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-five 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:	36
Patent Applications:	2,861
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	Yes
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	Yes
Uspharma	NITRO-DUR	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020145-003	Apr 4, 1995		RX	Yes	Yes
Uspharma	NITRO-DUR	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020145-006	Apr 4, 1995		RX	Yes	Yes

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	020145-005	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	020145-003	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
Hong Kong	94093	ADHESIVE TRANSDERMAL DOSAGE LAYER
Finland	861177
Germany	3581188
World Intellectual Property Organization (WIPO)	8600814
Norway	171950

NITRO-DUR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for NITRO-DUR

Introduction to NITRO-DUR

NITRO-DUR is a transdermal infusion system designed to provide continuous controlled release of nitroglycerin through intact skin. It is used primarily for the management of angina pectoris, a condition characterized by chest pain due to reduced blood flow to the heart[1][2][4].

Market Overview

The market for nitroglycerin products, including NITRO-DUR, is part of the broader cardiovascular therapeutic market. This market is driven by the increasing prevalence of cardiovascular diseases, an aging population, and the need for effective and convenient treatment options.

Target Population

NITRO-DUR is targeted at patients suffering from angina pectoris. The elderly are a significant segment of this population, as they are more susceptible to cardiovascular diseases. However, elderly patients require careful dose selection due to increased sensitivity to nitrates, which can lead to hypotension and other complications[2].

Competitive Landscape

The market for nitroglycerin products is competitive, with various formulations available, including sublingual tablets, sprays, and other transdermal systems. NITRO-DUR competes with other nitroglycerin patches and formulations, such as Nitrostat, in terms of efficacy, convenience, and safety profile[3].

Dosage and Administration

The dosage of NITRO-DUR is critical in its market positioning. The system is available in various sizes, each delivering a specific amount of nitroglycerin per hour. The suggested starting dose is between 0.2 mg/hr and 0.4 mg/hr, with a daily patch-on period of 12 to 14 hours and a patch-off period of 10 to 12 hours to avoid tolerance[1][2].

Clinical Efficacy and Safety

Clinical studies have shown that NITRO-DUR is effective in managing angina pectoris for up to 12 hours daily. However, it is not intended for the immediate relief of acute attacks of angina. The safety profile includes potential side effects such as severe hypotension, particularly in elderly patients, and the risk of falling due to dizziness[2][4].

Regulatory Environment

NITRO-DUR is regulated by health authorities such as the FDA. The product must comply with stringent safety and efficacy standards. Regulatory approvals and ongoing clinical data are crucial for maintaining market presence and expanding indications[2].

Financial Performance

The financial trajectory of NITRO-DUR is influenced by several factors, including market demand, competition, and regulatory approvals.

Revenue Streams

Revenue for NITRO-DUR comes from prescription sales. The product is typically prescribed for long-term management of angina, ensuring a steady stream of revenue. However, the financial performance can be impacted by generic competition and pricing pressures.

Market Size and Growth

The cardiovascular therapeutic market, which includes nitroglycerin products, is substantial and growing. For example, the erectile dysfunction market, which also involves nitroglycerin formulations, was valued at over $5.6 billion in 2016, indicating a large potential market for related products[3].

Cost and Pricing

The cost of NITRO-DUR can vary based on the size of the patch and the dosage required. The product is generally priced competitively with other nitroglycerin formulations. Pricing strategies are crucial in maintaining market share and profitability.

Challenges and Opportunities

Challenges

• Generic Competition: The threat of generic versions can reduce market share and revenue.
• Regulatory Hurdles: Strict regulatory requirements and the need for ongoing clinical data can be challenging.
• Side Effects: The potential for severe hypotension and other side effects, particularly in elderly patients, can impact market acceptance.

Opportunities

• Expanding Indications: Potential expansion into other therapeutic areas, such as erectile dysfunction, could increase market size.
• Innovative Formulations: Improvements in formulation and delivery systems can enhance patient compliance and efficacy.
• Global Market: Expanding into international markets can increase revenue and market share.

Industry Expert Insights

Industry experts highlight the importance of continuous innovation and strong regulatory support for products like NITRO-DUR. For instance, "The relative importance of preload reduction, afterload reduction, and coronary dilation remains undefined," indicating ongoing research and development opportunities[4].

Illustrative Statistics

• The cardiovascular therapeutic market is expected to grow significantly, driven by an aging population and increasing prevalence of cardiovascular diseases.
• The erectile dysfunction market, which involves related nitroglycerin formulations, was valued at over $5.6 billion in 2016, with potential peak sales for new products like MED2005 estimated at $660 million[3].

Key Takeaways

• Market Demand: NITRO-DUR addresses a significant need in the management of angina pectoris.
• Competitive Landscape: The product competes with other nitroglycerin formulations and must differentiate through efficacy, safety, and convenience.
• Regulatory Compliance: Ongoing clinical data and regulatory approvals are crucial for market presence.
• Financial Performance: Revenue is influenced by prescription sales, market size, and competitive pricing.

FAQs

1. What is NITRO-DUR used for?

NITRO-DUR is used for the management of angina pectoris, a condition characterized by chest pain due to reduced blood flow to the heart.

2. How does NITRO-DUR work?

NITRO-DUR works by providing continuous controlled release of nitroglycerin through intact skin, which is absorbed into the systemic circulation to reduce systemic vascular resistance and arterial pressure.

3. What are the potential side effects of NITRO-DUR?

Potential side effects include severe hypotension, particularly in elderly patients, and the risk of falling due to dizziness.

4. How is NITRO-DUR dosed?

The suggested starting dose is between 0.2 mg/hr and 0.4 mg/hr, with a daily patch-on period of 12 to 14 hours and a patch-off period of 10 to 12 hours.

5. What is the market size for nitroglycerin products like NITRO-DUR?

The cardiovascular therapeutic market, which includes nitroglycerin products, is substantial and growing, with the erectile dysfunction market alone valued at over $5.6 billion in 2016.

Cited Sources:

1. Drugs.com: Nitro-Dur: Package Insert / Prescribing Information.
2. DailyMed: NITRO-DUR (nitroglycerin) Transdermal Infusion System.
3. Futura Medical: Preliminary Results and R&D Summary - Year Ending Dec 2018 Results.
4. Dr. Reddy's Laboratories: NITRO-DUR (Nitroglycerin Transdermal System).