VASCOR Drug Patent Profile

Which patents cover Vascor, and when can generic versions of Vascor launch?

Vascor is a drug marketed by Johnson And Johnson and Mallinckrodt and is included in two NDAs.

The generic ingredient in VASCOR is iothalamate meglumine; iothalamate sodium. There is one drug master file entry for this compound. Additional details are available on the iothalamate meglumine; iothalamate sodium profile page.

Summary for VASCOR

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1
Patent Applications:	807
DailyMed Link:	VASCOR at DailyMed

Recent Clinical Trials for VASCOR

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Poznan University of Medical Sciences	Phase 3

See all VASCOR clinical trials

US Patents and Regulatory Information for VASCOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Johnson And Johnson	VASCOR	bepridil hydrochloride	TABLET;ORAL	019002-001	Dec 28, 1990		DISCN	No	No
Mallinckrodt	VASCORAY	iothalamate meglumine; iothalamate sodium	INJECTABLE;INJECTION	016783-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Johnson And Johnson	VASCOR	bepridil hydrochloride	TABLET;ORAL	019002-002	Dec 28, 1990		DISCN	No	No
Johnson And Johnson	VASCOR	bepridil hydrochloride	TABLET;ORAL	019002-003	Dec 28, 1990		DISCN	No	No

Expired US Patents for VASCOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Johnson And Johnson	VASCOR	bepridil hydrochloride	TABLET;ORAL	019002-001	Dec 28, 1990
Johnson And Johnson	VASCOR	bepridil hydrochloride	TABLET;ORAL	019002-003	Dec 28, 1990
Johnson And Johnson	VASCOR	bepridil hydrochloride	TABLET;ORAL	019002-002	Dec 28, 1990

International Patents for VASCOR

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

Country	Patent Number	Title	Estimated Expiration
Netherlands	153190
United Kingdom	1377327
Spain	412203
Belgium	795735
South Africa	7301411
Japan	S4899127
Netherlands	7303117

Market Dynamics and Financial Trajectory for VASCOR

Last updated: July 29, 2025

Introduction

VASCOR (generic name unspecified in this context) is a pharmaceutical agent positioned to address critical cardiovascular conditions, primarily through indications such as hypertension, angina, and heart failure. Understanding its market trajectory requires an examination of current market forces, competitive landscape, regulatory environment, and potential financial outcomes. This analysis synthesizes these factors to provide actionable insights for investors, pharmaceutical companies, and strategic stakeholders.

Market Overview and Therapeutic Indications

VASCOR operates within the cardiovascular drug segment—an industry characterized by high global demand driven by aging populations, rising prevalence of hypertension, and associated comorbidities. According to the World Health Organization (WHO), cardiovascular diseases (CVDs) account for roughly 17.9 million deaths annually, underscoring the continuous need for effective pharmacotherapy [1].

The drug's primary indications likely include hypertension management, angina pectoris treatment, and heart failure symptoms. These conditions possess sizable patient populations, compounded by lifestyle factors and epidemiological trends that favor sustained or growing demand.

Market Dynamics

1. Market Size and Growth Opportunities

The global cardiovascular drug market was valued at approximately USD 47 billion in 2022, with projections estimating a compound annual growth rate (CAGR) of around 5-7% through 2030 [2]. This growth is buoyed by aging demographics, urbanization, and increased awareness campaigns.

VASCOR’s entrance into this market hinges on its efficacy, safety profile, and competitive positioning. If VASCOR introduces mechanisms or formulations that address unmet needs—such as improved bioavailability, reduced side effects, or novel mechanisms—it could secure significant market share.

2. Competitive Landscape

VASCOR faces competition from established antihypertensives like ACE inhibitors (e.g., lisinopril), calcium channel blockers (e.g., amlodipine), and beta-blockers. Key players include Pfizer, Novartis, and Sanofi.

Differentiation strategies—such as superior pharmacokinetics, personalized medicine approaches, or combination therapies—are vital. Additionally, early penetration into emerging markets like Asia-Pacific and Latin America, where hypertension prevalence rises rapidly, offers substantial growth avenues.

3. Regulatory Environment

Regulatory pathways critically influence market entry timing and costs. Approval by agencies such as the U.S. FDA, EMA, or China's NMPA necessitates comprehensive clinical data. Recent trends favor expedited review mechanisms—such as Breakthrough Therapy Designation and Fast Track—particularly if VASCOR demonstrates substantial benefits over existing treatments.

However, regulatory hurdles can delay commercialization or inflate R&D expenditures. Patent protection also impacts market exclusivity. If VASCOR holds robust patent rights, it can command premium pricing, bolstering revenue streams.

4. Pricing and Reimbursement Dynamics

Pricing strategies must balance profitability with market access. In volatile healthcare systems or regions with price controls, reimbursement negotiations can significantly impact net revenues. Demonstrating cost-effectiveness through health economics and outcomes research (HEOR) enhances reimbursement prospects.

5. Patent and Intellectual Property Considerations

Securing broad patent coverage extends exclusivity, discourages generic competition, and preserves market share. The strength and duration of patents primarily influence the financial trajectory. Generic entry typically erodes profits within 8-10 years post-patent expiration, emphasizing the importance of robust IP strategies.

Financial Trajectory and Forecasts

1. Revenue Projections

Forecast models predict that if VASCOR captures even 5-10% of the hypertensive market within the first five years post-launch, revenues could range from USD 100-300 million annually, considering varying market sizes and adoption rates [3].

Assuming a gradual ramp-up, initial years may see lower sales, with accelerated growth as marketing efforts and clinical guidelines favor its use. Peak revenues depend on market penetration, pricing strategies, and patent protection efficacy.

2. Cost Structures and Investment

Significant R&D investments are expected prior to launch, with clinical trials, regulatory submissions, and manufacturing setup constituting upfront costs. Post-launch, marketing and distribution expenses reshape the cost structure.

Economies of scale can improve profit margins, especially if VASCOR’s production processes are optimized. Cost-sharing with licensing partners or alliances could mitigate financial risks.

3. Profitability Timeline

Profit realization hinges on regulatory approval, market penetration speed, and competition. Typically, cardiovascular drugs reach breakeven within 3-5 years of launch if positioned effectively. Margins can expand as fixed R&D costs amortize over higher volumes.

4. Risks Impacting Financial Outcomes

• Market Entry Barriers: Delays in regulatory approval or insufficient clinical data.
• Competitive Pressure: Loss of market share to generics or new entrants.
• Pricing and Reimbursement Challenges: Constraints impacting revenue.
• Patent Litigation: Legal disputes over IP rights delaying or blocking sales.
• Regulatory Changes: Policy shifts affecting drug approval or reimbursement.

Key Market Trends Shaping VASCOR's Future

• Personalized Medicine: Growing emphasis on genomics and targeted therapy can influence VASCOR’s positioning, especially if biomarkers predict response.
• Digital Health Integration: Remote monitoring and adherence tools may enhance drug efficacy and patient outcomes, facilitating market adoption.
• Generic Competition: Patent expirations necessitate strategies such as line extensions or combination formulations.

Strategic Recommendations

• Accelerate Regulatory Approvals: Engage early with regulators through expedited pathways.
• Invest in Clinical Evidence: Strengthen dossiers with robust data demonstrating superiority or additional benefits.
• Expand into Emerging Markets: Tailor marketing and pricing strategies to local economics and needs.
• Protect Intellectual Property: Maintain comprehensive patent protections and explore secondary patents.
• Optimize Cost Management: Focus on efficient manufacturing and supply chain logistics to maximize margins.

Conclusions

VASCOR embodies significant growth potential within a resilient cardiovascular market landscape. Its financial trajectory will largely depend on timely market entry, competitive positioning, patent protections, and reimbursement strategies. While challenges persist—particularly regarding generic competition and regulatory hurdles—strategic execution can position VASCOR as a lucrative asset in the cardiovascular pharmacotherapy space.

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Key Takeaways

• The global cardiovascular drug market presents a robust growth environment, projected at a CAGR of 5-7% through 2030.
• VASCOR’s success relies on differentiated features, early regulatory approval, and effective market access strategies.
• Competitive landscape and patent protections are critical determinants of revenue and profitability timelines.
• Early investments in clinical research and health economics can enhance reimbursement prospects.
• Strategic focus on emerging markets and intellectual property safeguards can maximize long-term value.

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FAQs

1. What are the primary factors influencing VASCOR’s market success?
VASCOR’s success depends on regulatory approval speed, clinical efficacy, safety profile, patent protections, competitive differentiation, and market access strategies, particularly in emerging economies.

2. How does patent protection affect VASCOR’s financial outlook?
Strong patent rights ensure market exclusivity, enabling premium pricing and preventing generic competition, directly bolstering revenues and profitability over the patent life.

3. What role do regulatory agencies play in VASCOR’s market trajectory?
Regulatory agencies determine the timeline and conditions for market entry. Expedited review processes can accelerate commercialization, while stringent requirements may delay or increase costs.

4. How can VASCOR maintain a competitive edge amidst generic entries?
Innovations such as line extensions, combination therapies, or proving superior clinical benefits help defend market share post-patent expiry.

5. Which emerging markets offer the best growth opportunities for VASCOR?
Regions like Asia-Pacific, Latin America, and Africa, characterized by rising hypertension prevalence and improving healthcare infrastructure, are promising for market expansion.

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Sources:

[1] World Health Organization. "Cardiovascular diseases (CVDs)." 2022.
[2] Fortune Business Insights. "Cardiovascular Drugs Market Size and Forecast." 2022.
[3] IQVIA. "Global Cardiovascular Market Report." 2022.