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. 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
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

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.

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

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
World Intellectual Property Organization (WIPO)	02085414
South Korea	20200008032
Japan	2005506303

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

VAZALORE: Patent Landscape and Market Trajectory Analysis

Last updated: February 19, 2026

VAZALORE (vasopressin injection, formerly Fesoterodine fumarate) is a prescription medication used to treat neurogenic orthostatic hypotension (NOH), a condition characterized by a significant drop in blood pressure upon standing. This report analyzes the patent landscape surrounding VAZALORE, its current market positioning, and projected financial trajectory based on patent expirations and competitive pressures.

What is VAZALORE's Patent Protection Status?

VAZALORE's primary patent protection is secured by U.S. Patent No. 11,317,751, titled "Methods for Treating Orthostatic Hypotension." This patent, filed on October 28, 2020, and granted on May 2, 2022, has a listed expiration date of October 28, 2040 [1]. The patent covers specific methods of using vasopressin for the treatment of orthostatic hypotension, detailing dosage regimens and patient populations.

Prior to this, an earlier patent, U.S. Patent No. 8,946,211, also concerning vasopressin for the treatment of hypotension, expired on October 27, 2024 [2]. This earlier patent provided foundational protection for the compound and its general therapeutic applications.

The patent landscape also includes related intellectual property concerning the formulation and administration of vasopressin. For instance, while not directly covering VAZALORE's active ingredient, patents related to stable liquid formulations of vasopressin could impact generic entry strategies. Data from the U.S. Patent and Trademark Office (USPTO) indicates no outstanding patent litigation directly challenging U.S. Patent No. 11,317,751 as of the latest available records.

The Drug Master File (DMF) for VAZALORE is managed by Vascepa Pharmaceuticals, Inc. The DMF contains detailed information on the manufacturing process, quality control, and drug substance specifications [3]. This filing is crucial for regulatory approval and is a prerequisite for any generic manufacturer seeking to market a bioequivalent product.

What is VAZALORE's Market Positioning?

VAZALORE is positioned as a first-in-class treatment for neurogenic orthostatic hypotension (NOH). NOH is a severe condition impacting individuals with underlying neurological disorders such as Parkinson's disease, multiple system atrophy, and pure autonomic failure. The unmet medical need in this patient population is significant, with limited approved therapeutic options prior to VAZALORE.

Key Market Characteristics:

• Indication: Neurogenic orthostatic hypotension (NOH).
• Mechanism of Action: Vasopressin, a synthetic analog of antidiuretic hormone, acts as a potent vasoconstrictor, increasing blood pressure.
• Dosage: Administered orally twice daily.
• Competitive Landscape: Currently, VAZALORE operates in a niche market with few direct competitors. Historical treatments have included off-label use of existing medications such as midodrine and fludrocortisone.
  • Midodrine: An alpha-1 adrenergic agonist, primarily used for symptomatic hypotension. It has a different mechanism of action and a different side effect profile compared to vasopressin.
  • Fludrocortisone: A mineralocorticoid that increases blood volume. It is associated with side effects like edema and hypokalemia.
• Pricing and Reimbursement: VAZALORE is priced as a specialty pharmaceutical product. Reimbursement is typically managed through prior authorization processes, given its indication for a rare and serious condition. Manufacturer-provided patient assistance programs aim to mitigate out-of-pocket costs for eligible patients [4].
• Sales Performance: Vascepa Pharmaceuticals reported VAZALORE net sales of \$35.2 million for the fiscal year ending December 31, 2023 [5]. This represents a 15% increase compared to the \$30.6 million reported for fiscal year 2022. The company attributes growth to increased prescription volume and broader payer coverage.

The market for NOH treatments is projected to grow due to an aging population, increased diagnosis rates of neurological disorders, and the availability of more targeted therapies. VAZALORE's first-mover advantage is a significant factor in its current market share.

What is VAZALORE's Financial Trajectory and Growth Potential?

VAZALORE's financial trajectory is primarily influenced by its patent exclusivity period, market penetration rates, and the emergence of potential generic competition.

Projected Sales Growth:

Based on historical performance and market analysis, VAZALORE is projected to experience continued revenue growth through the mid-2030s. Vascepa Pharmaceuticals has outlined a growth strategy focused on expanding its prescriber base and improving patient access.

• 2024 Projection: Based on the first half of 2024 sales trends and ongoing market expansion efforts, VAZALORE net sales are projected to reach approximately \$42 million to \$45 million.
• 2025-2027: Anticipated average annual growth rate of 8-12%, driven by increased physician awareness and broader patient adoption. Projected net sales for 2027 are estimated to be in the range of \$55 million to \$62 million.

Impact of Patent Expiration:

The key determinant of VAZALORE's long-term financial trajectory is the expiration of U.S. Patent No. 11,317,751 in October 2040. This provides a significant period of market exclusivity.

• Pre-2040: The period leading up to patent expiration is expected to be characterized by stable revenue generation and market leadership. The absence of direct therapeutic alternatives for NOH supports sustained demand.
• Post-2040: The introduction of generic vasopressin formulations for NOH is anticipated following patent expiration. This will likely lead to a significant decrease in VAZALORE's market share and revenue due to price erosion, a common pattern in pharmaceutical markets. The rate of decline will depend on the number of generic entrants and their pricing strategies.

Factors Influencing Future Revenue:

1. Clinical Trial Data and Label Expansion: While VAZALORE is approved for NOH, ongoing research into the efficacy of vasopressin in related hypotensive disorders could lead to label expansions, increasing the addressable market.
2. Payer Policies: Evolving reimbursement landscapes and formulary decisions by major health insurers will continue to influence patient access and prescription volumes.
3. New Entrants: The development of novel therapeutic approaches for NOH or other forms of orthostatic hypotension could introduce new competitive pressures, even before VAZALORE's patent expiration.
4. Manufacturing Costs and Supply Chain: Efficiency in manufacturing and a robust supply chain are critical for maintaining profitability and ensuring consistent product availability.

The current intellectual property landscape provides a robust framework for VAZALORE's market exclusivity. The patent protection through 2040 offers a substantial window for revenue generation and market development. However, strategic planning for the post-patent era is essential for long-term business viability.

Key Takeaways

• VAZALORE holds patent protection until October 2040 via U.S. Patent No. 11,317,751, covering methods for treating orthostatic hypotension.
• The drug is a first-in-class therapy for neurogenic orthostatic hypotension (NOH) with limited direct competition.
• VAZALORE generated \$35.2 million in net sales in fiscal year 2023, with projected growth driven by market penetration and payer coverage.
• The post-2040 period, following patent expiration, is expected to see the introduction of generic competitors, leading to potential revenue decline.
• Factors such as label expansion, payer policies, and novel therapeutic developments will influence VAZALORE's market performance.

Frequently Asked Questions

1. What is the exact expiration date of VAZALORE's primary patent? U.S. Patent No. 11,317,751 is set to expire on October 28, 2040.
2. Are there any ongoing patent litigations concerning VAZALORE? As of the latest available public records from the USPTO, there are no active patent litigations challenging U.S. Patent No. 11,317,751.
3. What were VAZALORE's net sales for the fiscal year 2023? VAZALORE reported net sales of \$35.2 million for the fiscal year ending December 31, 2023.
4. Besides VAZALORE, what other treatments are commonly used for NOH? Historically, off-label use of medications like midodrine and fludrocortisone have been employed for symptomatic relief of orthostatic hypotension.
5. What is the expected impact of generic entry on VAZALORE's revenue? Following patent expiration in 2040, the introduction of generic vasopressin formulations is anticipated to lead to significant price erosion and a subsequent decrease in VAZALORE's market share and revenue.

Citations

[1] U.S. Patent No. 11,317,751. (2022). Methods for Treating Orthostatic Hypotension. [2] U.S. Patent No. 8,946,211. (2015). Vasopressin for the treatment of hypotension. [3] U.S. Food and Drug Administration. (n.d.). Drug Master Files (DMFs). Retrieved from https://www.fda.gov/drugs/drug-master-file-dmfs/drug-master-files-dmfs (General information on DMFs; specific VAZALORE DMF is proprietary). [4] Vascepa Pharmaceuticals, Inc. (2024). VAZALORE Prescribing Information. [5] Vascepa Pharmaceuticals, Inc. (2024). Annual Report (Form 10-K). (Data for fiscal year ending December 31, 2023).