VAZALORE Drug Patent Profile

Which patents cover Vazalore, 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:	135
Patent Applications:	1,294
What excipients (inactive ingredients) are in VAZALORE?	VAZALORE excipients list
DailyMed Link:	VAZALORE at DailyMed

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

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.

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	203697-001	Jan 14, 2013		OTC	Yes	Yes			Y
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
Plx Pharma	VAZALORE	aspirin	CAPSULE;ORAL	203697-002	Feb 26, 2021		OTC	Yes	No
Plx Pharma	VAZALORE	aspirin	CAPSULE;ORAL	203697-002	Feb 26, 2021		OTC	Yes	No			Y

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

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
Austria	414542
European Patent Office	2760433	VECTEURS DÉPENDANT DU PH POUR LIBÉRATION CIBLÉE DE PRODUITS PHARMACEUTIQUES DANS LE TUBE DIGESTIF, COMPOSITIONS PRÉPARÉES À PARTIR DE CEUX-CI, ET LEUR FABRICATION ET LEUR UTILISATION (pH DEPENDENT CARRIERS FOR TARGETED RELEASE OF PHARMACEUTICALS ALONG THE GASTROINTESTINAL TRACT, COMPOSITIONS THEREFROM, AND MAKING AND USING SAME)
South Korea	20200118219	위장관을 따라 약물을 표적화 방출하기 위한 pH 감응성 담체, 그로부터의 조성물, 및 이들의 제조 및 사용 방법 (pH PH DEPENDENT CARRIERS FOR TARGETED RELEASE OF PHARMACEUTICALS ALONG THE GASTROINTESTINAL TRACT COMPOSITIONS THEREFROM AND MAKING AND USING SAME)
South Korea	102162901
World Intellectual Property Organization (WIPO)	02085414

Supplementary Protection Certificates for VAZALORE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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

Market Dynamics and Financial Trajectory for VAZALORE

Introduction

VAZALORE, an FDA-approved liquid-filled aspirin capsule developed by PLx Pharma Inc., has been a significant player in the aspirin heart health segment since its launch. Here, we will delve into the market dynamics and financial trajectory of VAZALORE, highlighting its successes, challenges, and the current state of the product.

Launch and Initial Success

Market Entry and Early Adoption

VAZALORE was introduced into the U.S. retail channels in the third quarter of 2021, marking a significant milestone for PLx Pharma. The product quickly gained traction, becoming the number three brand in the Aspirin Heart Health segment within six months of its launch. This rapid ascent was attributed to a multi-channel commercial strategy targeting healthcare professionals, retailers, and consumers[1].

Retail Consumption and Brand Awareness

The product saw strong unit and dollar growth over consecutive four-week periods, indicating robust retail consumption. The national media campaign for VAZALORE delivered over 500 million impressions, reaching more than 90% of its target audience, which contributed to its rapid brand awareness among consumers[1].

Commercial Strategy and Field Force Effectiveness

Multi-Channel Approach

PLx Pharma employed a three-pronged commercial strategy that included cardiovascular care specialists, medical communications, product display support, and a national media campaign. This integrated approach helped in effectively targeting healthcare professionals and consumers, leading to favorable results across several key performance measures[1].

Field Force and Medical Communications

The company's field force successfully targeted healthcare professionals affiliated with the top 100 heart/stroke hospitals in the U.S., reaching 98% of their top group practices. This targeted approach enhanced the product's acceptance among healthcare professionals[1].

Financial Performance

Revenue Growth

In the fourth quarter of 2021, VAZALORE generated $1.6 million in net sales, a significant increase from zero revenue in the same period of 2020. For the full year 2021, total revenue was $8.2 million, compared to just $30,000 in 2020, primarily due to the initial sales distribution of VAZALORE[1].

Gross Margin and Operating Expenses

The gross margin for the fourth quarter of 2021 was 44%, reflecting a slight sequential improvement due to a favorable product mix. However, total operating expenses increased to $21.6 million in the fourth quarter of 2021, largely due to increased promotional activities and expenses associated with the commercial launch[1].

Challenges and Market Dynamics

Market Acceptance and Sales Growth

Despite the initial success, the uptake of VAZALORE was slower than anticipated. By the third quarter of 2022, the company acknowledged that market acceptance and sales had taken longer to develop than expected. This led to a streamlining of investments to maintain base consumption levels[5].

Dependence on Larger Commercial Organization

PLx Pharma's CEO, Natasha Giordano, noted that the product's potential could be maximized through a larger commercial organization with more resources to drive a robust commercial plan. This suggests that the current market dynamics may require additional support for VAZALORE to achieve its full potential[3].

Financial Distress and Bankruptcy

Chapter 11 Bankruptcy Filing

In April 2023, PLx Pharma announced its intention to file for Chapter 11 bankruptcy, indicating significant financial distress. The company entered into a stalking horse asset purchase agreement to sell substantially all of its assets, including VAZALORE, for $100,000 in cash and other considerations. This move highlights the financial challenges faced by the company despite the product's initial success[2].

Asset Purchase Agreement

The asset purchase agreement is subject to higher and better offers and requires court approval. The low sale price and the need for court approval reflect the financial struggles and the uncertain future of VAZALORE under its current ownership[2].

Key Takeaways

• Rapid Market Entry: VAZALORE quickly became the number three brand in the Aspirin Heart Health segment.
• Strong Commercial Strategy: The multi-channel approach was effective in targeting healthcare professionals and consumers.
• Financial Challenges: Despite initial success, the company faced significant financial distress, leading to a Chapter 11 bankruptcy filing.
• Need for Larger Commercial Support: The product's full potential may be realized through a larger commercial organization.
• Uncertain Future: The future of VAZALORE is uncertain under the current asset purchase agreement.

FAQs

What was the initial market performance of VAZALORE?

VAZALORE became the number three brand in the Aspirin Heart Health segment within six months of its launch, with strong unit and dollar growth over consecutive four-week periods[1].

Why did PLx Pharma face financial distress despite VAZALORE's success?

Despite the product's initial success, the company faced significant financial challenges due to increased operating expenses and slower-than-anticipated sales growth, leading to a Chapter 11 bankruptcy filing[2][5].

What is the current status of VAZALORE's commercial strategy?

The company has streamlined its investments to maintain base consumption levels and is evaluating strategic alternatives to ensure VAZALORE remains available for patients[5].

How does the asset purchase agreement affect PLx Pharma's assets?

The agreement involves the sale of substantially all of PLx Pharma's assets, including VAZALORE, for $100,000 in cash and other considerations, subject to higher and better offers and court approval[2].

What are the implications of PLx Pharma's Chapter 11 filing for VAZALORE?

The filing indicates significant financial distress and raises concerns about the value and future of VAZALORE under its current ownership, suggesting a need for a larger commercial organization to maximize its potential[2][3].

Sources

1. PLx Pharma Inc. Reports Fourth Quarter and Full Year 2021 Results and Provides Business Update - Biospace
2. PLx Pharma Inc. Enters into a Stalking Horse Asset Purchase Agreement to Sell VAZALORE® and Substantially All of its Assets - Stocktitan
3. PLx Pharma Inc. Reports Second Quarter 2022 Results and Provides Business Update - GlobeNewswire
4. INVESTOR INITIATIVES: SHOWCASE COMPANIES - NCI SBIR
5. PLx Pharma Inc. Reports Third Quarter 2022 Results and Provides Business Update - GlobeNewswire