NITROMIST Drug Patent Profile

Which patents cover Nitromist, and what generic alternatives are available?

Nitromist is a drug marketed by Evus and is included in one NDA.

The generic ingredient in NITROMIST 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 Nitromist

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

Summary for NITROMIST

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	36
Patent Applications:	2,260
Drug Prices:	Drug price information for NITROMIST
What excipients (inactive ingredients) are in NITROMIST?	NITROMIST excipients list
DailyMed Link:	NITROMIST at DailyMed

See drug prices for NITROMIST

US Patents and Regulatory Information for NITROMIST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Evus	NITROMIST	nitroglycerin	AEROSOL, METERED;SUBLINGUAL	021780-001	Nov 2, 2006		RX	Yes	Yes

Expired US Patents for NITROMIST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Evus	NITROMIST	nitroglycerin	AEROSOL, METERED;SUBLINGUAL	021780-001	Nov 2, 2006

International Patents for NITROMIST

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

Country	Patent Number	Title	Estimated Expiration
Germany	69721020
Austria	237322
Denmark	0927032
World Intellectual Property Organization (WIPO)	9738687
Canada	2251564	PULVERISATEUR BUCCAL NON POLAIRE POUR NITROGLYCERINE (BUCCAL, NON-POLAR SPRAY FOR NITROGLYCERIN)
Portugal	927032

NITROMIST Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for NitroMist

Introduction to NitroMist

NitroMist, a nitrate vasodilator, is indicated for the acute relief of angina pectoris due to coronary artery disease. It is administered via a lingual spray, providing rapid relief from angina attacks.

Global Nitroglycerin Market Overview

The global nitroglycerin market, which includes products like NitroMist, is experiencing significant growth. The market size for nitroglycerin API was estimated at USD 22.9 million in 2024 and is expected to grow at a CAGR of 6% from 2024 to 2031[1].

Segmentation and Market Size

The medical nitroglycerin sprays market, a segment that includes NitroMist, was valued at USD 815.45 million in 2023 and is projected to reach USD 1685.24 million by 2032, with a CAGR of 8.4% during the forecast period[4].

Regional Market Performance

• North America: This region is expected to account for a notable market share, with the United States being the most profitable market. Companies like Evus Health Solutions, Perrigo Company plc, and Akrimax Pharmaceuticals have a significant presence here[4].
• Europe: The European market is also growing, driven by increasing demand for cardiovascular treatments and advancements in healthcare infrastructure[1].
• Asia Pacific: This region is expected to grow at a CAGR of 8% from 2024 to 2031, driven by economic development, urbanization, and an aging population[1].

Key Drivers of Growth

• Increasing Demand for Cardiovascular Treatments: The rise in sedentary lifestyles, stress, and poor dietary habits has led to an increase in cardiovascular diseases, driving the demand for nitroglycerin-based products like NitroMist[1].
• Aging Population: The global aging population is contributing significantly to the demand for cardiovascular medications[1].
• Advancements in Healthcare Infrastructure: Improvements in healthcare infrastructure and increasing awareness about cardiovascular health are driving market growth[1].

Challenges and Limitations

• High Production Costs: The high cost of nitroglycerin API is a significant barrier to market growth, affecting its accessibility and affordability for patients and healthcare providers[1].
• Stringent Regulations and Safety Concerns: Regulatory hurdles and safety concerns associated with nitroglycerin use can limit market expansion. Addressing these through technological advancements, process optimization, and regulatory collaborations is crucial[1].

Impact of COVID-19

The COVID-19 pandemic initially disrupted the global supply chain and manufacturing processes, leading to a decrease in nitroglycerin API production. However, as the pandemic progressed, the demand for nitroglycerin API increased, particularly in the healthcare sector. This surge in demand, coupled with the resumption of manufacturing activities, helped the market recover gradually[1].

Distribution and Sales Channels

• Conventional Retail Pharmacies: These pharmacies are expected to dominate the market, accounting for approximately half of the overall revenue share due to strong distribution networks and sufficient stock availability[4].
• Online Pharmacies: Online pharmacies are gaining momentum, driven by increased digital literacy and the pandemic-induced shift to online purchases. This sector is expected to grow at a high CAGR[4].

Key Players and Market Competition

The medical nitroglycerin sprays market includes major players such as Perrigo Company Plc., Evus Health Solutions LLC., ESPERO BIOPHARMA, INC, G. Pohl-Boskamp GmbH & Co., and others. These companies are focusing on expanding their production capacities and improving distribution networks to meet the growing demand[4].

Financial Trajectory

Given the projected growth of the nitroglycerin sprays market, NitroMist is likely to see significant financial growth. Here are some key financial indicators:

• Market Size: The global medical nitroglycerin sprays market is expected to grow from USD 815.45 million in 2023 to USD 1685.24 million by 2032[4].
• CAGR: The market is projected to grow at a CAGR of 8.4% from 2024 to 2032[4].
• Regional Revenue: North America, particularly the United States, is expected to contribute substantially to the revenue, driven by regulatory approvals and strong market presence of key players[4].

Pharmacokinetics and Clinical Use

NitroMist is rapidly absorbed following lingual spray administration, with detectable plasma levels of nitroglycerin and its metabolites within minutes. This rapid absorption is crucial for the acute relief of angina attacks[5].

Safety and Monitoring

The use of NitroMist requires careful clinical or hemodynamic monitoring, especially in patients with conditions like acute myocardial infarction or congestive heart failure, due to the risk of hypotension and tachycardia[5].

Key Takeaways

• The nitroglycerin sprays market, including NitroMist, is poised for significant growth driven by increasing demand for cardiovascular treatments.
• High production costs and stringent regulations are key challenges that need to be addressed.
• The market is expected to grow at a CAGR of 8.4% from 2024 to 2032.
• North America, particularly the United States, will be a major contributor to the market revenue.
• Online pharmacies are emerging as a significant sales channel.

FAQs

Q: What is the primary use of NitroMist? A: NitroMist is used for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.

Q: What is the projected CAGR for the medical nitroglycerin sprays market? A: The market is projected to grow at a CAGR of 8.4% from 2024 to 2032.

Q: Which region is expected to dominate the nitroglycerin sprays market? A: North America, particularly the United States, is expected to account for a notable market share.

Q: What are the major challenges facing the nitroglycerin API market? A: High production costs and stringent regulations are significant challenges.

Q: How is NitroMist administered and absorbed? A: NitroMist is administered via a lingual spray and is rapidly absorbed, with detectable plasma levels within minutes.

Cited Sources

1. Cognitive Market Research: Nitroglycerin API market report.
2. Chambers County: Report - Chambers County (irrelevant to the topic).
3. Cognitive Market Research: Nitroglycerin Market Report 2024 (Global Edition).
4. Zion Market Research: Medical Nitroglycerin Sprays Market Size, Share, Growth, Analysis.
5. Drugs.com: NitroMist: Package Insert / Prescribing Information.