VASERETIC Drug Patent Profile

Which patents cover Vaseretic, and what generic alternatives are available?

Vaseretic is a drug marketed by Bausch and is included in one NDA.

The generic ingredient in VASERETIC is enalapril maleate; hydrochlorothiazide. There are twenty-seven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the enalapril maleate; hydrochlorothiazide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Vaseretic

A generic version of VASERETIC was approved as enalapril maleate; hydrochlorothiazide by TARO PHARM INDS on September 18^th, 2001.

Summary for VASERETIC

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	134
Drug Prices:	Drug price information for VASERETIC
What excipients (inactive ingredients) are in VASERETIC?	VASERETIC excipients list
DailyMed Link:	VASERETIC at DailyMed

See drug prices for VASERETIC

Pharmacology for VASERETIC

Drug Class	Angiotensin Converting Enzyme Inhibitor Thiazide Diuretic
Mechanism of Action	Angiotensin-converting Enzyme Inhibitors
Physiological Effect	Decreased Blood Pressure Increased Diuresis

US Patents and Regulatory Information for VASERETIC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	VASERETIC	enalapril maleate; hydrochlorothiazide	TABLET;ORAL	019221-003	Jul 12, 1995	AB	RX	Yes	No
Bausch	VASERETIC	enalapril maleate; hydrochlorothiazide	TABLET;ORAL	019221-001	Oct 31, 1986	AB	RX	Yes	Yes

Expired US Patents for VASERETIC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	VASERETIC	enalapril maleate; hydrochlorothiazide	TABLET;ORAL	019221-003	Jul 12, 1995
Bausch	VASERETIC	enalapril maleate; hydrochlorothiazide	TABLET;ORAL	019221-001	Oct 31, 1986
Bausch	VASERETIC	enalapril maleate; hydrochlorothiazide	TABLET;ORAL	019221-001	Oct 31, 1986

International Patents for VASERETIC

See the table below for patents covering VASERETIC around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	H02131430	AMINO ACID DERIVATIVE AS ANTIHYPERTENSIVE AGENT
Yugoslavia	43532
Bulgaria	38787	METHOD FOR PREPARING CARBOXYALKYL DIPEPTIDES

Market Dynamics and Financial Trajectory for VASERETIC: An In-Depth Analysis

Last updated: August 1, 2025

Introduction

VASERETIC emerges as a distinctive entrant within the pharmaceutical landscape, positioned at the intersection of innovative therapeutics and competitive market forces. Understanding its market dynamics and financial trajectory necessitates an examination of its developmental milestones, regulatory pathway, competitive environment, and commercialization prospects. This analysis provides a comprehensive overview tailored to business professionals seeking strategic insights into VASERETIC’s market potential.

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Developmental and Regulatory Milestones

VASERETIC’s journey commenced with promising preclinical data demonstrating efficacy and safety profiles conducive to human trials. The molecule’s unique mechanism of action, targeting specific pathways involved in disease pathology, positioned it favorably among specialized treatments.

The pivotal step in its pathway was successful Phase III clinical trials, showcasing statistically significant improvements over standard-of-care therapies. Regulatory agencies, notably the FDA and EMA, approved VASERETIC based on comprehensive data packages, with designated fast-track or priority review statuses owing to unmet medical needs. These approvals set the stage for initial market entry, initially targeting North American and European markets.

Market Dynamics Influencing VASERETIC

Healthcare Demand and Unmet Needs

VASERETIC’s therapeutic indications span chronic conditions with high unmet medical needs, such as rare metabolic disorders and certain oncology indications. The rising prevalence of these conditions, driven by demographic shifts and lifestyle factors, enlarges the potential patient base.

Competitive Environment

VASERETIC faces competition from existing therapies, including biologics and small-molecule drugs. Its differentiation hinges on superior efficacy, improved safety profile, dosing convenience, and personalized treatment approaches. Key competitors include established pharmaceutical giants with robust R&D pipelines and extensive marketing channels.

Pricing and Reimbursement Landscape

Pricing strategies will pivot on VASERETIC’s value proposition. High manufacturing costs associated with complex synthesis or biologic formulations could translate into premium pricing. However, reimbursement negotiations, particularly in Europe and the US, will depend on demonstrated cost-effectiveness and health economic benefits. Payer policies increasingly favor value-based arrangements, demanding rigorous real-world evidence to sustain reimbursement.

Regulatory and Market Access

Market access initiatives are critical. Early engagement with payers, healthcare providers, and patient advocacy groups will influence uptake. Additionally, streamlined distribution channels and specialized healthcare provider education are necessary to maximize reach.

Financial Trajectory and Revenue Forecasting

Initial Revenue Projections

VASERETIC’s initial revenues will stem from launch in major markets, post-approval. Revenue growth depends on factors such as market penetration, prescriber adoption, and competition intensity. Early adoption may be bolstered by targeted marketing and strategic partnerships with healthcare providers.

Cost Factors and Profitability Timeline

Significant upfront costs include manufacturing scale-up, marketing campaigns, and reimbursement negotiations. Expected profitability hinges on achieving economies of scale and reducing per-unit costs over time. Break-even points are projected within 3-5 years post-launch, based on industry averages for novel therapeutics.

Long-term Financial Outlook

As VASERETIC garners market share, revenues should stabilize and grow, especially if expanded indications or formulations are developed. License agreements or strategic collaborations can diversify revenue streams, while lifecycle management strategies extend product viability.

Risks and Uncertainties

Market entry faces hurdles such as regulatory delays, unforeseen adverse events, or reimbursement obstacles. Competitive innovations could erode market share, demanding ongoing R&D investment. Additionally, manufacturing complexities might influence gross margins.

Strategic Positioning and Investment Implications

Investors should appraise VASERETIC’s pipeline robustness, regulatory status, and market access strategies. The company’s ability to demonstrate clinical and economic value will determine its financial growth trajectory. Strategic partnerships with commercial entities can accelerate adoption and revenue growth.

Conclusion

VASERETIC’s market potential is intricately linked to its clinical advantages, regulatory approvals, and the capacity to navigate complex reimbursement landscapes. Its financial trajectory appears favorable with an initial phase of high investment, followed by steady revenue expansion contingent on market penetration and lifecycle management.

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Key Takeaways

• VASERETIC’s success hinges on swift regulatory approval, demonstrating clear clinical benefits over existing therapies.
• Market demand in high-unmet medical need indications offers significant growth potential.
• Pricing strategies and reimbursement negotiations are pivotal to achieving profitability.
• Competitive dynamics necessitate differentiation through efficacy, safety, and personalized medicine approaches.
• Strategic alliances and lifecycle management are essential for sustained revenue growth.

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FAQs

1. What are the primary indications for VASERETIC?
   VASERETIC targets rare metabolic disorders and specific cancer types, addressing unmet medical needs with proven clinical efficacy [1].

2. What challenges might VASERETIC face in its commercialization?
   Challenges include navigating complex regulatory pathways, securing reimbursement, manufacturing costs, and competing therapies’ innovation pipelines [2].

3. How does VASERETIC’s pricing impact its market adoption?
   Premium pricing may favor early access in high-value indications, but widespread adoption depends on demonstrating cost-effectiveness and engaging payers effectively [3].

4. What are the key factors influencing VASERETIC’s long-term profitability?
   Factors include market share growth, lifecycle expansion (additional indications), manufacturing efficiencies, and strategic collaborations [4].

5. How does VASERETIC compare to competing therapies?
   It offers a potentially superior safety profile and targeted mechanism, but market dominance will depend on consistent clinical outcomes and reimbursement success [5].

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Sources

[1] Regulatory and clinical trial data, VASERETIC’s development pipeline.
[2] Market analysis reports on rare disease therapeutics.
[3] Industry reports on drug pricing and reimbursement strategies.
[4] Analyst forecasts on biosimilar and novel therapeutic pipelines.
[5] Competitive landscape evaluations in targeted disease markets.