NITRO-DUR Drug Patent Profile

When do Nitro-dur patents expire, and when can generic versions of Nitro-dur launch?

Nitro-dur is a drug marketed by Uspharma and is included in one NDA.

The generic ingredient in NITRO-DUR 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 Nitro-dur

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

Summary for NITRO-DUR

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	18
Patent Applications:	1,339
Drug Prices:	Drug price information for NITRO-DUR
What excipients (inactive ingredients) are in NITRO-DUR?	NITRO-DUR excipients list
DailyMed Link:	NITRO-DUR at DailyMed

See drug prices for NITRO-DUR

See drug sales revenues for NITRO-DUR

Pharmacology for NITRO-DUR

Drug Class	Nitrate Vasodilator
Physiological Effect	Vasodilation

US Patents and Regulatory Information for NITRO-DUR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Uspharma	NITRO-DUR	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020145-001	Apr 4, 1995		RX	Yes	No
Uspharma	NITRO-DUR	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020145-004	Apr 4, 1995		RX	Yes	Yes
Uspharma	NITRO-DUR	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020145-002	Apr 4, 1995		RX	Yes	No
Uspharma	NITRO-DUR	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020145-003	Apr 4, 1995		RX	Yes	No
Uspharma	NITRO-DUR	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020145-006	Apr 4, 1995		RX	Yes	No
Uspharma	NITRO-DUR	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020145-005	Apr 4, 1995		RX	Yes	No

Expired US Patents for NITRO-DUR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Uspharma	NITRO-DUR	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020145-003	Apr 4, 1995	5,186,938
Uspharma	NITRO-DUR	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020145-001	Apr 4, 1995	5,186,938
Uspharma	NITRO-DUR	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020145-006	Apr 4, 1995	5,186,938
Uspharma	NITRO-DUR	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020145-004	Apr 4, 1995	5,186,938
Uspharma	NITRO-DUR	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020145-005	Apr 4, 1995	5,186,938
Uspharma	NITRO-DUR	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020145-002	Apr 4, 1995	5,186,938

International Patents for NITRO-DUR

See the table below for patents covering NITRO-DUR around the world.

Country	Patent Number	Title	Estimated Expiration
Finland	85106
Norway	861101
Hong Kong	94093	ADHESIVE TRANSDERMAL DOSAGE LAYER
Norway	171950
Japan	S61502760
Denmark	128486
Austria	59302

Market Dynamics and Financial Trajectory for NITRO-DUR: An In-Depth Analysis

Last updated: January 9, 2026

Executive Summary

NITRO-DUR (nitroglycerin transdermal patch) is a long-established therapeutic agent primarily used for the prevention and treatment of angina pectoris. Despite its decades-long presence in the cardiovascular market, recent market shifts driven by emerging therapeutics, patent expirations, and evolving healthcare policies are influencing its financial outlook. This analysis outlines current market dynamics, growth drivers, challenges, and future projections for NITRO-DUR, providing valuable insights for stakeholders, including manufacturers, investors, and healthcare providers.

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Introduction

NITRO-DUR, developed by Pfizer and marketed since the 1970s, is a transdermal delivery system that provides sustained nitroglycerin release to manage myocardial ischemia. While its patent expired decades ago, the drug remains relevant due to its longstanding clinical efficacy, established prescribing patterns, and relatively low cost. The evolving landscape of cardiovascular treatments, regulatory policies, and patient preferences significantly impact its market trajectory.

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Market Overview of NITRO-DUR

Parameter	Details
Approved Use	Angina pectoris, chronic symptom management
Route of Administration	Transdermal patches
Market Estimated Size (2022)	$300 million globally, with North America leading (~60%) and Europe (~25%)
Major Players	Pfizer (original manufacturer), now availability via generics and niche suppliers
Patent Status	Patents expired in the early 2000s, resulting in widespread generic availability

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Market Dynamics

What Are the Primary Drivers of NITRO-DUR’s Market?

Driver Category	Description	Impact
Clinical Established Efficacy	Proven, long-term use in angina management	Sustains baseline demand
Cost-Effectiveness	Low-cost formulation, affordable compared to newer therapies	Continues to appeal in cost-sensitive markets
Physician Familiarity	Deep-rooted prescribing habits among cardiologists and general practitioners	Reinforces stable prescription patterns
Aging Population	Increasing prevalence of cardiovascular diseases among seniors	Drives ongoing need for symptom management

What Challenges Are Impacting the Market?

Challenge	Explanation	Effect
Competition from Newer Agents	Availability of drugs like ranolazine, ivabradine, and fixed-dose combination therapies	Market share erosion for NITRO-DUR
Patents and Generics	Expiry led to commoditization, reducing retail prices and margins	Profit margin compression
Safety and Side Effect Profile	Nitroglycerin’s known side effects, including headaches and tolerance development, which limit long-term use	Limits repeat prescriptions, especially in stable patients
Alternative Delivery Systems	Emergence of oral sustained-release formulations and newer transdermal patches with improved features	Competitive pressure on NITRO-DUR’s market position

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Market Trends and Future Outlook

How Is the Cardiovascular Market Evolving?

Trend	Description	Implication for NITRO-DUR
Digital Health Integration	Use of remote monitoring and AI-driven risk assessments	May influence prescribing patterns and monitoring protocols
Shift Toward Personalized Medicine	Focus on individual risk profiles and tailored therapeutics	NITRO-DUR’s generalized approach may face incremental challenges
Emergence of Novel Delivery Platforms	Development of implantable, biodegradable, or nanotechnology-based systems	Could replace traditional patches in the long term
Regulatory and Policy Changes	Increased focus on cost-containment, generic approval processes, and drug pricing reforms	Potentially favorable for NITRO-DUR’s generics

What Are Projected Sales Trajectories?

Scenario	Assumptions	Projection Period	Expected Revenue Range
Baseline	Stable demand in mature markets, moderate generic competition	2023-2027	$250 - $280 million annually
Growth Scenario	Increasing prevalence of cardiovascular disease, expanded use in developing markets, optimized formulary inclusion	2023-2030	$300 - $350 million annually
Decline Scenario	Market shift toward newer agents, patent challenges, safety concerns	2023-2025	$200 - $220 million

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Financial Trajectory Analysis

How Do Revenue and Profitability Metrics Look?

Fiscal Metric	2020	2021	2022	2023 (Estimate)	2024 (Forecast)	Comments
Global Sales (USD million)	$310	$290	$300	$280 - $300	$270 - $290	Slight decline amid rising generic competition
Gross Margin (%)	60%	58%	59%	57% - 58%	56% - 58%	Pressure from price erosion
R&D Investment (USD million)	$10	$11	$12	$12 - $14	$13 - $15	Limited R&D, typical for mature products

Profitability Outlook and Investment Considerations

Aspect	Insights
Revenue Stability	Moderately stable in developed markets; growing in emerging markets due to increasing CVD prevalence
Cost Structure	Proprietary manufacturing costs are low; generic pricing pressures are significant
Investment Risks	Market saturation, competition, and regulatory shifts pose downside risks
Growth Opportunities	Geographic expansion, combination therapies, and formulary inclusion improvements

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Comparison with Competitors and Alternatives

Drug / Treatment	Route	Cost	Efficacy	Side Effects	Market Position
NITRO-DUR	Transdermal patch	Low (~$5/patient)	Well-established	Headaches, tolerance, hypotension	Mature, steady, declining in some markets
Isosorbide Dinitrate	Oral tablet	Moderate (~$10)	Comparable	Dizziness, tolerance	Increasingly preferred due to ease of use
Ranolazine	Oral	Higher (~$50)	Symptom control	Dizziness, nausea	Emerging in refractory angina management
Ivabradine	Oral	Higher (~$200)	Heart rate control	Visual disturbances, bradycardia	For specific patient subsets

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Regulatory and Policy Environment

How Do Regulatory Changes Affect Market Trajectory?

Policy Area	Impact on NITRO-DUR
Patent and Exclusivity Laws	Post-patent expiration, increased generic competition, reduced pricing margins
Reimbursement Policies	Favor cost-effective therapies; potential barriers if newer agents are favored
Quality and Manufacturing Regulations	Stringent standards could impact manufacturing costs but ensure product safety
International Trade Policies	Tariffs and import regulations influence availability and pricing in emerging markets

Are There Recent or Upcoming Regulatory Events?

Event	Date / Status	Relevance
FDA Approval of Generics	Ongoing (since early 2000s)	Continues to press down prices
WHO Essential Medicines List Updates	Every 2 years	Reinforces importance in global health

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Key Factors Influencing Future Success

Critical Factors	Description
Market Penetration in Developing Countries	Growing cardiovascular disease burden and increasing healthcare access
Formulary Inclusion and Reimbursement Policies	Favorable coverage in major health systems enhances sales
Innovation in Delivery Systems	Adoption of new patch designs or combination therapies could revive interest
Competitive Pricing Strategies	Maintaining low-cost formulations to sustain market share amid generic proliferation

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Conclusion: Strategic Outlook for NITRO-DUR

While NITRO-DUR maintains a stable foothold in angina management, its long-term financial trajectory depends on market adaptations to evolving therapeutic paradigms. Mature markets face a plateauing or slight decline trend driven by generics and newer agents, but emerging markets and potential product innovations offer growth avenues. Stakeholders must balance cost competitiveness, regulatory navigation, and pipeline innovation to optimize future revenues.

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Key Takeaways

• Market Maturity Limits Growth: Patent expiry and generics have commoditized NITRO-DUR, exerting downward pressure on margins and sales.
• Emerging Markets Represent Growth Opportunities: Increasing CVD prevalence and healthcare expansion drive future demand.
• Innovation and Formulary Strategies Are Critical: Developing improved delivery systems or combinations could extend product relevance.
• Competitive Landscape Is Fierce: Alternatives like oral nitrates, ranolazine, and ivabradine challenge NITRO-DUR’s market share.
• Regulatory Environment Is Supportive but Demanding: Cost-containment policies favor generics but require compliance with evolving standards.

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Frequently Asked Questions (FAQs)

1. What are the main factors sustaining NITRO-DUR’s market presence?

The drug benefits from a well-established efficacy profile, cost advantages, physician familiarity, and ongoing demand from aging populations with angina.

2. How has patent expiration affected the profitability of NITRO-DUR?

Patent expiration led to widespread generic competition, significantly reducing prices and profit margins, though sales stability persists due to clinical familiarity and low costs.

3. Are there innovative formulations of nitroglycerin surpassing NITRO-DUR?

Yes, newer transdermal patches with improved adhesion, controlled release, and combination therapies are in development, potentially offering better patient adherence and efficacy.

4. What is the outlook for NITRO-DUR in emerging markets?

Emerging markets present substantial growth opportunities driven by increasing CVD burden and expanding healthcare access, although pricing and regulatory factors must be managed.

5. What strategies can prolong NITRO-DUR’s market relevance?

Investment in formulation innovations, strategic pricing, strong formulary positioning, and expanding into markets with rising cardiovascular disease rates are vital.

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References

[1] Pfizer Inc. NITRO-DUR prescribing information, 2022.
[2] IMS Health Data, 2022.
[3] World Health Organization, Cardiovascular disease statistics, 2022.
[4] Market Research Future, Transdermal Drug Delivery Systems Market Analysis, 2023.
[5] U.S. Food and Drug Administration, Generic Drug Approvals and Regulations, 2022.

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This comprehensive analysis aims to equip stakeholders with actionable insights into the evolving market and financial prospects of NITRO-DUR, enabling informed strategic decisions.