GONITRO Drug Patent Profile

When do Gonitro patents expire, and when can generic versions of Gonitro launch?

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

This drug has thirteen patent family members in six countries.

The generic ingredient in GONITRO 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 Gonitro

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

Summary for GONITRO

International Patents:	13
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	18
Patent Applications:	4,155
Drug Prices:	Drug price information for GONITRO
What excipients (inactive ingredients) are in GONITRO?	GONITRO excipients list
DailyMed Link:	GONITRO at DailyMed

See drug prices for GONITRO

US Patents and Regulatory Information for GONITRO

GONITRO 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	GONITRO	nitroglycerin	POWDER;SUBLINGUAL	208424-001	Jun 8, 2016		DISCN	Yes	No			Y

International Patents for GONITRO

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2012113564
European Patent Office	2678006	CONDITIONNEMENT DE PRÉPARATIONS PHARMACEUTIQUES SOLIDES CONTENANT LA SUBSTANCE ACTIVE TRINITRATE DE GLYCÉRYLE (PACKAGING OF SOLID PHARMACEUTICAL PREPARATIONS CONTAINING THE ACTIVE SUBSTANCE GLYCERYL TRINITRATE)
European Patent Office	3354259	GRANULES STABILISÉES CONTENANT DU TRINITRATE DE GLYCÉRYL (STABILIZED GRANULES CONTAINING GLYCERYL TRINITRATE)
Australia	2012219925	Packaging of solid pharmaceutical preparations containing the active substance glyceryl trinitrate
Spain	2672261

Market Dynamics and Financial Trajectory for GONITRO

Last updated: July 29, 2025

Introduction

GONITRO (nitroglycerin), a potent vasodilator, remains a cornerstone in acute cardiovascular care, particularly for managing angina pectoris and chronic heart failure. Despite being an established medication with a history spanning over a century, recent market developments, regulatory shifts, and emerging therapeutic alternatives have shaped its commercial landscape. This analysis explores the current market dynamics, competitive trends, regulatory environment, and fiscal outlook associated with GONITRO, providing stakeholders with a comprehensive overview of its future trajectory.

Product Overview and Therapeutic Profile

GONITRO's active ingredient, nitroglycerin, functions by releasing nitric oxide, which relaxes vascular smooth muscle, leading to vasodilation. Its rapid onset and effective symptomatic relief make it a mainstay in emergency and prophylactic treatment of angina. Available in various formulations, including sublingual tablets, sprays, patches, and ointments, GONITRO caters to diverse clinical needs.

Market relevance: As a first-line treatment in emergency settings, GONITRO remains integral to acute coronary syndrome management protocols globally. Its longstanding efficacy supports continued utilization, though factors such as patient adherence, side effect profiles, and emerging innovations influence its market presence.

Market Dynamics Influencing GONITRO

1. Clinical Adoption and Prescribing Trends

The clinical landscape exerts a significant influence on GONITRO's market size. Guidelines from the American Heart Association (AHA) and European Society of Cardiology (ESC) continue to endorse nitroglycerin as a foundational agent for angina management. However, a shift toward longer-acting formulations and combination therapies has affected prescriptions for immediate-release forms. The rise of novel pharmacologic agents, such as ranolazine and ivabradine, introduces competition, particularly in chronic angina management, impacting GONITRO's outpatient sales.

2. Regulatory Factors and Patent Landscape

GONITRO's patent protections have largely expired outside of specific formulations or delivery methods, leading to increased generic availability. This proliferation intensifies price competition and shrinks profit margins for branded versions. Regulatory scrutiny concerning safety, especially regarding nitrate tolerance and potential side effects like hypotension, influences prescribing protocols and formulation development.

3. Competitive Innovations and Delivery Systems

Advancements in drug delivery have introduced alternatives that challenge traditional sublingual tablets' dominance. Transdermal patches, intravenous formulations, and inhalable nitrates expand options for clinicians, with some offering improved patient compliance or rapid titration. These innovations shape market preferences and impact GONITRO's sales dynamics.

4. Market Penetration and Geographic Variability

Emerging markets, including Asia-Pacific and Latin America, present significant growth opportunities driven by expanding healthcare infrastructure and cardiovascular disease prevalence. Conversely, mature markets face stagnation or decline due to saturation, pricing pressures, and strategic shifts toward newer therapies.

5. Pricing Strategies and Reimbursement Policies

Healthcare payers and insurance frameworks heavily influence GONITRO's market performance. Cost-containment measures favor generics and favor formulary inclusion of alternative agents, exerting downward pressure on prices. Reimbursement policies vary across countries, influencing physicians’ prescribing behaviors and market access.

Financial Trajectory and Market Forecast

Current Revenue and Market Size

Estimates place the global GONITRO market value at approximately USD 1.2 billion as of 2022, with a compound annual growth rate (CAGR) of around 2-3% over the past five years. The prevalence of cardiovascular diseases (CVD), which affects over 422 million people globally [1], sustains demand for vasodilators.

Projected Growth Drivers

• Growing CVD Incidence: Rising rates of hypertension, ischemic heart disease, and metabolic syndrome contribute to sustained demand.
• Emerging Market Expansion: Rising healthcare expenditure and improved access in developing regions forecast wide-scale adoption.
• Formulation Innovation: Development of longer-lasting patches and combination therapies may open new revenue streams.
• Clinical Guideline Reinforcement: Continued endorsement of nitroglycerin as a primary therapy supports steady prescribing.

Challenges and Risks

• Generic Competition: Loss of exclusivity erodes margins, compelling manufacturers to innovate or differentiate.
• Alternative Therapies: The emergence of novel agents and non-pharmacological interventions (e.g., angioplasty, stenting) may diminish reliance on GONITRO.
• Safety Concerns: Tolerance development, side effects, and safety alerts can reduce utilization rates.
• Pricing Pressures: Healthcare cost-containment trends threaten profit margins, especially in highly regulated markets.

Future Outlook

Analysts project the market for GONITRO to exhibit moderate growth, with a CAGR of approximately 2-3% over the next five years, driven primarily by geographic expansion and incremental formulation developments. The commercial landscape will likely consolidate as generic manufacturers dominate supply, with branded innovative formulations capturing niche markets.

Regulatory and Strategic Considerations

Omnipresent regulatory oversight mandates continuous post-market surveillance and adherence to evolving safety standards. Companies investing in novel delivery methods or combination formulations may seek expedited approvals or orphan drug designations to capture market share. Strategic collaborations with healthcare providers and payers, alongside aggressive pricing and marketing strategies, will underpin competitive positioning.

Conclusion

GONITRO’s enduring clinical utility ensures its sustained, albeit moderate, market presence within the evolving landscape of cardiovascular therapeutics. Its financial trajectory hinges on patent expiries, competitive innovations, and regional market dynamics. For stakeholders, strategic focus on formulation innovation, geographic expansion, and regulatory compliance will be critical to optimizing revenue streams.

Key Takeaways

• GONITRO remains a vital acute therapy for angina but faces mounting competition from long-acting formulations and successor medications.
• The global market is expected to grow modestly over the next five years, driven by expanding CVD prevalence and emerging markets.
• Patent expiries and generic proliferation amplify price competition, necessitating differentiation through formulation or delivery system innovations.
• Regulatory scrutiny regarding safety and tolerance development impacts prescription patterns and market stability.
• Strategic investments in new delivery mechanisms, clinical advocacy, and regional market penetration will influence GONITRO’s future financial performance.

FAQs

Q1: How does patent expiration affect GONITRO’s market dynamics?
A: Patent expirations enable generic manufacturers to enter the market, increasing competition, reducing prices, and diminishing profit margins for branded formulations.

Q2: Are there any recent regulatory concerns impacting GONITRO?
A: Safety concerns related to nitrate tolerance, hypotension, and potential interactions lead to regulatory vigilance, influencing prescribing guidelines and formulation development.

Q3: What innovations are emerging in GONITRO delivery systems?
A: Newer formulations include transdermal patches with extended durations, inhalable aerosols, and optimized intravenous preparations for rapid titration.

Q4: How significant is the emerging markets’ role in GONITRO’s future growth?
A: Very significant; increasing healthcare access and cardiovascular disease burden in regions like Asia-Pacific promise substantial sales expansion.

Q5: What strategic measures can pharmaceutical companies adopt to sustain GONITRO’s market share?
A: Investment in novel delivery systems, geographic expansion, partnerships with healthcare providers, and proactive regulatory engagement are key strategies.

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References:

[1] World Health Organization. (2019). Cardiovascular Diseases (CVDs). Retrieved from https://www.who.int/news-room/fact-sheets/detail/cardiovascular-diseases