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:	20
Patent Applications:	282
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
National Heart, Lung, and Blood Institute (NHLBI)	Phase 4
University of Colorado, Denver	Phase 4
Memorial Sloan Kettering Cancer Center	Phase 2

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

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	9,604,948		Y	Y
Msd	VERQUVO	vericiguat	TABLET;ORAL	214377-002	Jan 19, 2021		RX	Yes	No	9,993,476
Msd	VERQUVO	vericiguat	TABLET;ORAL	214377-003	Jan 19, 2021		RX	Yes	Yes

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/005319 Treatment of symptomatic chronic heart failure	Authorised	no	no	no	2021-07-16

International Patents for vericiguat

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	201690521	СПОСОБ ПОЛУЧЕНИЯ ЗАМЕЩЕННЫХ 5-ФТОР-1H-ПИРАЗОЛОПИРИДИНОВ
Denmark	3421470
Japan	5883852

Supplementary Protection Certificates for vericiguat

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2576547	C202130044	Spain		PRODUCT NAME: VERICIGUAT Y SUS SALES, SOLVATOS Y SOLVATOS DE LAS SALES.; NATIONAL AUTHORISATION NUMBER: EU/1/21/1561; DATE OF AUTHORISATION: 20210716; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1561; DATE OF FIRST AUTHORISATION IN EEA: 20210716
2576547	132021000000137	Italy		PRODUCT NAME: VERICIGUAT(VERQUVO); AUTHORISATION NUMBER(S) AND DATE(S): 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

Market Dynamics and Financial Trajectory of Vericiguat

Introduction to Vericiguat

Vericiguat, marketed as Verquvo, is a novel pharmacotherapy developed by Bayer AG and Merck & Co. It is the first drug specifically designed to address high-risk cases of chronic heart failure with reduced ejection fraction (HFrEF), particularly in patients who have been hospitalized for heart failure or are receiving outpatient intravenous diuretics[1][5].

Market Context

The HFrEF market is highly competitive and has been dominated by generic treatments for decades. Recent approvals of major new drugs, such as Entresto (sacubitril/valsartan) in 2015 and Farxiga (dapagliflozin) in 2020, have further crowded the market. For new entrants to be successful, differentiation is crucial[1].

Unmet Patient Needs

Heart failure remains associated with high mortality, morbidity, and hospitalization rates. Patients with worsening HFrEF are at the highest risk of re-hospitalization and mortality, and treatments specifically evaluated for this subpopulation have been lacking. Vericiguat addresses this unmet need by reducing hospitalization rates and showing a trend toward reducing cardiovascular mortality[1].

Mechanism of Action and Clinical Benefits

Vericiguat works as a soluble guanylate cyclase stimulator, enhancing the effects of nitric oxide to increase cyclic guanosine monophosphate (cGMP) activity. This mechanism is distinct from current HF therapies, allowing it to be used as an add-on therapy with minimal risk of severe side effects. The VICTORIA trial demonstrated a 10% relative hazard reduction and an annualized absolute risk reduction of 4.2% in cardiovascular death or first hospitalization for heart failure compared to placebo[1][3][5].

Regulatory Approvals and Global Reach

Vericiguat was approved in the U.S. in January 2021 for the treatment of adults with chronic HFrEF following hospitalization for heart failure or receiving outpatient intravenous diuretics. It is currently under review by the European Medicines Agency (EMA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), and the Chinese National Medical Products Administration (NMPA)[1].

Market Potential and Financial Projections

Given its unique mechanism of action and clinical benefits, vericiguat is expected to find a niche among high-risk HFrEF patients. The drug's ease of use, once-daily oral dosing, and simple titration are anticipated to accelerate its uptake, especially post-hospitalization when drug switching or new drug initiation is most common. Analysts predict that vericiguat will be less exposed to direct competition from typical low-cost HF therapies due to its novel mechanism and will become a welcome addition to the treatment armamentarium[1].

Revenue Projections

The market potential for vericiguat is significant, with estimates suggesting it could reach substantial revenue. For instance, the drug's approval and subsequent market performance are expected to contribute to its financial trajectory, with projections indicating a potential market size that could justify its development and marketing costs[1].

Competitive Advantage

Vericiguat's differentiation from existing treatments is a key factor in its market success. Its ability to be prescribed as an add-on therapy without significant risk of severe side effects makes it an attractive option for clinicians. This unique positioning is expected to drive its acceptance and adoption in the clinical community[1][5].

Patient and Clinician Acceptance

The VICTORIA trial's results have been pivotal in demonstrating vericiguat's efficacy and safety. Patients with age less than 75 years, chronic renal insufficiency, LV ejection fraction <45%, and NYHA functional class III or IV appear to receive further benefit from vericiguat. This targeted efficacy is likely to enhance its acceptance among both patients and clinicians[5].

Renal Function and Safety

Studies have shown that vericiguat does not significantly impact renal function trajectories compared to placebo. The beneficial effects of vericiguat on the primary outcome were not influenced by baseline estimated glomerular filtration rate (eGFR), which is a critical factor in the management of heart failure patients[2].

Global Market Analysis

The global vericiguat API market is expected to grow, driven by increasing demand for effective heart failure treatments. Key regions and manufacturers are being closely monitored to understand production, demand, and market dynamics. This comprehensive analysis will help in forecasting the market size and growth factors from 2024 to 2030[4].

Challenges and Future Directions

While vericiguat has shown promising results, there are some concerns regarding its safety profile, particularly in subsets of patients with very high baseline N-terminal pro b-type natriuretic peptide (NT-proBNP) levels. Further investigation is needed to fully elucidate its role among available evidence-based therapies and target populations[3].

Key Takeaways

• Unique Mechanism: Vericiguat is the first drug to specifically address high-risk HFrEF patients through its soluble guanylate cyclase stimulator mechanism.
• Clinical Benefits: It reduces hospitalization rates and shows a trend toward reducing cardiovascular mortality.
• Regulatory Approvals: Approved in the U.S. and under review in other major regions.
• Market Potential: Expected to find a niche among high-risk HFrEF patients with significant revenue projections.
• Competitive Advantage: Differentiation from existing treatments due to its novel mechanism and safety profile.
• Patient and Clinician Acceptance: Targeted efficacy and ease of use are expected to enhance its acceptance.

FAQs

Q: What is vericiguat, and how does it work?

Vericiguat is a soluble guanylate cyclase stimulator that enhances the effects of nitric oxide to increase cyclic guanosine monophosphate (cGMP) activity, improving myocardial and vascular function.

Q: Who is the target population for vericiguat?

The target population includes adults with chronic heart failure with reduced ejection fraction (HFrEF) who have been hospitalized for heart failure or are receiving outpatient intravenous diuretics.

Q: What are the key clinical benefits of vericiguat?

Vericiguat reduces hospitalization rates and shows a trend toward reducing cardiovascular mortality in patients with severe, deteriorating HFrEF.

Q: Is vericiguat safe for patients with renal insufficiency?

Studies have shown that vericiguat does not significantly impact renal function trajectories compared to placebo, making it a viable option for patients with chronic renal insufficiency.

Q: What is the current regulatory status of vericiguat?

Vericiguat was approved in the U.S. in January 2021 and is currently under review by the EMA, PMDA, and NMPA.

Sources

1. Clarivate: Vericiguat | Clarivate
2. Wiley Online Library: Renal function and the effects of vericiguat in patients with heart failure
3. FDA: 214377Orig1s000 - accessdata.fda.gov
4. Southeast News Channel Nebraska: Research Report on Vericiguat API Market Size 2024-2030
5. American College of Cardiology: The Role of Vericiguat in the Expanding Realm of Heart Failure Pharmacotherapy