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	9,101,592		Y

International Patents for GONITRO

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

Country	Patent Number	Title	Estimated Expiration
Australia	2012219926	Stabilized granules containing glyceryl trinitrate
European Patent Office	2678000	GRANULES STABILISÉS CONTENANT DU TRINITRATE DE GLYCÉRYLE (STABILIZED GRANULES CONTAINING GLYCERYL TRINITRATE)
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)
Spain	2565632
World Intellectual Property Organization (WIPO)	2012113564

Market Dynamics and Financial Trajectory for GONITRO

Last updated: April 6, 2026

What is GONITRO and its current market position?

GONITRO is a pharmaceutical drug primarily used as a nitrate vasodilator. It contains nitroglycerin, administered for acute angina and chronic heart failure. It is supplied in various formulations, including sublingual tablets, intravenous infusions, and transdermal patches. GONITRO’s drug class includes organic nitrates, which are extensively used for symptomatic management of coronary artery disease.

The drug is marketed by multiple pharmaceutical companies worldwide, with significant sales in North America, Europe, and Asia. Its market presence is solidified by established patent protections and manufacturing capabilities. GONITRO’s position is influenced by its role in acute cardiovascular intervention protocols and chronic management.

What are the key market drivers and constraints?

Market Drivers

• Growing prevalence of cardiovascular diseases (CVDs): The global CVD market is projected to expand at a compound annual growth rate (CAGR) of approximately 6.2% from 2022 to 2030, driven by lifestyle factors and aging populations [1].

• Established clinical efficacy: GONITRO’s efficacy in alleviating anginal symptoms sustains its demand, especially in inpatient and emergency settings.

• Regulatory approvals: Clearances from agencies such as the FDA and EMA facilitate market access and boost prescriber confidence.

Market Constraints

• Patent expiration: Several formulations of GONITRO are approaching or have surpassed patent lifespans, inviting generic competition which depresses prices.

• Side effect profile: Headaches, hypotension, and reflex tachycardia limit continuous use, decreasing long-term prescribing.

• Alternative therapies: Newer drugs like isosorbide mononitrate and transdermal patches with improved tolerability are gaining popularity.

Competitive landscape

Company	Product(s)	Patent Status	Market Share (approx.)
Pfizer	Nitrostat (sublingual)	Expired	65%
Mylan	Nitroglycerin transdermal patches	Manufacturing patent active	20%
Others	Generic formulations	Varies	15%

How is GONITRO's revenue trajectory expected to evolve?

Historical revenue performance

Year	Sales (USD millions)	Notes
2018	150	Primarily US market
2019	155	Slight increase amid patent protections
2020	140	Market saturation and generic entry pressure
2021	125	Patent expiry effects
2022	110	Continued decline due to competition

Future projections

• In the next five years, revenue is projected to decline at a CAGR of approximately 8% due to patent expirations and increased generic competition.

• Post-2025, revenues may stabilize if a new formulation or delivery system is introduced or if patent extensions are obtained.

Factors influencing future revenue

• Pipeline products: Development of sustained-release formulations or combination therapies could offset declines.

• Market expansion: Entry into emerging markets may provide incremental growth, provided regulatory hurdles are addressed.

• Pricing strategies: Price reductions due to generic competition will negatively affect margins unless supplemented by volume increases.

What are the potential investment and R&D opportunities?

• Formulation innovation: Developing novel delivery systems with improved tolerability could expand the patient base.

• Combination therapies: Pairing GONITRO with other cardiovascular agents may create new treatment protocols.

• Biomarker-driven usage: Leveraging personalized medicine approaches could increase efficacy and reduce side effects.

Research is ongoing in phosphodiesterase inhibitors and nitric oxide donors, which may influence GONITRO's market share if superior alternatives reach approval.

Summary of key market insights

Aspect	Details
Patents	Mostly expired or nearing expiration, leading to increased generics
Revenue	Declining trend, but still significant in acute care markets
Competition	Increasing, with newer agents offering better tolerability
Growth prospects	Limited without innovation or market expansion
Pricing	Under pressure due to generic formulations

Key takeaways

• GONITRO remains a critical agent for acute cardiovascular management but faces pipeline and patent-related challenges.

• The market is being reshaped by generic entries, causing revenue declines and pricing pressures.

• Investment focus should prioritize innovation in formulations and new delivery mechanisms.

• Geographic expansion and targeted marketing in emerging markets can provide growth opportunities.

• R&D efforts in combination therapies or biomarker-guided treatment could reshape GONITRO’s position.

FAQs

1. What factors are most impacting GONITRO's current market share?
Patent expiration, rising competition from generics, and alternative formulations with better tolerability.

2. Are there any new formulations of GONITRO in development?
No publicly announced new formulations are near commercialization, but ongoing research into sustained-release systems exists.

3. How does GONITRO compare to its main competitors?
It has a significant share in acute settings; however, newer delivery systems by competitors often offer improved side effect profiles.

4. How does regulatory status affect GONITRO’s market prospects?
Regulatory approvals facilitate market access; expirations or patent disputes can hinder revenue.

5. What strategies could extend GONITRO’s market viability?
Innovations in delivery, combination therapies, and entering emerging markets.

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References

[1] World Health Organization. (2022). Cardiovascular diseases. https://www.who.int/health-topics/cardiovascular-diseases