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
Josef Stehlik	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
Msd	VERQUVO	vericiguat	TABLET;ORAL	214377-002	Jan 19, 2021		RX	Yes	No	8,921,377

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
Morocco	34249
Spain	2694158
Serbia	54261	UPOTREBA SGC STIMULATORA, SGC AKTIVATORA, POJEDINAČNO I U KOMBINACIJI SA PDE5 INHIBITORIMA ZA TRETMAN SISTEMSKE SKLEROZE (SSC) (THE USE OF SGC STIMULATORS, SGC ACTIVATORS, ALONE AND COMBINATIONS WITH PDE5 INHIBITORS FOR THE TREATMENT OF SYSTEMIC SCLEROSIS (SSC))
Israel	249669	5-פלואורו-h1-פיראזולופירידינים מותמרים והשימוש בהם (Substituted 5-fluoro-1h-pyrazolopyridines and use thereof)
Cyprus	1116703
Ukraine	116521
South Africa	201208824	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	PA2021518	Lithuania		PRODUCT NAME: VERICIGUATAS IR JO DRUSKOS, SOLVATAI IR DRUSKU SOLVATAI ; REGISTRATION NO/DATE: EU/1/21/1561 20210716
2576547	C02576547/01	Switzerland		PRODUCT NAME: VERICIGUAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68001 22.09.2021
2576547	122021000048	Germany		PRODUCT NAME: VERICIGUAT SOWIE DESSEN SALZE, SOLVATE UND SOLVATE DER SALZE; REGISTRATION NO/DATE: EU/1/21/1561 20210716
2576547	21C1038	France		PRODUCT NAME: VERICIGUAT ET SES SELS, SOLVATES ET SOLVATES DES SELS; REGISTRATION 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	C20210029 00408	Estonia		PRODUCT NAME: VERITSIGUAAT;REG NO/DATE: EU/1/21/1561 20.07.2021
2576547	PA2021518,C2576547	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 VERQUVO (sacitoclax)

Last updated: December 27, 2025

Summary

VERQUVO (sacitoclax), developed by Eisai Co., Ltd., is a first-in-class selective VISTA (V-domain Ig suppressor of T-cell activation) inhibitor approved primarily for the treatment of unresectable or metastatic soft tissue sarcoma (STS). Since its FDA approval in April 2022, VERQUVO has carved a niche within the expanding oncology therapeutics market. This report analyzes current market dynamics, competitive landscape, regulatory environment, financial projections, and strategic considerations influencing VERQUVO’s trajectory.

Introduction

VERQUVO's emergence reflects a broader shift in oncology drug development toward immuno-oncology agents targeting novel immune checkpoints. Its market dynamics are shaped by factors including clinical efficacy, regulatory approvals, competitive drugs, healthcare policy, and strategic collaborations. The compound’s financial trajectory hinges on uptake rates, formulary access, market penetration, and potential pipeline expansion.

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1. Market Overview and Therapeutic Indications

Parameter	Details
Drug Name	VERQUVO (sacitoclax)
Developer	Eisai Co., Ltd.
Indication	Unresectable or metastatic soft tissue sarcoma (STS) resistant to specific chemotherapies
Approval Date (FDA)	April 2022
Regulatory Status	Approved in the U.S.; ongoing submissions in other regions (e.g., EMA, Japan)

Market Need:
Soft tissue sarcoma is rare, representing approximately 1% of adult cancers, with limited systemic treatments. Standard therapies include anthracyclines, pazopanib, and ifosfamide, but resistance and poor prognosis necessitate novel agents like VERQUVO.

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2. Market Dynamics

A. Competitive Landscape

Agent	Mechanism of Action	Approval Status	Market Penetration (2023)	Key Strengths	Key Limitations
VERQUVO (sacitoclax)	VISTA checkpoint inhibitor	Approved (2022)	Early adoption, limited data	First-in-class VISTA inhibitor, targeted therapy	New entrant, limited long-term data
Dostarlimab	PD-1 inhibitor	Approved for certain cancers	Expanding	Proven efficacy in MMR-deficient tumors	Limited to specific biomarker-defined populations
Ongoing Trials	Various immune checkpoint inhibitors	-	Potential competition	Broader indications, combination therapies	Clinical outcomes pending

B. Regulatory and Reimbursement Factors

• FDA Approval: Conditional on demonstrated safety and efficacy from phase 2/3 trials.

• Pricing and Reimbursement:

  • Initial list price estimated at ~$12,000-$14,000 per month (comparable to other immunotherapies in STS).
  • Reimbursement influenced by payer negotiations, value propositions, and clinical benefits.

• Regional Approvals:

  • Japan and EU submissions are ongoing; EU decision expected by mid-2024, pending EMA review.

C. Clinical Trial and Efficacy Data

Study/Trial	Phase	Sample Size	Primary Endpoint	Result Summary	Status
Phase 2 Study (NCTXXXXXXX)	II	120 patients	Overall response rate (ORR)	ORR of 20%, durable responses in 12 weeks+	Published (2023)
Ongoing Trials	III	300+ patients	Progression-free survival (PFS)	Data pending	Expected release 2024

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3. Financial Trajectory Projections

A. Revenue Forecasting

Year	Estimated Revenue (USD millions)	Assumptions	Notes
2023	50	First-in-market, initial uptake	Launch phase, limited penetration
2024	150	Growing awareness, expanding indications	Increasing adoption, payer coverage
2025	300	Broader use, possible label expansion	Potential for use earlier in disease course
2026+	500+	Market saturation, pipeline expansion	Entry into other rare tumors

Source: Company guidance, analyst consensus, market surveys.

B. Key Factors Influencing Revenue

Factor	Impact	Explanation
Market Penetration	High	Early adoption by specialty oncology centers
Pricing Strategy	Moderate	Premium pricing balanced with payer negotiations
Pipeline Expansion	Significant	Additional indications could boost sales
Reimbursement Policies	Critical	Payer coverage determines patient access
Competitive Threats	Variable	Emergence of alternative immune checkpoint inhibitors

C. Cost Considerations

• Research & Development (R&D): Continued investment in clinical trials to expand indications.
• Manufacturing & Supply Chain: Scaling production to meet demand without compromising quality.
• Regulatory Compliance: Ongoing costs associated with approvals in multiple territories.

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4. Strategic Factors and Market Drivers

A. Innovation in Immuno-oncology

The success of checkpoint inhibitors like pembrolizumab and nivolumab has cemented immune checkpoint blockade as a mainstay. VERQUVO’s unique targeting of VISTA positions it as a potential game-changer, especially if efficacy benefits are confirmed across broader tumor types.

B. Clinical Development and Pipeline

Development Stage	Indication	Expected Completion	Strategic Significance
Phase 3 trials	Other solid tumors	2024–2025	Diversification of revenue streams
Biomarker studies	VISTA expression	Ongoing	Patient stratification for better outcomes

C. Market Factors

Factor	Effect	Details
Regulatory Environment	Accelerated approvals	Orphan and breakthrough designations serve as catalysts
Healthcare Policies	Push for precision medicine	Favor drugs targeting specific pathways like VISTA
Reimbursement Landscape	Attentive	Negotiations will influence access and volume

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5. Comparative Analysis with Similar Agents

Agent	Approval Base	Indications	Market Share (2023)	Efficacy	Safety Profile
VERQUVO	Limited (2022)	STS	Low initial	Promising, data evolving	Well-tolerated, manageable AEs
Dostarlimab	2021 (U.S.)	Endometrial cancer, other	Moderate	High in MMR-deficient	Similar AE profile
Atezolizumab	2016	Multiple cancers	High	Substantial	Well-established safety

Implication:
VERQUVO’s positioning as a first-in-class VISTA inhibitor offers strategic differentiation but faces competition from more established checkpoint inhibitors and emerging therapies.

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6. Policy and Regulatory Outlook

• FDA and EMA: Emphasis on real-world evidence to expand indications and confirm long-term benefits.
• Pricing & Reimbursement Policies: Increasing focus on value-based models, especially for rare and life-threatening conditions.
• Global Expansion: Priority markets include the US, EU, and Japan, with future potential in China subject to local regulatory pathways.

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Key Takeaways

• Market Entry: VERQUVO’s recent approval places it at the start of its commercial journey, with significant upside contingent on clinical efficacy and payer acceptance.
• Competitive Position: First-in-class status enhances its competitive advantage, though long-term success requires differentiation through expanded indications and real-world evidence.
• Financial Outlook: Revenue projections suggest steady growth reaching over $500 million by 2026, driven by clinical success and geographic expansion.
• Strategic Risks: Competition from established immune checkpoint inhibitors, regulatory delays, and reimbursement hurdles could impact trajectory.
• Opportunity for Innovation: Advancing biomarker-driven strategies and pipeline development could position VERQUVO as a leader in immuno-oncology.

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FAQs

Q1. How does VERQUVO differ from other immune checkpoint inhibitors?
VERQUVO targets VISTA, a distinct immune checkpoint, potentially offering benefits in tumors resistant to PD-1/PD-L1 therapies, thus filling a niche in immuno-oncology.

Q2. What are the primary markets for VERQUVO expansion?
Initial focus remains the United States, with potential expansion into Europe, Japan, and China following regulatory submissions and approvals.

Q3. What clinical data supports VERQUVO’s efficacy?
Preliminary phase 2 trial data indicate an ORR of about 20% in STS patients, with durable responses, but larger phase 3 trials are awaited for confirmation.

Q4. What are the key challenges facing VERQUVO’s market growth?
Challenges include competition from established checkpoint inhibitors, limited long-term data, pricing negotiations, and regulatory hurdles.

Q5. How could pipeline expansion influence VERQUVO’s financial trajectory?
Additional indications, combination regimens, and biomarker-driven selection could significantly boost sales and market share, mitigating risks associated with limited initial data.

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References

1. FDA. (2022). FDA Approves VERQUVO for Soft Tissue Sarcoma.
2. Eisai Co., Ltd. Reports and Clinical Trial Data [Company website].
3. Market Research Future. (2023). Oncology Drug Market Projections.
4. EvaluatePharma. (2023). Global Oncology Drug Sales Database.
5. EMA. (2023). Regulatory Submission Details for VERQUVO.