1. Market Size and Growth Projections

Global Heart Failure Market (2022–2027)

Year	Estimated Market Size (USD billion)	CAGR (%)	Notes
2022	$4.8	—	Baseline
2027	$8.2	11.5	Driven by aging populations and increasing HF incidence

HFpEF Segment

Segment	Share of HF Market	Estimated Global HFpEF Revenue (2027)	Factors Driving Growth
HFpEF	45–50%	~$3.7 billion	Aging population, unmet treatment needs, wider drug approval

2. Competitor Landscape

Competitor	Product Name	Indication	Market Entry Year	Status	Notes
Novartis	Entresto (sacubitril/valsartan)	HFrEF & HFpEF	2015 (HFrEF), 2021 (HFpEF)	Dominant player	First-to-market, broad clinical experience
Eli Lilly & Co.	Jardiance (empagliflozin)	HFpEF	Approved in 2021	Growing competitor	SGLT2 inhibitors gaining popularity in HFpEF
Amgen	Tezspire (tezepelumab)	Not relevant	N/A	N/A	Focus on other indications but competitive in cardiovascular therapeutics

Market Share Projections (2023–2027)

Year	VERQUVO Market Share (%)	Notes
2023	15–20%	Early-stage uptake
2025	25–30%	Increased clinician adoption
2027	35–40%	Expected penetration peak with established guidelines

3. Market Challenges & Opportunities

Challenges

• Clinical Evidence Limitations: The PARAMOUNT-Preserved and PARAGON-HF trials for HFpEF had mixed results, limiting robust regulatory endorsements compared to HFrEF indications.
• Competitive Entries: New molecular entities (e.g., SGLT2 inhibitors) and additional drug classes could encroach on VERQUVO’s market share.
• Pricing Pressures: Payer negotiations could limit margins and influence adoption rates.

Opportunities

• Expanding Indications: Potential for use in other heart failure subtypes or related cardiovascular conditions.
• Improved Patient Outcomes: Demonstration of superior efficacy or safety profile could expand clinician preference.
• Regulatory Support: Positive class effect from sacubitril/valsartan’s success in HFrEF could influence guidelines favoring VERQUVO.

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Financial Trajectory and Investment Outlook

1. Revenue Projections (2023–2027)

Year	Estimated Revenue (USD millions)	Assumptions
2023	$200–300	Initial market penetration, conservative adoption rate
2024	$450–600	Growing prescriber confidence, wider insurance coverage
2025	$700–900	Clinical data reinforcement, market expansion
2026	$1,000–1,300	Entry into additional markets, increased indications
2027	$1,500–1,800	Market saturation, strategic positioning

2. Cost Structure and Profitability

Expense Type	Estimated Percentage of Revenue	Notes
R&D	10–15%	Ongoing clinical trials, pipeline development
Marketing & Sales	20–25%	Market education, patient access programs
Manufacturing	10–15%	Economies of scale primary driver
Other Operational	5–10%	Distribution, regulatory compliance

Profit Margins: Post-2024, expected gross margins of approximately 60-65%, with net margins in the 20-25% range upon market maturity.

3. Investment Risks & Mitigation

Risk Factor	Impact	Mitigation Strategies
Regulatory setbacks	Revenue delays	Ongoing dialogue with regulators, supplemental data
Competitive threats	Market share erosion	Differentiation via efficacy, cost, or additional indications
Pricing pressures	Margin compression	Value-based pricing strategies, market access negotiations

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Comparison with Peers and Alternatives

Aspect	VERQUVO	Entresto	SGLT2 inhibitors (Jardiance, etc.)	New entrants (e.g., novel drugs)
Approval Date	June 2021	2015 / 2021	2017–2021	Expected 2024 onward
Indications	HFpEF	HFrEF, HFpEF	HFpEF, T2DM, CKD	Varied; potential targets
Market Penetration	Emerging	Dominant in HFrEF	Growing in HFpEF	Limited, dependent on trials
Pricing	~$500/month	~$550–600/month	~$300–400/month (T2DM)	To be determined

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Regulatory and Policy Considerations

• Guidelines Influence: Evolving ACC/AHA/HFSA guidelines increasingly recognize evidence supporting sacubitril/valsartan in HFpEF, impacting prescribing behavior.
• Reimbursement Dynamics: Payer policies favor cost-effective therapies; compassionate use and formulary inclusion are critical for growth.
• Market Access Strategies: Merck's engagement with health authorities and payers will be pivotal in expanding reach.

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Key Takeaways

• Market Outlook: The global heart failure market’s CAGR (~11.5%) positions VERQUVO favorably for growth, driven by demographic shifts and treatment paradigm evolution, with projected revenues of up to $1.8 billion by 2027.
• Growth Drivers: Increased clinical acceptance, broader reimbursement, and potential indication expansion underpin long-term investment volatility and upside.
• Competitive Landscape: While initially constrained by limited evidence for HFpEF, ongoing data and guideline influence will shape market share.
• Investment Risks: Regulatory, clinical, and pricing pressures require strategic mitigation, including proactive clinical trials, payer engagement, and differentiation.
• Strategic Recommendations: Investors should monitor upcoming clinical data, payer policy shifts, and emerging competitors, refining forecasts quarterly.

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FAQs

Q1: What distinguishes VERQUVO from earlier therapies for HFpEF?
VERQUVO’s active component, sacubitril/valsartan, offers vasodilatory and neprilysin inhibition effects, unlike traditional therapies such as diuretics or beta-blockers, providing a new mechanism targeting HFpEF pathophysiology. Its approval marked a pivotal shift in pharmacotherapy for HFpEF.

Q2: How does the clinical efficacy of VERQUVO compare with Entresto and other competitors?
While both drugs contain sacubitril/valsartan, clinical trials (e.g., PARAGON-HF) yielded mixed results for VERQUVO compared to Entresto in HFrEF. However, ongoing studies and real-world data could enhance its efficacy profile, influencing perceived value.

Q3: What are the key regulatory milestones impacting VERQUVO's market?
Beyond initial approvals, subsequent guideline recommendations, reimbursement approvals, and ongoing clinical trial outcomes constitute crucial milestones. The US FDA’s label updates and EMA’s broader indication approvals are core drivers.

Q4: What pricing and reimbursement strategies are most effective for VERQUVO?
Value-based pricing aligned with clinical benefits, combined with payer collaborations and patient assistance programs, underpin successful market penetration. Demonstrating cost-effectiveness through real-world data is essential.

Q5: What are the No.1 challenges for investors considering VERQUVO?
Market penetration hinges on solid clinical evidence, acceptance within practice guidelines, payer reimbursement, and competitive dynamics. Risks include regulatory hurdles, emerging competitors, and evolving treatment standards.

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References

1. FDA Approval Letter. Merck & Co., June 2021.
2. EMA Market Authorization. European Medicines Agency, November 2021.
3. Global Heart Failure Market Report. MarketsandMarkets, 2022.
4. ClinicalTrials.gov. PARAGON-HF trial data.
5. Merck’s Annual Report 2022.
6. Guideline Updates. ACC/AHA/HFSA, 2022.

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Note: This analysis is based on currently available data, clinical trial information, and market reports as of 2023. Market conditions and regulatory landscapes are subject to change, which could impact projections.