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. 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

US Patents and Regulatory Information for VAZALORE

VAZALORE is protected by six US patents.

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
Plx Pharma	VAZALORE	aspirin	CAPSULE;ORAL	203697-001	Jan 14, 2013		OTC	Yes	Yes			Y
Plx Pharma	VAZALORE	aspirin	CAPSULE;ORAL	203697-001	Jan 14, 2013		OTC	Yes	Yes			Y

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
South Korea	20030072565
South Korea	20140105436	PH DEPENDENT CARRIERS FOR TARGETED RELEASE OF PHARMACEUTICALS ALONG THE GASTROINTESTINAL TRACT, COMPOSITIONS THEREFROM, AND MAKING AND USING SAME
South Korea	100884493

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

Investment Scenario and Fundamentals Analysis for VAZALORE

Last updated: February 20, 2026

What is VAZALORE?

VAZALORE (brand name) is an oral liquid aspirin formulation designed for acute relief of pain, fever, and cardiovascular disease prevention. It has been developed using proprietary technology enabling aqueous liquid aspirin, allowing for rapid absorption. The drug targets both over-the-counter (OTC) pain markets and prescription cardiovascular indications.

Market Overview

The global aspirin market was valued at approximately USD 2.2 billion in 2021 and is projected to reach USD 2.5 billion by 2026, growing at a compound annual growth rate (CAGR) of 2.5%.[1] The growth is driven by rising awareness of cardiovascular health, an aging population, and the ongoing development of novel formulations.

Regulatory Status and Pathway

Approval Status

• VAZALORE received FDA approval in 2018 for the secondary prevention of myocardial infarction, ischemic stroke, and for the relief of mild to moderate pain.
• OTC availability for pain relief is pending or could be pursued, pending additional data and regulatory strategy.

Regulatory Challenges

• Novel liquid aspirin faces regulatory scrutiny regarding bioavailability comparability to standard aspirin tablets.
• Post-marketing Surveillance focuses on bleeding risks common to all aspirin formulations.

Competitive Positioning

Key Competitors

Drug Name	Formulation	Strengths	Weaknesses
Bayer Aspirin	Tablet	Established brand, global presence	Slower absorption, less flexible dosing
Bufferin	Tablet	Enteric-coated, reduces GI upset	Same absorption profile as Bayer, less rapid
Ascriptin	Tablet	Coated for GI protection	Similar absorption, less flexibility
Vazalore	Liquid aspirin	Rapid absorption, flexible dosing	New entrant, limited brand recognition

Differentiation Factors

• Liquid formulation offers faster onset of action.
• Dosing flexibility appeals to patients with swallowing difficulties.
• Potential for combination with other formulations or delivery systems.

Commercial and Financial Analysis

Revenue Potential

• Estimated peak market penetration: 10-15% of OTC and prescription aspirin markets.
• Price point: Approximately USD 0.30-$0.50 per dose, depending on dosing and packaging.
• Projected sales: USD 100-150 million annually within 5 years post-commercial scale-up (assuming 10-15% market share).

Cost Structure

• Manufacturing costs are higher than traditional tablet aspirin due to liquid formulation complexities.
• Margins depend on production volume, scale efficiencies, and pricing strategies.
• Estimated gross margin: 40-50%.

Market Adoption Barriers

• Cost premiums over generic aspirin.
• Consumer and clinician familiarity with existing formulations.
• Need for head-to-head clinical data demonstrating clinical superiority.

Investment Risks

• Regulatory delays or rejections.
• Competitive entry of new or reformulated aspirin products.
• Pricing pressures from generic manufacturers.
• Potential safety concerns, particularly bleeding risks.

Strategic Considerations

• Patent protections: Patents for VAZALORE extend to at least 2030.
• Partnerships: Collaboration with large pharmaceutical distributors could expand market access.
• Pipeline expansion: Development of combination products or alternative delivery systems.

Key Performance Indicators

• Time to market for OTC approval.
• Market share acquisition rate.
• Reimbursement and formulary placement.
• Safety profile and adverse event rates.

Conclusion

VAZALORE operates in a growing segment driven by patient preference shifts and pharmacokinetic advantages. Its success depends on regulatory approval pathways, market acceptance, and competitive positioning. The product has the potential for moderate growth; however, commercialization hurdles and competition are significant factors.

---

Key Takeaways

• VAZALORE's rapid absorption and dosing flexibility differentiate it from tablet aspirin.
• Market growth is driven by aging populations and increasing cardiovascular awareness.
• Commercial success depends on overcoming regulatory, clinical, and marketing challenges.
• Patent protection supports potential long-term market exclusivity.
• Financial viability hinges on achieving substantial market share and controlling production costs.

---

FAQs

1. What regulatory approvals does VAZALORE hold?
FDA approved VAZALORE in 2018 for secondary cardiovascular prevention and pain relief. OTC status remains under consideration.

2. How does VAZALORE compare in absorption speed to traditional aspirin?
Vazalore's liquid formulation provides faster absorption, leading to quicker onset of action.

3. What are the main competitors to VAZALORE?
Traditional tablet aspirin brands like Bayer Aspirin and Bufferin, which lack liquid formulations.

4. What are the main risks associated with investing in VAZALORE?
Regulatory delays, high manufacturing costs, market competition, and safety concerns related to bleeding risks.

5. What is the outlook for VAZALORE’s commercial success?
Moderate growth is possible if regulatory hurdles are cleared and market acceptance increases, especially with clear differentiation and strategic partnerships.

---

References

[1] MarketWatch. (2022). Aspirin market forecast. Retrieved from https://www.marketwatch.com