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-five 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:	8
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	4
Patent Applications:	3,039
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

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

International Patents for NITROSTAT

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

Country	Patent Number	Title	Estimated Expiration
Denmark	1019039
Slovenia	1019039
South Korea	20010030839

NITROSTAT Market Analysis and Financial Projection Experimental

Nitroglycerin API and Nitroglycerin Products: Market Dynamics and Financial Trajectory

Introduction

Nitroglycerin, a crucial medication for treating cardiovascular conditions such as angina, is experiencing significant growth in its market. This article delves into the market dynamics and financial trajectory of nitroglycerin, particularly focusing on Nitroglycerin API and various nitroglycerin products like Nitroglycerin sprays.

Global Nitroglycerin API Market Overview

The global Nitroglycerin API market is poised for substantial growth, driven by several key factors. As of 2024, the market size is estimated at USD 22.9 million and is expected to expand at a compound annual growth rate (CAGR) of 6.00% from 2024 to 2031[1].

Regional Market Breakdown

• North America: With a market size of USD 9.16 million in 2024, the North American Nitroglycerin API market is expected to grow at a CAGR of 4.2% from 2024 to 2031[1].
• Europe: The European market stands at USD 6.87 million in 2024, with a projected CAGR of 4.5% during the same period[1].
• Asia Pacific: This region holds a significant share, with a market size of USD 5.27 million in 2024 and an anticipated CAGR of 8% from 2024 to 2031[1].

Drivers of Market Growth

Several factors are driving the growth of the nitroglycerin market:

Increasing Prevalence of Cardiovascular Diseases

The rise in sedentary lifestyles, stress, and poor dietary habits has led to an increase in cardiovascular diseases globally. This surge in cardiovascular conditions, such as angina, is a primary driver for the demand of nitroglycerin API[1].

Aging Population

The global aging population is another significant factor contributing to the market growth. As the population ages, the incidence of cardiovascular diseases increases, thereby boosting the demand for nitroglycerin[1][3].

Advancements in Healthcare Infrastructure

Improvements in healthcare infrastructure and increasing awareness about cardiovascular health are also driving the market. Countries experiencing economic development and urbanization are particularly contributing to this growth[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 surged, especially in the healthcare sector. This increased demand, coupled with the resumption of manufacturing activities, resulted in a gradual recovery of the market[1].

Nitroglycerin Products: Market Dynamics

Medical Nitroglycerin Sprays

The global medical nitroglycerin sprays market is another segment experiencing growth. As of 2023, this market is valued at USD 110.9 million and is expected to reach USD 163.5 million by 2033, growing at a CAGR of 3.9% during this period[4].

Key Growth Factors

• Treatment of Angina: Nitroglycerin lingual sprays are primarily used to treat angina attacks in patients with coronary artery disease. This application is a major driver for the growth of the nitroglycerin sprays market[4].
• Preventive Use: The spray can also be used just before activities that may trigger angina episodes, further increasing its demand[4].

Challenges

Despite the growth, there are challenges such as resistance to tiny blood arteries in patients with microvascular angina and potential side effects like prolonged migraines, which may hinder the market's full potential[4].

Financial Trajectory of Key Players

Revenue and Market Share

Major pharmaceutical companies are significantly contributing to the nitroglycerin market's financial trajectory. For instance:

• Pfizer: Reported sales revenues in the multi-billion dollar range, with substantial contributions from its cardiovascular products[3].
• Mylan N.V.: Strong revenue from the generics market[3].
• Sun Pharmaceutical Industries: Annual revenues exceeding $2 billion, showcasing a healthy growth trajectory[3].

Innovations and Strategic Focus

Companies like Espero BioPharma are innovating with patent-protected formulations of nitroglycerin, including extended-release and unique delivery systems. These innovations are expected to drive significant market growth by capturing niche segments of patients requiring specialized treatment[3].

Market Segmentation

The nitroglycerin market is segmented into various types, including:

Tablets

Tablets are a traditional form of nitroglycerin administration and continue to be a significant segment of the market[3].

Ointments

Nitroglycerin ointments are another form, often used for topical application to relieve angina symptoms[3].

Patches

Transdermal patches are a convenient and continuous delivery system for nitroglycerin, offering steady release over a prolonged period[3].

Sprays

As discussed, nitroglycerin sprays are gaining popularity due to their ease of use and quick action in treating angina attacks[4].

Geographic Expansion and Emerging Markets

Geographic expansion, particularly in the Asia-Pacific region, is a key factor in the market's growth. Countries in this region are experiencing rapid economic development and urbanization, leading to increased demand for pharmaceuticals, including nitroglycerin[1][3].

Regulatory and Technological Advancements

Advancements in production technologies and regulatory support are enhancing supply chain efficiencies and driving the market forward. Increasing investments in healthcare infrastructure worldwide are also contributing to the positive outlook for the nitroglycerin market[1][3].

Key Takeaways

• The global Nitroglycerin API market is expected to grow at a CAGR of 6.00% from 2024 to 2031.
• The medical nitroglycerin sprays market is projected to reach USD 163.5 million by 2033, growing at a CAGR of 3.9%.
• Increasing prevalence of cardiovascular diseases, an aging population, and advancements in healthcare infrastructure are key drivers of market growth.
• Major pharmaceutical companies are innovating and strategically focusing on expanding their nitroglycerin API production capacities.
• Geographic expansion, especially in the Asia-Pacific region, is a significant factor in the market's growth.

FAQs

What is the current market size of the global Nitroglycerin API market?

The global Nitroglycerin API market size is estimated at USD 22.9 million in 2024[1].

What is the projected CAGR for the global Nitroglycerin API market from 2024 to 2031?

The global Nitroglycerin API market is expected to grow at a CAGR of 6.00% from 2024 to 2031[1].

Which region has the highest CAGR for the Nitroglycerin API market?

The Asia Pacific region has the highest CAGR of 8% for the Nitroglycerin API market from 2024 to 2031[1].

What is the primary use of nitroglycerin lingual sprays?

Nitroglycerin lingual sprays are primarily used to treat angina attacks in patients with coronary artery disease[4].

Which companies are key players in the nitroglycerin market?

Key players include Pfizer, Mylan N.V., Espero BioPharma, Sun Pharmaceutical Industries, Glenmark Pharmaceuticals, Troikaa, and Square Pharmaceuticals[3].

Sources

1. Cognitive Market Research: Nitroglycerin API market report.
2. NHTSA: NMVCCS Analytical User's Manual.
3. Reliable Research IQ: Nitroglycerin Market Report.
4. Future Market Insights: Medical Nitroglycerin Sprays Market Report.