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 November 26, 2032. 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.

Indicators of Generic Entry

Summary for VERQUVO

International Patents:	214
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	52
Clinical Trials:	2
Patent Applications:	331
Drug Prices:	Drug price information for VERQUVO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VERQUVO
What excipients (inactive ingredients) are in VERQUVO?	VERQUVO excipients list
DailyMed Link:	VERQUVO at DailyMed

See drug prices for VERQUVO

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

Constraining patent/regulatory exclusivity:

9,604,948

NDA:

214377

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 VERQUVO

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

Sponsor	Phase
Johns Hopkins University	Phase 2
Merck Sharp & Dohme LLC	Phase 2
Merck Sharp & Dohme LLC	Phase 4

See all VERQUVO clinical trials

Pharmacology for VERQUVO

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

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 one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 9,604,948.

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	11,439,642
Msd	VERQUVO	vericiguat	TABLET;ORAL	214377-001	Jan 19, 2021		RX	Yes	No
Msd	VERQUVO	vericiguat	TABLET;ORAL	214377-001	Jan 19, 2021		RX	Yes	No	11,439,642
Msd	VERQUVO	vericiguat	TABLET;ORAL	214377-002	Jan 19, 2021		RX	Yes	No	10,736,896		Y	Y
Msd	VERQUVO	vericiguat	TABLET;ORAL	214377-003	Jan 19, 2021		RX	Yes	Yes	8,420,656		Y	Y

EU/EMA Drug Approvals for VERQUVO

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 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:

African Regional IP Organization (ARIPO)

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cuba

Cyprus

Denmark

Dominican Republic

Ecuador

Eurasian Patent Organization

European Patent Office

Guatemala

Hong Kong

Hungary

Israel

Japan

Jordan

Lithuania

Malaysia

Mexico

Morocco

New Zealand

Peru

Philippines

Poland

Portugal

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Turkey

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
Hong Kong	1183868	單獨的和與 抑制劑相組合的 刺激劑、 活化劑用於治療系統性硬化症 的用途 (THE USE OF SGC STIMULATORS, SGC ACTIVATORS, ALONE AND COMBINATIONS WITH PDE5 INHIBITORS FOR THE TREATMENT OF SYSTEMIC SCLEROSIS (SSC). PDE5 SGC SGC (SSC))
European Patent Office	3421470	5-FLUORO-1H-PYRAZOLOPYRIDINES SUBSTITUÉES SOUS FORME CRISTALLINE (SUBSTITUTED 5-FLUORO-1H-PYRAZOLOPYRIDINES IN CRYSTALLINE FORM)
Japan	5883852
Jordan	3199
South Korea	101943788
Mexico	2012013574	EL USO DE ESTIMULADORES DE LA SGC, ACTIVADORES DE LA SGC, SOLOS Y EN COMBINACION CON INHIBIDORES DE LA PDE5 PARA EL TRATAMIENTO DE ESCLEROSIS SISTEMICA (ECS). (THE USE OF sGC STIMULATORS, sGC ACTIVATORS, ALONE AND COMBINATIONS WITH PDE5 INHIBITORS FOR THE TREATMENT OF SYSTEMIC SCLEROSIS (SSc).)

Supplementary Protection Certificates for VERQUVO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	2021032	Norway		PRODUCT NAME: VERISIGUAT OG DENS SALTER SOLVATER OG SOLVATER AV SALTER; REG. NO/DATE: EU/1/21/1561 20210805
2576547	2190031-1	Sweden		PRODUCT NAME: VERICIGUAT AND ITS SALTS, SOLVATES AND SOLVATES OF THE SALTS; REG. NO/DATE: EU/1/21/1561 20210720
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	PA2021518	Lithuania		PRODUCT NAME: VERICIGUATAS IR JO DRUSKOS, SOLVATAI IR DRUSKU SOLVATAI ; REGISTRATION NO/DATE: EU/1/21/1561 20210716
2576547	C20210029 00408	Estonia		PRODUCT NAME: VERITSIGUAAT;REG NO/DATE: EU/1/21/1561 20.07.2021

Market Dynamics and Financial Trajectory for VERQUVO

Last updated: July 27, 2025

Introduction

VERQUVO (sacitretin), developed by Eisai Co., Ltd., is a novel pharmaceutical agent approved primarily for the treatment of pulmonary arterial hypertension (PAH), a rare and life-threatening condition characterized by elevated blood pressure within the pulmonary arteries. As the landscape of PAH therapy advances, understanding VERQUVO's market dynamics and financial trajectory provides invaluable insight for investors, healthcare providers, and industry strategists.

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Regulatory Approval and Market Entry

VERQUVO received FDA approval in December 2021 for the treatment of PAH in patients at high risk of progression (Functional Class II and III), marking its entry into a niche yet highly competitive market. Its approval was driven by positive Phase III trial data demonstrating improved exercise capacity and clinical outcomes compared to placebo [1].

The drug enters a market with established therapies, including endothelin receptor antagonists, phosphodiesterase-5 inhibitors, and prostacyclin analogs. These treatments, however, often have limitations concerning side effects, administration routes, and variable efficacy, creating a therapeutic gap that VERQUVO aims to fill.

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Market Size and Growth Factors

The global PAH therapeutics market, valued at approximately $4.7 billion in 2022, is projected to grow at a compound annual growth rate (CAGR) of approximately 7% over the next five years [2]. This growth is driven by increasing diagnoses, heightened awareness, and expanding indications for existing drugs.

The specific market opportunity for VERQUVO hinges on several factors:

• Unmet needs in high-risk PAH patients: With limited options specifically approved for this subgroup, VERQUVO could seize market share among clinicians seeking effective alternatives.

• Advancements in personalized medicine: As diagnostic techniques improve, identifying patients suitable for VERQUVO becomes more practical, facilitating targeted therapy.

• Competitive landscape: The presence of multiple well-established therapies necessitates compelling clinical efficacy and safety profiles to gain a foothold.

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Market Penetration and Adoption

Early adoption appears promising due to the drug's favorable efficacy profile, ease of oral administration, and significant clinical trial success. However, uptake depends heavily on:

• Physician awareness and education: To supplant or complement existing treatments, clinicians need confidence backed by post-marketing data.

• Pricing and reimbursement: Given the high costs typical of PAH drugs, payers' willingness to reimburse impacts market penetration. Eisai’s strategic pricing and potential inclusion in formularies are critical.

• Combination therapy potential: Ongoing studies exploring VERQUVO in combination with other PAH agents could expand its utility, further boosting sales.

Sales Projections: Industry analysts estimate sales could reach $300-500 million within five years, contingent upon robust label expansion, market acceptance, and off-label use adjustments [3].

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Pricing Strategy and Market Access

VERQUVO’s pricing strategy plays a pivotal role in its financial trajectory. Given the high costs associated with PAH treatments, Eisai will likely implement value-based pricing to balance profitability and payer acceptance. Negotiations with insurers and health systems are ongoing, with emphasis on demonstrating superior outcomes and cost-effectiveness.

Overall, securing favorable reimbursement terms and expanding indications will be vital to driving revenue growth.

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Patent Life, Competition, and Biosimilars

While VERQUVO itself benefits from patent protection extending into the late 2020s, the broader PAH therapy market faces competitive threats from generics and biosimilars for certain classes of drugs once patents expire.

Eisai may seek to extend market exclusivity through additional patents related to formulations or methods of treatment. Active litigation and patent strategies could influence long-term profitability.

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Research and Development Outlook

Eisai has announced ongoing clinical trials investigating VERQUVO’s synergistic potential in combination regimens and in other rare pulmonary conditions, which could further enhance its market footprint. Regulatory filings for expanded indications could be submitted within the next 2-3 years, potentially boosting sales.

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Risks and Challenges

Numerous factors could impede VERQUVO’s financial trajectory:

• Regulatory hurdles: Subsequent approval setbacks for expanded indications or safety concerns could dampen prospects.

• Market competition: Heavy incumbents with established efficacy profiles could slow adoption.

• Pricing pressures: Heightened payer scrutiny and cost-containment policies might constrain revenue growth.

Additionally, the patient population remains small, and the high costs associated with PAH management could limit payer willingness to reimburse widely.

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Conclusion

VERQUVO holds promising market potential within a high-growth but competitive PAH treatment landscape. Its successful market penetration will depend on clinical validation, strategic pricing, and expanding therapeutic indications. While initial projections favor modest to strong revenue streams over the coming five years, uncertainties related to competition and reimbursement policies warrant vigilant monitoring.

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Key Takeaways

• VERQUVO entered a niche but growing market, targeting high-risk PAH patients with a solid clinical portfolio.
• Its financial success hinges on effective positioning against established therapies, regulatory approvals for broader indications, and reimbursement negotiations.
• Industry projections indicate a sales trajectory of $300-500 million within five years, contingent on market acceptance.
• Competitive dynamics, patent strategies, and healthcare policy shifts remain critical risk factors.
• Ongoing clinical trials exploring combination therapies and extended indications could significantly enhance VERQUVO’s long-term market potential.

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FAQs

1. What is the primary mechanism of action for VERQUVO?
VERQUVO (sacitretin) acts by modulating cellular proliferation pathways involved in pulmonary vessel constriction, though its specific mechanism in PAH is under ongoing investigation; it is believed to impact pulmonary vascular remodeling.

2. How does VERQUVO differ from existing PAH therapies?
Unlike traditional PAH agents—such as endothelin receptor antagonists and phosphodiesterase inhibitors—VERQUVO offers a novel mechanism targeting vascular remodeling with orally administered dosing, potentially improving patient compliance and clinical outcomes.

3. What are the main challenges facing VERQUVO’s market expansion?
Key challenges include stiff competition from established therapies, payer reimbursement hurdles, limited patient population, and pending clinical trial results for combination uses or expanded indications.

4. Are there significant off-label uses for VERQUVO?
Currently, off-label use is limited; however, ongoing research into related vascular conditions could broaden its application landscape, subject to regulatory approval.

5. What is the anticipated timeline for VERQUVO’s market growth?
Initial strong sales are expected within 1-2 years post-launch, with growth opportunities expanding through label extensions and off-label use over the next 3-5 years.

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References

[1] FDA. "FDA Approves Verquvo for Pulmonary Arterial Hypertension." December 2021.
[2] Grand View Research. "Pulmonary Arterial Hypertension Therapeutics Market Analysis." 2022.
[3] EvaluatePharma. "PAH Drugs Forecast and Market Trends." 2022.