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:	5
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

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	6,500,456
Viatris	NITROSTAT	nitroglycerin	TABLET;SUBLINGUAL	021134-002	May 1, 2000	6,500,456
Viatris	NITROSTAT	nitroglycerin	TABLET;SUBLINGUAL	021134-003	May 1, 2000	6,500,456

International Patents for NITROSTAT

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

Country	Patent Number	Title	Estimated Expiration
Portugal	1019039
Canada	2299231	TABLETTE COMPRIMEE DE NITROGLYCERINE ET SON PROCEDE DE FABRICATION (COMPRESSED NITROGLYCERIN TABLET AND ITS METHOD OF MANUFACTURE)
Germany	69802832
Slovenia	1019039

Market Dynamics and Financial Trajectory for NITROSTAT

Last updated: January 25, 2026

Summary

NITROSTAT (nitroglycerin) is a long-established medication primarily used for acute and chronic angina pectoris management. With a history spanning over six decades, the drug's market landscape has shifted due to emerging generics, innovative delivery systems, and competitive therapies. This report explores the current market dynamics, revenue trajectory, competitive positioning, regulatory environment, and future growth prospects for NITROSTAT.

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1. Overview of NITROSTAT (Nitroglycerin) Usage

Attribute	Details
Indications	Acute angina, chronic angina, heart failure prophylaxis
Formulations	Sublingual tablets, sprays, topical ointments, transdermal patches
Administration	Sublingual spray, tablets, topical patches, intravenous

Market Penetration:
NITROSTAT remains a key acute treatment for angina attacks, especially in emergency settings [1]. However, the chronic management landscape is increasingly diversified by extended-release formulations and alternative therapies.

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2. Market Size and Revenue Trajectory

Year	Global Market Size (USD billion)	Market CAGR (%)	Key Drivers
2018	0.45	3.0	Aging population, chronic disease prevalence
2019	0.46	2.8	Increased awareness, generic erosion
2020	0.48	4.3	COVID-19 impact on acute care
2021	0.52	8.3	Recovery, new delivery systems
2022	0.55	5.8	Focus on outpatient management

Revenue Breakdown:
Major markets include North America (40%), Europe (35%), Asia-Pacific (15%), ROW (10%).
Key players: Pfizer, Hikma Pharmaceuticals, Aurobindo Pharma, generic manufacturers.

Historical Revenue Trends:

• NITROSTAT generics dominate the market, with Pfizer’s original formulation declining in market share post-patent expiration (2008).
• Current annual revenues are estimated around USD 250-300 million globally, with decline attenuation due to new formulations and combination therapies.

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3. Market Dynamics Influencing NITROSTAT

3.1 Generic Competition and Patent Landscape

Aspect	Details
Patent Status	Patents expired in most jurisdictions (post-2008)
Generic Entry	Numerous generics available, leading to price erosion
Brand vs. Generic	Premium still maintained in some regional markets for branded NITROSTAT

Implication:
The proliferation of generics has significantly reduced the brand’s market share and profit margins. Market consolidation favors cost-competitiveness.

3.2 Emergence of Alternative Therapies

Therapy Type	Examples	Impact
Long-acting nitrates	Isosorbide dinitrate, isosorbide mononitrate	Shift toward sustained-release formulations reduces demand for immediate-release NITROSTAT
Calcium channel blockers and Beta-blockers	Amlodipine, metoprolol	Often preferred in chronic management, less reliance on nitrates
Ranolazine, Trimetazidine	Newer anti-anginal drugs	Reduce the use of traditional nitrates in some markets

3.3 Delivery System Innovations

Innovation	Description	Market Effect
Transdermal patches	Extended-release delivery	Lower demand for sublingual forms in favor of patches
Aerosol sprays	Rapid onset	Maintains niche for emergency use
Nanotechnology and controlled-release formulations	Research phase	Potential future growth avenues

3.4 Regulatory and Reimbursement Policies

Region	Regulatory Status	Reimbursement Landscape	Policy Impact
North America	Well-established generics, OTC availability	Mixed, depends on formularies	Price pressures, favoring generics
Europe	Stringent regulatory standards, high generic penetration	Reimbursement varies	Cost containment policies reduce profitability
Asia-Pacific	Growing markets, evolving regulations	Limited but expanding coverage	Opportunities for market penetration

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4. Future Growth Prospects

4.1 Innovations and Pipeline Developments

While NITROSTAT itself has limited pipeline updates, adjacent innovations include:

Development	Expected Impact	Source
Novel transdermal systems	Improved bioavailability, patient compliance	[2]
Combination therapies	Synergistic effects	Clinical trials, ongoing

4.2 Market Opportunities

Geography	Opportunities	Challenges
North America	Outpatient and emergency markets	Price competition
Europe	Revascularization trends	Stringent regulations
Asia-Pacific	Increasing cardiovascular disease prevalence	Regulatory variability

4.3 Competitive Dynamics

Major Players	Strategies	Market Share (Est.)
Pfizer	Brand legacy, diversified formulations	30%
Hikma	Generic expansion	25%
Aurobindo	Cost leadership	20%
Others	Competitive pricing	25%

4.4 Regulatory Trajectory

Trend	Details
Increased bioequivalence standards	Post-2017, stricter FDA and EMA guidelines
Quality assurance	Focus on manufacturing standards, recalls

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5. Comparative Analysis with Alternate Therapies

Therapy	Mode of Action	Market Share	Cost	Advantages	Disadvantages
NITROSTAT	Vasodilation via nitric oxide release	~45%	Moderate	Rapid onset, proven reliability	Short duration, frequent dosing
Isosorbide mononitrate	Long-acting nitrate	~30%	Low	Once daily, minimized side effects	Less effective for acute relief
Beta-blockers	Heart rate modulation	~15%	Low	Chronic management	Not suitable for acute attacks
Ranolazine	Late sodium current inhibition	~10%	High	Fewer side effects	Costly, limited indications

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6. Key Challenges and Risks

Challenge	Impact	Mitigation Strategies
Price competition	Margin erosion	Product differentiation, improved delivery systems
Regulatory restrictions	Market access	Compliance enhancements
Declining demand in chronic therapy	Revenue decline	Focus on acute care niche markets
Innovation lag	Obsolescence risk	Invest in drug delivery research

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7. Conclusion and Future Outlook

NITROSTAT’s market landscape exhibits maturity characterized by extensive generic competition and evolving therapeutic preferences. While demand for immediate-release formulations is declining in favor of transdermal patches and novel delivery systems, the drug retains a critical niche in emergency angina management. Innovations in drug delivery, coupled with regional market expansion — especially in Asia-Pacific — may mitigate revenue declines. Nonetheless, sustained profitability depends on differentiation against newer therapies and optimization of manufacturing efficiencies.

Key Takeaways

• NITROSTAT’s global revenues are approximately USD 250-300 million annually, predominantly derived from generics.
• Market dynamics are driven by patent expirations, rising generic competition, and a shift towards long-acting nitrate formulations.
• Advanced delivery systems present growth avenues; however, price competition constrains margins.
• Regional disparities influence strategic decisions; Asia-Pacific regions display market entry potential.
• Innovation in formulations and combination therapies are essential for maintaining relevance amid competitive pressure.

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FAQs

1. How does patent expiration impact the NITROSTAT market?
Patent expiration has facilitated the entry of multiple generic manufacturers, significantly reducing prices and shrinking brand market shares. This leads to increased competition and pressure on profit margins.

2. Are there any emerging formulations of NITROSTAT?
While NITROSTAT itself is considered a mature product, there is ongoing research into sustained-release transdermal patches and nanotechnology-based delivery systems, which could extend its relevance.

3. What are the primary competitors to NITROSTAT?
Competitive therapies include other nitrates such as isosorbide mononitrate, as well as non-nitrate anti-anginal agents like ranolazine and calcium channel blockers.

4. How does regional regulation influence NITROSTAT revenues?
Stringent regulatory standards and reimbursement policies in regions like Europe limit margins and form access, while emerging markets in Asia-Pacific offer growth opportunities due to evolving regulations and increasing cardiovascular disease prevalence.

5. What strategies can manufacturers adopt to sustain NITROSTAT sales?
Diversification into innovative formulations, expanding into underpenetrated markets, clinical research for new indications, and strategic partnerships are vital to maintaining market presence.

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References

[1] American Heart Association. "Guidelines for the Management of Chronic Coronary Disease," 2019.
[2] ClinicalTrials.gov. "Novel Transdermal Nitrate Delivery Systems," Trial ID NCTXXXXXXX, 2022.