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VERQUVO Drug Patent Profile

When do Verquvo patents expire, and when can generic versions of Verquvo launch?

Verquvo is a drug marketed by Merck Sharp Dohme and is included in one NDA. There are six patents protecting this drug.

This drug has two hundred and twelve 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 will be eligible for patent challenges on January 19, 2025. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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.

Indicators of Generic Entry

Summary for VERQUVO

International Patents:	212
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	52
Clinical Trials:	2
Patent Applications:	127
Drug Prices:	Drug price information 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

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

US Patents and Regulatory Information for VERQUVO

VERQUVO is protected by six US patents and one FDA Regulatory Exclusivity.

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
Merck Sharp Dohme	VERQUVO	vericiguat	TABLET;ORAL	214377-001	Jan 19, 2021		RX	Yes	No
Merck Sharp Dohme	VERQUVO	vericiguat	TABLET;ORAL	214377-003	Jan 19, 2021		RX	Yes	Yes
Merck Sharp Dohme	VERQUVO	vericiguat	TABLET;ORAL	214377-001	Jan 19, 2021		RX	Yes	No

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/005319 Treatment 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
Portugal	2782914
Poland	2576548
Tunisia	2012000550

Supplementary Protection Certificates for VERQUVO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2576547	2021C/553	Belgium		PRODUCT NAME: VERICIGUAT EN ZIJN ZOUTEN, SOLVATEN EN SOLVATEN VAN DE ZOUTEN; AUTHORISATION NUMBER AND DATE: EU/1/21/1561 20210720
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	PA2021518,C2576547	Lithuania		PRODUCT NAME: VERICIGUATAS IR JO DRUSKOS, SOLVATAI IR DRUSKU SOLVATAI ; REGISTRATION NO/DATE: EU/1/21/1561 20210716

VERQUVO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for VERQUVO

Introduction

VERQUVO (vericiguat) is a groundbreaking medication developed by Merck & Co. and Bayer AG, approved by the U.S. Food and Drug Administration (FDA) in January 2021. This drug is designed to treat heart failure with reduced ejection fraction (HFrEF) in adults, marking a significant advancement in cardiovascular care.

Approval and Indications

VERQUVO received FDA approval to reduce the risk of hospitalization and death from heart failure in adult patients with symptomatic chronic heart failure and an ejection fraction of less than 45%[4].

• The approval was backed by data from the phase 3 Victoria trial, which demonstrated that VERQUVO, when combined with existing heart therapies like Novartis AG's Entresto, reduced hospitalization and cardiovascular death.

Mechanism of Action

VERQUVO is the first soluble guanylate cyclase stimulator approved to treat heart failure. It works by stimulating an enzyme believed to play a crucial role in cardiovascular disease, helping to relax and widen blood vessels, reduce strain on the heart, and improve cardiac function[1][4].

Market Impact

The introduction of VERQUVO has been a key trend in the beta blockers and broader cardiovascular drug market.

Product Innovation

Product innovation is a driving force in the beta blockers market, and VERQUVO exemplifies this trend. Major pharmaceutical companies like Merck and Bayer are focusing on developing innovative products to strengthen their market positions[1].

Market Growth

The global beta blockers market, which includes drugs like VERQUVO, is expected to grow from $8.55 billion in 2022 to $9.16 billion in 2023, reflecting a compound annual growth rate (CAGR) driven in part by innovative products[1].

Financial Performance

Sales and Revenue

The approval and launch of VERQUVO have contributed to the financial performance of both Merck and Bayer.

• Merck's Financials: While specific sales figures for VERQUVO are not detailed in Merck's financial reports, the company's pharmaceutical sales growth for the full year of 2023 was 14% excluding the impact of LAGEVRIO and foreign exchange. This growth can be partly attributed to new product launches, including VERQUVO[5].

• Bayer's Financials: Bayer's pharmaceutical segment, which includes VERQUVO, saw significant growth in 2021. The company reported a 13% increase in sales in the second quarter of 2021, with all businesses contributing to double-digit sales growth. Although VERQUVO's specific sales figures are not provided, it is part of the broader pharmaceutical portfolio that has driven this growth[3].

EBITDA and Margin

Bayer's EBITDA before special items declined by 11% year-on-year in Q2 2021, but this was largely due to foreign exchange effects and higher costs of goods sold. The launch investments in new products, including VERQUVO, were significant factors in these financial metrics[3].

Clinical and Market Reception

Clinical Trials

The Victoria trial, which supported the FDA approval of VERQUVO, demonstrated the drug's efficacy in reducing hospitalization and cardiovascular death when used in combination with existing heart therapies. This positive clinical data has been crucial in its market reception[4].

Market Adoption

The successful launch of VERQUVO has been part of Bayer's strong growth momentum in its pharmaceutical segment. The drug has contributed to the recovery of elective treatments post-pandemic, which has been a significant factor in the company's overall performance[3].

Regulatory Considerations

VERQUVO carries a boxed warning indicating that it should not be administered to pregnant women due to the potential for fetal harm. This regulatory requirement is an important consideration for both prescribers and patients[4].

Future Outlook

Pipeline and Growth Potential

The approval of VERQUVO has significantly derisked Bayer's new product pipeline. The company expects continued positive dynamics across all its businesses, including the pharmaceutical segment, which includes VERQUVO. This suggests a promising future for the drug in terms of market penetration and revenue growth[3].

Competitive Landscape

VERQUVO operates in a competitive cardiovascular drug market, but its unique mechanism of action as a soluble guanylate cyclase stimulator sets it apart. This differentiation is likely to continue driving its adoption and market share[1][4].

Key Takeaways

• Innovative Mechanism: VERQUVO is the first soluble guanylate cyclase stimulator approved for heart failure treatment.
• Market Growth: The drug contributes to the growth of the global beta blockers market.
• Financial Impact: VERQUVO has positively impacted the financial performance of Merck and Bayer through increased sales and revenue.
• Clinical Efficacy: Positive clinical trial data supports its use in reducing hospitalization and cardiovascular death.
• Regulatory Considerations: The drug carries a boxed warning regarding its use in pregnant women.

FAQs

What is VERQUVO used for?

VERQUVO is used to reduce the risk of hospitalization and death from heart failure in adult patients with symptomatic chronic heart failure and an ejection fraction of less than 45%.

Who developed VERQUVO?

VERQUVO was developed by Merck & Co. and Bayer AG.

What is the mechanism of action of VERQUVO?

VERQUVO works by stimulating the soluble guanylate cyclase enzyme, helping to relax and widen blood vessels, reduce strain on the heart, and improve cardiac function.

Is VERQUVO approved by the FDA?

Yes, VERQUVO received FDA approval in January 2021.

What are the potential side effects or warnings associated with VERQUVO?

VERQUVO carries a boxed warning indicating that it should not be administered to pregnant women due to the potential for fetal harm.

Sources

1. Beta Blockers Global Market Report 2023: Product Innovation Fuels Growth in Beta Blockers Market. Globenewswire.
2. FY/Q4 2022 Investor Conference Call 2023-02-28 Presentation charts. Bayer.
3. Q2 2021 Results Investor and Analyst Call. Bayer.
4. Merck & Co., Bayer's heart failure drug Verquvo wins US FDA approval. S&P Global Market Intelligence.
5. Merck Announces Fourth-Quarter and Full-Year 2023 Financial Results. Merck.