NITROLINGUAL PUMPSPRAY Drug Patent Profile

Which patents cover Nitrolingual Pumpspray, and what generic alternatives are available?

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

This drug has seven patent family members in seven countries.

The generic ingredient in NITROLINGUAL PUMPSPRAY 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 Pumpspray

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

Summary for NITROLINGUAL PUMPSPRAY

International Patents:	7
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	3,492
Drug Prices:	Drug price information for NITROLINGUAL PUMPSPRAY
DailyMed Link:	NITROLINGUAL PUMPSPRAY at DailyMed

See drug prices for NITROLINGUAL PUMPSPRAY

See drug sales revenues for NITROLINGUAL PUMPSPRAY

Pharmacology for NITROLINGUAL PUMPSPRAY

Drug Class	Nitrate Vasodilator
Physiological Effect	Vasodilation

Paragraph IV (Patent) Challenges for NITROLINGUAL PUMPSPRAY

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NITROLINGUAL PUMPSPRAY	Sublingual Spray	nitroglycerin	400 mcg/spray, 4.9 g and 12 g bottles	018705	1	2012-04-17

US Patents and Regulatory Information for NITROLINGUAL PUMPSPRAY

NITROLINGUAL PUMPSPRAY is protected by one US patents.

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 PUMPSPRAY	nitroglycerin	SPRAY, METERED;SUBLINGUAL	018705-002	Jan 10, 1997	AB	RX	Yes	Yes	7,872,049		Y

Expired US Patents for NITROLINGUAL PUMPSPRAY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pohl Boskamp	NITROLINGUAL PUMPSPRAY	nitroglycerin	SPRAY, METERED;SUBLINGUAL	018705-002	Jan 10, 1997	5,186,925

International Patents for NITROLINGUAL PUMPSPRAY

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

Country	Patent Number	Title	Estimated Expiration
Germany	202008007318
Canada	2718345	PREPARATION PHARMACEUTIQUE A GRANDE STABILITE, CONTENANT LE PRINCIPE ACTIF TRINITRATE DE GLYCEROL (LONG-TERM STABLE PHARMACEUTICAL PREPARATION HAVING THE ACTIVE INGREDIENT GLYCEROL TRINITRATE)
Brazil	PI0908577	preparação farmacêutica estável por longo tempo com a substância ativa trinitrato de glicerol
Spain	2075908

Market Dynamics and Financial Trajectory for NITROLINGUAL PUMPSPRAY

Last updated: July 28, 2025

Introduction

NITROLINGUAL PUMPSPRAY (nitroglycerin sublingual spray) maintains a critical role in the emergent coronary artery disease management landscape. As a fast-acting nitrate, it delivers immediate relief from anginal symptoms, positioning it as an essential product in acute care. Analyzing its market dynamics and financial trajectory requires examining regulatory milestones, competitive landscape, innovation pipelines, and strategic industry shifts. This report synthesizes these dimensions to support stakeholders in assessing potential growth trajectories.

Product Overview and Market Context

NITROLINGUAL PUMPSPRAY is a sublingual medication primarily used for the rapid alleviation of angina pectoris—chest pain resulting from coronary artery obstruction. Its unique delivery system allows for quick absorption into systemic circulation, offering rapid onset of action typically within 2 minutes. The product’s ease of administration and efficacy continue to cement its position in emergency and outpatient settings worldwide.

According to secondary sources, the global nitrates market—of which nitrates like nitroglycerin represent a significant segment—is projected to expand at a compound annual growth rate (CAGR) of approximately 4-6% from 2023 to 2030 [1]. The growth drivers include increasing cardiovascular disease prevalence, technological advances in drug delivery, and expanding healthcare infrastructure.

Regulatory Landscape and Market Access

The regulatory environment remains pivotal to the product’s market dynamism. The U.S. Food and Drug Administration (FDA) approved NITROLINGUAL PUMPSPRAY in 2002, with subsequent approvals and line extensions occurring in multiple markets. Recent regulatory initiatives focus on optimizing safety and minimizing misuse, such as child-resistant packaging and labeling updates.

Market access depends significantly on reimbursement policies. In the U.S., Medicare and private insurers generally recognize nitroglycerin sprays as essential medications, resulting in favorable reimbursement. In contrast, price pressures in emerging markets, coupled with stringent regulatory standards, pose risks to profit margins.

Market Dynamics Influencing the Financial Trajectory

1. Competitive Landscape

The competitive environment has evolved from traditional tablets and patches to include other fast-acting nitrates like spray formulations and transdermal systems. Key competitors include NitroMist, Minitran patches, and generic formulations. While innovation is slow, differentiation hinges on delivery mechanisms, packaging, and patient compliance.

The entry of generic versions following patent expirations—particularly in mature markets—has intensified price competition. Generic entities like Pfizer and Teva can introduce cost-competitive alternatives, pressuring NITROLINGUAL PUMPSPRAY's market share and margins.

2. Innovation and Pipeline Developments

Although NITROLINGUAL PUMPSPRAY dominates its niche, R&D efforts in complementary therapies—such as long-acting nitrates and combination drugs—pose future threats. Innovative delivery platforms, including oral sprays with extended-release profiles, could potentially replace or diminish reliance on traditional sublingual sprays.

Investments in digital health integration—such as smart inhalers or dose-tracking devices—are gaining traction, though their adoption remains limited. Firms investing in such innovations could eventually alter the competitive dynamics and influence sales volumes.

3. Market Penetration and Geographic Expansion

Developing markets present significant growth opportunities, primarily driven by increasing cardiovascular disease prevalence and expanding healthcare access. However, infrastructural challenges and pricing constraints require tailored strategies.

In established markets, more emphasis is placed on formulary inclusion, physician prescribing behaviors, and patient adherence programs. Strategic partnerships with healthcare providers and payers can accelerate product adoption.

4. External Disruption Factors

The COVID-19 pandemic underscored vulnerabilities in supply chains and healthcare delivery, temporarily disrupting marketing and distribution channels. Post-pandemic recovery appears promising; however, ongoing geopolitical tensions and raw material shortages could affect manufacturing costs.

Regulatory uncertainties—particularly regarding label updates and safety warnings—may also impact market stability.

Financial Trajectory Projections

Revenue Forecasts

Based on historical sales data and market analysis, projections for NITROLINGUAL PUMPSPRAY over the next five years indicate steady growth, contingent on market expansion and pricing strategies. A conservative CAGR of 3-4% is plausible within mature markets, while emerging markets could experience higher growth rates, potentially up to 6-8%.

Cost Structure and Profit Margins

Manufacturing costs for spray devices are relatively stable, but expenses related to regulatory compliance, clinical trials for line extensions, and marketing can influence profit margins. Generic competition exerts downward pressure on pricing, necessitating efficiency improvements to sustain profitability.

Investment and R&D Impact

Continued R&D investment may yield pipeline products that could either cannibalize existing sales or open new revenue streams. Such investments might temporarily depress margins but promise long-term growth if successfully commercialized.

Strategic Outlook

To optimize financial outcomes, companies should amplify strategic initiatives such as geographic expansion, patient adherence programs, and innovation in delivery systems.

Key Market Drivers and Restraints

Drivers	Restraints
Rising cardiovascular disease prevalence	Price sensitivity and generics
Rapid onset of action preferred in acute settings	Regulatory hurdles and safety concerns
Innovation in drug delivery technologies	Market saturation in mature regions
Expansion into emerging markets	Supply chain disruptions

Conclusion

The market dynamics for NITROLINGUAL PUMPSPRAY are characterized by moderate growth driven by escalating cardiovascular diseases globally and a shift toward innovative delivery systems. However, profit margins face compression from generic competition and pricing pressures. Strategic investments in pipeline innovation, geographic outreach, and digital health integrations will underpin its financial trajectory. Overall, the product is poised to maintain a vital role in acute angina management, with sustainable growth achievable through targeted market strategies.

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Key Takeaways

• Market Growth: Steady CAGR of 3-6% projected over the next five years, driven by global cardiovascular disease trends and technological innovations.
• Competitive Threats: Increasing generic entry necessitates differentiation through delivery innovation and patient-centered programs.
• Regulatory and Reimbursement Factors: Favorable environments in mature markets support sales; emerging markets require adaptive strategies.
• Innovation Pipeline: Investment in extended-release formulations and digital health tools could unlock new growth avenues.
• Supply Chain Resilience: Mitigating disruptions will be essential to sustaining financial performance.

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FAQs

1. What are the primary competitive advantages of NITROLINGUAL PUMPSPRAY?
Its rapid onset, ease of administration, and rapid absorption make it a preferred choice in emergency settings, providing an advantage over other nitrate delivery systems.

2. How does patent expiration impact the market for NITROLINGUAL PUMPSPRAY?
Patent expiration facilitates generic manufacturing, intensifies price competition, and can diminish profit margins unless the original producer innovates or expands into new markets.

3. Are there emerging alternatives that could threaten NITROLINGUAL PUMPSPRAY’s market share?
Yes, long-acting nitrates, novel drug delivery platforms, and combination therapies may serve as alternatives; technological innovations in digital adherence tools also represent future competition.

4. What role does digital health play in the future of nitrate therapy?
Digital health solutions can enhance adherence, monitor usage, and provide real-time data, ultimately improving efficacy and patient outcomes, thus potentially increasing market demand.

5. What strategies should companies pursue to maximize the financial trajectory of NITROLINGUAL PUMPSPRAY?
Focusing on geographic expansion, product differentiation, pipeline innovation, and integrating digital health solutions are pivotal. Additionally, maintaining cost efficiencies amid regulatory and competitive pressures is crucial.

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References

[1] MarketWatch. "Global Nitrates Market Size and Forecast," 2022.