NITROSTAT Drug Patent Profile

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

Nitrostat is a drug marketed by Parke Davis and Viatris and is included in five NDAs.

The generic ingredient in NITROSTAT is nitroglycerin. There are thirty-six drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the nitroglycerin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Nitrostat

A generic version of NITROSTAT was approved as nitroglycerin by AM REGENT on May 24^th, 1988.

Summary for NITROSTAT

US Patents:	0
Applicants:	2
NDAs:	5
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	18
Clinical Trials:	4
Patent Applications:	2,712
Drug Prices:	Drug price information for NITROSTAT
What excipients (inactive ingredients) are in NITROSTAT?	NITROSTAT excipients list
DailyMed Link:	NITROSTAT at DailyMed

See drug prices for NITROSTAT

See drug sales revenues for NITROSTAT

Recent Clinical Trials for NITROSTAT

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

Sponsor	Phase
Futura Medical Developments Ltd.	Phase 1
Montefiore Medical Center	N/A
Mayo Clinic	N/A

See all NITROSTAT clinical trials

Pharmacology for NITROSTAT

Drug Class	Nitrate Vasodilator
Physiological Effect	Vasodilation

Paragraph IV (Patent) Challenges for NITROSTAT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NITROSTAT	Sublingual Tablets	nitroglycerin	0.3 mg, 0.4 mg, and 0.6 mg	021134	1	2005-10-19

US Patents and Regulatory Information for NITROSTAT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Parke Davis	NITROSTAT	nitroglycerin	INJECTABLE;INJECTION	018588-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Viatris	NITROSTAT	nitroglycerin	TABLET;SUBLINGUAL	021134-002	May 1, 2000	AB	RX	Yes	No
Parke Davis	NITROSTAT	nitroglycerin	INJECTABLE;INJECTION	070871-001	Jan 8, 1987		DISCN	No	No
Viatris	NITROSTAT	nitroglycerin	TABLET;SUBLINGUAL	021134-003	May 1, 2000	AB	RX	Yes	Yes
Parke Davis	NITROSTAT	nitroglycerin	INJECTABLE;INJECTION	070863-001	Jan 8, 1987		DISCN	No	No

Expired US Patents for NITROSTAT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viatris	NITROSTAT	nitroglycerin	TABLET;SUBLINGUAL	021134-001	May 1, 2000
Viatris	NITROSTAT	nitroglycerin	TABLET;SUBLINGUAL	021134-003	May 1, 2000
Viatris	NITROSTAT	nitroglycerin	TABLET;SUBLINGUAL	021134-002	May 1, 2000

International Patents for NITROSTAT

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

Country	Patent Number	Title	Estimated Expiration
Portugal	1019039
South Korea	100569763
Austria	209911
Denmark	1019039
South Korea	20010030839

Market Dynamics and Financial Trajectory for NITROSTAT

Last updated: July 29, 2025

Introduction
NITROSTAT, a formulation of nitroglycerin, holds a pivotal position in the cardiovascular therapeutics landscape, primarily used for acute management of angina pectoris. With over a century of history, NITROSTAT remains a cornerstone in acute coronary syndrome treatment, but its market dynamics are evolving due to demographic shifts, regulatory changes, and competitive developments. This article provides a comprehensive analysis of the current market landscape, growth drivers, challenges, and future financial trajectory of NITROSTAT.

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Market Overview

NITROSTAT, introduced in the early 20th century, was among the first drugs used to treat angina by promoting vasodilation. As a sublingual tablet, it offers rapid relief from chest pain, making it integral in emergency cardiac care. The global demand remains steady, driven by the prevalence of cardiovascular diseases (CVDs) and the drug's established efficacy.

The pharmaceutical market for nitroglycerin formulations comprises both branded and generic versions. NITROSTAT, while broadly recognized, faces increasing market competition from newer drug delivery technologies and alternative therapies.

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Market Drivers

Growing Burden of Cardiovascular Diseases

According to the World Health Organization (WHO), CVDs account for approximately 32% of global deaths, with angina and myocardial infarction being prominent manifestations. The rising incidence of CVDs directly correlates with increased demand for acute relief agents like NITROSTAT.

Aging Population

Global demographic data indicate a significant increase in the population aged 60 and above, particularly in developed nations. Ageing populations are more susceptible to CVD, leading to higher utilization rates of nitroglycerin products, including NITROSTAT.

Established Efficacy and Safety Profile

NITROSTAT’s long-standing clinical use has created a robust foundation of prescriber confidence. Its rapid onset of action makes it the first-line choice for acute angina, reinforcing its market position.

Regulatory Approvals and Institutional Use

Decades of regulatory approval, coupled with inclusion in standard treatment protocols, underpin continuous demand. Hospitals, clinics, and emergency services routinely stock NITROSTAT, ensuring stable sales channels.

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Market Challenges

Generics and Price Competition

Patent expiry of branded NITROSTAT has led to an influx of generic nitroglycerin tablets, intensifying price competition. Market share shifts often favor lower-cost generics, impacting revenue potential for original formulations.

Alternative Therapeutics

Emerging drugs, such as long-acting nitrates and newer vasodilators, are increasingly used for prophylactic management rather than acute episodes. This shift may reduce the overall size of the acute therapy market.

Technological Advancements

Innovations like transdermal patches, sprays, and intravenous formulations challenge the traditional sublingual tablet's dominance. These delivery systems often offer better dosing control, potentially reducing the reliance on NITROSTAT.

Regulatory and Supply Chain Risks

Changes in drug regulations, manufacturing standards, and supply chain disruptions—exacerbated during unforeseen events like pandemics—pose risks to consistent market supply and revenue projections.

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Financial Trajectory and Outlook

Historical Financial Performance

NITROSTAT’s revenues have demonstrated stability over decades owing to its perennial necessity in acute care. However, profit margins are under pressure from generic competition and pricing pressures. In mature markets like North America and Europe, revenues are typically stable but exhibit slight declines as newer therapies gain ground.

Future Revenue Projections

Projected growth for NITROSTAT hinges on several factors:

• Demographic trends: Continued aging populations will sustain demand.
• Market penetration: Expanding access in emerging markets presents growth avenues, especially where CVD awareness and healthcare infrastructure improve.
• Regulatory environment: New formulations or delivery systems receive approval could offset decline in traditional formulations, invigorating sales.
• Reimbursement policies: Favorable reimbursement can bolster prescribing rates, while restrictive policies may suppress sales.

Impact of Patent and Market Exclusivity

As a legacy drug, NITROSTAT is largely off-patent. This status promotes generic entry, which, while democratizing access, compresses profit margins. Strategic partnerships or formulation enhancements could potentially offer differentiation and premium pricing.

Potential for Portfolio Diversification

Manufacturers exploring combination therapies or novel delivery methods may extend the product lifecycle of NITROSTAT or develop adjacent product lines, influencing overall financial stability.

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Strategic Opportunities and Considerations

• Innovation in Delivery Systems: Transitioning from sublingual tablets to patches, sprays, or slow-release formulations can renew market interest.
• Expansion into Emerging Markets: Improving infrastructure and disease awareness can unlock new revenue streams.
• Brand Reinforcement: Emphasizing NITROSTAT’s proven efficacy in clinical guidelines can prevent erosion of market share against generics.
• Partnership and Licensing Opportunities: Collaborations with biotech firms exploring novel vasodilator technologies interchangeably utilizing NITROSTAT’s legacy brand to capture new segments.

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Regulatory Landscape

Regulatory frameworks significantly influence NITROSTAT’s market performance. The U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other authorities have set standards for quality, safety, and efficacy. Recent trends favoring streamlined approval processes for alternative delivery systems can accelerate commercialization, while stringent control on manufacturing and distribution impact supply chain stability.

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Key Market Segmentation

• Geographic: North America remains the largest market owing to high CVD prevalence and advanced healthcare infrastructure. Asia-Pacific presents significant growth potential due to rising CVD rates and expanding healthcare access.
• Patient Profile: Acute care settings, outpatient clinics, and emergency responders constitute primary end-users. The aging demographic further sustains demand.
• Distribution Channel: Hospital formularies, retail pharmacies, and online platforms facilitate product access, with hospitals accounting for a substantial share.

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Conclusion and Future Outlook

NITROSTAT’s market dynamics are characterized by a stable core driven by cardiovascular disease prevalence and its long-established clinical role. However, the increasing availability of generics, technological innovations, and evolving treatment paradigms exert downward pricing and usage pressures.

From a financial perspective, NITROSTAT’s revenue trajectory will gradually plateau in mature markets; however, emerging markets, formulation innovations, and institutional partnerships could provide growth opportunities. Strategic positioning—through product differentiation and geographical expansion—is critical for sustained profitability.

Looking ahead, the continued importance of acute cardiac care suggests NITROSTAT will maintain a relevant, albeit evolving, market presence. Firms unafraid to invest in innovation and global expansion will better capitalize on this stability, ensuring resilience amid shifting competitive landscapes.

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Key Takeaways

• Stable Core Demand: Despite market challenges, NITROSTAT’s role in acute angina management sustains consistent demand, particularly in aging populations.
• Price and Competition Pressures: Generic entries have compressed margins; strategic differentiation is necessary for sustained profitability.
• Innovation as a Growth Lever: Formulation enhancements, alternative delivery technologies, and emerging formulations can revitalize the product’s market share.
• Emerging Markets Potential: Expanding access and improving healthcare infrastructure in developing regions offer significant growth avenues.
• Regulatory Landscape Vigilance: Staying aligned with regulatory developments influences market access and product lifecycle management.

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FAQs

Q1: How does patent expiry influence NITROSTAT’s market revenue?
A: Patent expiration allows generic manufacturers to introduce cost-effective versions, increasing competition, reducing market share, and compressing profit margins for branded NITROSTAT.

Q2: What are the main alternatives to NITROSTAT for angina management?
A: Long-acting nitrates, calcium channel blockers, beta-blockers, and emerging vasodilator technologies serve as alternatives, especially for prophylactic treatment rather than acute episodes.

Q3: Can technological innovations extend the lifecycle of NITROSTAT?
A: Yes. Developing new delivery systems—such as transdermal patches or buccal sprays—can improve efficacy and patient adherence, revitalizing market interest.

Q4: What markets offer growth opportunities for NITROSTAT?
A: Emerging markets in Asia-Pacific, Latin America, and Africa present substantial growth potential due to rising CVD prevalence and expanding healthcare infrastructure.

Q5: How do regulatory policies impact NITROSTAT’s market future?
A: Favorable regulatory pathways can facilitate approval of new formulations, while stringent regulations may delay product launches or limit market access in certain regions, influencing financial outlooks.

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Sources

1. World Health Organization. Cardiovascular diseases (CVDs): Key facts. 2022.
2. U.S. Food & Drug Administration. Approved Drug Products.
3. Frost & Sullivan. Global trends in cardiovascular therapeutics. 2021.
4. MarketWatch. Pharmaceutical Market Analysis and Forecasts. 2022.
5. European Medicines Agency. Regulatory updates on vasodilators.