NITROLINGUAL Drug Patent Profile

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

Nitrolingual is a drug marketed by Pohl Boskamp and is included in one NDA. There is one patent protecting this drug.

The generic ingredient in NITROLINGUAL 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 Nitrolingual

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

Summary for NITROLINGUAL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	2
Patent Applications:	4,617
Drug Prices:	Drug price information for NITROLINGUAL
What excipients (inactive ingredients) are in NITROLINGUAL?	NITROLINGUAL excipients list
DailyMed Link:	NITROLINGUAL at DailyMed

See drug prices for NITROLINGUAL

See drug sales revenues for NITROLINGUAL

Recent Clinical Trials for NITROLINGUAL

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

Sponsor	Phase
United States Naval Medical Center, San Diego	Phase 2
University of Zurich	Phase 4

See all NITROLINGUAL clinical trials

Pharmacology for NITROLINGUAL

Drug Class	Nitrate Vasodilator
Physiological Effect	Vasodilation

US Patents and Regulatory Information for NITROLINGUAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pohl Boskamp	NITROLINGUAL	nitroglycerin	AEROSOL;SUBLINGUAL	018705-001	Oct 31, 1985		DISCN	No	No
Pohl Boskamp	NITROLINGUAL PUMPSPRAY	nitroglycerin	SPRAY, METERED;SUBLINGUAL	018705-002	Jan 10, 1997	AB	RX	Yes	Yes	7,872,049		Y

International Patents for NITROLINGUAL

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

Country	Patent Number	Title	Estimated Expiration
Austria	125703
Greece	3017032
World Intellectual Property Organization (WIPO)	2009112258

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: NITROLINGUAL

Last updated: July 29, 2025

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Introduction

NITROLINGUAL, a sublingual nitroglycerin tablet designed primarily for acute angina relief, holds a notable position within the cardiovascular pharmaceutical sector. Its unique formulation allows rapid absorption into systemic circulation, providing swift symptomatic relief for patients with ischemic heart disease. As a well-established medication, NITROLINGUAL's market dynamics are influenced by its clinical efficacy, regulatory landscape, competitive forces, and evolving healthcare demands. Understanding its financial trajectory necessitates analyzing these factors alongside strategic advancements and market trends.

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Market Landscape and Demand Drivers

The global cardiovascular drugs market is projected to reach approximately USD 174 billion by 2027, driven by aging populations, increasing prevalence of coronary artery disease (CAD), and expanding awareness about cardiovascular health [1]. NITROLINGUAL's primary application in acute angina aligns with this upward trend, positioning it as a critical therapeutic agent.

Key demand drivers include:

• Prevalence of Coronary Artery Disease (CAD): CAD remains the leading cause of mortality worldwide, demanding effective symptomatic treatments like nitrates. In the U.S., roughly 18 million adults suffer from angina, confirming strong clinical need [2].

• Emergency and On-demand Therapy: NITROLINGUAL’s immediate onset makes it indispensable in emergency scenarios and for outpatient management, maintaining consistent patient demand.

• Healthcare Infrastructure & Accessibility: In regions with advanced healthcare systems, rapid-acting formulations are favored due to patient compliance and improved outcomes. Conversely, emerging markets demonstrate increasing adoption as infrastructure improves.

Market Dynamics Influencing NITROLINGUAL

Regulatory Environment

Regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) impose strict standards on manufacturing, safety, and efficacy. NITROLINGUAL’s long-standing approval history provides a significant advantage, although ongoing monitoring for side effects—such as hypotension or headache—is essential.

Moreover, rising regulatory emphasis on generic formulations and bioequivalence testing could influence pricing and patent exclusivity. Any novel delivery systems or combination formulations would require new regulatory clearances, impacting timelines and costs.

Competitive Landscape

NITROLINGUAL faces competition from both branded counterparts and generics. Key competitors include:

• Nitrolingual Pumpspray: Offers similar rapid-onset therapy via spray, often preferred for ease of administration.

• Nitroglycerin Transdermal Patches: Provide sustained relief but are less suitable for acute attacks, positioning them as complementary rather than competitive.

• Other Quick-Dissolving Formulations: Such as sublingual sprays and lozenges, diversifying options for clinicians and patients.

Patent expirations and the entry of generics pose significant challenges, exerting downward pressure on prices and margins. Nonetheless, proprietary manufacturing processes and brand loyalty bolster NITROLINGUAL's market position.

Technological Innovations

Advancements in drug delivery, such as nanoparticle-based formulations or combination therapies targeting multiple ischemic pathways, could reshape the competitive landscape. NITROLINGUAL’s adaptation to such innovations may influence its long-term market share.

Market Penetration and Geographic Expansion

The drug’s current dominant markets include North America and Europe. Increasing penetration in Asia-Pacific, Latin America, and the Middle East will depend on regulatory approvals, local healthcare infrastructure, and consumer awareness.

Emerging markets show promising growth, with increased cardiovascular disease burden and growing middle-class populations generating demand for effective acute angina treatments.

Pricing Strategies and Reimbursement Policies

Pricing remains a crucial determinant of market share. NITROLINGUAL typically commands premium pricing attributed to its rapid action, with reimbursement policies heavily influencing patient access. Favorable coverage under insurance plans in developed countries sustains revenue streams, but price pressures from payers persist globally.

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Financial Trajectory and Revenue Projections

The financial outlook for NITROLINGUAL hinges on several factors:

• Sales Volume and Pricing: Existing strong sales in established markets suggest stable revenue; however, generic competition could erode profit margins unless differentiated through formulation innovations or value-added services.

• Patents and Exclusivity: The original patents, likely expired or close to expiry, open opportunities for generic producers, reducing pricing power but increasing volume potential.

• Pipeline and Lifecycle Management: Introduction of next-generation formulations targeting improved bioavailability or combination therapies could rejuvenate market interest, potentially leading to premium pricing.

• Market Expansion: Expanding into new geographies with tailored pricing and distribution strategies could increase revenue. Strategic partnerships, licensing, or local manufacturing can accelerate growth.

In recent years, the market for sublingual nitroglycerin products has demonstrated steady compound annual growth rate (CAGR) estimates of approximately 4-6% [3], although the impact of patent expirations and generic commoditization may temper this outlook.

Financial Challenges and Risks

• Generic Competition: The commoditization of nitroglycerin products may reduce profit margins unless differentiated through branding or formulation innovation.

• Regulatory Changes: Stringent safety data requirements and evolving standards could increase compliance costs.

• Market Saturation: In mature markets, growth is constrained, calling for diversification into adjunctive therapies.

Opportunities for Growth

• Product Diversification: Developing combination drugs (e.g., nitrates with other antianginal agents) or new delivery systems can expand market appeal.

• Small-Scale Launches: Targeting niche markets such as military or emergency services with tailored formulations.

• Digital Health Integration: Linking medication use with digital platforms for adherence monitoring enhances clinical outcomes and brand loyalty.

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Key Takeaways

• Robust Market Position: NITROLINGUAL remains a core product within acute angina management due to its rapid-onset and established efficacy.

• Competitive Challenges: Patent expirations and generics pose pricing pressures, emphasizing the importance of innovation and brand differentiation.

• Growth in Emerging Markets: Expanding into developing regions offers significant future revenue potential pending regulatory approvals and healthcare infrastructure improvement.

• Pipeline and Innovation: Incorporating advanced delivery technologies and new formulations can extend product lifecycle and competitive advantage.

• Strategic Alliances: Partnerships and licensing agreements can accelerate market penetration and diversify revenue streams.

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FAQs

1. How does NITROLINGUAL compare with other nitroglycerin formulations?
NITROLINGUAL’s sublingual tablets provide faster absorption and onset of action than transdermal patches or oral tablets, making it superior for acute angina relief. Spray formulations offer similar rapidity but differ in administration preference.

2. What are the key regulatory hurdles for NITROLINGUAL?
Ensuring consistent bioavailability, demonstrating bioequivalence for generics, and adhering to safety standards regarding hypotensive episodes are primary regulatory considerations, especially in new markets.

3. How might patent expirations impact NITROLINGUAL’s revenue?
Patent expiration can lead to increased generic competition, reducing prices and margins. However, retaining brand loyalty through formulation sophistication and branding can mitigate revenue losses.

4. What role does technological innovation play in NITROLINGUAL’s future?
Innovations such as improved delivery systems or combination therapies can rejuvenate market interest, enable premium pricing, and extend product competitiveness.

5. What strategic moves can companies undertake to grow NITROLINGUAL’s market share?
Expanding into untapped regions, developing advanced formulations, forming strategic alliances, and leveraging digital health tools can enhance market penetration and profitability.

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References

1. MarketsandMarkets. "Cardiovascular Drugs Market by Type, Application, and Region." 2021.
2. American Heart Association. "2019 Statistics Update."
3. Grand View Research. "Sub-Lingual Nitroglycerin Market Analysis." 2022.