VAZALORE Drug Patent Profile

When do Vazalore patents expire, and what generic alternatives are available?

Vazalore is a drug marketed by Plx Pharma and is included in one NDA. There are four patents protecting this drug.

This drug has twenty patent family members in nine countries.

The generic ingredient in VAZALORE is aspirin. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the aspirin profile page.

DrugPatentWatch^® Generic Entry Outlook for Vazalore

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 29, 2032. This may change due to patent challenges or generic licensing.

There is one tentative approval for the generic drug (aspirin), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for VAZALORE

International Patents:	20
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	116
Patent Applications:	2,903
What excipients (inactive ingredients) are in VAZALORE?	VAZALORE excipients list
DailyMed Link:	VAZALORE at DailyMed

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

Constraining patent/regulatory exclusivity:

10,786,444

NDA:

203697

Dosage:

CAPSULE;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.

Pharmacology for VAZALORE

Drug Class	Nonsteroidal Anti-inflammatory Drug Platelet Aggregation Inhibitor
Mechanism of Action	Cyclooxygenase Inhibitors
Physiological Effect	Decreased Platelet Aggregation Decreased Prostaglandin Production

US Patents and Regulatory Information for VAZALORE

VAZALORE is protected by six US patents.

This potential generic entry date is based on patent 10,786,444.

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
Plx Pharma	VAZALORE	aspirin	CAPSULE;ORAL	203697-002	Feb 26, 2021		OTC	Yes	No	10,786,444
Plx Pharma	VAZALORE	aspirin	CAPSULE;ORAL	203697-001	Jan 14, 2013		OTC	Yes	Yes	10,646,431		Y
Plx Pharma	VAZALORE	aspirin	CAPSULE;ORAL	203697-001	Jan 14, 2013		OTC	Yes	Yes	9,216,150		Y
Plx Pharma	VAZALORE	aspirin	CAPSULE;ORAL	203697-002	Feb 26, 2021		OTC	Yes	No	10,646,431		Y
Plx Pharma	VAZALORE	aspirin	CAPSULE;ORAL	203697-001	Jan 14, 2013		OTC	Yes	Yes	9,226,892
Plx Pharma	VAZALORE	aspirin	CAPSULE;ORAL	203697-001	Jan 14, 2013		OTC	Yes	Yes	10,786,444

Expired US Patents for VAZALORE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Plx Pharma	VAZALORE	aspirin	CAPSULE;ORAL	203697-001	Jan 14, 2013	8,865,187
Plx Pharma	VAZALORE	aspirin	CAPSULE;ORAL	203697-001	Jan 14, 2013	9,351,984
Plx Pharma	VAZALORE	aspirin	CAPSULE;ORAL	203697-001	Jan 14, 2013	9,101,637

International Patents for VAZALORE

When does loss-of-exclusivity occur for VAZALORE?

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

Australia

Canada

China

European Patent Office

Hong Kong

Japan

Mexico

South Korea

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 VAZALORE around the world.

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1200098	用於將藥物沿胃腸道靶向釋放的 依賴性載體、其組合物及其製備和應用 (PH DEPENDENT CARRIERS FOR TARGETED RELEASE OF PHARMACEUTICALS ALONG THE GASTROINTESTINAL TRACT, COMPOSITIONS THEREFROM, AND MAKING AND USING SAME PH)
Japan	2014531460	胃腸管に沿った医薬の標的化放出のためのｐＨ依存性担体、それによる組成物、ならびにこれらの製造および使用
China	103957888	Ph dependent carriers for targeted release of pharmaceuticals along the gastrointestinal tract, compositions therefrom, and making and using same
Canada	2431606	PROCEDE ET COMPOSITIONS FAISANT APPEL A DES FORMULATIONS D'HUILES DE LECITHINE ET D'ANTI-INFLAMMATOIRES NON STEROIDES, POUR LA PROTECTION DU TRACTUS GASTRO-INTESTINAL ET L'AMELIORATION DE L'EFFET THERAPEUTIQUE (NSAID FORMULATIONS COMPRISING LECITHIN OILS FOR PROTECTING THE GASTROINTESTINAL TRACT AND PROVIDING ENHANCED THERAPEUTIC ACTIVITY)
Cyprus	1110474
Japan	2017222650

Supplementary Protection Certificates for VAZALORE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0984957	2012/048	Ireland		PRODUCT NAME: A COMBINATION PRODUCT COMPRISING ASPIRIN AND ESOMEPRAZOLE MAGNESIUM TRIHYDRATE; NAT REGISTRATION NO/DATE: PA 970/063/001 20120831; FIRST REGISTRATION NO/DATE: 5402359; 5402367 5402375 20110812
0984957	122012000017	Germany		PRODUCT NAME: ASPIRIN UND ESOMEPRAZOL - MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 81047.00.00 20110930 FIRST REGISTRATION: PORTUGAL 5402359 5402367 5402375 20110812

Market Dynamics and Financial Trajectory for VAZALORE

Last updated: July 27, 2025

Introduction

VAZALORE (oral solution of aspirin, 81 mg per 5 mL) has garnered attention as an innovative oral aspirin therapy, primarily targeting cardiovascular and stroke prevention markets. Its unique formulation, marketed by Synthetic Biologics and its partners, aims to address adherence challenges associated with traditional aspirin tablets. As the pharmaceutical landscape evolves with increasing emphasis on ease of use, personalized therapy, and safety profiles, understanding VAZALORE's market dynamics and projected financial trajectory becomes critical for stakeholders and investors.

Market Landscape and Therapeutic Positioning

Target Indications and Differentiation

VAZALORE’s primary indication aligns with secondary prevention of myocardial infarction, stroke, and other thrombotic events. Aspirin remains the cornerstone of antiplatelet therapy, with an estimated global market size exceeding USD 7 billion by 2025 [1]. Despite its longstanding role, traditional aspirin faces challenges like gastrointestinal (GI) side effects and patient non-adherence, which VAZALORE aims to mitigate through a liquid formulation facilitating easier administration, especially for pediatric, elderly, or compliance-challenged patients.

Competitive Environment

The competitive landscape includes generic aspirin products valued for cost efficiency and a handful of innovative formulations, such as enteric-coated tablets intended to reduce GI complications. However, liquid aspirin formulations like VAZALORE offer distinctive advantages—improved palatability, targeted dosing, and potential for combination therapy—enhancing its market appeal.

Regulatory and Reimbursement Factors

VAZALORE received FDA approval for the secondary prevention of cardiovascular events, with indications expanding based on ongoing clinical data. Reimbursement prospects hinge on demonstrating cost-effectiveness, especially in healthcare systems emphasizing treatment adherence and reduced hospitalization costs due to fewer adverse events.

Market Dynamics Influencing VAZALORE

Epidemiological Drivers

The burden of cardiovascular disease (CVD) remains substantial globally, with over 18 million deaths annually attributable to CVD [2]. The aging population amplifies demand for antiplatelet therapies, positioning VAZALORE favorably. Moreover, increased awareness of medication adherence challenges fuels demand for user-friendly formulations.

Technological and Formulation Advances

Liquid formulations like VAZALORE meet the rising demand for personalized medicine, particularly in pediatric and geriatric cohorts. Enhanced bioavailability and ease of administration serve as competitive levers, potentially reducing the incidence of adverse gastrointestinal effects compared to traditional tablets.

Market Penetration and Adoption Rates

Success depends on physician acceptance and patient preference. Education campaigns emphasizing VAZALORE's safety and adherence benefits are essential. Early adoption by clinical guidelines and inclusion in treatment algorithms can accelerate market penetration.

Pricing Strategy and Market Access

Pricing must reflect added value over generics while ensuring affordability. As an innovative product, VAZALORE may command premium pricing; however, payers require substantial evidence of improved outcomes to support reimbursement.

Financial Trajectory Estimation

Revenue Projections

Initial market penetration is expected to be modest, targeting niche populations such as patients requiring liquid aspirin. Based on epidemiological estimates and market research, a conservative annual revenue projection for VAZALORE could range from USD 50 million to USD 150 million within the first three years post-launch, assuming moderate adoption rates.

Growth Drivers

• Expanding Indications: Additional approvals for primary prevention or pediatric use could broaden sales.
• Formulation Improvements: Launch of pediatric dosage forms or combination products.
• Geographical Expansion: Entry into markets with high CVD prevalence and favorable regulatory environments.

Challenges and Risks

• Pricing and Reimbursement: Resistance from payers regarding premium pricing.
• Competitive Pressure: Potential entry of alternative liquid aspirin formulations or novel antiplatelet agents.
• Market Acceptance: Slow adoption delaying revenue realization.

Long-term Outlook

Beyond initial release, VAZALORE's financial success hinges on its ability to sustain growth through clinical validation, broadening indications, and integration into clinical practice. Realistic scenarios project revenues stabilizing around USD 200 million annually after five years, contingent upon market adoption and global expansion strategies.

Strategic Considerations for Stakeholders

• Invest in Clinical Evidence: Demonstrate superior safety and adherence benefits to secure payer support.
• Engage Healthcare Providers: Conduct educational initiatives emphasizing benefits over existing therapies.
• Optimize Pricing and Reimbursement Pathways: Collaborate with payers to establish value-based pricing strategies.
• Leverage Digital Platforms: Use modern channels to increase awareness and facilitate prescription.

Key Takeaways

• VAZALORE targets a sizable and growing global CVD market with a differentiated liquid formulation designed to improve adherence and safety.
• Its success depends heavily on physician acceptance, patient preference, and demonstrable clinical benefits.
• Market penetration will be gradual, with initial revenue estimates reflecting niche adoption, but with significant upside potential through indications expansion and geographic rollout.
• Long-term financial stability requires strategic alignment with reimbursement policies, competitive positioning, and ongoing clinical validation.

Frequently Asked Questions

1. What advantages does VAZALORE offer over traditional aspirin tablets?
VAZALORE’s liquid formulation enhances ease of administration, especially for pediatric and elderly populations, and potentially reduces gastrointestinal side effects due to more controlled absorption.

2. How does VAZALORE compare in cost-effectiveness to generics?
While premium-priced relative to generics, VAZALORE’s benefits in improving adherence and reducing adverse events can translate into savings for healthcare systems, supporting its cost-effectiveness in appropriate populations.

3. What are the primary challenges in commercializing VAZALORE?
Key challenges include establishing physician and patient acceptance, securing favorable reimbursement, and competing with well-established generic aspirin products.

4. Are there ongoing clinical trials that could influence VAZALORE’s market trajectory?
Yes, clinical studies are evaluating expanded indications and safety profiles, which could facilitate broader acceptance and approval for additional uses.

5. What is the potential for VAZALORE’s adoption in emerging markets?
High CVD burden and increasing healthcare infrastructure investments make emerging markets attractive, provided regulatory pathways are navigated and affordability is addressed.

References

[1] Mordente, A., et al. (2021). Aspirin: A review of pharmacological aspects, therapeutic uses, and future prospects. Current Drug Metabolism, 22(12), 973-985.

[2] World Health Organization. (2021). Cardiovascular Diseases (CVDs). Retrieved from WHO official website.

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This comprehensive analysis aims to equip stakeholders with insights into VAZALORE’s market standing and future financial potential, facilitating strategic and investment decisions.