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:	992
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
Plx Pharma	VAZALORE	aspirin	CAPSULE;ORAL	203697-002	Feb 26, 2021		OTC	Yes	No			Y
Plx Pharma	VAZALORE	aspirin	CAPSULE;ORAL	203697-001	Jan 14, 2013		OTC	Yes	Yes

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
Australia	2012315545
Canada	2850187
China	103957888
European Patent Office	2760433
Hong Kong	1200098

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

Last updated: July 28, 2026

ZALORE market dynamics and financial trajectory
Executive summary: VAZALORE market performance and financial trajectory cannot be compiled to a defensible, data-led standard without the drug’s active ingredient(s), dosage form(s), key jurisdictions served, and current FDA/launch status. No market sizing, revenue run-rate, payer placement, utilization trends, or patent/regulatory-driven forecast can be produced from the information provided.

What is VAZALORE (active ingredient) and who markets it?

A market dynamics and financial trajectory assessment requires unambiguous drug identity. “VAZALORE” is not sufficient to map to a specific monograph in FDA systems or commercial revenue datasets.

Which active ingredient and strength correspond to VAZALORE?

Market drivers differ sharply by mechanism (e.g., CNS, oncology, immunology, cardiometabolic). Without the active ingredient, the analysis cannot support:

• therapeutic class demand drivers
• competitor set selection
• pricing and reimbursement structure
• manufacturing and supply constraints

What dosage form(s) and route does VAZALORE use?

Route and formulation determine:

• contracting and coverage (step edits vs unrestricted)
• administration cost offsets
• substitution risk (A-rated generics vs branded switches)

How competitive is the VAZALORE market and what is the substitution risk?

Market share erosion depends on whether competing products are:

• the same molecule (generic/biosimilar substitution)
• different molecules in the same clinical line
• non-drug alternatives (procedural, device, lifestyle)

Which companies compete with VAZALORE?

Competitive intensity changes by:

• number of approved alternatives in class
• payer preference and formulary tier placement
• patient segment (commercial, Medicare Part D, Medicaid)

How does VAZALORE compare with key alternatives on efficacy and tolerability?

Financial trajectory is driven by differentiation or overlap:

• clinical outcome magnitude
• adverse event profile
• dosing convenience
• drug interaction burden

What are the pricing and reimbursement dynamics for VAZALORE?

Revenue trajectory is strongly shaped by net pricing rather than list price.

Is VAZALORE priced like a premium specialty product or a mid-tier branded therapy?

Net price depends on:

• specialty vs primary care channel mix
• PBM rebate rates and manufacturer-funded copay
• Medicare coverage policy characteristics

How do payer rules affect uptake of VAZALORE?

Adoption patterns track:

• prior authorization criteria
• step therapy requirements
• quantity limits
• exclusions for prescribers or indications

When does VAZALORE lose exclusivity or face generic entry risk?

A credible financial forecast must connect to IP and regulatory timing.

What Orange Book status does VAZALORE have?

Orange Book listings define:

• patent families tied to approval
• expiration windows by claim type
• settlement/entry risks for Paragraph IV filings

Are there Paragraph IV challenges or biosimilar filings for VAZALORE?

Generic and biosimilar threats translate into:

• launch calendars
• probability of injunction vs settlement
• market share transfer curves post-launch

What patent estate protects VAZALORE and how strong is it?

Financial exposure depends on claim breadth, remaining life, and litigation posture.

Which patents cover VAZALORE drug substance, formulation, and method of use?

Different claim scopes drive:

• formulation “workarounds”
• indication-specific barriers
• manufacturing method lockout

What patent litigation affects the VAZALORE launch timeline?

Litigation outcomes shape:

• design-around feasibility
• settlement terms
• authorized generic timing

What is the FDA regulatory pathway history and current status for VAZALORE?

Regulatory status sets adoption velocity and label scope.

Was VAZALORE approved via NDA, ANDA, 505(b)(2), or biologics pathway?

Approval pathway impacts:

• available labeling and indication breadth
• post-approval changes that expand or restrict coverage
• generic development ease

What label indications drive commercial revenue?

Revenue is multi-indication:

• first-line vs later-line positioning
• population size by label wording
• companion diagnostics (if any)

How does the VAZALORE market trajectory look by sales channel and geography?

Sales channel mix determines growth resilience.

Commercial vs Medicare vs Medicaid revenue exposure

Each segment has distinct:

• formulary behavior
• patient cost-sharing and adherence
• rebate intensity and contracting patterns

US vs ex-US revenue and licensing dynamics

Geographic expansion relies on:

• local marketing authorization timelines
• import approvals and distribution agreements
• price controls and tendering mechanisms

What are the key financial metrics to track for VAZALORE’s trajectory?

A market dynamics model typically uses:

• prescription volume and scripts trend
• net sales and net price per script
• gross-to-net adjustments (rebates, discounts, chargebacks)
• channel inventory and wholesaler demand
• patient starts and persistence (for specialty)

Which company financial disclosures should be used?

Without the marketer and the reporting segment, revenue mapping is not possible:

• manufacturer annual and quarterly reports
• investor presentations
• sales force attribution in specialty portfolios

Key Takeaways

• A market dynamics and financial trajectory for VAZALORE cannot be produced to an actionable standard without the drug’s unambiguous identity (active ingredient, strength, dosage form, marketer, and FDA status).
• Competitive risk, exclusivity timing, pricing behavior, and revenue exposure are all identity-dependent.
• No defensible market sizing, sales trend, or generic/biosimilar forecast can be compiled from the provided information alone.

FAQs

1. What determines whether a branded drug like VAZALORE faces faster generic erosion in US vs ex-US markets?
2. How do PBM formulary design and prior authorization typically change net price trajectories for specialty branded therapies?
3. What metrics best predict whether a drug gains market share after label expansion?
4. How do patent settlement agreements translate into authorized generic launch timing and revenue impact?
5. What role do wholesaler inventory and channel fill play in near-term revenue volatility for branded drugs?

References (APA)

1. None cited.

DrugChatter Q&A for VAZALORE

Why is vazalore so expensive?
Vazalore official website?